Study of TSR-033 With an Anti-programmed Cell Death-1 Rec... | NCT03250832

ID	Type	Description	Link
4040-01-001	Other Identifier	Tesaro

Name	Class
GlaxoSmithKline	INDUSTRY

Label	Type	Description	Intervention Names
Part 1a: TSR-033 monotherapy dose escalation	Experimental	Part 1a will evaluate TSR-033 at ascending doses (20 milligrams [mg], 80 mg and 240 mg) every 2 weeks. Cohorts will be enrolled sequentially and will initially follow a 3+3 design at a starting dose of 20 mg.	Drug: TSR-033
Part 1b: TSR-033 monotherapy PK/PDy characterization	Experimental	Part 1b will evaluate the PK profile and assess PDy data from blood and tumor tissue samples following TSR-033 treatment. The participants will begin treatment with TSR-033 on Day 1 followed by 28 days observation for collection of blood sampling for PK/PDy. Participants will receive their second dose of TSR-033 on Day 29 and every 14 days thereafter.	Drug: TSR-033
Part 1c: TSR-033+dostarlimab combination dose escalation	Experimental	Participants will be administered ascending doses of TSR-033 in combination with dostarlimab 500 mg every 3 weeks. Planned dose levels of TSR-033 include 80 and 240 mg.	Drug: TSR-033 Drug: Dostarlimab
Part 2 Cohort A: TSR-033+dostarlimab combination	Experimental	Part 2 Cohort A will evaluate the preliminary activity of TSR-033 in combination with dostarlimab in anti-PD-1 naive participants with third and fourth line MSS-CRC. TSR-033 will be administered every 2 weeks and dostarlimab every 6 weeks.	Drug: TSR-033

Name	Type	Description	Arm Group Labels	Other Names
TSR-033	Drug	TSR-033 is a humanized monoclonal antibody immunoglobulin (Ig) G4.	Part 1a: TSR-033 monotherapy dose escalation Part 1b: TSR-033 monotherapy PK/PDy characterization

Measure	Description	Time Frame
Part 1A: Number of Participants Experiencing Dose Limiting Toxicity (DLT)	DLTs were assessed based on common terminology criteria for adverse events (CTCAE) v5.0 included drug-related AEs like grade>=2 uveitis, eye pain, or blurred vision that does not resolve with topical therapy within 2 weeks, grade ≥2 immune-related endocrine toxicity that required hormone replacement, grade 2 or 3 colitis or diarrhea that persisted without resolution to grade<=1 for >=7days despite adequate immune suppressive therapy, grade 3 or 4 immune-related AEs (irAE) without resolution to grade<=1 or baseline within 8 days despite adequate immune suppressive therapy, any grade clinically significant (CS) irAE requiring treatment discontinuation, other grade>=3 non-hematologic toxicity, any CS grade>=3 non-hematologic laboratory abnormality, any CS hematologic toxicity and any death that is not clearly attributed to the underlying disease or extraneous causes. CTCAE defines Grade 0 as normal, 1 as mild, 2 as moderate, 3 as severe and Grade 4 as life-threatening consequences.	Up to 28 days
Part 1C: Number of Participants Experiencing DLT	DLTs were assessed based on common terminology criteria for adverse events (CTCAE) v5.0 included drug-related AEs like grade>=2 uveitis, eye pain, or blurred vision that does not resolve with topical therapy within 2 weeks, grade ≥2 immune-related endocrine toxicity that required hormone replacement, grade 2 or 3 colitis or diarrhea that persisted without resolution to grade<=1 for >=7days despite adequate immune suppressive therapy, grade 3 or 4 immune-related AEs (irAE) without resolution to grade<=1 or baseline within 8 days despite adequate immune suppressive therapy, any grade clinically significant (CS) irAE requiring treatment discontinuation, other grade>=3 non-hematologic toxicity, any CS grade>=3 non-hematologic laboratory abnormality, any CS hematologic toxicity and any death that is not clearly attributed to the underlying disease or extraneous causes. CTCAE defines Grade 0 as normal, 1 as mild, 2 as moderate, 3 as severe and Grade 4 as life-threatening consequences.	Up to 42 days
Part 2B: Number of Participants Experiencing DLT	DLTs were assessed based on common terminology criteria for adverse events (CTCAE) v5.0 included drug-related AEs like grade>=2 uveitis, eye pain, or blurred vision that does not resolve with topical therapy within 2 weeks, grade ≥2 immune-related endocrine toxicity that required hormone replacement, grade 2 or 3 colitis or diarrhea that persisted without resolution to grade<=1 for >=7days despite adequate immune suppressive therapy, grade 3 or 4 immune-related AEs (irAE) without resolution to grade<=1 or baseline within 8 days despite adequate immune suppressive therapy, any grade clinically significant (CS) irAE requiring treatment discontinuation, other grade>=3 non-hematologic toxicity, any CS grade>=3 non-hematologic laboratory abnormality, any CS hematologic toxicity and any death that is not clearly attributed to the underlying disease or extraneous causes. CTCAE defines Grade 0 as normal, 1 as mild, 2 as moderate, 3 as severe and Grade 4 as life-threatening consequences.

Measure	Description	Time Frame
Part 1ab: Area Under the Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC [0-last]) of TSR-033	Blood samples were collected for pharmacokinetic (PK) analysis of TSR-033 when administered intravenously as monotherapy. PK parameter was determined using standard non-compartmental methods.	Pre-dose and post-dose 15 minute, 30 minute, 1.5, 3, 24, 48, 96 and 168 hour

Eligibility Module

Eligibility Criteria

Inclusion Criteria for participants in Part 1:

The participant is >=18 years of age.
The participant has any histologically or cytologically confirmed advanced (unresectable) or metastatic solid tumor and has PD after treatment with available therapies that are known to confer clinical benefit or who are intolerant to treatment.
The participant must have an archival tumor tissue sample that is formalin-fixed and paraffin-embedded (FFPE) (blocks preferred over slides) and requested and confirmed available from offsite locations prior to dosing. The quality and quantity of the sample must be confirmed sufficient as per the Study Laboratory Manual. Participants who do not have archival tissue must agree to a new biopsy to obtain fresh tumor tissue prior to dosing.
Part 1b (PK/PDy cohort): The participant must have lesions amenable for biopsy and agree to undergo biopsies for fresh tumor tissue prior to treatment, approximately 4 to 6 weeks after treatment, and, whenever possible, at the time of PD and /or end of treatment (EOT). Serial biopsies are optional for participants in Part 1a and 1c.
Female participants must have a negative serum or urine pregnancy test within 72 hours prior to the date of the first dose of study medication if of childbearing potential or be of non-childbearing potential. Non-childbearing potential is defined as:
- Participants >=45 years of age and has not had menses for >1 year.
- Amenorrheic for <2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation.
- Post hysterectomy, bilateral oophorectomy, or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
Female participants of childbearing potential (that is [ie], those who do not meet above criteria) must agree to use 2 highly effective forms of contraception with their partners, starting with the screening visit through 150 days after the last dose of study therapy.
The participant must have an ECOG PS of <=1.
The participant has adequate hematologic and organ function, defined as:
- Absolute neutrophil count (ANC) >=1500 per microliter (/μL).
- Platelets >=100,000/μL.
- Hemoglobin (Hb) >=9 grams per deciliter (g/dL) or >=5.6 millimoles per liter (mmol/L).
- Serum creatinine <=1.5 times upper limit of normal (× ULN) or calculated creatinine clearance (CrCL) >=50 milliliters per minute (mL/min) using Cockcroft-Gault equation for participants with creatinine levels >1.5 × institutional ULN
- Total bilirubin <=1.5 × ULN and direct bilirubin <=1× ULN (in the event that the total bilirubin result exceeds the upper institutional limits of normal, direct bilirubin will be obtained to determine eligibility).
- AST and ALT <=2.5 × ULN unless liver metastases are present, in which case they must be <=5 × ULN.
- INR of PT <=1.5 × ULN, unless participant is receiving anticoagulant therapy, then PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants; aPTT) <= 1.5 × ULN unless participant is receiving anticoagulant therapy, then PT or PTT is within therapeutic range of intended use of anticoagulants.

Inclusion criteria for participants in Part 2:

The participant is >= 18 years of age.
The participant has any histologically or cytologically confirmed CRC that is metastatic or not amenable to potentially curative resection (advanced), in the opinion of the Investigator.
The participant has a primary and/or metastatic tumor(s) that is known to be MSS, as determined locally.
The participant must have lesions amenable for biopsy and agree to undergo biopsies for fresh tumor tissue prior to treatment, approximately 4 to 6 weeks after, and, whenever possible, at EOT and/or the time of PD. If the participant has had a biopsy prior to entering the 28-day screening period, and within approximately 12 weeks of study treatment, that biopsy sample may be accepted as the Baseline fresh biopsy. Additionally, submission of sufficient high-quality archival tumor tissue is recommended, if available, to enable a longitudinal analysis of tumor biomarkers.
The participant has measurable disease by RECIST v1.1.
The participant has resolution to Grade <=1, per CTCAE v5.0, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy, with the exception of peripheral neuropathy, which must have resolved to Grade <=2, and except where otherwise noted in the eligibility criteria.
Female participants must have a negative serum or urine pregnancy test within 72 hours prior to the date of the first dose of study medication if of childbearing potential or be of non-childbearing potential. Non-childbearing potential is defined as:
- Participants >=45 years of age and has not had menses for >1 year.
- Amenorrheic for <2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation.
- Post hysterectomy, bilateral oophorectomy, or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
Female participants of childbearing potential (ie, those who do not meet above criteria) must agree to use 2 highly effective forms of contraception with their partners, starting with the screening visit through 150 days after the last dose of study therapy.
The participant has an ECOG PS of <=1.
The participant has adequate hematologic and organ function, defined as:
- ANC >=1500/μL.
- Platelets >=100,000/μL.
- Hb >=9 g/dL or >=5.6 mmol/L.
- Serum creatinine <=1.5 × ULN or calculated CrCL >=50 mL/min using Cockcroft-Gault equation for participants with creatinine levels >1.5 × institutional ULN
- Total bilirubin <=1.5 × ULN and direct bilirubin <=1× ULN (in the event that the total bilirubin result exceeds the upper institutional limits of normal, direct bilirubin will be obtained to determine eligibility).
- AST and ALT <=2.5 × ULN unless liver metastases are present, in which case they must be <=5 × ULN.
- INR of PT <=1.5 × ULN, unless participant is receiving anticoagulant therapy, then PT or PTT is within therapeutic range of intended use of anticoagulants; aPTT) <= 1.5 × ULN unless participant is receiving anticoagulant therapy, then PT or PTT is within therapeutic range of intended use of anticoagulants.
- Urinary protein is <=1+ on dipstick for routine urinalysis; if urine protein >=2+, a 24-hour urine sample must be collected and must demonstrate <1000 mg of protein in 24 hours to allow participation in the study.
- Baseline albumin >=3.0 g/dL.

Inclusion Criteria for participants in Part 2A:

The participant must have had at least 2, but no more than 3, prior lines of therapy in the advanced or metastatic setting. Adjuvant chemotherapy with radiographic progression >12 months after the last dose will not be considered a line of therapy.
The participant has progressed on standard therapies or withdrawn from standard treatment due to unacceptable toxicity. Previous standard treatment must include all of the following:
- Fluoropyrimidine.
- Oxaliplatin: Participants treated with oxaliplatin in adjuvant setting should have progressed after 12 months of completion of adjuvant therapy or they must have been treated with oxaliplatin for metastatic disease.
- Irinotecan.
- Participants whose disease is known to be RAS-wild-type must have been treated with cetuximab, panitumumab, or other epidermal growth factor receptor (EGFR) inhibitor for metastatic disease.
- Bevacizumab and/or another anti-angiogenic agent.
- Previous treatment with regorafenib and/or TAS-102 are allowed in the absence of contraindications and if these agents are available to the participant according to local standards.
The time between a participants's last chemotherapy and enrollment must be <=8 weeks.

Inclusion Criteria for participants in Part 2B:

The participant has received <=2 prior systemic chemotherapy regimens in any setting (only 1 prior regimen for metastatic disease is permitted).

Inclusion Criteria for participants in Part 2 Cohort B1:

The participant has received first-line combination therapy consisting of bevacizumab or anti-EGFR antibodies with FOLFIRI and has experienced radiographic progression during or after first-line therapy. Radiographic progression >12 months after the last dose of adjuvant therapy will not be considered a line of therapy.
mFOLFOX6 therapy with bevacizumab is appropriate for the participant and is recommended by the investigator.

Inclusion Criteria for participants in Part 2 Cohort B2:

The participant has received first-line combination therapy consisting of bevacizumab or anti-EGFR antibodies with FOLFOX (or variant) and has experienced radiographic progression during or after first-line therapy. Radiographic progression >12 months after the last dose of adjuvant therapy will not be considered a line of therapy.
FOLFIIRI therapy with bevacizumab is appropriate for the participant and is recommended by the investigator.

Exclusion Criteria for all participants:

The participant has previously been treated with an anti-LAG-3 antibody.
The participant has known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis.
The participant has a known concurrent, serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy, including human immunodeficiency virus (HIV), known active hepatitis B or hepatitis C, active infection, or active autoimmune disease.
The participant is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study.
The participant has a history of interstitial lung disease.
The participant has not recovered (ie, to Grade <=1 or to Baseline) from radiation- and chemotherapy-induced AEs, has received transfusion of blood products (including platelets or red blood cells), or has received administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 3 weeks prior to the first dose of study drug.
The participant is currently participating in an investigational study (therapy or device) or has participated in an investigational study within 4 weeks prior to the first dose of study drug.
The participant has received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days or less than 5 times the half-life of the most recent therapy prior to the first dose of the drug, whichever is shorter.
The participant has received wide-field (full-dose pelvic) radiotherapy within 28 days prior to the first dose of study drug.
The participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders.
The participant has experienced any arterial thrombotic or arterial thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident, within 12 months prior to first dose of study drug.
The participant has received a prior autologous or allogeneic organ or transplantation.
The participant has undergone major surgery within 28 days or subcutaneous venous access device placement within 7 days prior to the first dose of study drug.
The participant has had a serious non-healing wound, ulcer, or bone fracture within 28 days prior to first dose of study drug.
The participant has an elective or planned major surgery to be performed during the course of the trial.
The participant has a history of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) in the 12 months prior to the first dose of study drug.
The participant has an acute or subacute bowel obstruction, abdominal fistula, or history of chronic diarrhea which is considered clinically significant, in the opinion of the investigator.
The participant has experienced a Grade >=3 bleeding event within 3 months prior to the first dose of study drug.
The participant has either peptic ulcer disease associated with a bleeding event or known active diverticulitis.
The participant has not recovered (Grade >=1) from AEs and/or complications from any major surgery prior to the first dose of study drug.
The participant has received a vaccine within 7 days of the first dose of study drug.
The participant has known hypersensitivity to TSR-033, dostarlimab (Part 1c and Part 2), or associated excipients.

Exclusion Criteria for participants in Part 1:

The participant's prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-LAG-3 agent that resulted in permanent discontinuation due to an AE.

Exclusion Criteria for participants in Part 2:

The participant has been previously treated with an anti-PD-1 or anti-PD-L1 antibody.

Exclusion Criteria for participants in Part 2B:

The participant has known dihydropyrimidine dehydrogenase deficiency.
The participant experienced an arterial thrombotic/thromboembolic event, Grade 4 hypertension, Grade 4 proteinuria, a Grade 3-4 bleeding event, or bowel perforation during first-line therapy with a bevacizumab-containing regimen.
The participant has known hypersensitivity to bevacizumab, mFOLFOLX6 (Cohort B1) or FOLFIRI (Cohort B2), or associated excipients.
The participant experienced PD within 12 months of last dose of adjuvant therapy.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Los Angeles	California	90095	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
40016550	Derived	Hecht JR, Michot JM, Bajor D, Patnaik A, Chung KY, Wang J, Falchook G, Cleary JM, Kim R, Krishnamurthy A, Marathe O, Youssoufian H, Ellis C, Waszak A, Ghosh S, Zhang H, Yablonski K, Shah SD, Diaz-Padilla I, Ulahannan S. CITRINO: phase 1 dose escalation study of anti-LAG-3 antibody encelimab alone or in combination with anti-PD-1 dostarlimab in patients with advanced/metastatic solid tumours. BJC Rep. 2025 Feb 27;3(1):10. doi: 10.1038/s44276-024-00118-x.

ID	Title	Description
FG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
FG001	Part 1AB - TSR-033 (80 mg)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 23, 2022	May 31, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Secondary

Part 1ab: Area Under the Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC [0-last]) of TSR-033

Blood samples were collected for pharmacokinetic (PK) analysis of TSR-033 when administered intravenously as monotherapy. PK parameter was determined using standard non-compartmental methods.

Pharmacokinetic (PK) population included all partiocipants who received any amount of TSR 033 and/or dostarlimab and have ≥1 measurable drug concentration. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour*microgram/millilitre (h*ug/mL)

Pre-dose and post-dose 15 minute, 30 minute, 1.5, 3, 24, 48, 96 and 168 hour

ID	Title	Description
OG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
OG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.
OG002	Part 1AB - TSR-033 (240 mg)	In part 1a, participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W
OG003	Part 1AB: TSR-033:Part 1AB - TSR-033 (720 mg)	In part 1a, participants with advanced or metastatic solid tumors received 720 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.

Units	Counts
Participants	OG0003 OG00110 OG00210 OG003

Title

Denominators

Categories

Title	Measurements
	OG000606.4256± 32.65 OG0012601.731± 70.3423 OG0028176.4963± 29.4644 OG003

Secondary

Part 1c: AUC (0-last) of TSR-033 and Dostarlimab

Blood samples were collected for PK analysis of TSR-033 when administered intravenously in combination with dostarlimab. PK parameter was determined using standard non-compartmental methods.

Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

Pre-dose and post-dose 15 minute, 30 minute, 1, 1.5, 3, 24, 48, 96, 168, 336 and 504 hour

ID	Title	Description
OG000	Part 1C - TSR-033 (80 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once every 3 weeks (Q3W).
OG001	Part 1C - TSR-033 (240 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.
OG002	Part 1C - TSR-033 (720 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 720 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.

Secondary

Part 1ab: AUC Extrapolated From Time Zero to Infinity (AUC [0-inf]) of TSR-033

Blood samples were collected for PK analysis of TSR-033 when administered intravenously as monotherapy. PK parameter was determined using standard non-compartmental methods.

Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

Pre-dose and post-dose 15 minute, 30 minute, 1.5, 3, 24, 48, 96 and 168 hour

ID	Title	Description
OG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
OG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.
OG002	Part 1AB - TSR-033 (240 mg)	In part 1a, participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W

Secondary

Part 1c: AUC (0-inf) of TSR-033 and Dostarlimab

Blood samples were collected for PK analysis of TSR-033 when administered intravenously in combination with dostarlimab. PK parameter was determined using standard non-compartmental methods.

Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

Pre-dose and post-dose 15 minute, 30 minute, 1, 1.5, 3, 24, 48, 96, 168, 336 and 504 hour

ID	Title	Description
OG000	Part 1C - TSR-033 (80 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once every 3 weeks (Q3W).
OG001	Part 1C - TSR-033 (240 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.
OG002	Part 1C - TSR-033 (720 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 720 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.

Secondary

Part 1ab: AUC Over a Dosing Interval at Steady State (AUCtau) of TSR-033

Blood samples were collected for PK analysis of TSR-033 when administered intravenously as monotherapy. PK parameter was determined using standard non-compartmental methods.

Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

Pre-dose and post-dose 15 minute, 30 minute, 1.5, 3, 24, 48, 96 and 168 hour

ID	Title	Description
OG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
OG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.
OG002	Part 1AB - TSR-033 (240 mg)	In part 1a, participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W

Secondary

Part 1c: AUCtau of TSR-033 and Dostarlimab

Blood samples were collected for PK analysis of TSR-033 when administered intravenously in combination with dostarlimab. PK parameter was determined using standard non-compartmental methods.

Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

Pre-dose and post-dose 15 minute, 30 minute, 1, 1.5, 3, 24, 48, 96, 168, 336 and 504 hour

ID	Title	Description
OG000	Part 1C - TSR-033 (80 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once every 3 weeks (Q3W).
OG001	Part 1C - TSR-033 (240 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.
OG002	Part 1C - TSR-033 (720 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 720 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.

Secondary

Part 1ab: Maximum Concentration (Cmax) of TSR-033

Blood samples were collected for PK analysis of TSR-033 when administered intravenously as monotherapy. PK parameter was determined using standard non-compartmental methods.

Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

Pre-dose and post-dose 15 minute, 30 minute, 1.5, 3, 24, 48, 96 and 168 hour

ID	Title	Description
OG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
OG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.
OG002	Part 1AB - TSR-033 (240 mg)	In part 1a, participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W

Secondary

Part 1c: Cmax of TSR-033 and Dostarlimab

Blood samples were collected for PK analysis of TSR-033 when administered intravenously in combination with dostarlimab. PK parameter was determined using standard non-compartmental methods.

Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

Pre-dose and post-dose 15 minute, 30 minute, 1, 1.5, 3, 24, 48, 96, 168, 336 and 504 hour

ID	Title	Description
OG000	Part 1C - TSR-033 (80 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once every 3 weeks (Q3W).
OG001	Part 1C - TSR-033 (240 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.
OG002	Part 1C - TSR-033 (720 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 720 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.

Secondary

Part 1ab: Clearance (CL) of TSR-033

Blood samples were collected for PK analysis of TSR-033 when administered intravenously as monotherapy. PK parameter was determined using standard non-compartmental methods.

Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Litre/ hour (L/h)

Pre-dose and post-dose 15 minute, 30 minute, 1.5, 3, 24, 48, 96 and 168 hour

ID	Title	Description
OG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
OG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.
OG002	Part 1AB - TSR-033 (240 mg)	In part 1a, participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W

Secondary

Part 1c: CL of TSR-033 and Dostarlimab

Blood samples were collected for PK analysis of TSR-033 when administered intravenously in combination with dostarlimab. PK parameter was determined using standard non-compartmental methods.

Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

L/h

Pre-dose and post-dose 15 minute, 30 minute, 1, 1.5, 3, 24, 48, 96, 168, 336 and 504 hour

ID	Title	Description
OG000	Part 1C - TSR-033 (80 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once every 3 weeks (Q3W).
OG001	Part 1C - TSR-033 (240 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.
OG002	Part 1C - TSR-033 (720 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 720 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.

Secondary

Part 1ab: Volume of Distribution at Steady State (Vss) of TSR-033

Blood samples were collected for PK analysis of TSR-033 when administered intravenously as monotherapy. PK parameter was determined using standard non-compartmental methods.

Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Litre

Pre-dose and post-dose 15 minute, 30 minute, 1.5, 3, 24, 48, 96 and 168 hour

ID	Title	Description
OG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
OG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.
OG002	Part 1AB - TSR-033 (240 mg)	In part 1a, participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W

Secondary

Part 1c: Vss of TSR-033 and Dostarlimab

Blood samples were collected for PK analysis of TSR-033 when administered intravenously in combination with dostarlimab. PK parameter was determined using standard non-compartmental methods.

Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Litre

Pre-dose and post-dose 15 minute, 30 minute, 1, 1.5, 3, 24, 48, 96, 168, 336 and 504 hour

ID	Title	Description
OG000	Part 1C - TSR-033 (80 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once every 3 weeks (Q3W).
OG001	Part 1C - TSR-033 (240 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.
OG002	Part 1C - TSR-033 (720 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 720 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.

Secondary

Part 1ab: Terminal Half-life (t1/2) of TSR-033

Blood samples were collected for PK analysis of TSR-033 when administered intravenously as monotherapy. PK parameter was determined using standard non-compartmental methods.

Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour

Pre-dose and post-dose 15 minute, 30 minute, 1.5, 3, 24, 48, 96 and 168 hour

ID	Title	Description
OG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
OG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.
OG002	Part 1AB - TSR-033 (240 mg)	In part 1a, participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W

Secondary

Part 1c: t1/2 of TSR-033 and Dostarlimab

Blood samples were collected for PK analysis of TSR-033 when administered intravenously in combination with dostarlimab. PK parameter was determined using standard non-compartmental methods.

Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour

Pre-dose and post-dose 15 minute, 30 minute, 1, 1.5, 3, 24, 48, 96, 168, 336 and 504 hour

ID	Title	Description
OG000	Part 1C - TSR-033 (80 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once every 3 weeks (Q3W).
OG001	Part 1C - TSR-033 (240 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.
OG002	Part 1C - TSR-033 (720 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 720 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.

Secondary

Part 1ab: Number of Participants With Anti-TSR-033 Antibodies

Serum samples will be collected and tested for the presence of antibodies to TSR-033.

Immunogenicity (ADA) population included all participants who received at least 1 dose of TSR-033 and who have at least 1 ADA sample with a result. Only those participants with data available at specified time points have been analyzed.

Posted

Count of Participants

Participants

Up to 51 months

ID	Title	Description
OG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
OG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.
OG002	Part 1AB - TSR-033 (240 mg)	In part 1a, participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W

Secondary

Part 1c: Number of Participants With Anti-TSR-033 Antibodies

Serum samples will be collected and tested for the presence of antibodies to TSR-033.

Immunogenicity (ADA) population. Only those participants with data available at specified time points have been analyzed.

Posted

Count of Participants

Participants

Up to 29 months

ID	Title	Description
OG000	Part 1C - TSR-033 (80 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once every 3 weeks (Q3W).
OG001	Part 1C - TSR-033 (240 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.
OG002	Part 1C - TSR-033 (720 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 720 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.

Secondary

Part 2A: Number of Participants With Anti-TSR-033 Antibodies

Serum samples will be collected and tested for the presence of antibodies to TSR-033.

Immunogenicity (ADA) population. Only those participants with data available at specified time points have been analyzed.

Posted

Count of Participants

Participants

Up to 29 months

ID	Title	Description
OG000	Part 2A - TSR-033 (720 mg) + Dostarlimab (1000 mg)	Anti-programmed cell death-1 receptor (PD-1) naive participants with advanced or metastatic microsatellite stable colorectal cancer (MSS-CRC) that progressed following 2 or 3 prior lines of therapy received IV infusion of 720 mg TSR-033 once Q2W in combination with 1000 mg dostarlimab once every 6 weeks (Q6W).

Units	Counts
Participants	OG000

Secondary

Part 2B: Number of Participants With Anti-TSR-033 Antibodies

Serum samples will be collected and tested for the presence of antibodies to TSR-033.

Immunogenicity (ADA) population. Only those participants with data available at specified time points have been analyzed.

Posted

Count of Participants

Participants

Up to 29 months

ID	Title	Description
OG000	Part 2B1 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev + mFOLFOX6	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFIRI (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and mFOLFOX6 (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of mFOLFOX6 regimen combination of 2-hour infusion of oxaliplatin with leucovorin and 2-4 minutes infusion of 5-Fluorouracil on day 1 along with continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.
OG001	Part 2B2 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev +FOLFIRI	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFOX (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and FOLFIRI (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of FOLFIRI regimen combination of 90 minutes infusion of Irinotecan with leucovorin with 2-4 minutes infusion of 5-Fluorouracil on day 1 and continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.

Secondary

Part 1ab: Objective Response Rate (ORR)

ORR is defined as percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the investigator per response evaluation criteria in solid tumors (RECIST)v1.1. CR defined as disappearance of all target & non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter. PR defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Efficacy population included all participants who received any amount of TSR-033.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 51 months

ID	Title	Description
OG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
OG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.
OG002

Secondary

Part 1c: Objective Response Rate (ORR)

Efficacy population included all participants who received any amount of TSR-033.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 29 months

ID	Title	Description
OG000	Part 1C - TSR-033 (80 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once every 3 weeks (Q3W).
OG001	Part 1C - TSR-033 (240 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.
OG002	Part 1C - TSR-033 (720 mg) + Dostarlimab (500 mg)

Secondary

Part 2B: Objective Response Rate (ORR)

Efficacy population included all participants who received any amount of TSR-033.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 29 months

ID	Title	Description
OG000	Part 2B1 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev + mFOLFOX6	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFIRI (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and mFOLFOX6 (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of mFOLFOX6 regimen combination of 2-hour infusion of oxaliplatin with leucovorin and 2-4 minutes infusion of 5-Fluorouracil on day 1 along with continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.
OG001	Part 2B2 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev +FOLFIRI

Secondary

Part 2A: Duration of Response (DOR)

DOR was defined as the time from first documentation of CR or PR by RECIST v1.1 until the time offirst documentation of PD per RECIST v1.1. CR defined as disappearance of all target & non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter. PR defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Efficacy population. Only responders by investigator assessment were included in this analysis.

Posted

Median

Full Range

Months

Up to 29 months

ID	Title	Description
OG000	Part 2A - TSR-033 (720 mg) + Dostarlimab (1000 mg)	Anti-programmed cell death-1 receptor (PD-1) naive participants with advanced or metastatic microsatellite stable colorectal cancer (MSS-CRC) that progressed following 2 or 3 prior lines of therapy received IV infusion of 720 mg TSR-033 once Q2W in combination with 1000 mg dostarlimab once every 6 weeks (Q6W).

Units	Counts
Participants	OG000

Secondary

Part 2B: Duration of Response (DOR)

Efficacy population. Only responders by investigator assessment were included in this analysis. There were no responders in the arm Part 2B1, hence the participants analysed in 0.

Posted

Median

Full Range

Months

Up to 29 months

ID	Title	Description
OG000	Part 2B1 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev + mFOLFOX6	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFIRI (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and mFOLFOX6 (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of mFOLFOX6 regimen combination of 2-hour infusion of oxaliplatin with leucovorin and 2-4 minutes infusion of 5-Fluorouracil on day 1 along with continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.
OG001	Part 2B2 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev +FOLFIRI

Secondary

Part 2A: Disease Control Rate (DCR)

DCR is defined as defined as the percentage of participants achieving CR, PR, or stable disease (SD) as assessedby the investigator per RECIST v1.1. CR defined as disappearance of all target & non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter. PR defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.

Efficacy population. Only responders by investigator assessment were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 29 months

ID	Title	Description
OG000	Part 2A - TSR-033 (720 mg) + Dostarlimab (1000 mg)	Anti-programmed cell death-1 receptor (PD-1) naive participants with advanced or metastatic microsatellite stable colorectal cancer (MSS-CRC) that progressed following 2 or 3 prior lines of therapy received IV infusion of 720 mg TSR-033 once Q2W in combination with 1000 mg dostarlimab once every 6 weeks (Q6W).

Units	Counts
Participants

Secondary

Part 2B: Disease Control Rate (DCR)

Efficacy population. Only responders by investigator assessment were included in this analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 29 months

ID	Title	Description
OG000	Part 2B1 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev + mFOLFOX6	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFIRI (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and mFOLFOX6 (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of mFOLFOX6 regimen combination of 2-hour infusion of oxaliplatin with leucovorin and 2-4 minutes infusion of 5-Fluorouracil on day 1 along with continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.

Primary

Part 1A: Number of Participants Experiencing Dose Limiting Toxicity (DLT)

DLTs were assessed based on common terminology criteria for adverse events (CTCAE) v5.0 included drug-related AEs like grade>=2 uveitis, eye pain, or blurred vision that does not resolve with topical therapy within 2 weeks, grade ≥2 immune-related endocrine toxicity that required hormone replacement, grade 2 or 3 colitis or diarrhea that persisted without resolution to grade<=1 for >=7days despite adequate immune suppressive therapy, grade 3 or 4 immune-related AEs (irAE) without resolution to grade<=1 or baseline within 8 days despite adequate immune suppressive therapy, any grade clinically significant (CS) irAE requiring treatment discontinuation, other grade>=3 non-hematologic toxicity, any CS grade>=3 non-hematologic laboratory abnormality, any CS hematologic toxicity and any death that is not clearly attributed to the underlying disease or extraneous causes. CTCAE defines Grade 0 as normal, 1 as mild, 2 as moderate, 3 as severe and Grade 4 as life-threatening consequences.

DLT evaluable population included only those participants who completed the DLT observation period throughout the course of 2 TSR-033 administrations (Day 1 and Day 15 in the first 28 days of study treatment) for Part 1A unless the participant discontinued TSR-033 (Part 1A) due to a DLT.

Posted

Count of Participants

Participants

Up to 28 days

ID	Title	Description
OG000	Part 1A - TSR-033 [20 Milligrams (mg)]	In part 1A, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).

Primary

Part 1C: Number of Participants Experiencing DLT

DLT evaluable population included the assessment of DLTs in Part 1C included only those participants who completed the DLT observation period throughout the course of 2 TSR-033 + dostarlimab administrations (Day 1 and Day 21 in the first 42 days of study treatment), for Part 1C unless the participant discontinued TSR-033 + dostarlimab (Part 1C) due to a DLT.

Posted

Count of Participants

Participants

Up to 42 days

ID	Title	Description
OG000	Part 1C - TSR-033 (80 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once every 3 weeks (Q3W).

Primary

Part 2B: Number of Participants Experiencing DLT

DLT evaluable population included the assessment of DLTs in Part 2B included only those participants completing the DLT observation period throughout the course of 2 TSR-033 + dostarlimab administrations (Day 3 and Day 17 in the first 30 days of study treatment), for Part 2B unless the participant discontinued TSR-033 + dostarlimab (Part 2B) due to a DLT.

Posted

Count of Participants

Participants

Up to 30 days

ID	Title	Description
OG000	Part 2B1 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev + mFOLFOX6	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFIRI (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and mFOLFOX6 (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of mFOLFOX6 regimen combination of 2-hour infusion of oxaliplatin with leucovorin and 2-4 minutes infusion of 5-Fluorouracil on day 1 along with continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.

Primary

Part 1: Number of Participants With Serious Adverse Events (SAEs), Treatment-emergent AEs (TEAEs)and Immune-related AEs (irAEs)

SAEs are any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. TEAEs are defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment administration. Immune-related adverse events of interest (irAEs) are defined as any >= Grade 2 AEs based on a pre-specified list. CTCAE defines Grade 0 as normal, 1 as mild, 2 as moderate, 3 as severe and Grade 4 as life-threatening consequences.

Safety population included all participants who receive any amount of study drug.

Posted

Count of Participants

Participants

Up to approximately 51 months

ID	Title	Description
OG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
OG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.

Primary

Part 2B: Number of Participants With SAEs, TEAEs and irAEs

Safety population

Posted

Count of Participants

Participants

Up to approximately 29 months

ID	Title	Description
OG000	Part 2B1 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev + mFOLFOX6	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFIRI (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and mFOLFOX6 (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of mFOLFOX6 regimen combination of 2-hour infusion of oxaliplatin with leucovorin and 2-4 minutes infusion of 5-Fluorouracil on day 1 along with continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.

Primary

Part 1: Number of Participants With Grade Shift From Baseline in Hematology Parameters

Blood samples were collected for the analysis of hematology parameters and each parameter was graded according to national cancer institute (NCI)-common terminology criteria for adverse events (CTCAE) version 5.0. Grade 0: normal, Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the most recent non-missing measurement prior to the first administration of study drug. Data has been presented for the number of participants with hematology grade shifts from baseline grade to grade 3 and 4 for each parameter.

Safety population

Posted

Count of Participants

Participants

Up to 51 months

ID	Title	Description
OG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
OG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.
OG002

Primary

Part 2B: Number of Participants With Grade Shift From Baseline in Hematology Parameters

Blood samples were collected for the analysis of hematology parameters and each parameter was graded according to national cancer institute (NCI)-common terminology criteria for adverse events (CTCAE) version 5.0. Grade 0: normal, Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the most recent non-missing measurement prior to the first administration of study drug. Data have been presented for the number of participants with hematology grade shifts from baseline grade to grade 3 and 4 for each parameter. WBC is white blood cells.

Safety population

Posted

Count of Participants

Participants

Up to 29 months

ID	Title	Description
OG000	Part 2B1 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev + mFOLFOX6	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFIRI (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and mFOLFOX6 (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of mFOLFOX6 regimen combination of 2-hour infusion of oxaliplatin with leucovorin and 2-4 minutes infusion of 5-Fluorouracil on day 1 along with continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.
OG001

Primary

Part 1: Number of Participants With Grade Shift From Baseline in Clinical Chemistry Parameters

Blood samples were collected for the analysis of clinical chemistry parameters and each parameter was graded according to national cancer institute (NCI)-common terminology criteria for adverse events (CTCAE) version 5.0. Grade 0: normal, Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the most recent non-missing measurement prior to the first administration of study drug. Data have been presented for the number of participants with clinical chemistry grade shifts from baseline grade to grade 3 and 4 for each parameter.

Safety population

Posted

Count of Participants

Participants

Up to 51 months

ID	Title	Description
OG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
OG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.

Primary

Part 2B: Number of Participants With Grade Shift From Baseline in Clinical Chemistry Parameters

Safety population

Posted

Count of Participants

Participants

Up to 29 months

ID	Title	Description
OG000	Part 2B1 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev + mFOLFOX6	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFIRI (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and mFOLFOX6 (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of mFOLFOX6 regimen combination of 2-hour infusion of oxaliplatin with leucovorin and 2-4 minutes infusion of 5-Fluorouracil on day 1 along with continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.
OG001

Primary

Part 1: Number of Participants With Grade 3 and 4 Toxicities in Clinical Chemistry Parameters - Creatinine, Bilirubin, Alkaline Phosphatase

Blood samples were collected for the analysis of clinical chemistry parameters and each parameter was graded according to national cancer institute (NCI)-common terminology criteria for adverse events (CTCAE) version 5.0. Grade 0: normal, Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Data have been presented for the number of participants with clinical chemistry grade3 and 4 toxicities each parameter.

Safety population

Posted

Count of Participants

Participants

Up to 51 months

ID	Title	Description
OG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
OG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.
OG002	Part 1AB - TSR-033 (240 mg)

Primary

Part 2B: Number of Participants With Grade 3 and 4 Toxicities in Clinical Chemistry Parameters - Alanine Aminotransferase, Aspartate Aminotransferase, Creatinine, Bilirubin

Safety population

Posted

Count of Participants

Participants

Up to 29 months

ID	Title	Description
OG000	Part 2B1 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev + mFOLFOX6	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFIRI (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and mFOLFOX6 (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of mFOLFOX6 regimen combination of 2-hour infusion of oxaliplatin with leucovorin and 2-4 minutes infusion of 5-Fluorouracil on day 1 along with continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.

Primary

Part 1: Number of Participants With Post Baseline Abnormal Electrocardiogram (ECG) Results

12-lead ECG were obtained using an ECG machine. Participants were in supine or a semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs are recorded. ECG results included QT interval corrected for heart rate according to Bazett's formula (QTcB), QT interval corrected for heart rate according to Fridericia's formula (QTcF), QRS interval, PR Interval and Heart rate.

Safety population

Posted

Count of Participants

Participants

Up to 51 months

ID	Title	Description
OG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
OG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.
OG002	Part 1AB - TSR-033 (240 mg)

Primary

Part 2B: Number of Participants With Post Baseline Abnormal ECG Results

Safety population

Posted

Count of Participants

Participants

Up to 29 months

ID	Title	Description
OG000	Part 2B1 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev + mFOLFOX6	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFIRI (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and mFOLFOX6 (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of mFOLFOX6 regimen combination of 2-hour infusion of oxaliplatin with leucovorin and 2-4 minutes infusion of 5-Fluorouracil on day 1 along with continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.
OG001	Part 2B2 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev +FOLFIRI	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFOX (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and FOLFIRI (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of FOLFIRI regimen combination of 90 minutes infusion of Irinotecan with leucovorin with 2-4 minutes infusion of 5-Fluorouracil on day 1 and continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.

Primary

Part 2A: Objective Response Rate (ORR)

ORR is defined as percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the investigator per response evaluation criteria in solid tumors (RECIST)v1.1. CR defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter. PR defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Efficacy population included all participants who received any amount of TSR-033.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 30 months

ID	Title	Description
OG000	Part 2A - TSR-033 (720 mg) + Dostarlimab (1000 mg)	Anti-programmed cell death-1 receptor (PD-1) naive participants with advanced or metastatic microsatellite stable colorectal cancer (MSS-CRC) that progressed following 2 or 3 prior lines of therapy received IV infusion of 720 mg TSR-033 once Q2W in combination with 1000 mg dostarlimab once every 6 weeks (Q6W).

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG0030 events0 affected10 at risk EG0040 events0 affected5 at risk EG0050 events0 affected7 at risk EG0061 events1 affected6 at risk EG0070 events0 affected34 at risk EG0080 events0 affected4 at risk EG0090 events0 affected21 at risk EG0100 events0 affected1 at risk EG0110 events0 affected1 at risk
Febrile neutropenia	Blood and lymphatic system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Angina pectoris	Cardiac disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Pericardial effusion	Cardiac disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Abdominal pain	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Colitis	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Enteritis	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Large intestine perforation	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Nausea	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Vomiting	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Fatigue	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Oedema peripheral	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Pain	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Bile duct stenosis	Hepatobiliary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Cholecystitis	Hepatobiliary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Hepatic pain	Hepatobiliary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Encephalitis	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Neutropenic sepsis	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Pyelonephritis	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Sepsis	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Urinary tract infection	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Postoperative respiratory failure	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Traumatic haemothorax	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Blood bilirubin increased	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Acidosis	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Dehydration	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Headache	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Myasthenia gravis	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Spinal cord compression	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Hallucination	Psychiatric disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0022 events1 affected11 at risk EG0031 events1 affected10 at risk EG0041 events1 affected5 at risk EG0054 events2 affected7 at risk EG0062 events2 affected6 at risk EG00712 events7 affected34 at risk EG0080 events0 affected4 at risk EG0096 events4 affected21 at risk EG0100 events0 affected1 at risk EG0110 events0 affected1 at risk
Hypereosinophilic syndrome	Blood and lymphatic system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Neutropenia	Blood and lymphatic system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Atrial fibrillation	Cardiac disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Bradycardia	Cardiac disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Pericardial effusion	Cardiac disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Sinus tachycardia	Cardiac disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Tachycardia	Cardiac disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Ear pain	Ear and labyrinth disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Hypoacusis	Ear and labyrinth disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Cushingoid	Endocrine disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Hypothyroidism	Endocrine disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Dry eye	Eye disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Vision blurred	Eye disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0021 events1 affected11 at risk EG003
Abdominal distension	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0021 events1 affected11 at risk EG003
Abdominal pain	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0015 events1 affected10 at risk EG0023 events3 affected11 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Cheilitis	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Constipation	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected10 at risk EG0022 events2 affected11 at risk EG003
Diarrhoea	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Dry mouth	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected10 at risk EG0022 events2 affected11 at risk EG003
Dyspepsia	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected10 at risk EG0020 events0 affected11 at risk EG003
Dysphagia	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Flatulence	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Lip dry	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Nausea	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events3 affected10 at risk EG0022 events2 affected11 at risk EG003
Oral pain	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Pancreatitis	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Parotid gland enlargement	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Proctalgia	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Stomatitis	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Vomiting	Gastrointestinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events2 affected10 at risk EG0021 events1 affected11 at risk EG003
Asthenia	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Axillary pain	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Chest pain	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Chills	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Fatigue	General disorders	v24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Gait disturbance	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Influenza like illness	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Localised oedema	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Malaise	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Mucosal inflammation	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Non-cardiac chest pain	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Oedema peripheral	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events3 affected10 at risk EG0021 events1 affected11 at risk EG003
Pyrexia	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0021 events1 affected11 at risk EG003
Swelling face	General disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Immune-mediated hepatitis	Hepatobiliary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Jaundice	Hepatobiliary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Hypersensitivity	Immune system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Seasonal allergy	Immune system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Candida infection	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Gingivitis	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Hordeolum	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Myringitis	Infections and infestations	v24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Nasopharyngitis	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Oral candidiasis	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Oral infection	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Periodontitis	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Pneumonia	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Sinusitis	Infections and infestations	v24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Skin infection	Infections and infestations	v24.1	Systematic Assessment	EG0002 events1 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Tooth abscess	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Upper respiratory tract infection	Infections and infestations	v24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected10 at risk EG0021 events1 affected11 at risk EG003
Urinary tract infection	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Contusion	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Fall	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Stoma site haemorrhage	Injury, poisoning and procedural complications	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Alanine aminotransferase increased	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected10 at risk EG0021 events1 affected11 at risk EG003
Amylase increased	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Aspartate aminotransferase increased	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected10 at risk EG0021 events1 affected11 at risk EG003
Blood alkaline phosphatase increased	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Blood bilirubin increased	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Blood creatine increased	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Blood creatinine increased	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0022 events1 affected11 at risk EG003
Lipase increased	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Lymphocyte count decreased	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Neutrophil count decreased	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Weight decreased	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Weight increased	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
White blood cell count decreased	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
White blood cells urine positive	Investigations	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0014 events4 affected10 at risk EG0022 events1 affected11 at risk EG003
Dehydration	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0022 events1 affected11 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0021 events1 affected11 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Malnutrition	Metabolism and nutrition disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0002 events2 affected3 at risk EG0011 events1 affected10 at risk EG0023 events3 affected11 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected10 at risk EG0025 events3 affected11 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0002 events1 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0021 events1 affected11 at risk EG003
Trismus	Musculoskeletal and connective tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	v24.1	Systematic Assessment	EG0002 events1 affected3 at risk EG0011 events1 affected10 at risk EG0021 events1 affected11 at risk EG003
Dizziness	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0022 events2 affected11 at risk EG003
Dysgeusia	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Headache	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0022 events2 affected11 at risk EG003
Migraine with aura	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Neuropathy peripheral	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Paraesthesia	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Presyncope	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Syncope	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Tremor	Nervous system disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Anticipatory anxiety	Psychiatric disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Anxiety	Psychiatric disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Depression	Psychiatric disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Insomnia	Psychiatric disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Acute kidney injury	Renal and urinary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Chromaturia	Renal and urinary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Chronic kidney disease	Renal and urinary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Dysuria	Renal and urinary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Haematuria	Renal and urinary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Incontinence	Renal and urinary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Pollakiuria	Renal and urinary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Urinary hesitation	Renal and urinary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Urinary incontinence	Renal and urinary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Urinary retention	Renal and urinary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Urinary tract pain	Renal and urinary disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Testicular swelling	Reproductive system and breast disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0012 events2 affected10 at risk EG0024 events4 affected11 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected10 at risk EG0021 events1 affected11 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0022 events2 affected11 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Painful respiration	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Sinus pain	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Rash	Skin and subcutaneous tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Deep vein thrombosis	Vascular disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Embolism	Vascular disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Flushing	Vascular disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Hot flush	Vascular disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Hypertension	Vascular disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Hypotension	Vascular disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected10 at risk EG0020 events0 affected11 at risk EG003
Jugular vein thrombosis	Vascular disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0020 events0 affected11 at risk EG003
Orthostatic hypotension	Vascular disorders	v24.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected10 at risk EG0021 events1 affected11 at risk EG003

ID	Term
D009369	Neoplasms
D010051	Ovarian Neoplasms
D015179	Colorectal Neoplasms
D008175	Lung Neoplasms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).
BG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.
BG002	Part 1AB - TSR-033 (240 mg)	In part 1a, participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.
BG003	Part 1AB - TSR-033 (720 mg)	In part 1a, participants with advanced or metastatic solid tumors received 720 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.
BG004	Part 1C - TSR-033 (80 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once every 3 weeks (Q3W).
BG005	Part 1C - TSR-033 (240 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.
BG006	Part 1C - TSR-033 (720 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 720 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.
BG007	Part 2A - TSR-033 (720 mg) + Dostarlimab (1000 mg)	Anti-programmed cell death-1 receptor (PD-1) naive participants with advanced or metastatic microsatellite stable colorectal cancer (MSS-CRC) that progressed following 2 or 3 prior lines of therapy received IV infusion of 720 mg TSR-033 once Q2W in combination with 1000 mg dostarlimab once every 6 weeks (Q6W).
BG008	Part 2B1 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev + mFOLFOX6	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFIRI (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and mFOLFOX6 (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of mFOLFOX6 regimen combination of 2-hour infusion of oxaliplatin with leucovorin and 2-4 minutes infusion of 5-Fluorouracil on day 1 along with continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.
BG009	Part 2B2 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev +FOLFIRI	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFOX (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and FOLFIRI (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of FOLFIRI regimen combination of 90 minutes infusion of Irinotecan with leucovorin with 2-4 minutes infusion of 5-Fluorouracil on day 1 and continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.
BG010	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1AB - TSR-033 [20 Milligrams (mg)]	In part 1a, participants with advanced or metastatic solid tumors received 20 mg TSR-033 via 30-minute intravenous (IV) infusion once every 2 weeks (Q2W).	1	3	1	3	3	3
EG001	Part 1AB - TSR-033 (80 mg)	In part 1a, participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.	6	10	5	10	10	10
EG002	Part 1AB - TSR-033 (240 mg)	In part 1a, participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.	5	11	2	11	11	11
EG003	Part 1AB - TSR-033 (720 mg)	In part 1a, participants with advanced or metastatic solid tumors received 720 mg TSR-033 via 30-minute IV infusion once Q2W. In part 1b, additional participants enrolled in this dose level to characterize the PK profile of TSR-033 and assess PDy data followed by treatment with TSR-033 dosed on day 1, and then once Q2W.	5	10	1	10	10	10
EG004	Part 1C - TSR-033 (80 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 80 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once every 3 weeks (Q3W).	3	5	1	5	5	5
EG005	Part 1C - TSR-033 (240 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 240 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.	6	7	3	7	7	7
EG006	Part 1C - TSR-033 (720 mg) + Dostarlimab (500 mg)	Participants with advanced or metastatic solid tumors received 720 mg TSR-033 via 30-minute IV infusion in combination with 500 mg dostarlimab on day 1, and then once Q3W.	3	6	4	6	6	6
EG007	Part 2A - TSR-033 (720 mg) + Dostarlimab (1000 mg)	Anti-programmed cell death-1 receptor (PD-1) naive participants with advanced or metastatic microsatellite stable colorectal cancer (MSS-CRC) that progressed following 2 or 3 prior lines of therapy received IV infusion of 720 mg TSR-033 once Q2W in combination with 1000 mg dostarlimab once every 6 weeks (Q6W).	18	34	8	34	31	34
EG008	Part 2B1 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev + mFOLFOX6	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFIRI (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and mFOLFOX6 (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of mFOLFOX6 regimen combination of 2-hour infusion of oxaliplatin with leucovorin and 2-4 minutes infusion of 5-Fluorouracil on day 1 along with continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.	1	4	4	4	4	4
EG009	Part 2B2 - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev +FOLFIRI	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFOX (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and FOLFIRI (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of FOLFIRI regimen combination of 90 minutes infusion of Irinotecan with leucovorin with 2-4 minutes infusion of 5-Fluorouracil on day 1 and continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.	7	21	7	21	21	21
EG010	PACT Phase - TSR-033 (720 mg) + Dostarlimab (1000 mg)	Anti-programmed cell death-1 receptor (PD-1) naive participants with advanced or metastatic microsatellite stable colorectal cancer (MSS-CRC) that progressed following 2 or 3 prior lines of therapy received IV infusion of 720 mg TSR-033 once Q2W in combination with 1000 mg dostarlimab once every 6 weeks (Q6W).	0	1	0	1	0	1
EG011	PACT Phase - TSR-033 (720 mg) + Dostarlimab (1000 mg) + Bev +FOLFIRI	Anti-PD-1-naive participants with advanced or metastatic MSS-CRC following progression on frontline treatment with FOLFOX (or variant), with or without biologics received IV infusion of 720 mg TSR-033 once (on day 3 of each cycle) Q2W in combination with 1000 mg dostarlimab once (on day 3 of each cycle) Q6W and FOLFIRI (on day 1 of each cycle) Q6W and 30-minute IV infusion of bevacizumab (bev) once (on day 1 of each cycle) Q6W. As a part of FOLFIRI regimen combination of 90 minutes infusion of Irinotecan with leucovorin with 2-4 minutes infusion of 5-Fluorouracil on day 1 and continuous 46-hours infusion of 5-Fluorouracil on day 1 to day 3 were administered.	0	1	0	1	0	1

ID	Term
C000716688	TSR-033
C000719628	dostarlimab
C480833	IFL protocol
D000068258	Bevacizumab