A First-in-human Study to Evaluate the Safety and Tolerab... | NCT05397171

ID	Type	Description	Link
2021-005438-41	EudraCT Number

Name	Class
ImaginAb, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Substudy 1 - Parts A, B, and C	Experimental	Part A: AZD8853 monotherapy dose escalation Part B1 and Part B2: AZD8853 monotherapy safety expansion at dose levels and indications determined to be safe in Part A Part C1 and Part C2: AZD8853 monotherapy safety and preliminary efficacy expansion at dose levels and indications determined to be safe in Parts A and B	Drug: AZD8853
Substudy 1 - Parts B1 and B2 with CD8+ PET	Experimental	Sub-set of participants from Parts B1 and B2 will also receive investigational CD8+ T cell targeted radioactive tracer, Zirconium-89 crefmirlimab berdoxam with PET scans	Drug: Zirconium-89 crefmirlimab berdoxam

Name	Type	Description	Arm Group Labels	Other Names
AZD8853	Drug	Monotherapy given until progressive disease or upon meeting other discontinuation criteria.	Substudy 1 - Parts A, B, and C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	The safety and tolerability of AZD8853 in participants with selected advanced/metastatic solid tumors was assessed. As per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, severity scale ranged from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. This outcome measure was assessed only for substudy 1 Part A.	From Day 1 up to 90 (±7 days) days after the last dose of AZD8853 (1 Year)
Number of Participants With Dose Limiting Toxicity (DLT)	DLTs (in dose escalation Parts only) of AZD8853 in participants with selected advanced/metastatic solid tumors was assessed. The DLTs are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) as per NCI-CTCAE version 5.0 non-hematological toxicity or hematological toxicity. This outcome measure was assessed only for substudy 1 Part A.	From Cycle 1 Day 1 to end of Cycle 1 (21 days)

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR)	ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR). This outcome measure was assessed only for substudy 1 Part A.	First dose until progression of disease (PD) or last evaluable assessment in the absence of progression (1 Year)

Eligibility Module

Eligibility Criteria

*Key Inclusion Criteria*

All Substudies:

At least one measurable target lesions per RECIST 1.1.
Eastern Cooperative Group (ECOG) of 0-1.
Life expectancy of ≥ 12 weeks
Adequate organ and marrow function as defined in the protocol

Substudy 1:

Histologically or cytologically confirmed locally advanced, unresectable or metastatic NSCLC, MSS-CRC, or UC.
Documented progression from previous therapy
NSCLC:

3.a. At least 1 line of systemic therapy in the advanced / metastatic setting 3.b.Must have received anti-PD-1/anti-PD-L1 agent with or without chemotherapy 3.c. Part B and C: Documented no sensitizing EGFR mutations or ALK fusions/rearrangements

4. MSS-CRC: 4.a. At least 2 prior lines of systemic therapy in the advanced / metastatic setting, including specific therapies defined in the protocol

5. UC: 5.a. At least 1 prior line of systemic therapy in the advanced / metastatic setting, including either a platinum-containing regimen and/or an anti-PD-1 or anti-PD-L1 drug 6. Provision of archival tissue or unstained slides 7. Part B: Willing to provide mandatory biposies at screening and on study 8. Part B-CD8+ PET: At least 1 non-liver lesion suitable for PET imaging

*Key Exclusion Criteria*

All Substudies:

Unresolved toxicities ≥ Grade 2 per CTCAE 5.0 from prior therapy, with some exceptions defined in the protocol
Symptomatic CNS metastases or leptomeningeal disease
Active or ongoing infections, or uncontrolled intercurrent illness as defined in the protocol
Active or prior documented autoimmune or inflammatory disorder
Body weight loss of > 10% within 30 days of screening visit
Type 2 diabetes requiring management by metformin, where metformin cannot be switched to another treatment at least 7 days prior to starting study treatment

Substudy 1:

Must not have had a toxicity from a checkpoint inhibitor that lead to permanent discontinuation of immunotherapy
Participants with brain metastases, unless treated, asymptomatic, stable, and not requiring treatment

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Atlanta	Georgia	30322	United States
Research Site

Label	URL
CSR Synopsis	View source
SAP redacted	View source

IPD Sharing Statement Module

ID	Title	Description
FG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 milligrams (mg) every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
FG001	AZD8853 1000 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 11, 2022	Jun 4, 2024

ID	Title	Description
BG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
BG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
BG002	AZD8853 3000 mg	Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0003 BG0016 BG0027 BG00316

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

Primary

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

The safety and tolerability of AZD8853 in participants with selected advanced/metastatic solid tumors was assessed.

As per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, severity scale ranged from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

This outcome measure was assessed only for substudy 1 Part A.

Safety set included all participants who received any amount of IP.

Posted

Count of Participants

Participants

From Day 1 up to 90 (±7 days) days after the last dose of AZD8853 (1 Year)

ID	Title	Description
OG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG002	AZD8853 3000 mg	Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG0003 OG0016 OG0027

Title

Denominators

Categories

Any AE

Title	Measurements
	OG0003 OG0014 OG0026

Any AE possibly related to treatment

Primary

Number of Participants With Dose Limiting Toxicity (DLT)

DLTs (in dose escalation Parts only) of AZD8853 in participants with selected advanced/metastatic solid tumors was assessed. The DLTs are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) as per NCI-CTCAE version 5.0 non-hematological toxicity or hematological toxicity. This outcome measure was assessed only for substudy 1 Part A.

DLT evaluable set included enrolled participants who completed the DLT evaluation period (defined as 21 days after receiving the first infusion of IP) with at least 75% dosing and had completed safety evaluation requirements during the DLT evaluation period.

Posted

Count of Participants

Participants

From Cycle 1 Day 1 to end of Cycle 1 (21 days)

ID	Title	Description
OG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG002	AZD8853 3000 mg

Secondary

Objective Response Rate (ORR)

ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR). This outcome measure was assessed only for substudy 1 Part A.

Response evaluable set included all dosed participants who had measurable disease at baseline. Here, "number of participants analyzed" specifies all participants who were evaluated for this outcome measure.

Posted

Count of Participants

Participants

First dose until progression of disease (PD) or last evaluable assessment in the absence of progression (1 Year)

ID	Title	Description
OG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG002	AZD8853 3000 mg	Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

Secondary

Disease Control Rate (DCR) at 15 Weeks

Disease control was defined as a best overall response (BOR) of confirmed CR or PR or having stable disease (SD) (without subsequent cancer therapy) maintained for greater than or equal to (>=) 14 weeks (study week 15) from first IP. Disease control rate at study week 15 weeks (DCR-15) was defined as the percentage of participants who had disease control at study week 15 weeks. This outcome measure was assessed only for substudy 1 Part A.

Response evaluable set included all dosed participants who had measurable disease at baseline.

Posted

Count of Participants

Participants

15 weeks

ID	Title	Description
OG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG002	AZD8853 3000 mg	Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

Secondary

Duration of Response (DOR)

The DOR was defined as the time from the date of first documented response (which was subsequently confirmed) until the date of documented progression or death in the absence of disease progression. This outcome measure was assessed only for substudy 1 Part A.

Response evaluable set included all dosed participants who had measurable disease at baseline. Only participants in the response evaluable set who had a response were planned to include. However, data was not evaluated for this outcome measure as there were no objective responses available for any participant at any dose level.

Posted

First documented response until date of first documented disease progression or study end (1 Year)

ID	Title	Description
OG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG002	AZD8853 3000 mg	Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

Secondary

Progression Free Survival (PFS)

The PFS was defined as the time from the start of study intervention until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from study intervention or received another anti-cancer therapy prior to progression.

This outcome measure was assessed only for substudy 1 Part A.

Safety set included all participants who received any amount of IP.

Posted

Median

Full Range

Months

First dose until documented disease progression or study end (1 Year)

ID	Title	Description
OG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG002	AZD8853 3000 mg	Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

Secondary

Percentage Change From Baseline in Tumor Size

Tumor size was the sum of the longest diameters (or short axis measurements for lymph nodes) of the target lesions (TLs). Percentage change in tumor size was determined for participants with measurable disease at baseline. Baseline for Response evaluation criteria in solid tumors (RECIST) version 1.1 was defined as the last evaluable assessment prior to first IP dose. This outcome measure was assessed only for substudy 1 Part A.

Response evaluable set included all dosed participants who had measurable disease at baseline. Here, "n" (number analyzed in each raw) signifies the participants with available data that were analyzed for each timepoint for this outcome measure.

Posted

Median

Full Range

Percentage change in tumor size

Baseline (pre-treatment) up to Week 6 and Week 15

ID	Title	Description
OG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG002	AZD8853 3000 mg

Secondary

Overall Survival (OS)

Overall survival was defined as the time from the start of treatment until death due to any cause.

This outcome measure was assessed only for substudy 1 Part A.

Safety set included all participants who received any amount of IP.

Posted

Median

90% Confidence Interval

Months

First dose until study end (1 Year)

ID	Title	Description
OG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG002	AZD8853 3000 mg	Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

Units

Secondary

Percentage Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Levels From Baseline

Change in ctDNA is defined as the percentage change in ctDNA from baseline to each timepoint for the safety population. This outcome measure was assessed only for substudy 1 Part A.

Safety set included all participants who received any amount of IP. Here, "number of participants analyzed" specifies all participants who were evaluated for this outcome measure and "n" (number analyzed in each raw) signifies the participants with available data that were analyzed for each timepoint for this outcome measure.

Posted

Mean

Standard Deviation

Percentage change from baseline in ctDNA

Baseline (pre-treatment), Day 8 of Cycle 1, Days 1 and 8 of Cycle 2, Day 1 of Cycles 3, 4, 5, 7 (each cycle is equal to 21 days)

ID	Title	Description
OG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG002	AZD8853 3000 mg

Secondary

Maximum Observed Concentration (Cmax) of AZD8853

The pharmacokinetic (PK) (Cmax) of AZD8853 in serum when administered in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.

PK analysis set included all participants who received at least one dose of IP with at least one reportable concentration.

Posted

Mean

Standard Deviation

Micrograms per milliliter (ug/mL)

0 hour, 15 minutes, 2 hours, 6 hours, 24 hours, 168 hours and 336 hours post EOI of Cycle 1 (each cycle equals to 21 days)

ID	Title	Description
OG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG002	AZD8853 3000 mg	Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

Secondary

Area Under the Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of AZD8853

The PK (AUClast) of AZD8853 in serum when administered in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.

PK analysis set included all participants who received at least one dose of IP with at least one reportable concentration.

Posted

Mean

Standard Deviation

Hours*microgram per milliliter (h*ug/mL)

0 hour, 15 minutes, 2 hours, 6 hours, 24 hours, 168 hours and 336 hours post EOI of Cycle 1 (each cycle equals to 21 days)

ID	Title	Description
OG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG002	AZD8853 3000 mg	Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

Secondary

Partial Area Under the Plasma Concentration-time Curve From Time 0 to 504 Hours Post Dose (AUC[0-504 Hours]) of AZD8853

The PK (AUC[t1-t2]) of AZD8853 in serum when administered in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.

PK analysis set included all participants who received at least one dose of IP with at least one reportable concentration.

Posted

Mean

Standard Deviation

h*ug/mL

0 hour, 15 minutes, 2 hours, 6 hours, 24 hours, 168 hours and 336 hours post EOI of Cycle 1 (each cycle equals to 21 days)

ID	Title	Description
OG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG002	AZD8853 3000 mg	Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

Secondary

Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUCinf) of AZD8853

The PK (AUCinf) of AZD8853 in serum when administered in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.

PK analysis set included all participants who received at least one dose of IP with at least one reportable concentration.

Posted

Mean

Standard Deviation

h*ug/mL

0 hour, 15 minutes, 2 hours, 6 hours, 24 hours, 168 hours and 336 hours post EOI of Cycle 1 (each cycle equals to 21 days)

ID	Title	Description
OG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG002	AZD8853 3000 mg	Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

Secondary

Number of Participants With Positive Anti-drug Antibody (ADA) of AZD8853

The immunogenicity of AZD8853 in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.

Immunogenicity analysis set included all participants who received at least one dose of IP who have a non-missing baseline ADA result and at least 1 non-missing post-baseline ADA result.

Posted

Count of Participants

Participants

From Day 1 up to 90 (±7 days) days after the last dose of AZD8853 (1 year)

ID	Title	Description
OG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG002	AZD8853 3000 mg	Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

Secondary

Percentage Change From Baseline in Circulating Growth Differentiation Factor 15 (GDF15) Serum Levels

The pharmacodynamics (PD) activity of AZD8853 by assessment of candidate biomarkers in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy1 Part A.

End of infusion= EOI; End of treatment= EOT

PD analysis set included all participants who received at least one dose of IP with at least one reportable concentration. Here, "number of participants analyzed" specifies all participants who were evaluated for this outcome measure and "n" (number analyzed in each raw) signifies the participants with available data that were analyzed for each timepoint for this outcome measure.

Posted

Mean

Standard Deviation

Percentage change from baseline in GDF15

0 hours post EOI of Cycle 1 Day 1, Day 1 (Pre-dose) of Cycles 2 and 3 (each cycle equals to 21 days) and 90-days post EOT of 90 days follow-up

ID	Title	Description
OG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
OG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Syncope	Vascular disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected7 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected7 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected7 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected7 at risk
Sepsis	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected7 at risk
Blood bilirubin increased	Investigations	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected7 at risk
Embolism	Vascular disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected7 at risk
Cardiac arrest	Cardiac disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected7 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected7 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected7 at risk
Pyrexia	General disorders	MedDRA 26.0	Non-systematic Assessment	EG0002 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Non-systematic Assessment	EG0002 affected3 at risk EG0010 affected6 at risk EG0022 affected7 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected7 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected7 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected7 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0011 affected6 at risk EG0023 affected7 at risk
Hypotension	Vascular disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected7 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected7 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0011 affected6 at risk EG0023 affected7 at risk
Chills	General disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Sacral pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected7 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected7 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0011 affected6 at risk EG0021 affected7 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected7 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 affected3 at risk EG0011 affected6 at risk EG0021 affected7 at risk
Fatigue	General disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0022 affected7 at risk
Haematoma	Vascular disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected7 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0012 affected6 at risk EG0020 affected7 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Localised oedema	General disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected7 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected7 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0012 affected6 at risk EG0020 affected7 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected7 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Oral pain	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Hypersensitivity	Immune system disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Tooth infection	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected7 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Weight decreased	Investigations	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Weight increased	Investigations	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected7 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected7 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Hemiparesis	Nervous system disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Insomnia	Psychiatric disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0021 affected7 at risk
Urine odour abnormal	Renal and urinary disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected7 at risk
Hypertension	Vascular disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected7 at risk

ID	Term
D001749	Urinary Bladder Neoplasms
D015179	Colorectal Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung
D002295	Carcinoma, Transitional Cell

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases
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
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AZD8853 300 mg	Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.	2	3	2	3	3	3
EG001	AZD8853 1000 mg	Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.	3	6	3	6	4	6
EG002	AZD8853 3000 mg	Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.	3	7	2	7	6	7