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| ID | Type | Description | Link |
|---|---|---|---|
| J1E-MC-JZEA | Other Identifier | Eli Lilly and Company | |
| 2018-003871-37 | EudraCT Number |
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Study did not achieve its primary objective due to early termination of the study
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The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3434172, a PD-1/PD-L1 bispecific antibody, in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 Milligram (mg) - 10 mg LY3434172 | Experimental | 3 mg LY3434172 administered intravenously (IV) on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation. |
|
| 30 mg LY3434172 | Experimental | 30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation. |
|
| 100 mg LY3434172 | Experimental | 100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3434172 | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | A DLT is defined as adverse event/s of grade 3 or higher that occurs during the DLT observation period, which is Cycle 1 of each dose escalation cohort, and is clinically significant and definitely, probably, or possibly related to LY3434172, in the opinion of the investigator. | Baseline through Cycle 1 (Up to 42 Day Cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3434172 | PK: Cmin of LY3434172 | PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; Cycle 1 Day 15 (C1D15): Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion |
| PK: Maximum Concentration (Cmax) of LY3434172 |
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Inclusion Criteria:
Exclusion Criteria:
Have symptomatic central nervous system (CNS) malignancy or metastasis not requiring concurrent treatment, including but not limited to surgery, radiation, corticosteroids and/or anticonvulsants to treat CNS metastases, and their disease is asymptomatic and radiographically stable for at least 30 days.
Have moderate or severe cardiovascular disease.
Have active or suspected autoimmune disease (eg. autoimmune vasculitis, autoimmune myocarditis, among others).
Have serious concomitant systemic disorder that would compromise the participant's ability to adhere to the protocol, including known infection with human immunodeficiency virus (HIV) unless they are well controlled on highly active antiretroviral therapy (HAART) therapy with no evidence of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections within the last 2 years, and CD4 T-cells count > 350 cells/µl , active hepatitis B virus (HBV), active hepatitis C virus (HCV), active autoimmune disorders, or prior documented severe autoimmune or inflammatory disorders requiring immunosuppressive treatment.
Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea.
Evidence of interstitial lung disease or noninfectious pneumonitis (active or treated by corticosteroid therapy).
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| St Vincent's Hospital |
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| Label | URL |
|---|---|
| A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced Cancer | View source |
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Completers are defined as participants who were observed for both primary and secondary outcomes.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3 Milligram (mg) - 10 mg LY3434172 | 3 mg LY3434172 administered intravenously (IV) on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation. |
| FG001 | 30 mg LY3434172 | 30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation. |
| FG002 | 100 mg LY3434172 | 100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 3 mg - 10 mg LY3434172 | 3 mg LY3434172 administered IV on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation. |
| BG001 | 30 mg LY3434172 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Dose Limiting Toxicities (DLTs) | A DLT is defined as adverse event/s of grade 3 or higher that occurs during the DLT observation period, which is Cycle 1 of each dose escalation cohort, and is clinically significant and definitely, probably, or possibly related to LY3434172, in the opinion of the investigator. | All participants who received any quantity of LY3434172, regardless of their eligibility for the study. | Posted | Count of Participants | Participants | No | Baseline through Cycle 1 (Up to 42 Day Cycle) |
|
Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3 mg -10 mg LY3434172 | 3 mg LY3434172 administered IV on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
Study terminated by sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 2, 2019 | Apr 27, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 29, 2019 | Apr 27, 2022 | SAP_001.pdf |
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PK: Cmax of LY3434172 |
| PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; C1D15: Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion |
| PK: Area Under the Curve From Zero to Time to Last Measurable Concentration (AUC0-tlast) of LY3434172 | PK: AUC 0-tlast of LY3434172 | PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; C1D15: Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion |
| Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | ORR: Percentage of participants who have received any amount of study drug, have at least one postbaseline tumor image, and achieved a best overall response (BOR) of confirmed Complete Response (CR) is defined a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Baseline through Measured Progressive Disease (Up to 8.4 Months) |
| Duration of Response (DOR) | DOR is defined only for responders (participants with a confirmed CR or PR). It is measured from the date of first evidence of a confirmed CR or PR to the date of the first observed radiographically documented progressive disease (PD), or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, DoR will be censored at the date of the last complete objective progression-free disease assessment. | Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 8.4 Months) |
| Time to Response (TTR) | TTR is defined as the time from the date of first study treatment until the first evidence of confirmed CR or PR. | Baseline to Date of CR or PR (Up to 8.4 Months) |
| Disease Control Rate (DCR): Percentage of Participants Who Exhibit Stable Disease (SD), CR or PR | Disease control rate is defined as the number of participants with SD, confirmed PR, or confirmed CR (CR+PR+SD) divided by the number of enrolled participants who have received any quantity of study treatment. | Baseline through Measured Progressive Disease (Up to 8.4 Months) |
| Sydney |
| New South Wales |
| 2010 |
| Australia |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Institut Claudius Regaud - IUCT Oncopole | Toulouse | 31059 | France |
| Asan Medical Center | Songpa-gu | Seoul | 05505 | South Korea |
30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation. |
| BG002 | 100 mg LY3434172 | 100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation. |
| BG003 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 |
| 30 mg LY3434172 |
30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation. |
| OG002 | 100 mg LY3434172 | 100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation. |
|
|
| Secondary | Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3434172 | PK: Cmin of LY3434172 | All participants who received at least one dose of LY3434172 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; Cycle 1 Day 15 (C1D15): Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) of LY3434172 | PK: Cmax of LY3434172 | All participants who received at least one dose of LY3434172 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; C1D15: Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion |
|
|
|
| Secondary | PK: Area Under the Curve From Zero to Time to Last Measurable Concentration (AUC0-tlast) of LY3434172 | PK: AUC 0-tlast of LY3434172 | All participants who received at least one dose of LY3434172 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (hr*ng/mL) | PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; C1D15: Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion |
|
|
|
| Secondary | Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | ORR: Percentage of participants who have received any amount of study drug, have at least one postbaseline tumor image, and achieved a best overall response (BOR) of confirmed Complete Response (CR) is defined a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All participants who received any quantity of LY3434172, regardless of their eligibility for the study. | Posted | Number | Percentage of participants | Baseline through Measured Progressive Disease (Up to 8.4 Months) |
|
|
|
| Secondary | Duration of Response (DOR) | DOR is defined only for responders (participants with a confirmed CR or PR). It is measured from the date of first evidence of a confirmed CR or PR to the date of the first observed radiographically documented progressive disease (PD), or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, DoR will be censored at the date of the last complete objective progression-free disease assessment. | All participants who received any quantity of LY3434172, regardless of their eligibility for the study. | Posted | Median | 95% Confidence Interval | Months | Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 8.4 Months) |
|
|
|
| Secondary | Time to Response (TTR) | TTR is defined as the time from the date of first study treatment until the first evidence of confirmed CR or PR. | All participants who received any quantity of LY3434172, regardless of their eligibility for the study. | Posted | Median | 95% Confidence Interval | Months | Baseline to Date of CR or PR (Up to 8.4 Months) |
|
|
|
| Secondary | Disease Control Rate (DCR): Percentage of Participants Who Exhibit Stable Disease (SD), CR or PR | Disease control rate is defined as the number of participants with SD, confirmed PR, or confirmed CR (CR+PR+SD) divided by the number of enrolled participants who have received any quantity of study treatment. | All participants who received any quantity of LY3434172, regardless of their eligibility for the study. | Posted | Number | percentage of participants | Baseline through Measured Progressive Disease (Up to 8.4 Months) |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | 30 mg LY3434172 | 30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation | 1 | 4 | 1 | 4 | 4 | 4 |
| EG002 | 100 mg LY3434172 | 100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation. | 2 | 3 | 1 | 3 | 3 | 3 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
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| Cycle 1 Day 15 |
|
|
| Cycle 1 Day 15 |
|
|
| C1D15 |
|
|
| Title | Measurements |
|---|---|
|