Description:
The reason for this study is to see if the study drug LY3435151 is safe in participants with
advanced solid tumors.
Title
- Brief Title: A Study of LY3435151 in Participants With Solid Tumors
- Official Title: A Phase 1a/1b Study of LY3435151 Administered to Patients With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
17364
- SECONDARY ID:
J1Q-MC-JZIA
- NCT ID:
NCT04099277
Conditions
- Solid Tumor
- Triple-negative Breast Cancer
- Gastric Adenocarcinoma
- Head and Neck Squamous Cell Carcinoma
- Cervical Carcinoma
- High Grade Serous Ovarian Carcinoma
- Hepatocellular Carcinoma
- Undifferentiated Pleomorphic Sarcoma
- Leiomyosarcoma
Interventions
| Drug | Synonyms | Arms |
|---|
| LY3435151 | | LY3435151 + Pembrolizumab Dose Escalation |
| Pembrolizumab | | LY3435151 + Pembrolizumab Dose Escalation |
Purpose
The reason for this study is to see if the study drug LY3435151 is safe in participants with
advanced solid tumors.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| LY3435151 Dose Escalation | Experimental | LY3435151 administered intravenously (IV). | |
| LY3435151 + Pembrolizumab Dose Escalation | Experimental | LY3435151 and Pembrolizumab administered IV. | |
| LY3435151 Dose Expansion | Experimental | LY3435151 administered IV. | |
| LY3435151 + Pembrolizumab Dose Expansion | Experimental | LY3435151 and Pembrolizumab administered IV. | |
Eligibility Criteria
Inclusion Criteria:
- Participant must have certain types of cancer, which your study doctor will discuss
with you
- Participant must have stopped other forms of treatment for cancer, which your study
doctor will discuss with you
- Participant must be able and willing to provide a sample of your tumor before
beginning treatment and once while on treatment. For certain tumor types, the outcome
of the biopsy may exclude you from the study treatment (for Phase 1b)
- Participant must agree to use birth control
- Participant must have progressed through or are intolerant to therapies with known
clinical benefit, which your study doctor will discuss with you
Exclusion Criteria:
- Participant must not have a history of tuberculosis, uncontrolled HIV or uncontrolled
hepatitis B or C virus infection
- Participant must not have an autoimmune disease, which your study doctor will discuss
with you
- Participant must not use corticosteroids, which your study doctor will discuss with
you
- Participant must not have heart disease, Crohn's disease or brain cancer
- Participant must not be pregnant or breastfeeding
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of Participants with LY3435151 Dose-Limiting Toxicities (DLTs) |
| Time Frame: | Baseline through Cycle 2 (21 Day Cycles) |
| Safety Issue: | |
| Description: | Number of Participants with LY3435151 DLTs |
Secondary Outcome Measures
| Measure: | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151 |
| Time Frame: | Predose Cycle 1 Day 1 through Predose Cycle 5 Day 1 (21 Day Cycles) |
| Safety Issue: | |
| Description: | PK: Cmax of LY3435151 |
| Measure: | PK: Cmax of LY3435151 in Combination with Pembrolizumab |
| Time Frame: | Predose Cycle 1 Day 1 through Predose Cycle 5 Day 1 (21 Day Cycles) |
| Safety Issue: | |
| Description: | PK: Cmax of LY3435151 in Combination with Pembrolizumab |
| Measure: | Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) |
| Time Frame: | Baseline through Disease Progression or Death (Estimated up to 12 Months) |
| Safety Issue: | |
| Description: | ORR: Percentage of Participants with CR or PR |
| Measure: | Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease |
| Time Frame: | Baseline through Measured Progressive Disease (Estimated up to 12 Months) |
| Safety Issue: | |
| Description: | DCR: Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease |
| Measure: | Duration of Response (DoR) |
| Time Frame: | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 12 Months) |
| Safety Issue: | |
| Description: | DoR |
| Measure: | Time to Response (TTR) |
| Time Frame: | Baseline to Date of CR or PR (Estimated up to 12 Months) |
| Safety Issue: | |
| Description: | TTR |
| Measure: | Progression Free Survival (PFS) |
| Time Frame: | Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 12 Months) |
| Safety Issue: | |
| Description: | PFS |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | Eli Lilly and Company |
Trial Keywords
- immunotherapy
- CD226 agonist
Last Updated
April 15, 2020
