A Study of LY3200882 in Participants With Solid Tumors

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.

Official Title
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A Phase 1 Study of LY3200882 in Patients With Solid Tumors

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: LY3200882
* Drug: LY3300054
* Drug: Gemcitabine
* Drug: nab-Paclitaxel
* Drug: Cisplatin
* Radiation: Intensity Modulated Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participant must have histological or cytological evidence of cancer. Have adequate organ function. Have Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1. Are able to swallow capsules and tablets. Exclusion Criteria: Have moderate or severe cardiovascular disease. Have a serious concomitant systemic disorder. Have acute leukemia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3200882 Schedule 1 Escalation<br> | Drug: LY3200882<br>* Administered orally<br>|
| Experimental: LY3200882 Schedule 2 Escalation<br> | Drug: LY3200882<br>* Administered orally<br>|
| Experimental: LY3200882 Schedule 1 Expansion<br> | Drug: LY3200882<br>* Administered orally<br>|
| Experimental: LY3200882 Schedule 2 Expansion<br> | Drug: LY3200882<br>* Administered orally<br>|
| Experimental: LY3200882 + LY3300054<br> | Drug: LY3200882<br>* Administered orally<br>Drug: LY3300054<br>* Administered intravenously<br>|
| Experimental: LY3200882 + Gemcitabine + nab-Paclitaxel<br> | Drug: LY3200882<br>* Administered orally<br>Drug: Gemcitabine<br>* Administered intravenously<br>Drug: nab-Paclitaxel<br>* Administered intravenously<br>|
| Experimental: LY3200882 + Cisplatin + Radiation<br> | Drug: LY3200882<br>* Administered orally<br>Drug: Cisplatin<br>* Administered intravenously<br>Radiation: Intensity Modulated Radiotherapy<br> <br> |
| Experimental: Japanese Arm LY3200882<br> | Drug: LY3200882<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) |  | Cycle 1 (28 days) | 
| Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) |  | Baseline through Disease Progression or Death (estimated at up to 12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Curve (AUC) (AUC[0-24]) at Steady State of LY3200882 |  | Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles) | 
| PK: AUC Zero to Infinity (AUC[0-∞]) at Steady State of LY3200882 |  | Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles) | 
| ORR: Percentage of Participants with CR or PR |  | Baseline through Disease Progression or Death (estimated at up to 12 months) | 
| Overall Survival (OS) |  | Baseline to Date of Death from Any Cause (estimated at up to 12 months) | 
| Duration of Response (DoR) |  | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months) | 
| Progression-Free Survival (PFS) |  | Baseline to Disease Progression or Death (estimated at up to 12 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TGF Beta