A Study of LY3200882 in Participants With Solid Tumors

Phase 1

Active, not recruiting

Interventions: Drug: LY3200882
Drug: Cisplatin
Drug: LY3300054
Drug: Gemcitabine
Drug: nab-Paclitaxel
Radiation: Intensity Modulated Radiotherapy

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
LY3200882 + Gemcitabine + nab-Paclitaxel	nab-Paclitaxel	-
LY3200882 + Cisplatin + Radiation	LY3200882	-
LY3200882 + Cisplatin + Radiation	Cisplatin	-
LY3200882 + Cisplatin + Radiation	Intensity Modulated Radiotherapy	-
Japanese Arm LY3200882	LY3200882	-
LY3200882 Schedule 1 Escalation	LY3200882	-
LY3200882 Schedule 2 Escalation	LY3200882	-
LY3200882 Schedule 1 Expansion	LY3200882	-
LY3200882 Schedule 2 Expansion	LY3200882	-
LY3200882 + LY3300054	LY3200882	-
LY3200882 + LY3300054	LY3300054	-
LY3200882 + Gemcitabine + nab-Paclitaxel	LY3200882	-
LY3200882 + Gemcitabine + nab-Paclitaxel	Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)
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)
Overall Survival (OS)	Baseline to Date of Death from Any Cause (estimated at up to 12 months)
Progression-Free Survival (PFS)	Baseline to Disease Progression or Death (estimated at up to 12 months)

Locations (18): St Vincent's Hospital Sydney
🇦🇺
Sydney, New South Wales, Australia
Greenslopes Private Hospital
🇦🇺
Greenslopes, Queensland, Australia
CHRU de Lille
🇫🇷
Lille, France
Universitätsklinikum Würzburg A. ö. R.
🇩🇪
Würzburg, Bayern, Germany
Gustave Roussy
🇫🇷
Villejuif Cedex, France
Istituto Clinico Humanitas
🇮🇹
Rozzano, Milano, Italy
Hospital Universitario 12 de Octubre
🇪🇸
Madrid, Spain
Hospital Clínico Universitario de Valencia
🇪🇸
Valencia, Spain
Hospital Universitari Vall d'Hebron
🇪🇸
Barcelona, Spain
Weill Cornell Medical College
🇺🇸
New York, New York, United States
Princess Margaret Hospital (Ontario)
🇨🇦
Lai Chi Kok, Kowloon, Canada
Hopital Saint-Louis
🇫🇷
Paris, Cedex 10, France
Ospedale Policlinico Giambattista Rossi, Borgo Roma
🇮🇹
Verona, Italy
National Cancer Center Hospital
🇯🇵
Chuo-Ku, Tokyo, Japan
Calvary Mater Newcastle
🇦🇺
Newcastle, New South Wales, Australia
Charité Campus Virchow-Klinikum
🇩🇪
Berlin, Germany
University of Texas MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States
University of Louisville
🇺🇸
Louisville, Kentucky, United States