The purpose of this study is to find out whether the study drug, LY4170156, is safe,tolerable and effective in participants with advanced solid tumors. The study isconducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib(dose-expansion). The study will last up to approximately 4 years.
Not Provided
Drug: LY4170156
Intravenous
Other Name: sofetabart mipitecan
Drug: bevacizumab
IV
Drug: carboplatin
IV
Drug: Itraconazole
oral
Drug: pembrolizumab
IV
Inclusion Criteria:
- Have one of the following solid tumor cancers:
- Dose Escalation: Ovarian (epithelial ovarian, primary peritoneal, and fallopian
tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer
(NSCLC), triple negative breast cancer (TNBC), pancreatic cancer, or colorectal
cancer (CRC)
- Dose Optimization: Ovarian (epithelial ovarian, primary peritoneal, and
fallopian tube) and endometrial cancer
- Dose Expansion: Low grade serous ovarian cancer, cervical cancer, NSCLC, and
TNBC
Exclusion Criteria:
- Individual with known or suspected uncontrolled central nervous system (CNS)
metastases
- Individual with history of carcinomatous meningitis
- Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic
infection
- Individual with evidence of corneal keratopathy or history of corneal transplant
- Any serious unresolved toxicities from prior therapy
- Significant cardiovascular disease
- Prolongation of QT interval corrected for heart rate using Fridericia's formula
(QTcF) ≥ 470 milliseconds (ms)
- History of pneumonitis/interstitial lung disease
- Individuals who are pregnant, breastfeeding or plan to breastfeed during study or
within 30 days of last dose of study intervention
HonorHealth
Scottsdale, Arizona, United States
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, United States
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, United States
NYU Langone Health - Long Island
Mineola, New York, United States
New York University (NYU) Clinical Cancer Center
New York, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University (OSU) Wexner Medical Center
Columbus, Ohio, United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
START Mountain Region
West Valley City, Utah, United States
Cancer Research SA
Adelaide, Australia
Icon Cancer Centre South Brisbane
QLD, Australia
Centre Leon Berard
Lyon, France
Institut de Cancerologie de l'Ouest - site St-Herblain
Saint-Herblain, France
Oncopole Claudius Regaud
Toulouse, France
Istituto Europeo di Oncologia
Milan, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Shizuoka Cancer Center
Shizuoka, Japan
National Cancer Center Hospital
Tokyo, Japan
Cancer Institute Hospital of JFCR
Tokyo, Japan
National Cancer Center
Goyang-si Gyeonggi-do, South Korea
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director
Eli Lilly and Company