A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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 is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
HonorHealth
RECRUITING
Scottsdale
California
University of California, San Diego (UCSD) - Moores Cancer Center
RECRUITING
La Jolla
Michigan
South Texas Accelerated Research Therapeutics (START) Midwest
RECRUITING
Grand Rapids
New York
NYU Langone Health - Long Island
RECRUITING
Mineola
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
RECRUITING
New York
New York University (NYU) Clinical Cancer Center
RECRUITING
New York
Ohio
The Ohio State University (OSU) Wexner Medical Center
RECRUITING
Columbus
Texas
The University of Texas - MD Anderson Cancer Center
RECRUITING
Houston
Utah
START Mountain Region
RECRUITING
West Valley City
Other Locations
Australia
Cancer Research SA
RECRUITING
Adelaide
Icon Cancer Centre South Brisbane
RECRUITING
Qld
France
Centre Leon Berard
RECRUITING
Lyon
Institut de Cancerologie de l'Ouest - site St-Herblain
RECRUITING
Saint-herblain
Oncopole Claudius Regaud
RECRUITING
Toulouse
Italy
Istituto Europeo di Oncologia
RECRUITING
Milan
Istituto Clinico Humanitas
RECRUITING
Rozzano
Japan
Shizuoka Cancer Center
RECRUITING
Shizuoka
Cancer Institute Hospital of JFCR
RECRUITING
Tokyo
National Cancer Center Hospital
RECRUITING
Tokyo
Republic of Korea
National Cancer Center
RECRUITING
Goyang-si Gyeonggi-do
Spain
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2027-04
Participants
Target number of participants: 495
Treatments
Experimental: LY4170156 (Dose-escalation, Cohort A1)
Escalating doses of LY4170156 administered intravenously (IV)
Experimental: LY4170156 (Cohort A1 Parts A and C)
LY4170156 administered IV
Experimental: LY4170156 Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B)
LY4170156 administered IV and itraconazole administered orally
Experimental: LY4170156 (Dose-optimization, Cohort A2)
Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV
Experimental: LY4170156 (Enrichment Cohort A3)
Monotherapy administered IV
Experimental: LY4170156 (Combination Cohort A4)
Combination with bevacizumab administered IV
Experimental: LY4170156 (Combination Cohort A5)
Combination with carboplatin administered IV
Experimental: LY4170156 Combination with Pembrolizumab (Dose-optimization Cohort A6)
Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV with pembrolizumab
Experimental: LY4170156 (Dose-expansion, Cohort B1-B4)
LY4170156 administered IV
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company