The purpose of this study is to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion). The study will last up to approximately 5 years.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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, TNBC, and high grade endometrioid cancer
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
Primary outcome measure(s)
Phase 1a: To determine the recommended phase 2 dose (RP2D) of Sofe-M (LY4170156) — 1 Cycle (21 or 28 days) Number of participants with dose-limiting toxicities (DLTs)
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with bevacizumab — 1 Cycle (21 or 28 days) Number of participants with DLTs
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with carboplatin — 1 Cycle (21 or 28 days) Number of participants with DLTs
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with pembrolizumab — 1 Cycle (21 or 28 days) Number of participants with DLTs
Phase 1b: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: Overall response rate (ORR) — Up to Approximately 60 Months or 5 Years ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Phase 2: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: ORR — Up to Approximately 60 Months or 5 Years ORR per RECIST 1.1
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — Up to Approximately 60 Months or 5 Years A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Trial sites (24)
Facility
City
Region
Status
HonorHealth
Scottsdale
Arizona
Recruiting
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla
California
Recruiting
Emory University
Atlanta
Georgia
Not Yet Recruiting
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids
Michigan
Recruiting
NYU Langone Health - Long Island
Mineola
New York
Recruiting
New York University (NYU) Clinical Cancer Center
New York
New York
Recruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York
New York
Recruiting
The Ohio State University (OSU) Wexner Medical Center
Columbus
Ohio
Recruiting
The University of Texas - MD Anderson Cancer Center
Houston
Texas
Recruiting
START Mountain Region
West Valley City
Utah
Recruiting
Cancer Research SA
Adelaide
Australia
Recruiting
Icon Cancer Centre South Brisbane
QLD
Australia
Recruiting
Centre Leon Berard
Lyon
France
Recruiting
Institut de Cancerologie de l'Ouest - site St-Herblain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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