Recruiting
Phase 1

LY4170156

Sponsor:

Eli Lilly and Company

Code:

NCT06400472

Conditions

Ovarian Neoplasms

Endometrial Neoplasms

Uterine Cervical Neoplasms

Carcinoma, Non-Small-Cell Lung

Triple Negative Breast Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sofe-M

bevacizumab

carboplatin

Itraconazole

pembrolizumab

Study Details

Brief summary:

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.

Conditions

Ovarian Neoplasms

Endometrial Neoplasms

Uterine Cervical Neoplasms

Carcinoma, Non-Small-Cell Lung

Triple Negative Breast Neoplasms

Study ID

NCT06400472

Start date

May 20, 2024

Status verified date

Sep, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

575 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sofe-M (Dose-escalation, Cohort A1)

Escalating doses of Sofe-M administered intravenously (IV)

experimental: Sofe-M (Cohort A1 Parts A and C)

Sofe-M administered IV

experimental: Sofe-M Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B)

Sofe-M administered IV and itraconazole administered orally

experimental: Sofe-M (Dose-optimization, Cohort A2)

Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV

experimental: Sofe-M (Enrichment Cohort A3)

Monotherapy administered IV

experimental: Sofe-M (Combination Cohort A4)

Combination with bevacizumab administered IV

experimental: Sofe-M (Combination Cohort A5)

Combination with carboplatin administered IV

experimental: Sofe-M Combination with Pembrolizumab (Dose-optimization Cohort A6)

Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with pembrolizumab

experimental: Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7)

Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with or without bevacizumab

experimental: Sofe-M (Dose-expansion, Cohort B2-B4)

Sofe-M administered IV

experimental: Sofe-M (Dose-expansion, Cohort B1)

Sofe-M administered IV

Interventions

Sofe-M

Intravenous

bevacizumab

IV

carboplatin

IV

Itraconazole

oral

pembrolizumab

IV

Primary outcome measure

  • Phase 1a: To determine the recommended phase 2 dose (RP2D) of Sofe-M (LY4170156) [ Time Frame: 1 Cycle (21 or 28 days) ]
  • Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with bevacizumab [ Time Frame: 1 Cycle (21 or 28 days) ]
  • Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with carboplatin [ Time Frame: 1 Cycle (21 or 28 days) ]
  • Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with pembrolizumab [ Time Frame: 1 Cycle (21 or 28 days) ]
  • Phase 1b: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: Overall response rate (ORR) [ Time Frame: Up to Approximately 60 Months or 5 Years ]
  • Phase 2: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: ORR [ Time Frame: Up to Approximately 60 Months or 5 Years ]
  • Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Up to Approximately 60 Months or 5 Years ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

HonorHealth

Recruiting

Scottsdale, Arizona, United States, 85258

University of California, San Diego (UCSD) - Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

South Texas Accelerated Research Therapeutics (START) Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

NYU Langone Health - Long Island

Recruiting

Mineola, New York, United States, 11501

New York University (NYU) Clinical Cancer Center

Recruiting

New York, New York, United States, 10016

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

The Ohio State University (OSU) Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

The University of Texas - MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-4000

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Folate receptor alpha
  • NSCLC
  • Ovarian cancer
  • Cervical cancer
  • Endometrial cancer
  • Solid tumor
  • Lung cancer
  • Breast cancer
  • Pancreatic cancer
  • Colorectal cancer
  • Anti-drug conjugate
  • Phase I
  • Chemotherapy
  • sofe-m

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-04.