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A Study of Sofe-M in Participants With Selected Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started2024-05-20
View on ClinicalTrials.gov ↗
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.

Amendment history 6 changes detected by DataLookout

2026-09-05
Primary endpoint(s) modified
WasNumber of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration, Phase 1a: To determine the RP2D or optimal dose of LY4170156 with bevacizumab, Phase 1a: To determine the RP2D or optimal dose of LY4170156 with carboplatin, Phase 1a: To determine the RP2D or optimal dose of LY4170156 with pembrolizumab, Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156, Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR)
NowNumber of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration, Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with bevacizumab, Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with carboplatin, Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with pembrolizumab, Phase 1a: To determine the recommended phase 2 dose (RP2D) of Sofe-M (LY4170156), Phase 1b: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: Overall response rate (ORR), Phase 2: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: ORR
2026-09-05
Enrollment increased: 495 → 575 participants
2026-09-05
Trial arms changed: 9 → 11
2026-09-05
Primary completion pushed: 2027-02 → 2029-06
2026-09-05
Completion pushed: 2027-04 → 2029-06
2026-09-05
Interventions modified
Trial Details
NCT Number NCT06400472
Lead Sponsor Eli Lilly and Company
Conditions Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Pancreatic Neoplasm, Colorectal Neoplasms
Enrollment 575 participants
Start Date 2024-05-20
Primary Completion 2029-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-04