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Itraconazole / Ovarian Neoplasms / Uterine Cervical Neoplasms · Phase 1 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registry record describing an active Phase 1/1b/2 study of Sofe-M (LY4170156), a novel agent under investigation for advanced solid tumors. No results are posted; the record documents study design, planned enrollment, primary outcome measures, and drug combinations being tested. Interpretation of efficacy or safety is not possible until results are published.
Phase 1, Interventional, Randomized, Parallel, Open label, Treatment purpose. Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Pancreatic Neoplasm, Co…; age from 18 Years. Intervention: Sofe-M (Dose-escalation, Cohort A1); Sofe-M (Cohort A1 Parts A and C); Sofe-M Alone or with Itraconazole. Drug-Drug Interaction (D…; Sofe-M (Dose-optimization, Cohort A2); Sofe-M (Enrichment Cohort A3); Sofe-M (Combination Cohort A4); Sofe…. n = 575. 24 sites across 7 countries.
This is a clinical trial registry record describing an active Phase 1/1b/2 study of Sofe-M (LY4170156), a novel agent under investigation for advanced solid tumors. No results are posted; the record documents study design, planned enrollment, primary outcome measures, and drug combinations being tested. Interpretation of efficacy or safety is not possible until results are published.
This is a registry record only; no efficacy or safety results are posted or available for interpretation. Phase 1 design focuses on tolerability and RP2D; antitumor activity (ORR) is a secondary Phase 1b/2 measure and surrogate endpoint.
No clinical guidance can be drawn from this registry record, as the study is recruiting and results are not yet reported. The work is preliminary dose-finding and early safety assessment in a novel drug class.
This is a Phase 1/1b/2 early-stage trial registration with no posted results; it describes planned enrollment and primary endpoints only, reflecting hypothesis-generating and dose-finding work typical of first-in-human oncology studies.
As stated by the source record.
Quoted from the source exactly as published.
No clinical guidance can be drawn from this registry record, as the study is recruiting and results are not yet reported. The work is preliminary dose-finding and early safety assessment in a novel drug class.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06400472). This is a study registration, not published results. Lead sponsor: Eli Lilly and Company. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 575 participants (ESTIMATED). Conditions: Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Pancreatic Neoplasm, Colorectal Neoplasms. Interventions: DRUG: Sofe-M; DRUG: bevacizumab; DRUG: carboplatin; DRUG: Itraconazole; DRUG: pembrolizumab. Primary outcome measures: Phase 1a: To determine the recommended phase 2 dose (RP2D) of Sofe-M (LY4170156) , 1 Cycle (21 or 28 days); Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with bevacizumab , 1 Cycle (21 or 28 days); Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with carboplatin , 1 Cycle (21 or 28 days); Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with pembrolizumab , 1 Cycle (21 or 28 days); Phase 1b: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: Overall response rate (ORR) , Up to Approximately 60 Months or 5 Years; Phase 2: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: ORR , 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 , Up to Approximately 60 Months or 5 Years. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.