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LY4257529 / Standard of Care Anticancer Therapies / Colorectal Neoplasms · Phase 1 Trial
ClinicalTrials.gov · August 6, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 clinical trial registration for LY4257496, a GRPR-targeting agent, in participants with GRPR-positive advanced cancers. The study is actively recruiting and has not yet reported results; primary endpoints include maximum tolerated dose, dose-limiting toxicities, and objective response rate depending on study phase.
Phase 1, Interventional, Non Randomized, Parallel, Open label, Basic Science purpose. Breast Neoplasms, Colorectal Neoplasms, Prostate Neoplasm, Endometrial Neoplasms, Neoplasm Metastasis, Stomach Neoplasms, Esophageal Neoplasms; age from 18 Years. Intervention: LY4257496 Phase 1a Dose Escalation (Cohort A1); LY4257496 Phase 1a Dose Optimization (Cohort A2); LY4257496 + Standard of Care Phase 1b Cohort B; LY4257496 Phase 1b Cohort C; LY4257496 Phase 1b Cohort D. Compared with: Standard of Care Anticancer Therapies. n = 421. 32 sites across 7 countries.
This is a Phase 1 clinical trial registration for LY4257496, a GRPR-targeting agent, in participants with GRPR-positive advanced cancers. The study is actively recruiting and has not yet reported results; primary endpoints include maximum tolerated dose, dose-limiting toxicities, and objective response rate depending on study phase.
No safety, tolerability, or efficacy data are available at this stage
The source did not state who this applies to in practice.
This is a clinical trial registry record for an ongoing Phase 1 study with no results posted; the study is actively recruiting and outcome data are not yet available.
As stated by the source record.
Quoted from the source exactly as published.
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 (NCT07114601). This is a study registration, not published results. Lead sponsor: Eli Lilly and Company. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 421 participants (ESTIMATED). Conditions: Breast Neoplasms, Colorectal Neoplasms, Prostate Neoplasm, Endometrial Neoplasms, Neoplasm Metastasis, Stomach Neoplasms, Esophageal Neoplasms. Interventions: DRUG: LY4257496; DRUG: Standard of Care Anticancer Therapies; DIAGNOSTIC_TEST: LY4257529. Primary outcome measures: Phase 1a Dose Escalation: Maximum Tolerated Dose of LY4257496 , From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days; Phase 1a Dose Optimization: Number of Dose Limiting Toxicities of LY4257496 , From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days; Phase 1b Dose Expansion and Optimization: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) , From C1D1 through efficacy follow-up, estimated as Week 42. Cycle = 42 weeks. Brief summary: The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.