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NCT05614739 · ClinicalTrials.gov record · last posted 2026-08-20

FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3

Study acronym: FORAGER-1
StatusRecruiting
PhasePhase 1
Started2023-01-12
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from the ClinicalTrials.gov record
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of Vepugratinib by itself or when it is combined with other medicines that treat cancer. Vepugratinib may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Study participation could last up to approximately 6 years, depending on which part of the study you join.

Protocol amendment history 3 changes detected by DataLookout

2026-08-21
Primary endpoint(s) modified
WasNumber of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration, Phase 1a: To determine the recommended dose of LOXO-435: Safety, number of participants with dose-limiting toxicities (DLTs), Phase 1b: To evaluate the preliminary antitumor activity of LOXO-435: Overall response rate (ORR)
NowComplete Response Rate (CRR) in Participants with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG IR NMIBC), Overall Response Rate (ORR), PK of Midazolam, Rosuvastatin, and Digoxin Administered Alone and in the Presence of Vepugratinib: Area Under the Concentration versus Time Curve (AUC[0-inf]), Pharmacokinetics (PK) of Vepugratinib: Area Under the Concentration versus Time Curve (AUC)
2026-08-21
Enrollment increased: 535 → 677 participants
2026-08-21
Trial arms changed: 5 → 8
Trial Details
NCT Number NCT05614739
Lead Sponsor Eli Lilly and Company
Conditions Urinary Bladder Neoplasms, Neoplasm Metastasis, Ureteral Neoplasms
Enrollment 677 participants
Start Date 2023-01-12
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-20