OncoMatch/Clinical Trials/NCT05614739
FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3
Is NCT05614739 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including LOXO-435 and Pembrolizumab for urinary bladder neoplasms.
Treatment: LOXO-435 · Pembrolizumab · enfortumab vedotin — The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined with other standard medicines that treat cancer. LOXO-435 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). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: FGFR3 pathway alteration
solid tumor cancer with an FGFR3 pathway alteration on molecular testing in tumor or blood sample that is deemed as actionable
Required: FGFR3 alteration
Presence of an alteration in FGFR3 or its ligands
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — locally advanced or metastatic
Cohort A2, B2, B3 participants must have received at least one prior regimen, and cohorts B1 and B4 participants at least 2 prior regimens, in the locally advanced or metastatic setting
Must have received: FGFR inhibitor (erdafitinib)
Cohort B1/B4: Participants must have been previously treated with erdafitinib
Cannot have received: FGFR inhibitor
Cohort B2, B5, and C1: Participants must be FGFR inhibitor naïve
Lab requirements
Cardiac function
Significant cardiovascular disease; Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF)
Significant cardiovascular disease; Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Arizona - Cancer Center · Tucson, Arizona
- City of Hope · Duarte, California
- University of California, Los Angeles (UCLA) - Division of Hematology-Oncology · Los Angeles, California
- University of California - Irvine · Orange, California
- University of California (UC) Davis Comprehensive Cancer Center · Sacramento, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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