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 (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
Other
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 →Frequently asked questions
Is NCT05614739 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior FGFR inhibitor disqualifies patients from enrollment.
Does this trial require FGFR3?
Yes, FGFR3 pathway alteration is a required biomarker for enrollment.
Does this trial require FGFR3?
Yes, FGFR3 alteration is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages