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FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3
NCT05614739 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG LOXO-435
- DRUG enfortumab vedotin
Study Locations (20)
California
- City of Hope — Duarte
- University of California, Los Angeles (UCLA) - Division of Hematology-Oncology — Los Angeles
- University of California - Irvine — Orange
- University of California (UC) Davis Comprehensive Cancer Center — Sacramento
- Stanford Cancer Center — Stanford
New York
- New York University (NYU) — New York
- Weill Cornell Medicine — New York
- Icahn School of Medicine at Mount Sinai — New York
- Columbia University — New York
Louisiana
- Mary Bird Perkins Cancer Center — Baton Rouge
- Ochsner Clinic Foundation — New Orleans
Arizona
- University of Arizona - Cancer Center — Tucson
Florida
- Advent Health — Orlando
Georgia
- Emory University Hospital — Atlanta
Illinois
- The University of Chicago Medical Center (UCMC) — Chicago
Indiana
- Indiana University (IU) Melvin and Bren Simon Cancer Center — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 535 participants |
| Start Date | 2023-01-12 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05614739
The ClinicalTrials.gov registry entry for NCT05614739 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 535 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Neoplasm Metastasis appearing as the primary indexed condition, and to 3 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05614739 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, New York, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05614739 about?
NCT05614739 is a clinical study titled "FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3". 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...
What is the current status of trial NCT05614739?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 535 participants. The study started on 2023-01-12. Estimated completion is 2027-06.
What conditions does trial NCT05614739 study?
This clinical trial studies the following conditions: Neoplasm Metastasis, Urinary Bladder Neoplasms, Ureteral Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05614739?
The interventions under investigation include: Pembrolizumab (DRUG), LOXO-435 (DRUG), enfortumab vedotin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05614739?
This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05614739 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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