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NCT05614739 · ClinicalTrials.gov registry record · Phase 1
FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3
A Phase 1 study of Neoplasm Metastasis and Urinary Bladder Neoplasms, sponsored by Eli Lilly and Company.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 535
- Enrollment target
- 20
- Study locations
NCT05614739: Recruiting Phase 1 study of Neoplasm Metastasis and Urinary Bladder Neoplasms, sponsored by Eli Lilly and Company.
NCT05614739 is a Phase 1 study of Neoplasm Metastasis and Urinary Bladder Neoplasms that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 535 participants, above the 403-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (33% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05614739, a Phase 1 study of Neoplasm Metastasis and Urinary Bladder Neoplasms, is actively recruiting participants, sponsored by Eli Lilly and Company.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 535 participants
- Enrollment target
- 20
- Study locations
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 |
What NCT05614739 shows while recruiting
NCT05614739 is an interventional study that assigns participants to a tested intervention. The registered 535 participants enrollment target is mid-sized for trials with a published cap, above the 403-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (33% higher).
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.
NCT05614739 names 20 study sites across 12 states, led by California, New York, Louisiana.
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.
What interventions are being tested in trial NCT05614739?
The interventions under investigation include: Pembrolizumab (DRUG), LOXO-435 (DRUG), enfortumab vedotin (DRUG).
Who is sponsoring clinical trial NCT05614739?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Neoplasm Metastasis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05614739's enrollment target sits among peer trials
535 11th of 41 higher than 31 of 41 other Neoplasm Metastasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasm Metastasis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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