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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 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.

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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

Neoplasm Metastasis Urinary Bladder Neoplasms Ureteral Neoplasms

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

FieldValue
Enrollment Target 535 participants
Start Date 2023-01-12
Est. Completion 2027-06
Phase Phase 1

Sponsor

Eli Lilly and Company

1,341 total trials

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What the Registry Record Tells You About NCT05614739

The ClinicalTrials.gov registry entry for NCT05614739 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 535 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 403-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (33% higher). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.