Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine UCLA
Dates
study started
completion around
Principal Investigator
by Alexandra Drakaki, MD (ucla)
Headshot of Alexandra Drakaki
Alexandra Drakaki

Description

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.

Official Title

FORAGER-1: A Phase 1, Open-Label, Multicenter Study of LOXO-435 (LY3866288) in Locally Advanced or Metastatic Solid Tumors Including Urothelial Cancer With FGFR3 Alterations

Details

This is an open-label, multi-center, phase 1 study in participants with FGFR3-altered advanced solid tumor malignancy including metastatic urothelial cancer (UC). The study will be conducted in 2 phases: Phase 1a dose escalation (Cohort A1) and dose optimization (Cohort A2) and Phase 1b dose expansion. Phase 1a will assess safety, tolerability, and pharmacokinetics of LOXO-435 to determine the optimal dose for further expansion.

Phase 1b will include 6 dose expansion cohorts to evaluate the efficacy and safety of LOXO-435 as monotherapy or in combinations with pembrolizumab with or without enfortumab vedotin.

Keywords

Urinary Bladder Neoplasms, Neoplasm Metastasis, Ureteral Neoplasms, Bladder Cancer, Bladder Urothelial Carcinoma, Urinary Bladder Cancer, Urinary Tract Cancer, Renal Pelvis Cancer, Ureter Cancer, Neoplasms, Pembrolizumab, LOXO-435, enfortumab vedotin

Eligibility

Locations

Lead Scientist at University of California Health

  • Alexandra Drakaki, MD (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 116 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of LOXO-435 in Patients With Cancer With a Change in a Gene Called FGFR3
ID
NCT05614739
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 535 study participants
Last Updated