Trials / Recruiting
RecruitingNCT05614739
FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 535 (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LOXO-435 | Oral |
| DRUG | Pembrolizumab | IV |
| DRUG | enfortumab vedotin | IV |
Timeline
- Start date
- 2023-01-12
- Primary completion
- 2027-06-01
- Completion
- 2027-06-01
- First posted
- 2022-11-14
- Last updated
- 2026-03-23
Locations
83 sites across 14 countries: United States, Australia, Canada, China, France, Germany, Israel, Italy, Japan, Netherlands, Norway, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05614739. Inclusion in this directory is not an endorsement.