FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3

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NCT05614739 · readout ≤ 315 d

Sponsored by Eli Lilly and Company (industry) · LLY — their whole pipeline →.

Phase

Phase 1

Status

Recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

535estimated

Sites

Countries

Australia, Canada, China +11

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2023-01-12

actual

When the study began enrolling

Primary completion

Jun 2027

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Jun 2027

estimated

The whole study's end, after follow-up

First posted

2022-11-14

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-06-18

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Urinary Bladder Neoplasms
Neoplasm Metastasis
Ureteral Neoplasms

Interventions

Drug: LOXO-435 — also filed as LY3866288
Drug: Pembrolizumab
Drug: enfortumab vedotin

Primary outcomes

what the primary-completion date above is the date OF

Phase 1a: To determine the recommended dose of LOXO-435: Safety, number of participants with dose-limiting toxicities (DLTs)

measured Minimum of the first 21-day cycle of LOXO-435 treatment

Phase 1b: To evaluate the preliminary antitumor activity of LOXO-435: Overall response rate (ORR)

measured Up to approximately 30 months or 2.5 years

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

measured Up to approximately 30 months or 2.5 years

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