LOXO-435 for Bladder Cancer

(FORAGER-1 Trial)

Recruiting at 124 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: CNS malignancy, CNS metastases, cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

535 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing LOXO-435, a new drug, to see if it can help treat advanced cancers with a specific genetic change. It aims to block a gene that helps cancer cells grow. The study will check the drug's safety and effectiveness in these patients. LOX may be a potential effective therapeutic target to treat colorectal cancer.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors, including bladder cancer, that have a specific gene change (FGFR3). They must have tried all standard treatments or refuse them and be in good physical condition. Pregnant women and those with uncontrolled brain metastases, serious heart conditions, unresolved side effects from prior therapies, or certain eye disorders cannot join.

Inclusion Criteria

My cancer has a specific genetic change in FGFR3 that can be targeted for treatment.

I have had at least one treatment for my advanced or metastatic cancer.

I may or may not have been treated with FGFR inhibitors before.

Exclusion Criteria

I have a serious heart condition.

Participants who are pregnant, lactating, or plan to breastfeed during the study or within 6 months of the last dose of study treatment. Participants who have stopped breastfeeding may be enrolled

Your heart's electrical activity takes longer than normal to reset between beats.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation and Optimization

Phase 1a includes dose escalation and optimization to assess safety, tolerability, and pharmacokinetics of LOXO-435 to determine the recommended phase 2 dose (RP2D).

Up to 2 months

Dose Expansion

Phase 1b includes dose expansion cohorts to evaluate the efficacy and safety of LOXO-435 at the RP2D in participants with FGFR3-altered advanced solid tumors.

Up to 30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LOXO-435

Trial Overview The study tests LOXO-435's safety and effectiveness on cancers linked to the FGFR3 gene alteration. Participants will also receive Pembrolizumab. The trial involves different cohorts based on previous treatments and genetic profiles of the tumors. It can last up to 2.5 years.

Participant Groups

Group I: Phase 1b: Cohort B5 LOXO-435 Plus Pembrolizumab Plus Enfortumab Vedotin Experimental Treatment 3 Interventions

LOXO-435 administered orally in combination with pembrolizumab administered IV and enfortumab vedotin administered IV

Group II: Phase 1b: Cohort B3 LOXO-435 Plus Pembrolizumab Experimental Treatment 2 Interventions

LOXO-435 administered orally in combination with pembrolizumab administered intravenously (IV)

Group III: Phase 1b: Cohort B1, B2, B4, and C1 LOXO-435 Monotherapy Dose Expansion Experimental Treatment 1 Intervention

LOXO-435 administered orally

Group IV: Phase 1a: Cohort A2 LOXO-435 Monotherapy Dose Optimization Experimental Treatment 1 Intervention

LOXO-435 administered orally

Group V: Phase 1a: Cohort A1 LOXO-435 Monotherapy Dose Escalation Experimental Treatment 1 Intervention

LOXO-435 administered orally

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Loxo Oncology, Inc.

Industry Sponsor

Trials

72

Recruited

11,600+

Jacob Van Naarden

Loxo Oncology, Inc.

Chief Executive Officer since 2019

A.B. in Molecular Biology from Princeton University

Dr. Jennifer Low

Loxo Oncology, Inc.

Chief Medical Officer since 2014

MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology