535 Participants Needed

LOXO-435 for Bladder Cancer

(FORAGER-1 Trial)

Recruiting at 125 trial locations
PA
Tm
Overseen ByThere 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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

C1

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

Are You a Good Fit for This Trial?

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.
See 11 more

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.
See 6 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Phase 1b: Cohort B5 LOXO-435 Plus Pembrolizumab Plus Enfortumab VedotinExperimental Treatment3 Interventions
Group II: Phase 1b: Cohort B3 LOXO-435 Plus PembrolizumabExperimental Treatment2 Interventions
Group III: Phase 1b: Cohort B1, B2, B4, and C1 LOXO-435 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Group IV: Phase 1a: Cohort A2 LOXO-435 Monotherapy Dose OptimizationExperimental Treatment1 Intervention
Group V: Phase 1a: Cohort A1 LOXO-435 Monotherapy Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

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 profile image

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 profile image

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

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