LOXO-435 for Bladder Cancer
(FORAGER-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and effectiveness of a new drug, LOXO-435, for treating bladder cancer and other solid tumors with a specific gene change (FGFR3). Researchers aim to determine how well LOXO-435 works alone and in combination with other cancer treatments. People with solid tumor cancers that have this gene change and who have tried other treatments might be suitable for this study. Participants will take LOXO-435 orally, and some may receive it with other cancer drugs intravenously.
As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that LOXO-435 is generally well-tolerated when taken alone. In studies where patients took doses of 200 mg twice a day or more, most did not experience severe side effects, indicating a favorable safety profile and promising early results.
The safety of LOXO-435 combined with pembrolizumab, a common cancer treatment, has also been studied. Although specific side effects from this combination are not fully detailed, research on pembrolizumab in other treatments suggests it is usually safe.
The combination of LOXO-435 with both pembrolizumab and enfortumab vedotin is under study as well. Enfortumab vedotin has FDA approval for use with pembrolizumab, indicating a known level of safety.
Overall, early study data suggest that LOXO-435, whether used alone or with other medicines, is generally safe. However, ongoing research will provide more detailed information.12345Why are researchers excited about this trial's treatments?
Researchers are excited about LOXO-435 for bladder cancer because it offers a fresh approach compared to the current standard treatments, which often include chemotherapy and immunotherapy. LOXO-435 is a targeted therapy that works by inhibiting specific proteins involved in tumor growth, setting it apart from the broader mechanisms of existing options. Additionally, in some trial arms, LOXO-435 is combined with pembrolizumab and enfortumab vedotin, potentially enhancing its effectiveness through a multi-pronged attack on cancer cells. This combination could offer improved outcomes by harnessing the strengths of different treatment types.
What evidence suggests that this trial's treatments could be effective for bladder cancer?
In previous studies, LOXO-435 showed promising results for treating cancers with changes in the FGFR3 gene, such as bladder cancer. It demonstrated strong cancer-fighting effects and was well-tolerated, meaning patients did not experience severe side effects. In this trial, some participants will receive LOXO-435 alone, while others will receive it with pembrolizumab, a type of immune therapy that has shown even more potential in fighting cancer. Additionally, early findings suggest that adding enfortumab vedotin, another cancer drug, could enhance the combination's effectiveness. These results make LOXO-435 a hopeful option for those with FGFR3-altered cancers.12356
Who Is on the Research Team?
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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).
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LOXO-435
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
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
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
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