Vepugratinib for Bladder Cancer

(FORAY Trial)

Not yet recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, vepugratinib, to determine its effectiveness for certain types of bladder cancer. The focus is on two types: low-grade, intermediate-risk non-muscle invasive bladder cancer (which hasn't spread into the muscle) and low-grade upper tract urothelial carcinoma (cancer in the tubes connecting the kidney to the bladder). Participants will take vepugratinib orally to evaluate its efficacy and safety. Suitable candidates have a confirmed diagnosis of one of these cancer types and a specific genetic marker called FGFR3. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that vepugratinib is likely to be safe for humans?

Research shows that vepugratinib is under study to determine its safety for treating bladder cancer. Although specific safety details for vepugratinib in humans are not available, its progression to Phase 2 clinical trials indicates it has passed initial safety tests, suggesting it is considered safe enough for testing in more people.

For patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG IR NMIBC), treatments like UGN-102 have been explored as potential alternatives to surgery. While UGN-102 differs from vepugratinib, its development for similar conditions indicates an interest in safer, non-surgical treatments. However, specific safety information for vepugratinib in these conditions is not available.

In summary, while detailed safety data for vepugratinib is lacking, its advancement to Phase 2 trials suggests a level of safety that permits further research. Participants should consult their healthcare providers to discuss any concerns and better understand the potential risks and benefits.12345

Why do researchers think this study treatment might be promising for bladder cancer?

Vepugratinib is unique because it targets bladder cancer with a novel approach. Unlike current standard treatments like Bacillus Calmette-Guérin (BCG) or chemotherapy, Vepugratinib is administered orally, which may offer a more convenient option for patients. Researchers are excited about its potential to treat low-grade intermediate-risk non-muscle invasive bladder cancer and low-grade upper tract urothelial carcinoma by directly inhibiting specific pathways involved in cancer cell growth. This targeted mechanism could lead to fewer side effects and improved outcomes compared to traditional therapies.

What evidence suggests that vepugratinib might be an effective treatment for bladder cancer?

Research suggests that vepugratinib, a drug with potential for treating bladder issues, might be effective for low-grade, intermediate-risk non-muscle invasive bladder cancer (LG IR NMIBC). In this trial, participants in Cohort A will receive vepugratinib for LG IR NMIBC. Although specific data on vepugratinib for this cancer is lacking, similar treatments like UGN-102 have shown lasting positive results, suggesting that vepugratinib might work similarly.

For low-grade upper tract urothelial carcinoma (LG UTUC), participants in Cohort B will receive vepugratinib. Studies on similar treatments have shown that many patients experience complete recovery, with 42 out of 71 patients achieving this outcome. These encouraging results stem from targeting specific pathways that promote cancer growth, which vepugratinib also aims to do.13678

Who Is on the Research Team?

1(

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 low-grade, intermediate-risk non-muscle invasive bladder cancer or low-grade upper tract urothelial cancer. Participants should not have muscle-invasive disease and must meet other health requirements set by the study team.

Inclusion Criteria

I am able to care for myself and do daily activities.
I have low-grade, intermediate-risk non-muscle invasive bladder cancer now.
I have a confirmed FGFR3 mutation or fusion in my cancer.
See 2 more

Exclusion Criteria

I have had local treatment within the last 8 weeks.
I have upper tract urothelial cancer present at the same time as my main diagnosis.
I have had high-grade urothelial carcinoma or carcinoma in situ within the past 3 years.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Vepugratinib orally for the treatment of low-grade, intermediate-risk non-muscle invasive bladder cancer or low-grade upper tract urothelial carcinoma

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Vepugratinib

Trial Overview

The study is testing a new drug called vepugratinib to see how well it works and how safe it is in treating certain types of early-stage bladder and urinary tract cancers. The treatment period can last up to 5 years.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cohort B: VepugratinibExperimental Treatment1 Intervention
Group II: Cohort A: VepugratinibExperimental 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

Citations

UGN-102 Emerges As Potential Surgical Alternative for ...

“These interim data demonstrate that primary chemoablation of low-grade, intermediate-risk non–muscle-invasive bladder cancer using UGN-102 ...

Intermediate-risk Non-muscle-invasive Bladder Cancer

Final recommendations achieved >75% agreement. KEY FINDINGS AND LIMITATIONS: The IBCG recommends inclusion of only low-grade (LG; G1 and G2) ...

Intermediate-risk Non-muscle-invasive Bladder Cancer

The IBCG recommends defining IR NMIBC as any TaLG tumor that is either recurrent or multifocal or has size ≥3 cm, OR any T1LG tumor. If the 3 ...

UGN-102 shows better results after 12 months of treatment for ...

UGN-102 shows better results after 12 months of treatment for low-grade intermediate- ...

Maximizing NMIBC Outcomes: Personalized, Risk-Adapted ...

Bladder cancer experts review modern intravesical therapies and share strategies for personalizing treatment plans for patients across the NMIBC spectrum.

UGN-102 for Recurrent Low-Grade Intermediate-Risk ...

Purpose: – We report the duration of response to UGN-102 treatment in patients with recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer ...

Intermediate Risk Non-Muscle Invasive Bladder Urothelial ...

A finding indicating the presence of an intermediate risk bladder urothelial carcinoma that does not invade muscle.