What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as chemotherapy, radiation therapy, and newer therapeutic agents like FX-909, have a range of side effects. Chemotherapy can cause neutropenic sepsis, nausea, vomiting, hair loss, and increased risk of infection. Radiation therapy may lead to bladder irritation, increased urinary frequency, and bowel dysfunction. Newer agents like FX-909, while still under investigation, may have side effects including gastrointestinal disturbances, fatigue, and potential hematologic toxicity. It is crucial for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Several FDA-approved treatments for bladder cancer include targeted therapies and immunotherapies. Erdafitinib, an FGFR inhibitor, is approved for patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations. Immunotherapies such as Atezolizumab and Pembrolizumab, which are checkpoint inhibitors targeting PD-L1 and PD-1 respectively, have also been approved for advanced urothelial carcinoma, particularly in patients who have progressed during or after platinum-containing chemotherapy. Enfortumab vedotin, an antibody-drug conjugate targeting Nectin-4, is another approved option for patients who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy.

What other types of research exist?

Promising novel alternatives to FX-909 for bladder cancer patients include: <ol> <li>Enfortumab Vedotin: An antibody-drug conjugate targeting Nectin-4, showing efficacy in patients previously treated with platinum and PD-1/PD-L1 inhibitors.</li> <li></li> </ol> Sacituzumab Govitecan: An antibody-drug conjugate targeting Trop-2, effective in patients progressing after platinum-based chemotherapy and checkpoint inhibitors. 3. Erdafitinib: A pan-FGFR inhibitor for patients with FGFR genetic alterations, demonstrating efficacy in advanced urothelial carcinoma. 4. Pembrolizumab: An immune checkpoint inhibitor (anti-PD-1) used as first-line treatment in cisplatin-ineligible patients and showing long-term benefits. 5. Atezolizumab: Another immune checkpoint inhibitor (anti-PD-L1) used in patients with locally advanced or metastatic urothelial carcinoma, particularly those ineligible for cisplatin.

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FX-909 for Bladder Cancer

Phase 1

Recruiting

Led By Gopa Iyer, MD

Research Sponsored by Flare Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 3 years

Awards & highlights

Summary

This trial tests a new tablet called FX-909 for safety and proper dosage in patients with advanced solid tumors, especially advanced urothelial carcinoma. Doctors will closely monitor patients to understand how the drug works and its effects on the body and tumors.

Who is the study for?

This trial is for adults (18+) with advanced solid tumors, including urothelial carcinoma, that have worsened after standard treatments or when such treatments aren't suitable. Participants must be in relatively good health otherwise (ECOG status 0-2), able to consent, and have a tumor sample available. Pregnant or breastfeeding women, individuals with recent serious heart issues, uncontrolled infections like HIV/HCV, severe lung function impairment, certain gastrointestinal disorders, or those who've had recent chemotherapy are excluded.

What is being tested?

The study tests the safety and appropriate dosage of FX-909 taken orally by patients with advanced cancers. It involves daily intake of FX-909 tablets while monitoring effects through regular site visits for blood tests and imaging scans like CT/MRI to assess how the body responds to the treatment over time.

What are the potential side effects?

While specific side effects of FX-909 are not listed here as it's under investigation, participants will record any outcomes from taking the drug which may include typical cancer medication side effects such as nausea, fatigue, digestive issues or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess dose-limiting toxicities, the incidence and severity of adverse events and serious adverse events associated with FX-909 (Safety and Tolerability)

Secondary study objectives

To characterize the pharmacokinetic profile of FX 909 in patients with advanced solid malignancies

To characterize the pharmacokinetic profile of FX-909 in patients with advanced solid malignancies

To define the preliminary recommended phase 2 dose of FX-909, and/or maximum tolerated dose (MTD)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Expansion ExpansionExperimental Treatment1 Intervention

When a preliminary RP2D has been identified (this dose may be equal to or below the MTD) evaluate the antitumor activity in locally advanced (unresectable) and metastatic urothelial carcinoma.

Group II: Dose EscalationExperimental Treatment1 Intervention

3+3 design, 5 dose levels,

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bladder cancer treatments primarily include chemotherapy, immunotherapy, and targeted agents. Chemotherapy, such as cisplatin-based regimens, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Immunotherapy, including checkpoint inhibitors like atezolizumab and pembrolizumab, enhances the body's immune response against cancer cells by blocking proteins that suppress immune activity. Targeted agents, which are being explored in trials like FX-909, aim to interfere with specific molecular pathways critical for cancer cell survival and proliferation. These treatments are crucial for bladder cancer patients as they offer multiple avenues to attack the cancer, potentially improving outcomes and offering options for those who may not respond to traditional therapies.

[The role of immunotherapy in the modern treatment of urothelial carcinoma].Emerging drugs for urothelial carcinoma.

Find a Location

Who is running the clinical trial?

Flare Therapeutics Inc.Lead Sponsor

Gopa Iyer, MDPrincipal InvestigatorMemorial Slone Kettering

1 Previous Clinical Trials

271 Total Patients Enrolled

Media Library

FX-909 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05929235 — Phase 1

Bladder Cancer Clinical Trial 2023: FX-909 Highlights & Side Effects. Trial Name: NCT05929235 — Phase 1

FX-909 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05929235 — Phase 1

Bladder Cancer Research Study Groups: Expansion Expansion, Dose Escalation

~49 spots leftby Sep 2026

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