What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as enfortumab vedotin, often cause side effects like fatigue, peripheral neuropathy, rash, decreased appetite, and gastrointestinal issues (nausea and diarrhea). Severe side effects can include hyperglycemia, skin reactions, and neutropenia. Combining enfortumab vedotin with other therapies, such as ALX148, may enhance efficacy but could also increase the risk of immune-related adverse events.

What prior FDA approvals exist?

Enfortumab vedotin is an FDA-approved antibody-drug conjugate used for the treatment of urothelial carcinoma, a common type of bladder cancer. It targets Nectin-4, a protein highly expressed in urothelial cancer cells, delivering a cytotoxic agent directly to the tumor. The combination of enfortumab vedotin with other therapies, such as immune checkpoint inhibitors, is being actively studied to enhance its efficacy. Other FDA-approved treatments for bladder cancer include immune checkpoint inhibitors like pembrolizumab and atezolizumab, which target PD-1/PD-L1 pathways to boost the immune system's response against cancer cells.

What other types of research exist?

Promising novel alternatives to ALX148 for bladder cancer patients include: 1) Pembrolizumab, an immune checkpoint inhibitor, which has shown efficacy as a second-line therapy. 2) Nivolumab, another immune checkpoint inhibitor, which has demonstrated benefits in recurrent metastatic urothelial carcinoma. 3) Combination therapies such as nivolumab plus ipilimumab, which have shown improved outcomes in advanced renal cell carcinoma and may be applicable to bladder cancer. 4) Targeted therapies like enfortumab vedotin alone or in combination with other agents, which continue to show promise in clinical trials.

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Microtubule Inhibitor

Evorpacept + Enfortumab Vedotin for Bladder Cancer

Phase 1

Recruiting

Research Sponsored by ALX Oncology 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 up to 5 years

Awards & highlights

Summary

This trial is testing a new treatment (ALX148) combined with another cancer drug (enfortumab vedotin) and possibly other treatments. It targets patients with urothelial carcinoma, a type of bladder cancer. ALX148 helps the immune system fight cancer, while enfortumab vedotin directly attacks the cancer cells.

Who is the study for?

This trial is for adults with advanced bladder cancer that can't be removed by surgery or has spread, and who have already tried chemotherapy and immune checkpoint inhibitors. They should not have severe nerve damage, active brain metastases, previous treatment with certain drugs like enfortumab vedotin or anti-CD47/SIRPα agents, uncontrolled eye conditions, or diabetes.

What is being tested?

The study tests Evorpacept (ALX148) in combination with Enfortumab Vedotin to see how safe they are together and how the body responds. It's an early-phase trial where all participants receive both medications to assess their combined effects on bladder cancer.

What are the potential side effects?

Potential side effects may include reactions at the infusion site, fatigue, nausea, skin rash, decreased appetite, neuropathy (nerve problems), as well as blood count changes which could increase infection risk. The severity of side effects can vary from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: Evorpacept (ALX148) + Enfortumab VedotinExperimental Treatment2 Interventions

Phase 1a Dose Escalation: Evorpacept (ALX148) infusions will be administered every two weeks. Enfortumab vedotin will be administered at 1.25 mg/kg IV on Days 1, 8, and 15 of each 28-day cycle.

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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

Enfortumab vedotin, an antibody-drug conjugate, targets Nectin-4 on urothelial carcinoma cells and delivers a cytotoxic agent to kill these cells while sparing normal cells. ALX148 enhances this effect by blocking the CD47-SIRPα interaction, a mechanism cancer cells use to avoid immune detection. This combination aims to improve immune system recognition and destruction of cancer cells, offering bladder cancer patients potentially more effective and targeted treatment options with fewer side effects.

[Mechanism of action of intravesical BCG. Biological bases and clinical applicability.][The role of immunotherapy in the modern treatment of urothelial carcinoma].

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Who is running the clinical trial?

ALX Oncology Inc.Lead Sponsor

8 Previous Clinical Trials

1,279 Total Patients Enrolled

Media Library

Enfortumab Vedotin (Microtubule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05524545 — Phase 1

Bladder Cancer Research Study Groups: Evorpacept (ALX148) + Enfortumab Vedotin

Bladder Cancer Clinical Trial 2023: Enfortumab Vedotin Highlights & Side Effects. Trial Name: NCT05524545 — Phase 1

Enfortumab Vedotin (Microtubule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05524545 — Phase 1

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