Your session is about to expire
← Back to Search
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 24 months
Awards & highlights
Study Summary
This trial tests a new drug combo to treat bladder cancer. It'll measure safety, how it works in the body, and how well it works.
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.Check my eligibility
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.See study design
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 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v. 5.0)), timing, seriousness, and relationship to study therapy
First Cycle Dose limiting toxicities (DLTs)
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.
Find a Location
Who is running the clinical trial?
ALX Oncology Inc.Lead Sponsor
8 Previous Clinical Trials
1,310 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is normal.My bone marrow is working well.I have been treated with a drug that boosts my immune system.I have moderate to severe nerve damage.My bladder cancer cannot be removed by surgery and has spread.I have brain metastases that are causing symptoms or are not under control.My liver is working well.I am physically able to care for myself.I have been treated with enfortumab vedotin or similar drugs before.I have an eye condition but it's under control with treatment.My diabetes has been under control for the last 3 months.I have been treated with platinum-based chemotherapy before.My bladder cancer has come back or gotten worse.I have never been treated with anti-CD47 or anti-SIRPα medications.
Research Study Groups:
This trial has the following groups:- Group 1: Evorpacept (ALX148) + Enfortumab Vedotin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings available for participation in this experiment?
"Clinical trials.gov confirms this trial is open to participants, with the first posting on November 2nd 2022 and last update taking place on January 23rd 2023."
Answered by AI
What potential adverse reactions have been observed in individuals using Evorpacept (ALX148) + Enfortumab Vedotin?
"Given the limited safety and efficacy data, Evorpacept (ALX148) + Enfortumab Vedotin received a score of 1."
Answered by AI
How many research locations are actively conducting this experiment within the city limits?
"This medicinal trial is open to enrollees at Moffitt Cancer Center in Tampa, University of Chicago Medicine in Chiacgo, and Massachusett's General in Boston. Additionally, 10 other US facilities are currently participating as well."
Answered by AI
How many people have volunteered to take part in this clinical experiment?
"ALX Oncology Inc. is responsible for conducting the trial and has mandated that a minimum of 30 participants are necessary to generate valid results. Patients may find eligible sites at Moffitt Cancer Center, Tampa or University of Chicago Medicine in Illinois."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger