A Study of EVOLVE104 for Advanced Urothelial and Squamous Cell Carcinomas
This study is testing a new medicine called EVOLVE104 for people with advanced bladder cancer or certain types of squamous cell carcinoma (a type of skin cancer that can also affect the lung, esophagus, or tongue). You might be able to join if your cancer has progressed after standard treatments, or if you couldn't receive those treatments. The main goals are to see how safe EVOLVE104 is, what side effects it might cause, and to find the best dose. Researchers will also look at how well the medicine works. This study plans to enroll about 160 participants.
- Study design
- This is a Phase 1a/1b study, which means it's an early-stage study to test safety and find the right dose. It is expected to enroll about 160 participants.
- What's involved
- You would receive EVOLVE104 as an intravenous (IV) infusion. Treatment is expected to last about 10 months, or until your disease progresses or side effects become too severe.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from the start of the study through its completion, which is expected to be an average of 10 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
At a glance
Conditions
Where it's being run
15 sites across 10 statesStudy leadership
- EvolveImmune Study Team · STUDY_DIRECTOR · EvolveImmune United, Inc
Who to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)Baseline, through study completion, an average of 10 months.
TEAEs will be assessed during routine study visits and compared to Baseline to continuously evaluate safety and tolerability
- Number of patients with Dose Limiting Toxicities (DLTs)Baseline, through study completion, an average of 10 months.
Protocol-defined potential DLTs will be assessed by the Safety Review Committee at routine intervals.
- To determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) for EVOLVE104Baseline, through study completion, an average of 10 months.
Safety evaluations will occur consistently for each subject and across patients to assess MTD or RDE. Evaluations include analysis of TEAEs as well as ongoing assessments of laboratories, ECGs and physical examinations.
- To determine the recommended phase 2 dose (RP2D) of EVOLVE104Safety evaluations will be done as described above. PK and PD to be done each cycle (28 days) at pre-dose and post dose starting Day 1 at various time points, dependent upon treatment regimen assigned, through study completion, an average of 10 months.
Selection of the RP2D will be based on the aggregate safety, efficacy, PK, and PD observations for the entire study