A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas

Condition(s) studied

Investigational drug(s) / intervention(s)

EVOLVE104: EVOLVE104 is provided as a solution for injection via IV infusion

EVOLVE104: Dose levels for Phase 1b will be determined based on the outcome of Phase 1a

Study summary

The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic cancer who meet all eligibility criteria may be eligible to participate in the study.

Eligibility

Primary outcome measure(s)

• 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 EVOLVE104 — Baseline, 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 EVOLVE104 — Safety 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

Trial sites (16)

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