A Phase 1b/2 Multisite Dose-finding and Expansion Study of WTX-330 in Adult Patients With Selected Advanced or Metastatic Solid Tumors or Lymphoma

StatusCompleted
PhasePhase 1/2
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Final enrollment: 24 participants (planned 100)
    • Primary completion date changed from estimate of Aug 2028 to Apr 23, 2026
    • Start date: May 7, 2025 to Apr 21, 2025
    • Eligibility criteria expanded, about 35 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 5 of 5 sites
    v3
  3. Study sites: 1 to 5
    • Start date changed from estimate of Apr 2025 to May 7, 2025
    v2
  4. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to evaluate the safety and tolerability of the study drug WTX-330 when administered using a fixed dose regimen or a step-up dose regimen in adult patients with selected advanced or metastatic solid tumors or lymphoma. In addition to safety and tolerability, the study aims to: * determine the maximum initial dose of WTX-330 that may be used in the step-up dose regimen * determine whether the step-up dose regimen can increase WTX-330 exposure in patients due to improved tolerability * determine the maximum tolerated dose (MTD) of WTX-330 and/or recommended dose for expansion (RDE) for each regimen * evaluate the antitumor activity of WTX-330 * characterize the pharmacokinetic (PK) profile of WTX-330 * characterize the interferon gamma (IFNγ) profile after treatment with WTX-330 * evaluate changes in immunological biomarkers * determine the impact of WTX-330 on overall survival (OS) Study participants will participate in a dose- and regimen-finding phase (Part 1) followed by a dose expansion phase (Part 2) where they will be assigned to one of three arms (A, B and C).
Trial Details
NCT Number NCT06939283
Lead Sponsor Werewolf Therapeutics, Inc.
Conditions
(from sponsor)		 Advanced or Metastatic Solid Tumors, Non-Hodgkin Lymphoma
Related terms Lymphoma, Non-Hodgkin, Neoplasms
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov