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NCT06939283 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Non-Hodgkin Lymphoma and Advanced or Metastatic Solid Tumors, sponsored by Werewolf Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 5
- Study locations
NCT06939283 is a Phase 1 study of Non-Hodgkin Lymphoma and Advanced or Metastatic Solid Tumors that is active but no longer recruiting, run by Werewolf Therapeutics. The registered enrollment target is 100 participants, below the 151-participant average among 104 other Non-Hodgkin Lymphoma trials with a reported enrollment target (34% lower). The trial reports 5 study locations across 5 states.
The verdict
NCT06939283, a Phase 1 study of Non-Hodgkin Lymphoma and Advanced or Metastatic Solid Tumors, is active but no longer recruiting, sponsored by Werewolf Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 5
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- DRUG WTX-330
Study Locations (5)
Arizona
- HonorHealth Research Institute - Scottsdale
Georgia
- Emory Winship Cancer Institute - Atlanta
Illinois
- Northwestern University - Chicago
Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis
Texas
- NEXT Oncology - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-05-07 |
| Est. Completion | 2028-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06939283
The ClinicalTrials.gov registry entry for NCT06939283 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 151-participant average among 104 other Non-Hodgkin Lymphoma trials with a reported enrollment target (34% lower). The listed sponsor is Werewolf Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which WTX-330 is the first listed.
NCT06939283 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Arizona, Georgia, Illinois.
Frequently Asked Questions
What is clinical trial NCT06939283 about?
NCT06939283 is a clinical study titled "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". 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 stu...
What is the current status of trial NCT06939283?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2025-05-07. Estimated completion is 2028-08.
What conditions does trial NCT06939283 study?
This clinical trial studies the following conditions: Non-Hodgkin Lymphoma, Advanced or Metastatic Solid Tumors.
What interventions are being tested in trial NCT06939283?
The interventions under investigation include: WTX-330 (DRUG).
Who is sponsoring clinical trial NCT06939283?
This trial is sponsored by Werewolf Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06939283 being conducted?
This trial has 5 study locations across Arizona, Georgia, Illinois, Indiana, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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