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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

NCT06939283 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-10

No results posted yet for this 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

Interventions

DRUG

WTX-330

Investigational Product

Sponsors & Collaborators

  • Werewolf Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-07
Primary Completion
2028-08-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06939283 on ClinicalTrials.gov