NCT05678998

WTX-330 in Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma

A Phase 1 (First-In-Human [FIH]), Multi-Site, Dose Escalation and Expansion Study of WTX-330 in Adult Patients With Advanced or Metastatic Solid Tumors or Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Werewolf Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A first-in-human, Phase 1, open-label, multicenter study of WTX-330 administered as a monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma.

Detailed description

This is a first-in-human, Phase 1, open-label, multicenter study to evaluate the safety, tolerability and preliminary efficacy of WTX-330, a conditionally-activated IL-12 prodrug, when administered as a monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma. Dose escalation will be conducted in patients with advanced and/or metastatic solid tumors who are refractory to all standard of care therapies. Dose expansion will be conducted in two arms: Arm A will enroll patients with indications for which a checkpoint inhibitor (CPI) is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1 treatment regimen, and Arm B will enroll patients with tumor types for which CPI therapy is not indicated/approved.

Conditions

• Advanced or Metastatic Solid Tumors
• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	WTX-330	Investigation Product

Timeline

• Start date: 2022-12-06
• Primary completion: 2024-12-23
• Completion: 2025-02-05
• First posted: 2023-01-10
• Last updated: 2026-01-06
• Results posted: 2026-01-06

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study