Dose Escalation Study of WTX-124 as Monotherapy and in Combination With Pembrolizumab (Pembro) in Patients With Selected Advanced or Metastatic Solid Tumors

Active:	Yes
Cancer Type:	Melanoma	NCT ID:	NCT05479812
Trial Phases:	Phase I	Protocol IDs:	WTX-124x2101 (primary) NCI-2022-08451
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Werewolf Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05479812

Summary

A first-in-human, Phase I, open-label, multicenter study of WTX-124 administered as
monotherapy and in combination with pembrolizumab to patients with advanced solid tumors.

Objectives

This is a first-in-human, Phase I, open-label, multicenter study designed to evaluate the
safety, tolerability and preliminary efficacy of WTX-124, a conditionally-activated IL-2
prodrug, when administered as monotherapy and in combination with pembrolizumab, for the
treatment of patients with advanced solid tumors. Part 1 of the study is dose escalation of
WTX-124, both as monotherapy and in combination with pembrolizumab. Part 2 is comprised of
four arms in which WTX-124 will be administered as monotherapy and in combination with
pembrolizumab to patients with advanced or metastatic cutaneous malignant melanoma or
advanced or metastatic renal cell carcinoma.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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