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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Werewolf Therapeutics, Inc.
Study ID
NCT05479812
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • WTX-124 — DRUG
    Investigation Product Monotherapy
  • pembrolizumab — DRUG
    Investigation Product in combination with approved therapy

Study Details

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 or metastatic solid tumors.

Key Dates

Start date
May 20, 2022
Status verified
May 2025
Primary completion
Jul 1, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: WTX-124 monotherapy dose escalation
    WTX-124 monotherapy dose escalation
  • Experimental: WTX-124 in combination with pembro dose escalation
    WTX-124 in combination with pembrolizumab (pembro) dose escalation
  • Experimental: Arm A: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic RCC.
    Arm A: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic RCC.
  • Experimental: Arm B: WTX-124 monotherapy dose expansion. Advanced or metastatic cutaneous malignant melanoma.
    Arm B: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cutaneous malignant melanoma.
  • Experimental: Arm C: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cSCC.
    Arm C: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cSCC.
  • Experimental: Arm D: WTX-124 in combination with pembro dose expansion. Advanced or metastatic RCC.
    Arm D: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic RCC.
  • Experimental: Arm E: WTX-124 with pembro dose expansion. Advanced or metastatic cutaneous melanoma.
    Arm E: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic cutaneous melanoma.
  • Experimental: Arm F: WTX-124 in combination with pembro dose expansion. Advanced/metastatic PD-L1-positive NSCL
    Arm F: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic PD-L1-positive NSCLC lines.

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy [ Time Frame: 4 weeks ]

Locations (14)

FacilityCityStateZIPSite coordinators
HonorHealthScottsdaleArizona85258-
Moffitt Cancer CenterTampaFlorida33612-
Emory Winship Cancer InstituteAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202-
Minnesota Oncology Hematology, P.A.Maple GroveMinnesota55369-
Hackensack University Medical CenterHackensackNew Jersey07601-
Roswell Park Comprehensive Cancer CareBuffaloNew York14203-
Westchester Medical CenterHawthorneNew York10532-
Providence Cancer Institute Franz ClinicPortlandOregon97213-
Texas Oncology - Austin MidtownAustinTexas78705-1165-
University of Texas Southwestern Medical CenterDallasTexas75390-8852-
NEXT OncologyHoustonTexas77054-
NEXT OncologySan AntonioTexas78229-

Find similar trials in Scottsdale, AZ

By research site
HonorHealth· Scottsdale, AZMoffitt Cancer Center· Tampa, FLEmory Winship Cancer Institute· Atlanta, GANorthwestern University· Chicago, ILIndiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INMinnesota Oncology Hematology, P.A.· Maple Grove, MN

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