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
A Multicenter Phase I/Ib Dose Escalation and Expansion Study of WTX-124 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced or Metastatic Solid Tumors
3 other identifiers
interventional
150
1 country
14
Brief 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 or metastatic solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2022
Longer than P75 for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2022
CompletedFirst Submitted
Initial submission to the registry
July 14, 2022
CompletedFirst Posted
Study publicly available on registry
July 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
February 9, 2026
May 1, 2025
4.1 years
July 14, 2022
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Incidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy
4 weeks
Incidence of treatment emergent adverse events in monotherapy and combination therapy
24 months
Incidence of changes in clinical laboratory abnormalities in monotherapy and combination therapy
24 months
Dose Expansion - Incidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy
4 weeks
Dose Expansion - Incidence of treatment emergent adverse events in monotherapy and combination therapy
24 months
Dose Expansion - Incidence of changes in clinical laboratory abnormalities in monotherapy and combination therapy
24 months
Dose Expansion - Investigator-assessed objective response rate (ORR) per RECIST 1.1 and iORR by iRECIST in monotherapy and combination therapy
24 months
Secondary Outcomes (12)
Plasma concentrations of WTX-124 and free IL-2
24 months
Investigator-assessed objective response rate (ORR) per RECIST 1.1 and iORR by iRECIST in monotherapy and combination therapy
24 months
Changes in circulating immune cell populations in response to monotherapy and combination therapy
24 months
Changes in soluble cytokines in response to monotherapy and combination therapy
24 months
Changes in tumor immune profile in response to monotherapy and combination therapy
24 months
- +7 more secondary outcomes
Study Arms (8)
WTX-124 monotherapy dose escalation
EXPERIMENTALWTX-124 monotherapy dose escalation
WTX-124 in combination with pembro dose escalation
EXPERIMENTALWTX-124 in combination with pembrolizumab (pembro) dose escalation
Arm A: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic RCC.
EXPERIMENTALArm A: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic RCC.
Arm B: WTX-124 monotherapy dose expansion. Advanced or metastatic cutaneous malignant melanoma.
EXPERIMENTALArm B: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cutaneous malignant melanoma.
Arm C: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cSCC.
EXPERIMENTALArm C: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cSCC.
Arm D: WTX-124 in combination with pembro dose expansion. Advanced or metastatic RCC.
EXPERIMENTALArm D: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic RCC.
Arm E: WTX-124 with pembro dose expansion. Advanced or metastatic cutaneous melanoma.
EXPERIMENTALArm E: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic cutaneous melanoma.
Arm F: WTX-124 in combination with pembro dose expansion. Advanced/metastatic PD-L1-positive NSCL
EXPERIMENTALArm F: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic PD-L1-positive NSCLC lines.
Interventions
Investigation Product Monotherapy
Investigation Product in combination with approved therapy
Eligibility Criteria
You may qualify if:
- Each patient must meet all the following criteria to participate in the study:
- Has histological or cytological documentation of a solid tumor indication for which a CPI (e.g. anti-PD-(L)1 is indicated for all parts of the clinical study;
- Monotherapy Dose Escalation:
- Patients with relapsed/refractory locally advanced or metastatic solid tumors for which immunotherapy is approved, who have progressed on or are intolerant to standard therapy, including CPIs, or for whom no standard therapy with proven benefit exists.
- Combination Dose Escalation:
- Patients with relapsed/refractory locally advanced or metastatic solid tumors for which immunotherapy is approved, who have progressed on or are intolerant to standard therapy or for whom no standard therapy with proven benefit exists.
- Monotherapy Dose Expansion:
- Arm A: Patients with relapsed advanced or metastatic RCC who have received no more than 4 prior lines of therapy in the advanced or metastatic setting
- Arm B: Patients with relapsed advanced or metastatic cutaneous malignant melanoma who have received no more than 2 prior lines of therapy for BRAF V600 wild type and no more than 3 prior lines of therapy for BRAF V600 mutant melanoma.
- Arm C: Patients with relapsed advanced or metastatic cSCC who have received no more than 2 prior lines of systemic therapy
- Combination Dose Expansion:
- Arm D: Patients with RCC who have received no more than 3 prior lines of therapy
- Arm E: Patients with cutaneous melanoma who may be naïve to all prior therapy for advanced or metastatic disease. For BRAF wild type melanoma, patients should have received no more than 2 prior lines of therapy. For BRAF V600 mutant disease, patients should have received no more than 3 prior lines of therapy.
- Arm F: Patients with PD-L1-positive NSCLC who have received no more than 3 prior lines;
- ≥18 years of age;
- +6 more criteria
You may not qualify if:
- Have a history of another active malignancy (a second cancer) within the previous 2 years except for localized cancers that are not related to the current cancer being treated, are considered cured, and, in the opinion of the Investigator, presents a low risk of recurrence. These exceptions include, but are not limited to, basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast;
- Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease;
- Have received prior IL-2-directed therapy;
- Have had an allogeneic tissue/solid organ transplant;
- Have known symptomatic brain metastases requiring steroids;
- Have significant cardiovascular disease;
- Have an active autoimmune disease that required systemic treatment in the past 2 years;
- Diagnosis of immunodeficiency, is on immunosuppressive therapy, or is receiving chronic systemic or enteric steroid therapy
- Major surgery (excluding placement of vascular access) within 2 weeks prior to the first dose of study drug;
- Investigational agent or anticancer therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug;
- Has received prior radiotherapy within 2 weeks of start of study treatment. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease;
- Any unresolved toxicities from prior therapy greater than NCI CTCAE version 5.0 Grade 1 at the time of starting study drug with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy;
- Received a live or live-attenuated vaccine within 30 days of the first dose of study drug; Note: Administration of killed vaccines or other formats are allowed.
- Active, uncontrolled systemic bacterial, viral, or fungal infection;
- HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Werewolf Therapeutics, Inc.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (14)
HonorHealth
Scottsdale, Arizona, 85258, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, 55369, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Comprehensive Cancer Care
Buffalo, New York, 14203, United States
Westchester Medical Center
Hawthorne, New York, 10532, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213, United States
Texas Oncology - Austin Midtown
Austin, Texas, 78705-1165, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8852, United States
NEXT Oncology
Houston, Texas, 77054, United States
NEXT Oncology
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2022
First Posted
July 29, 2022
Study Start
May 20, 2022
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
February 9, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share