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NCT05479812 | RECRUITING | Metastatic Solid Tumor

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
Sponsor:

Werewolf Therapeutics, Inc.

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.

Condition or disease

Metastatic Solid Tumor

Advanced Solid Tumor

Intervention/treatment

WTX-124

pembrolizumab

Phase

PHASE1

Detailed Description:

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 dose expansion and is comprised of six 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2022-05-20
Estimated Primary Completion Date : 2026-07-01
Estimated Study Completion Date : 2026-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • Each patient must meet all the following criteria to participate in the study
    • 1. 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;
    • 2. 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 1 prior line of therapy
        • Combination Dose Expansion:
        • 1. Arm D: Patients with RCC who have received no more than 3 prior lines of therapy
        • 2. 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.
        • 3. Arm F: Patients with PD-L1-positive NSCLC who have received no more than 3 prior lines;
        • 3. ≥18 years of age;
        • 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
        • 5. Has at least 1 measurable lesion per RECIST 1.1(lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions);
        • 6. Agrees to undergo a pre-treatment and on-treatment biopsy of a primary or metastatic solid tumor lesion;
        • 7. Has adequate organ and bone marrow function;
        • 8. Willingness of men and women of reproductive potential to observe highly effective birth control for the duration of treatment and for 4 months following the last dose of study drug;
        • 9. Additional criteria may apply
        Exclusion Criteria
        • 1. 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;
        • 2. Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease;
        • 3. Have received prior IL-2-directed therapy;
        • 4. Have had an allogeneic tissue/solid organ transplant;
        • 5. Have known symptomatic brain metastases requiring steroids;
        • 6. Have significant cardiovascular disease;
        • 7. Have an active autoimmune disease that required systemic treatment in the past 2 years;
        • 8. Diagnosis of immunodeficiency, is on immunosuppressive therapy, or is receiving chronic systemic or enteric steroid therapy
        • 9. Major surgery (excluding placement of vascular access) within 2 weeks prior to the first dose of study drug;
        • 10. Investigational agent or anticancer therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug;
        • 11. 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;
        • 12. 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;
        • 13. 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.
        • 14. Active, uncontrolled systemic bacterial, viral, or fungal infection;
        • 15. HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease;
        • 16. Active infection as determined by hepatitis B surface antigen and hepatitis B core antibody, or hepatitis B virus DNA by quantitative polymerase chain reaction (qPCR) testing;
        • 17. Active infection as determined by hepatitis C virus (HCV) antibody or HCV RNA by qPCR testing;
        • 18. Pregnant or lactating;
        • 19. History of hypersensitivity to any of the study drug components;
        • 20. Additional criteria may apply.
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

Location Details

NCT05479812

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

HonorHealth

Scottsdale, Arizona, United States, 85258

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612

RECRUITING

United States, Georgia

Emory Winship Cancer Institute

Atlanta, Georgia, United States, 30322

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, Indiana

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States, 46202

RECRUITING

United States, Minnesota

Minnesota Oncology Hematology, P.A.

Maple Grove, Minnesota, United States, 55369

RECRUITING

United States, New Jersey

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

RECRUITING

United States, New York

Roswell Park Comprehensive Cancer Care

Buffalo, New York, United States, 14203

TERMINATED

United States, New York

Westchester Medical Center

Hawthorne, New York, United States, 10532

RECRUITING

United States, Oregon

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States, 97213

RECRUITING

United States, Texas

Texas Oncology - Austin Midtown

Austin, Texas, United States, 78705-1165

RECRUITING

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390-8852

RECRUITING

United States, Texas

NEXT Oncology

Houston, Texas, United States, 77054

RECRUITING

United States, Texas

NEXT Oncology

San Antonio, Texas, United States, 78229