RECRUITING

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

Conditions

Metastatic Solid Tumor Advanced Solid Tumor WTX-124 pembrolizumab Tumors Cutaneous Malignant Melanoma mRCC Renal Carcinoma IL-2 Cutaneous SCC (cutaneous squamous cell carcinoma)NSCLC (non-small cell lung cancer)

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-05-20

Study Completion:2025-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05479812

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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: * 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 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	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.

Inclusion Criteria

Exclusion Criteria

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:
* 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
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

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.

Contacts and Locations

Study Contact

Study Director

CONTACT

617-675-1865

clinicaltrials@werewolftx.com

Study Locations (Sites)

HonorHealth

Scottsdale, Arizona, 85258

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

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

NEXT Oncology

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Werewolf Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-20

Study Completion Date2025-07-31

Study Record Updates

Study Start Date2022-05-20

Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

WTX-124
pembrolizumab
Tumors
Cutaneous Malignant Melanoma
mRCC
Renal Carcinoma
IL-2
Cutaneous SCC (cutaneous squamous cell carcinoma)
NSCLC (non-small cell lung cancer)

Additional Relevant MeSH Terms

Metastatic Solid Tumor
Advanced Solid Tumor