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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Investigation Product Monotherapy
Investigation Product in combination with approved therapy
HonorHealth
Scottsdale, Arizona, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory Winship Cancer Institute
Incidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy
Time frame: 4 weeks
Incidence of treatment emergent adverse events in monotherapy and combination therapy
Time frame: 24 months
Incidence of changes in clinical laboratory abnormalities in monotherapy and combination therapy
Time frame: 24 months
Dose Expansion - Incidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy
Time frame: 4 weeks
Dose Expansion - Incidence of treatment emergent adverse events in monotherapy and combination therapy
Time frame: 24 months
Dose Expansion - Incidence of changes in clinical laboratory abnormalities in monotherapy and combination therapy
Time frame: 24 months
Dose Expansion - Investigator-assessed objective response rate (ORR) per RECIST 1.1 and iORR by iRECIST in monotherapy and combination therapy
Time frame: 24 months
Plasma concentrations of WTX-124 and free IL-2
Time frame: 24 months
Investigator-assessed objective response rate (ORR) per RECIST 1.1 and iORR by iRECIST in monotherapy and combination therapy
Time frame: 24 months
Changes in circulating immune cell populations in response to monotherapy and combination therapy
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Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer Care
Buffalo, New York, United States
Westchester Medical Center
Hawthorne, New York, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, United States
...and 4 more locations
Time frame: 24 months
Changes in soluble cytokines in response to monotherapy and combination therapy
Time frame: 24 months
Changes in tumor immune profile in response to monotherapy and combination therapy
Time frame: 24 months
Investigator-assessed objective response rate (ORR) per RECIST 1.1 and iORR by iRECIST in monotherapy and combination therapy (in advanced or metastatic renal cell carcinoma and advanced or metastatic cutaneous malignant melanoma)
Time frame: 24 months
Antidrug antibody (ADA) occurrence
Time frame: 24 months
Duration of response
Time frame: 24 months
Progression free survival
Time frame: 24 months
Overall survival
Time frame: 36 months
To investigate immunological biomarkers in peripheral blood and tumor that may correlate with the treatment outcome of WTX-124 as monotherapy or in combination with pembrolizumab
Time frame: 24 months
To assess tumor biopsies for potential biomarkers of target engagement and immune pathway activation
Time frame: 24 months