The goal of this clinical trial is to evaluate the safety and tolerability of the study drug WTX-330 when administered using a fixed dose regimen or a step-up dose regimen in adult patients with selected advanced or metastatic solid tumors or lymphoma. In addition to safety and tolerability, the study aims to: * determine the maximum initial dose of WTX-330 that may be used in the step-up dose regimen * determine whether the step-up dose regimen can increase WTX-330 exposure in patients due to improved tolerability * determine the maximum tolerated dose (MTD) of WTX-330 and/or recommended dose for expansion (RDE) for each regimen * evaluate the antitumor activity of WTX-330 * characterize the pharmacokinetic (PK) profile of WTX-330 * characterize the interferon gamma (IFNγ) profile after treatment with WTX-330 * evaluate changes in immunological biomarkers * determine the impact of WTX-330 on overall survival (OS) Study participants will participate in a dose- and regimen-finding phase (Part 1) followed by a dose expansion phase (Part 2) where they will be assigned to one of three arms (A, B and C).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Investigational Product
HonorHealth Research Institute
Scottsdale, Arizona, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
NEXT Oncology
San Antonio, Texas, United States
Incidence of Dose Limiting Toxicities (DLTs)
Time frame: 4 weeks
Incidence of treatment emergent adverse events
Time frame: 24 months
Incidence of changes in clinical laboratory abnormalities
Time frame: 24 months
Overall response rate (ORR) by response evaluation criteria in solid tumors (RECIST) 1.1 and the immune-overall response rate (iORR) by immune RECIST (iRECIST; Part 2, Arms A and B) or response by Lugano classification (Part 2, Arm C)
Time frame: 24 months
Duration of response (DOR) by response evaluation criteria in solid tumors (RECIST) 1.1 and immune RECIST (iRECIST; Part 2, Arms A and B) or based on Lugano classification (Part 2, Arm C)
Time frame: 24 months
Characterize the plasma concentrations of WTX-330, free IL-12 and interferon gamma (IFNγ)
Time frame: 24 months
Changes in PD-L1 expression in tumor biopsies
Time frame: 24 months
Duration of response (DOR) by response evaluation criteria in solid tumors (RECIST) 1.1 and immune RECIST (iRECIST; Part 1 and Part 2, Arms A and B) or based on Lugano classification (Part 2, Arm C)
Time frame: 24 months
Progression-free survival (PFS) by response evaluation criteria in solid tumors (RECIST) 1.1 and immune RECIST (iRECIST; Part 1 and Part 2, Arms A and B) or based on Lugano classification (Part 2, Arm C)
Time frame: 24 months
Overall survival (OS) after treatment with WTX-330 in Part 2 based on death, start of new anticancer therapies, withdrawal of consent or lost to follow-up
Time frame: 36 months
Incidence of WTX-330 antidrug antibodies
Time frame: 24 months
Titers of WTX-330 antidrug antibodies
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.