A first-in-human, Phase 1, open-label, multicenter study of WTX-330 administered as a monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma.
This is a first-in-human, Phase 1, open-label, multicenter study to evaluate the safety, tolerability and preliminary efficacy of WTX-330, a conditionally-activated IL-12 prodrug, when administered as a monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma. Dose escalation will be conducted in patients with advanced and/or metastatic solid tumors who are refractory to all standard of care therapies. Dose expansion will be conducted in two arms: Arm A will enroll patients with indications for which a checkpoint inhibitor (CPI) is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1 treatment regimen, and Arm B will enroll patients with tumor types for which CPI therapy is not indicated/approved.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Investigation Product
HonorHealth
Scottsdale, Arizona, United States
Emory Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Indiana University
Incidence of Dose Limiting Toxicities (DLTs)
A DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle of treatment with WTX-330 and meets any of the criteria included in the protocol
Time frame: 4 weeks
Incidence of Treatment Emergent Adverse Events
AEs were graded and documented in accordance with NCI-CTCAE version 5.0
Time frame: 24 months
Incidence of Changes in Clinical Laboratory Abnormalities
Change from baseline is provided as baseline grade or "normal/low/high" and worst post-baseline grade.
Time frame: 24 months
Investigator-assessed Objective Response Rate (ORR) by RECIST 1.1 and Immune ORR by iRECIST (for Solid Tumors) or Response by Lugano Criteria (for Lymphomas)
RECIST = Response Evaluation Criteria in Solid Tumors
Time frame: 24 months
Plasma Concentrations of WTX-330 Cycle 1 - C Max
PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of WTX-330 Cycle 1 - Time of Maximum Concentration Observation
PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Indianapolis, Indiana, United States
Mass General Hospital
Boston, Massachusetts, United States
Facility Name: Roswell Park Comprehensive Cancer Care
Buffalo, New York, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
NEXT Oncology
San Antonio, Texas, United States
Plasma Concentrations of WTX-330 Cycle 1 - Half Life
PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of WTX-330 Cycle 1 - AUC
PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose.
Time frame: 14 days
Plasma Concentrations of WTX-330 Cycle 2 - C Max
PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of WTX-330 Cycle 2 - Time of Maximum Concentration Observation
PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of WTX-330 Cycle 2 - Half Life
PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of WTX-330 Cycle 2 - AUC
PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose.
Time frame: 14 days
Plasma Concentrations of IL-12 Cycle 1 - C Max
PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of IL-12 Cycle 1 - Time of Maximum Concentration Observation
PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of IL-12 Cycle 1 - Half Life
PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Plasma Concentrations of IL-12 Cycle 1 - AUC
PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose.
Time frame: 14 days
Plasma Concentrations of IL-12 Cycle 2 - C Max
PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of IL-12 Cycle 2 - Time of Maximum Concentration Observation
PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of IL-12 Cycle 2 - Half Life
PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Time frame: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Plasma Concentrations of IL-12 Cycle 2 - AUC
PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose.
Time frame: 14 days
Antidrug Antibody (ADA) Occurrence
ADA were measured at Baseline and Post Baseline. "Positive" post baseline applies if at least one post-baseline value was positive.
Time frame: 24 months