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Brief Title: WTX-330 in Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma
Official Title: A Phase 1 (First-In-Human [FIH]), Multi-Site, Dose Escalation and Expansion Study of WTX-330 in Adult Patients With Advanced or Metastatic Solid Tumors or Lymphoma
Study ID: NCT05678998
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
HonorHealth, Scottsdale, Arizona, United States
Emory Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Indiana University, 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