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A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
Sponsor: Antengene Biologics Limited
Summary
ATG-031 study (alias: PERFORM) is a multicenter, open-label, Phase 1 study of ATG-031 in patients with advanced solid tumors or B-NHL. The study design includes a Dose Escalation Phase and a Dose Expansion Phase, and will enroll patients with advanced solid tumors (i.e., preferred tumor types) or relapsed/refractory (R/R) B-NHLs. The study's primary objective is to evaluate the safety and tolerability of ATG-031 and determine the RP2D(Refered Phase II dose) of ATG-031.
Official title: A First-in-Human Phase I Study of ATG-031 in Patients With Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2023-12-08
Completion Date
2027-06-30
Last Updated
2025-06-09
Healthy Volunteers
No
Interventions
ATG-031
ATG-031 will be infused Q3W on Day 1 of each cycle, at the starting dose of 0.03 mg/kg and a maximum dose of 9 mg/kg in the Dose Escalation Phase, and the defined MTD if available or OBD in the Dose Expansion Phase. Based on the emerging PK, PDx, safety, and other relevant data, SRC may decide to explore alternative dosing schedules.
Locations (4)
University of California San Francisco (UCSF)
San Francisco, California, United States
Regents of the University of Colorado
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States