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RECRUITING
NCT06028373
PHASE1

A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas

Sponsor: Antengene Biologics Limited

View on ClinicalTrials.gov

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

DRUG

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