NCT06028373

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

A First-in-Human Phase I Study of ATG-031 in Patients With Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Antengene Biologics Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This 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. Dose Escalation Phase: approximately 30-48 patients . Dose Expansion Phase: the number of patients enrolled will depend on the number of disease cohorts to be expanded and data observed in the Dose Escalation Phase.The Dose Escalation Phase will enroll patients with advanced solid tumors. Based on data from dose escalation (e.g., adverse events \[AEs\], dose-limiting toxicity \[DLT\], efficacy data, pharmacodynamic \[PDx\] data, or pharmacokinetic \[PK\] data), the Dose Expansion Phase will enroll patients with selected advanced solid tumors or B-NHL.

Conditions

• Advanced Solid Tumors
• B-cell Non-Hodgkin Lymphomas

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-08
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2023-09-08
• Last updated: 2025-06-09

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study