RecruitingPhase 1NCT06028373

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

Sponsor

Antengene Biologics Limited

Enrollment

80 participants

Start Date

Dec 8, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors B-cell Non-Hodgkin Lymphomas

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental drug called ATG-031 for people with advanced solid tumors or B-cell non-Hodgkin lymphoma (a type of blood cancer) that has stopped responding to all standard treatments. ATG-031 is a new immunotherapy-type drug designed to reactivate the immune system against cancer. **You may be eligible if...** - You are 18 or older with an advanced solid tumor or B-cell non-Hodgkin lymphoma - Your cancer has relapsed or stopped responding to all available standard therapies - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - Your cancer involves the brain or spinal fluid (CNS malignancy), unless stable for at least 4 weeks - You have had cancer treatment within the past 21 days - You have active hepatitis B, hepatitis C, or HIV - You have had a serious immune-related side effect from prior immunotherapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGATG-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.