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

Description

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.

Conditions

Advanced Solid Tumors, B-cell Non-Hodgkin Lymphomas

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California San Francisco (UCSF), San Francisco, California, United States, 94102

Aurora

Regents of the University of Colorado, Aurora, Colorado, United States, 80045

New Haven

Yale University, New Haven, Connecticut, United States, 06520- 8087

Houston

University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Histological or cytologically confirmed advanced solid tumor or B-NHL which have relapsed from or been refractory to all locally available standard therapies.
  • 2. Adequate hepatic function:
  • 1. AST and ALT ≤ 2.5×times ULN (≤ 5 × ULN if liver metastases).
  • 2. Total bilirubin ≤ 1.5×ULN (except Gilbert syndrome).
  • 3. Lipase and amylase ≤ 2×ULN.
  • 3. Adequate renal function: calculated creatinine clearance of ≥ 40 mL/min using the Cockroft- Gault formula.
  • 4. Adequate bone marrow function without growth factors or blood transfusion within 7 days of the first dose of study treatment.
  • 1. Absolute neutrophil count (ANC) ≥ 1.5×109/L.
  • 2. Platelet count ≥ 100×109/L.
  • 3. Hemoglobin ≥ 90 g/L.
  • 1. Patients with CNS malignancies, except those who are clinically stable for ≥ 4 weeks and off corticosteroids following prior surgery, whole-brain radiation, or stereotactic radiosurgery.
  • 2. Received any other investigational product or prior systemic anticancer therapy including chemotherapy, immunotherapy, radiotherapy, or other anticancer within 21 days prior to first dose of study
  • 3. Grade ≥3 irAEs or irAEs that lead to discontinuation of prior immunotherapy.8. Other primary malignancies developed within 5 years prior to the first dose of the study treatment
  • 4. Other primary malignancies developed within 5 years prior to the first dose of the study treatment
  • 5. Have active or previous autoimmune diseases that are likely to recur or are at risk of such diseases judged by the investigator.
  • 6. Major cardiovascular disease
  • 7. Active hepatitis B and/or hepatitis C (HBV-DNA or HCV-RNA detectable by local laboratory, respectively).
  • 8. Patients with history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
  • 9. A history of allograft organ transplantation for solid tumor or allogeneic hematopoietic stem cell transplantation for B-NHL patients).
  • 10. Patients who are pregnant or lactating.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Antengene Biologics Limited,

Study Record Dates

2026-06-30