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

Last updated: April 19, 2024
Sponsor: Antengene Biologics Limited
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Lymphoma, B-cell

Treatment

ATG-031

Clinical Study ID

NCT06028373
ATG-031-001
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Key Inclusion Criteria:

  1. Histological or cytologically confirmed advanced solid tumor or B-NHL which haverelapsed from or been refractory to all locally available standard therapies.
  2. Adequate hepatic function:
  3. AST and ALT ≤ 2.5×times ULN (≤ 5 × ULN if liver metastases).
  4. Total bilirubin ≤ 1.5×ULN (except Gilbert syndrome).
  5. Lipase and amylase ≤ 2×ULN.
  6. Adequate renal function: calculated creatinine clearance of ≥ 40 mL/min using theCockroft- Gault formula.
  7. Adequate bone marrow function without growth factors or blood transfusion within 7days of the first dose of study treatment.
  8. Absolute neutrophil count (ANC) ≥ 1.5×109/L.
  9. Platelet count ≥ 100×109/L.
  10. Hemoglobin ≥ 90 g/L.

Exclusion

Key Exclusion Criteria:

  1. Patients with CNS malignancies, except those who are clinically stable for ≥ 4 weeksand off corticosteroids following prior surgery, whole-brain radiation, orstereotactic radiosurgery.
  2. Received any other investigational product or prior systemic anticancer therapyincluding chemotherapy, immunotherapy, radiotherapy, or other anticancer within 21days prior to first dose of study
  3. Grade ≥3 irAEs or irAEs that lead to discontinuation of prior immunotherapy.8. Otherprimary malignancies developed within 5 years prior to the first dose of the studytreatment
  4. Other primary malignancies developed within 5 years prior to the first dose of thestudy treatment
  5. Have active or previous autoimmune diseases that are likely to recur or are at risk ofsuch diseases judged by the investigator.
  6. Major cardiovascular disease
  7. Active hepatitis B and/or hepatitis C (HBV-DNA or HCV-RNA detectable by locallaboratory, respectively).
  8. Patients with history of human immunodeficiency virus (HIV) infection or acquiredimmunodeficiency syndrome (AIDS).
  9. A history of allograft organ transplantation for solid tumor or allogeneichematopoietic stem cell transplantation for B-NHL patients).
  10. Patients who are pregnant or lactating.

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: ATG-031
Phase: 1
Study Start date:
December 08, 2023
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • University of California San Francisco (UCSF)

    San Francisco, California 94102
    United States

    Active - Recruiting

  • Regents of the University of Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Yale University

    New Haven, Connecticut 06520- 8087
    United States

    Active - Recruiting

  • University of Texas M.D. Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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