search
Back to results

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

Primary Purpose

Advanced Solid Tumors, B-cell Non-Hodgkin Lymphomas

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ATG-031
Sponsored by
Antengene Biologics Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumors focused on measuring ATG-031, solid tumor, CD 24

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Histological or cytologically confirmed advanced solid tumor or B-NHL which have relapsed from or been refractory to all locally available standard therapies. Adequate hepatic function: AST and ALT ≤ 2.5×times ULN (≤ 5 × ULN if liver metastases). Total bilirubin ≤ 1.5×ULN (except Gilbert syndrome). Lipase and amylase ≤ 2×ULN. Adequate renal function: calculated creatinine clearance of ≥ 40 mL/min using the Cockroft- Gault formula. Adequate bone marrow function without growth factors or blood transfusion within 7 days of the first dose of study treatment. Absolute neutrophil count (ANC) ≥ 1.5×109/L. Platelet count ≥ 100×109/L. Hemoglobin ≥ 90 g/L. Key Exclusion Criteria: 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. 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 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 Other primary malignancies developed within 5 years prior to the first dose of the study treatment Have active or previous autoimmune diseases that are likely to recur or are at risk of such diseases judged by the investigator. Major cardiovascular disease Active hepatitis B and/or hepatitis C (HBV-DNA or HCV-RNA detectable by local laboratory, respectively). Patients with history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). A history of allograft organ transplantation for solid tumor or allogeneic hematopoietic stem cell transplantation for B-NHL patients). Patients who are pregnant or lactating.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ATG-031

    Arm Description

    Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose levels are 0.03 mg/kg、 0.1 mg/kg、0.3 mg/kg 、1.0 mg/kg 、2.0 mg/kg、4.0 mg/kg 、6.0 mg/kg 、9.0 mg/kg.

    Outcomes

    Primary Outcome Measures

    AE
    Evaluate the safety and tolerability of ATG-031
    DLT
    Evaluate the safety and tolerability of ATG-031
    RP2D
    RP2D will be determined based on safety, tolerability, PK, and preliminary efficacy data

    Secondary Outcome Measures

    Full Information

    First Posted
    August 25, 2023
    Last Updated
    August 31, 2023
    Sponsor
    Antengene Biologics Limited
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06028373
    Brief Title
    A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
    Official Title
    A First-in-Human Phase I Study of ATG-031 in Patients With Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 13, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    June 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Antengene Biologics Limited

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Solid Tumors, B-cell Non-Hodgkin Lymphomas
    Keywords
    ATG-031, solid tumor, CD 24

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Sequential Assignment
    Model Description
    Dose levels are 0.03 mg/kg、 0.1 mg/kg、0.3 mg/kg 、1.0 mg/kg 、2.0 mg/kg、4.0 mg/kg 、6.0 mg/kg 、9.0 mg/kg
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ATG-031
    Arm Type
    Experimental
    Arm Description
    Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose levels are 0.03 mg/kg、 0.1 mg/kg、0.3 mg/kg 、1.0 mg/kg 、2.0 mg/kg、4.0 mg/kg 、6.0 mg/kg 、9.0 mg/kg.
    Intervention Type
    Drug
    Intervention Name(s)
    ATG-031
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    AE
    Description
    Evaluate the safety and tolerability of ATG-031
    Time Frame
    90 days after last dose of treatment
    Title
    DLT
    Description
    Evaluate the safety and tolerability of ATG-031
    Time Frame
    at the end of cycle 2 ( each cycle is 21 days)
    Title
    RP2D
    Description
    RP2D will be determined based on safety, tolerability, PK, and preliminary efficacy data
    Time Frame
    at the end of dose escalation, about 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key Inclusion Criteria: Histological or cytologically confirmed advanced solid tumor or B-NHL which have relapsed from or been refractory to all locally available standard therapies. Adequate hepatic function: AST and ALT ≤ 2.5×times ULN (≤ 5 × ULN if liver metastases). Total bilirubin ≤ 1.5×ULN (except Gilbert syndrome). Lipase and amylase ≤ 2×ULN. Adequate renal function: calculated creatinine clearance of ≥ 40 mL/min using the Cockroft- Gault formula. Adequate bone marrow function without growth factors or blood transfusion within 7 days of the first dose of study treatment. Absolute neutrophil count (ANC) ≥ 1.5×109/L. Platelet count ≥ 100×109/L. Hemoglobin ≥ 90 g/L. Key Exclusion Criteria: 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. 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 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 Other primary malignancies developed within 5 years prior to the first dose of the study treatment Have active or previous autoimmune diseases that are likely to recur or are at risk of such diseases judged by the investigator. Major cardiovascular disease Active hepatitis B and/or hepatitis C (HBV-DNA or HCV-RNA detectable by local laboratory, respectively). Patients with history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). A history of allograft organ transplantation for solid tumor or allogeneic hematopoietic stem cell transplantation for B-NHL patients). Patients who are pregnant or lactating.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ashley Liu
    Phone
    0431292256
    Email
    ting.liu@antengene.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ran Wei
    Phone
    13810001510
    Email
    ran.wei@antengene.com

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs