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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06028373
Recruitment Status : Recruiting
First Posted : September 8, 2023
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Antengene Corporation ( Antengene Biologics Limited )

Study Description
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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（Refered Phase II dose） of ATG-031.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors B-cell Non-Hodgkin Lymphomas Drug: ATG-031 Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: A First-in-Human Phase I Study of ATG-031 in Patients With Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
Actual Study Start Date : December 8, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ATG-031 dose level 1

Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase.

Dose level is 0.03 mg/kg

 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.
Active Comparator: ATG-031 dose level 2

Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase.

Dose level is 0.1 mg/kg

 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.
Active Comparator: ATG-031 dose level 3

Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase.

Dose level is 0.3 mg/kg

 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.
Active Comparator: ATG-031 dose level 4

Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase.

Dose level is 1.0 mg/kg

 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.
Active Comparator: ATG-031 dose level 5

Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase.

Dose level is 2.0 mg/kg

 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.
Active Comparator: ATG-031 dose level 6

Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase.

Dose level is 4.0 mg/kg

 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.
Active Comparator: ATG-031 dose level 7

Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase.

Dose level is 6.0 mg/kg

 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.
Active Comparator: ATG-031 dose level 8

Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase.

Dose level is 9.0 mg/kg

 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.


Outcome Measures
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Primary Outcome Measures :
  1. AE [ Time Frame: 90 days after last dose of treatment ]
    Evaluate the safety and tolerability of ATG-031

  2. DLT [ Time Frame: at the end of cycle 2 ( each cycle is 21 days) ]
    Evaluate the safety and tolerability of ATG-031

  3. RP2D [ Time Frame: at the end of dose escalation, about 1 year ]
    RP2D will be determined based on safety, tolerability, PK, and preliminary efficacy data


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion 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.

Key Exclusion Criteria:

  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06028373


Contacts
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Contact: Ashley Liu 0431292256 ting.liu@antengene.com
Contact: Ran Wei 13810001510 ran.wei@antengene.com

Locations
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United States, California
University of California San Francisco (UCSF) Recruiting
San Francisco, California, United States, 94102
Contact: Bridget Keenan, PhD         
Principal Investigator: Bridget Keenan, PhD         
United States, Colorado
Regents of the University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Alexis Leal, MD         
Principal Investigator: Alexis Leal         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520- 8087
Contact: Joseph Kim, MD         
Principal Investigator: Joseph Kim, MD         
United States, Texas
University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Siqing Fu, MD         
Principal Investigator: Siqing Fu         
Sponsors and Collaborators
Antengene Biologics Limited
More Information
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Responsible Party: Antengene Biologics Limited
ClinicalTrials.gov Identifier: NCT06028373    
Other Study ID Numbers: ATG-031-001
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antengene Corporation ( Antengene Biologics Limited ):
ATG-031
solid tumor
CD 24
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases