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

NCT06028373 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ATG-031-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

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.

Conditions

Advanced Solid Tumors; B-cell Non-Hodgkin Lymphomas

Keywords

ATG-031; solid tumor; CD 24

Outcome Measures

Primary Outcomes (3)

• AE

  Evaluate the safety and tolerability of ATG-031

  90 days after last dose of treatment

• DLT

  Evaluate the safety and tolerability of ATG-031

  at the end of cycle 2 ( each cycle is 21 days)

• RP2D

  RP2D will be determined based on safety, tolerability, PK, and preliminary efficacy data

  at the end of dose escalation, about 1 year

Study Arms (8)

ATG-031 dose level 1

ACTIVE COMPARATOR

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 dose level 2

ACTIVE COMPARATOR

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 dose level 3

ACTIVE COMPARATOR

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 dose level 4

ACTIVE COMPARATOR

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 dose level 5

ACTIVE COMPARATOR

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 dose level 6

ACTIVE COMPARATOR

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 dose level 7

ACTIVE COMPARATOR

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 dose level 8

ACTIVE COMPARATOR

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

Interventions

ATG-031 DRUG

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.

ATG-031 dose level 1; ATG-031 dose level 2; ATG-031 dose level 3; ATG-031 dose level 4; ATG-031 dose level 5; ATG-031 dose level 6; ATG-031 dose level 7; ATG-031 dose level 8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antengene Biologics Limited: lead

Study Sites (4)

University of California San Francisco (UCSF)

San Francisco, California, 94102, United States

RECRUITING

Regents of the University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520- 8087, United States

RECRUITING

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Central Study Contacts

Ashley Liu

CONTACT

0431292256; ting.liu@antengene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose levels are 0.03 mg/kg、 0.1 mg/kg、0.3 mg/kg 、0.5mg/kg ,or other dose level less than 1.0mg/kg determined by SRC

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 8, 2023
• Study Start: December 8, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 9, 2025

Record last verified: 2025-06

Locations

US (4)