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Monoclonal Antibodies

ATG-031 for Cancer

Phase 1
Recruiting
Research Sponsored by Antengene Biologics Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Must not have
Major cardiovascular disease
A history of allograft organ transplantation for solid tumor or allogeneic hematopoietic stem cell transplantation for B-NHL patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of dose escalation, about 1 year
Awards & highlights

Summary

"This trial, also known as PERFORM, is studying ATG-031 in patients with advanced solid tumors or B-NHL. It includes two phases - Dose Escalation and Dose Expansion

Who is the study for?
This trial is for adults with advanced solid tumors or B-cell Non-Hodgkin Lymphomas that have not responded to standard treatments. Participants must have good kidney function, adequate blood counts without recent transfusions, and stable enzyme levels indicating proper liver function.
What is being tested?
The PERFORM study is testing a new medication called ATG-031 in two phases: first to find the safest dose (Dose Escalation Phase) and then to see how well it works at that dose (Dose Expansion Phase).
What are the potential side effects?
While specific side effects of ATG-031 are not listed, common ones for cancer drugs include fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding tendencies, and potential liver or kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood counts meet the required levels without needing transfusions or growth factors recently.
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My liver functions are within the required limits.
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My cancer has not responded to standard treatments.
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My kidneys work well enough, with a creatinine clearance of 40 mL/min or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a significant heart condition.
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I have had an organ or stem cell transplant for cancer.
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I had severe side effects from previous immunotherapy that made me stop treatment.
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I have not had any other cancer types in the last 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of dose escalation, about 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of dose escalation, about 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AE
DLT
RP2D

Trial Design

8Treatment groups
Active Control
Group I: ATG-031 dose level 1Active Control1 Intervention
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
Group II: ATG-031 dose level 5Active Control1 Intervention
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
Group III: ATG-031 dose level 6Active Control1 Intervention
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
Group IV: ATG-031 dose level 4Active Control1 Intervention
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
Group V: ATG-031 dose level 2Active Control1 Intervention
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
Group VI: ATG-031 dose level 7Active Control1 Intervention
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
Group VII: ATG-031 dose level 8Active Control1 Intervention
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
Group VIII: ATG-031 dose level 3Active Control1 Intervention
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

Find a Location

Who is running the clinical trial?

Antengene Biologics LimitedLead Sponsor
2 Previous Clinical Trials
196 Total Patients Enrolled
~30 spots leftby Dec 2025
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