Status:
RECRUITING
A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
Lead Sponsor:
Antengene Biologics Limited
Conditions:
Advanced Solid Tumors
B-cell Non-Hodgkin Lymphomas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 Expa...
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 Escalati...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
December 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06028373
Start Date
December 8 2023
End Date
June 30 2027
Last Update
June 9 2025
Active Locations (4)
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1
University of California San Francisco (UCSF)
San Francisco, California, United States, 94102
2
Regents of the University of Colorado
Aurora, Colorado, United States, 80045
3
Yale University
New Haven, Connecticut, United States, 06520- 8087
4
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030