Last updated: April 19, 2024
Sponsor: Antengene Biologics Limited
Overall Status: Active - Recruiting
Phase
1
Condition
Lymphoma
Lymphoma, B-cell
Treatment
ATG-031
Clinical Study ID
NCT06028373
ATG-031-001
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- Histological or cytologically confirmed advanced solid tumor or B-NHL which haverelapsed 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 theCockroft- Gault formula.
- Adequate bone marrow function without growth factors or blood transfusion within 7days of the first dose of study treatment.
- Absolute neutrophil count (ANC) ≥ 1.5×109/L.
- Platelet count ≥ 100×109/L.
- Hemoglobin ≥ 90 g/L.
Exclusion
Key Exclusion Criteria:
- Patients with CNS malignancies, except those who are clinically stable for ≥ 4 weeksand off corticosteroids following prior surgery, whole-brain radiation, orstereotactic radiosurgery.
- Received any other investigational product or prior systemic anticancer therapyincluding chemotherapy, immunotherapy, radiotherapy, or other anticancer within 21days prior to first dose of study
- Grade ≥3 irAEs or irAEs that lead to discontinuation of prior immunotherapy.8. Otherprimary malignancies developed within 5 years prior to the first dose of the studytreatment
- Other primary malignancies developed within 5 years prior to the first dose of thestudy treatment
- Have active or previous autoimmune diseases that are likely to recur or are at risk ofsuch diseases judged by the investigator.
- Major cardiovascular disease
- Active hepatitis B and/or hepatitis C (HBV-DNA or HCV-RNA detectable by locallaboratory, respectively).
- Patients with history of human immunodeficiency virus (HIV) infection or acquiredimmunodeficiency syndrome (AIDS).
- A history of allograft organ transplantation for solid tumor or allogeneichematopoietic stem cell transplantation for B-NHL patients).
- Patients who are pregnant or lactating.
Study Design
Total Participants: 48
Treatment Group(s): 1
Primary Treatment: ATG-031
Phase: 1
Study Start date:
December 08, 2023
Estimated Completion Date:
June 30, 2026
Study Description
Connect with a study center
University of California San Francisco (UCSF)
San Francisco, California 94102
United StatesActive - Recruiting
Regents of the University of Colorado
Aurora, Colorado 80045
United StatesActive - Recruiting
Yale University
New Haven, Connecticut 06520- 8087
United StatesActive - Recruiting
University of Texas M.D. Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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