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A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
NCT06028373 · Antengene Corporation
In plain English
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Official title
A First-in-Human Phase I Study of ATG-031 in Patients With Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
About this study
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.
Eligibility 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.
Study design
Enrollment target: 80 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-12-08
Estimated completion: 2027-06-30
Last updated: 2025-06-09
Interventions
Drug: ATG-031
Primary outcomes
- • AE (90 days after last dose of treatment)
- • DLT (at the end of cycle 2 ( each cycle is 21 days))
- • RP2D (at the end of dose escalation, about 1 year)
Sponsor
Antengene Biologics Limited · industry
Contacts & investigators
ContactAshley Liu · contact · ting.liu@antengene.com · 0431292256
All locations (4)
University of California San Francisco (UCSF)Recruiting
San Francisco, California, United States
Regents of the University of ColoradoRecruiting
Aurora, Colorado, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
University of Texas M.D. Anderson Cancer CenterRecruiting
Houston, Texas, United States