A First-in-Human Phase I Study of ATG-031 in Patients With Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
Antengene Biologics Limited
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.
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 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, pharmacody…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugATG-031
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.
Locations (4)
- University of California San Francisco (UCSF)San Francisco, California
- Regents of the University of ColoradoAurora, Colorado
- Yale UniversityNew Haven, Connecticut
- University of Texas M.D. Anderson Cancer CenterHouston, Texas