A First-in-Human Phase I Study of ATG-031 in Patients With Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
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.
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 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.
Arms & 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.
Outcome measures
Primary
AE
Evaluate the safety and tolerability of ATG-031
Time frame: 90 days after last dose of treatment
DLT
Evaluate the safety and tolerability of ATG-031
Time frame: at the end of cycle 2 ( each cycle is 21 days)
RP2D
RP2D will be determined based on safety, tolerability, PK, and preliminary efficacy data
Time frame: at the end of dose escalation, about 1 year
Eligibility criteria
Study locations (4)
University of California San Francisco (UCSF)
San Francisco, California, 94102
Regents of the University of Colorado
Aurora, Colorado, 80045
Yale University
New Haven, Connecticut, 06520- 8087
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030