Primary Objective:~To assess in patients with R/R T-ALL or AML~Maximum tolerated dose of STI-6129~Phase 2 recommended dose~Safety of STI-6129~Secondary Objectives:~Efficacy of STI-6129, overall response rate (CR+CRi+MLFS)~Evaluate rate of negative measurable residual disease (MRD)~Evaluate overall survival, duration of response, event-free survival~No. of patients transitioning to stem-cell transplantation~Exploratory Objectives:~- Evaluate the association of biomarkers with safety and efficacy in patients with R/R T-ALL or AML treated with STI-6129 CD38 ADC STI-6129 - R/R T-ALL, AML
This is an open-label, phase 1b/2 trial. It is designed to identify the recommended phase 2 dose (RP2D) of STI-6129, and the safety and efficacy of this anti-CD38-Duostatin 5.2 antibody-drug conjugate (ADC) for the treatment of R/R T-ALL and AML who have exhausted standard of care treatment.