Acute Myeloid Leukemia (AML) Clinical Trial
Official title:
A Phase 1 Study of Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory T-Acute Lymphoblastic Leukemia/Lymphoma (T-ALL) or Acute Myeloid Leukemia (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.
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 ;
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