Spots Global Cancer Trial Database for STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis
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Trial Identification
Brief Title: STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis
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)
Study ID: NCT05519527
Study Description
Brief Summary: 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.
Detailed Description: 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Abhishek Maiti, MBBS
Affiliation: amaiti@mdanderson.org
Role: PRINCIPAL_INVESTIGATOR
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