NCT05519527

STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis

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)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Refractory T Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	Part 1 (STI-6129)	Given by vein (IV)
DRUG	Part 2 (STI-6129)	Given by vein (IV)

Timeline

• Start date: 2022-08-16
• Primary completion: 2023-02-15
• Completion: 2023-02-15
• First posted: 2022-08-29
• Last updated: 2023-08-31

Regulatory

• FDA-regulated drug study