Acute Myeloid Leukemia (AML), Refractory T Acute Lymphoblastic Leukemia
Conditions
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
Interventions
DRUGPart 1 (STI-6129)
Given by vein (IV)
DRUGPart 2 (STI-6129)
Given by vein (IV)
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be enrolled in the study, patients must satisfy all inclusion criteria, as follows: 1. Age greater than or equal to 18 years. 2. Confirmed diagnosis of R/R T-ALL or R/R AML by bone marrow evaluation. Note that patients must have failed treatment with available therapies known to be active for treatment of their T-ALL/AML 3. ECOG performance status of 0, 1, or 2 4. Pulse oximetry greater than or equal to 92% on room air 5. Be willing and able to comply with the study schedule and all other protocol requirements 6. Females of childbearing potential (FCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative pregnancy test during the Screening Period prior to treatment. All heterosexually active FCBP and all heterosexually active male patients must agree to use effective methods of birth control throughout the study Subject
Exclusion criteria
To be enrolled in the study, patients must not satisfy any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of the adverse events (Aes) -The severity of the adverse events (Aes) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V.5 | through completion of study or an average of 1 year. |
Outcome results
None listed