A Phase 1, Open-Label, Dose Escalation and Expansion Study of STX-0712 in Patients With Advanced Hematologic Malignancies
Summary
This is a first-in-human, multicenter, open-label, phase 1 study to evaluate the safety, PK, PD and preliminary efficacy of STX-0712 in patients with advanced CMML and AML for whom there are no further treatment options known to confer clinical benefit.
Detailed description
This is an open-label, non-randomized phase 1 trial to assess the safety and preliminary efficacy of STX-0712 in refractory/resistant CMML and relapsed/refractory monocytic or monocytic-predominant AML. The study will be conducted in two parts: Dose Escalation (Part 1) and Dose Expansion (Part 2). Dose Escalation will accrue CMML and AML patients across 2 cohorts using the BOIN adaptive design, followed by Dose Expansion in both cohorts using Simon's 2-Stage Design. Cohort 1 will enroll approximately 3-6 CMML patients at each dose level. After at least two dose levels have been deemed safe in Cohort 1, the Sponsor may decide to open Cohort 2 to enroll AML patients. Approximately 20 patients will be enrolled in each Dose Expansion cohort. All eligible participants will be administered the study drug, STX-0712, as a single intravenous (IV) infusion every 21 days. Patients will remain on study therapy until treatment discontinuation criteria are met.
Arms & interventions
- BiologicalSTX-0712
STX-0712 is IV administered every 21 days until the patient discontinues treatment.
Outcome measures
Primary
To determine the maximum tolerated dose (MTD) and/or minimum effective dose (MED)
Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period
Time frame: Until the end of Dose Escalation (approximately 12 months)
Secondary
To evaluate the overall safety and tolerability of STX-0712
Time frame: Until the end of the study (approximately 24 months)
To evaluate the initial anti-tumor activity of STX-0712 in the CMML and AML cohorts
Time frame: Until the end of the study (approximately 24 months)
To evaluate the initial anti-tumor activity of STX-0712 in the CMML and AML cohorts
Time frame: Until the end of the study (approximately 24 months)
Pharmacokinetics of STX-0712: maximum concentration (Cmax)
Time frame: Until the end of the study (approximately 24 months)
Pharmacokinetics of STX-0712: time to reach maximum concentration (Tmax)
Time frame: Until the end of the study (approximately 24 months)
Pharmacokinetics of STX-0712: area under the curve (AUC)
Time frame: Until the end of the study (approximately 24 months)
Pharmacokinetics of STX-0712: half-life (t½)
Time frame: Until the end of the study (approximately 24 months)
To characterize the PD profile of STX-0712 after single and repeat-dose administration
Time frame: Until the end of the study (approximately 24 months)
Eligibility criteria
Study locations (7)
Stanford University
Stanford, California, 94305
Moffitt
Tampa, Florida, 12902
DFCI
Boston, Massachusetts, 02215
Mayo Clinic
Rochester, Minnesota, 55905
OHSU
Portland, Oregon, 97239
Vanderbilt University
Nashville, Tennessee, 37232
MD Anderson Cancer Center
Houston, Texas, 77030