A Phase 1, Open-Label, Dose Escalation and Expansion Study of STX-0712 in Patients With Advanced Hematologic Malignancies
Solu Therapeutics, Inc
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Refractory/resistant CMML, defined as: Diagnosis of CMML 1 or 2; and has not responded to at least 4 cycles of hypomethylating agents (HMAs)(for myeloproliferative CMML - HMAs or hydroxyurea) or discontinued prior to 4 cycles due to toxicity or has progressive disease OR * Relapsed/refractory monocytic or monocytic predominant AML. Monocytic predominant AML is defined as ≥50% monocytes and/or monocytic precursors (promonocytes/monoblasts) and expressing at least two monocytic markers including CD4, CD11c, CD14, CD36, or CD64; and peripheral blood white blood cell (WBC) \…
Interventions
- BiologicalSTX-0712
STX-0712 is IV administered every 21 days until the patient discontinues treatment.
Locations (7)
- Stanford UniversityStanford, California
- MoffittTampa, Florida
- DFCIBoston, Massachusetts
- Mayo ClinicRochester, Minnesota
- OHSUPortland, Oregon
- Vanderbilt UniversityNashville, Tennessee