Actively Recruiting
Phase 1 Open-Label Study of STX-0712 Given by IV Infusion Every 21 Days for Adults With Advanced Chronic Myelomonocytic Leukemia or Acute Myeloid Leukemia
Led by Solu Therapeutics, Inc · Updated on 2026-02-09
105
Participants Needed
7
Research Sites
25 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, pharmacokinetics, pharmacodynamics, and early effectiveness of STX-0712 in patients with advanced Chronic Myelomonocytic Leukemia CMML and Acute Myeloid Leukemia AML who have no remaining treatment options known to provide clinical benefit. This is a first-in-human, open-label, phase 1 trial conducted in multiple centers, focusing on patients with refractory or resistant CMML and relapsed or refractory monocytic or monocytic-predominant AML. The study aims to understand dosing and initial effects of STX-0712. The study is divided into two parts Dose Escalation and Dose Expansion. Dose Escalation will enroll CMML and AML patients in two cohorts to identify safe dosage levels using adaptive designs, followed by Dose Expansion cohorts to further evaluate these doses. STX-0712 is given as a single intravenous infusion every 21 days, and patients continue treatment until they meet criteria for discontinuation. Approximately 20 patients will be enrolled in each Dose Expansion cohort. Participants will undergo assessments to determine the maximum tolerated dose and minimum effective dose during Dose Escalation, lasting about 12 months. The overall safety, tolerability, anti-tumor activity, and pharmacokinetic and pharmacodynamic profiles of STX-0712 will be monitored for up to 24 months. Evaluations include laboratory tests, ECGs, and clinical examinations. Participants must comply with study visits and procedures during treatment and follow-up periods.
CONDITIONS
Brief Title
A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)
Research Team
H
Head of Clinical Operations
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