NCT06950034

A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)

A Phase 1, Open-Label, Dose Escalation and Expansion Study of STX-0712 in Patients With Advanced Hematologic Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Solu Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Myelomonocytic Leukemia
• Chronic Myelomonocytic Leukemia (CMML)
• Chronic Myelomonocytic Leukemia-1
• Chronic Myelomonocytic Leukemia-2
• Refractory Chronic Myelomonocytic Leukemia
• CMML
• Acute Myeloid Leukemia
• Acute Myeloid Leukemia (AML)
• Acute Myeloid Leukemia Post Cytotoxic Therapy
• Acute Myeloid Leukemias
• Refractory Acute Myeloid Leukemia (AML)
• Acute Monocytic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	STX-0712	STX-0712 is IV administered every 21 days until the patient discontinues treatment.

Timeline

• Start date: 2025-03-13
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2025-04-29
• Last updated: 2026-02-09

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study