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

NCT06950034 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-02-09

No results posted yet for this study

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.

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

BIOLOGICAL

STX-0712

STX-0712 is IV administered every 21 days until the patient discontinues treatment.

Sponsors & Collaborators

  • Solu Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer, MD, MSc, MBA · Solu Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-13
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06950034 on ClinicalTrials.gov