Health Trials

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

ConditionsChronic Myelomonocytic LeukemiaChronic Myelomonocytic Leukemia (CMML)Chronic Myelomonocytic Leukemia-1Chronic Myelomonocytic Leukemia-2Refractory Chronic Myelomonocytic LeukemiaCMMLAcute Myeloid LeukemiaAcute Myeloid Leukemia (AML)Acute Myeloid Leukemia Post Cytotoxic TherapyAcute Myeloid LeukemiasRefractory Acute Myeloid Leukemia (AML)Acute Monocytic Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSolu Therapeutics, Inc

About this trial

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.

Eligibility criteria

Qualifiers

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) <30,000/µL (microliters) and <20% circulating blasts.

Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.

Life expectancy of >2 months and stable enough to complete two cycles of STX-0712, in the opinion of the Investigator.

Disqualifiers

Has any of the following disease-specific conditions: For CMML: Myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap syndromes other than CMML. For AML: Acute Promyelocytic Leukemia (APL) or Isolated extramedullary disease.

Eligible for an immediate allogenic stem cell transplant (alloSCT).

Current active use of nicotine products including tobacco, nicotine patches or vaping products.

Prior bone marrow transplant (BMT) within 6 months of date of consent; or transplanted patients who received the last dose of immunosuppressive therapies within 3 months of date of consent.

Trial design

Treatments tested in this trial

  • STX-0712

Treatment groups

105 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Solu Therapeutics, Inc

Lead sponsor

Source ClinicalTrials.gov