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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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • STX-0712

    Biological/Vaccine

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

Treatment groups

105 Participants
are divided into 4 treatment groups
Group A: Dose Escalation in CMML PatientsExperimental treatment 1 intervention
Group B: Dose Escalation in AML PatientsExperimental treatment 1 intervention
Group C: Dose Expansion in CMMLExperimental treatment 1 intervention
Group D: Dose Expansion in AMLExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To determine the maximum tolerated dose (MTD) and/or minimum effective dose (MED)

Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period

Time frame
Until the end of Dose Escalation (approximately 12 months)

Secondary outcomes

1

To evaluate the overall safety and tolerability of STX-0712

Incidence of adverse events (AEs), characterized overall and by type, seriousness, relationship to study treatment, timing, and severity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

Time frame
Until the end of the study (approximately 24 months)
2

To evaluate the initial anti-tumor activity of STX-0712 in the CMML and AML cohorts

Investigator-assessed overall response rate (ORR) as measured by standard response criteria: For CMML: Proportion of participants achieving complete response (CR), complete cytogenetic remission, partial response (PR), marrow response, and clinical benefit according to the 2015 myelodysplastic/myeloproliferative neoplasms International Working Group (MDS/MPN IWG) criteria. For AML: Proportion of participants achieving complete remission (CR), CR with partial hematologic recovery (CRh), complete remission with incomplete count recovery (CRi), morphological leukemia-free state (MLFS), and PR according to modified European Leukemia Network (ELN) 2022 criteria

Time frame
Until the end of the study (approximately 24 months)
3

To evaluate the initial anti-tumor activity of STX-0712 in the CMML and AML cohorts

Absolute decrease in peripheral blood monocytes by 50% from baseline in CMML and AML.

Time frame
Until the end of the study (approximately 24 months)
4

Pharmacokinetics of STX-0712: maximum concentration (Cmax)

maximum concentration (Cmax)

Time frame
Until the end of the study (approximately 24 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Solu Therapeutics, Inc

Lead sponsor

Source ClinicalTrials.gov
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