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

Part of paid clinical trials in Stanford, California.

Sponsor
Solu Therapeutics, Inc
Study ID
NCT06950034
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 13, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
105 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation in CMML Patients
    STX-0712 will be administered every 21 days.
  • Experimental: Dose Escalation in AML Patients
    STX-0712 will be administered every 21 days.
  • Experimental: Dose Expansion in CMML
    STX-0712 will be administered every 21 days.
  • Experimental: Dose Expansion in AML
    STX-0712 will be administered every 21 days.

Primary Outcome Measure

To determine the maximum tolerated dose (MTD) and/or minimum effective dose (MED) [ Time Frame: Until the end of Dose Escalation (approximately 12 months) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Jack Taw
[email protected]
6507232781
Principal Investigator, MD (PRINCIPAL_INVESTIGATOR)
MoffittTampaFlorida12902
Jhada Hunter
[email protected]
(813)745-0286
Jeff Edelman
[email protected]
Principal Investigator, MD (PRINCIPAL_INVESTIGATOR)
DFCIBostonMassachusetts02215
Jessica Lee
[email protected]
617-632-4038
Principal Investigator, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Amy Vagness
[email protected]
507-284-9523
Principal Investigator, MBBS (PRINCIPAL_INVESTIGATOR)
OHSUPortlandOregon97239
Emma Solanki
[email protected]
503-418-1034
Tara Lundberg
[email protected]
Principal Investigator, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt UniversityNashvilleTennessee37232
Jennifer Vanorden
[email protected]
(615) 322-5000
Principal Investigator, MBBS (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Stephany Hendrickson
[email protected]
UNK
Research Nurse Manager
[email protected]
713-792-4478
Principal Investigator, MD (PRINCIPAL_INVESTIGATOR)

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