Phase 1 Study of Shattuck Labs (SL)-172154 in Subjects With MDS or AML (NCT05275439) | Clinical Trial Compass
TerminatedPhase 1
Phase 1 Study of Shattuck Labs (SL)-172154 in Subjects With MDS or AML
Stopped: Development discontinued
United States106 participantsStarted 2022-03-17
Plain-language summary
SL03-Old Hundred(OHD)-104 is designed as a Phase 1a/1b open label, trial to evaluate the safety, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of SL-172154 monotherapy as well as in combination with azacitidine or in combination with Azacitidine and Venetoclax.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject has voluntarily agreed to participate by giving written informed consent in accordance with ICH/GCP guidelines and applicable local regulations.
✓. Age ≥ 18 years.
✓. For subjects with AML, confirmation of AML diagnosis by 2016 WHO criteria \[Arber, 2016\] (World Health Organization \[WHO\] classification, excluding acute promyelocytic leukemia \[APL\]).
✓. Subjects with MDS must have:
✓. morphologically confirmed diagnosis of MDS by 2016 WHO criteria \[Arber, 2016\] with \<20% blasts in bone marrow per bone marrow biopsy/aspirate or peripheral blood.
✓. confirmation of intermediate, high or very high risk category by Revised International Prognostic Scoring System (IPSS-R).
✓. \[Dose Escalation Cohort - SL-172154 Monotherapy\] Subjects with AML must have relapsed/refractory disease (≥5% blasts by manual aspirate differential, flow cytometry, or immunohistochemistry) following at least 1 prior line of therapy but no more than 4 prior lines of therapy. Subjects with higher-risk MDS must have relapsed/refractory disease following at least 1 prior line but no more than 4 prior lines of therapy.
✓. Prior hydroxyurea or other supportive care in the form of transfusions or growth factors will not be considered prior therapy.
✕. Subjects requiring agents other than hydroxyurea to control blast counts within 14 days prior to the first dose of study treatment.
✕. Evidence of active bleeding or bleeding diathesis or major coagulopathy (including familial).
✕. \[Only for Cohorts Including Venetoclax in the Regimen\] Subject has received strong and/or moderate CYP3A inducers within 7 days prior to the first dose of venetoclax.
✕. Use of systemic corticosteroids (\>10 mg daily of prednisone or equivalent) or other non-steroidal immunosuppressive medication, current or within 14 days of the first dose of study treatment with the following exceptions (i.e., the following are allowed within 14 days of first dose):
✕. Receipt of live attenuated vaccine within 30 days of first dose of SL-172154 treatment.
✕. Subject has active, uncontrolled infection (e.g., viral, bacterial, or fungal). Subjects are eligible if infection is controlled with antibiotics, antivirals and/or antifungals.