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A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
RECRUITINGPhase 1Sponsored by SEED Therapeutics, Inc.
Actively Recruiting
PhasePhase 1
SponsorSEED Therapeutics, Inc.
Started2025-12-01
Est. completion2029-12-31
Eligibility
Age16 Years+
Healthy vol.Accepted
Locations6 sites
View on ClinicalTrials.gov →
NCT07197554
Summary
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
Eligibility
Age: 16 Years+Healthy volunteers accepted
Inclusion Criteria: * Age ≥ 18 years on the day of signing the consent form, except for adolescents with Ewing Sarcoma or other malignancies for which there is a biological rationale to support participation, in which case the participant is ≥ 16 years old. * Has a metastatic or locally advanced and unresectable solid tumor. * Has at least 1 measurable lesion or evaluable disease per RECIST v1.1. * Has an ECOG performance status ≤ 2 at screening. * Has adequate organ function as defined in the protocol. Exclusion Criteria: * Has received prior radiotherapy within 2 weeks of treatment. * Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate, provided they are radiologically stable * Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days or 5 half-lives, whichever is shorter. * Had major surgery within 28 days before study therapy administration * Has toxicities from previous anticancer therapies that have not resolved to baseline levels, with the exception of alopecia and peripheral neuropathy. * Has previously received a RBM39 inhibitor/degrader.
Conditions7
Advanced Solid TumorsBiliary Tract Cancer (BTC)CancerEwing SarcomaHepatocellular Carcinoma (HCC)Liver CancerLiver Disease
Locations6 sites
The City of Hope National Medical Center
Duarte, California, 91010
Hoag Memorial Hospital
Newport Beach, California, 92263
Mass General Brigham Cancer Institute
Boston, Massachusetts, 02114
Greg Cote
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
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Actively Recruiting
PhasePhase 1
SponsorSEED Therapeutics, Inc.
Started2025-12-01
Est. completion2029-12-31
Eligibility
Age16 Years+
Healthy vol.Accepted
Locations6 sites
View on ClinicalTrials.gov →
NCT07197554