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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

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
Kathryn Zurcher626-218-3029kzurcher@coh.org
Hoag Memorial Hospital
Newport Beach, California, 92263
Holland Orndorff949-764-7110Holland.Orndorff@hoag.org
Mass General Brigham Cancer Institute
Boston, Massachusetts, 02114
Greg Cote
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Rebecca DiVirgilio617-582-7140rebecca_divirgilio@dfci.harvard.edu
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Pri Wartanian210-685-2159wartant@mskcc.org

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