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NCT07197554PHASE1Recruiting

A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies

SEED Therapeutics, Inc.

Start Date

12/1/2025

Completion Date

12/31/2029

Summary

A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies

Detailed Description

This Phase 1/1b study is evaluating the safety, tolerability, and preliminary anticancer activity of ST-01156 in participants with advanced solid malignancies. The study will be conducted in 2 parts. Part 1 (Dose Escalation) will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anticancer activity of SD-01156 in participants with advanced solid malignancies, many of whom have a biological rationale to be targeted with an inhibitor of RBM39. Part 1 will also seek to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ST-01156.

Eligibility Criteria

Age Range: 16 years to No maximum

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.

Interventions

DRUG

ST-01156

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Conditions

Advanced Solid TumorsEwing SarcomaHepatocellular Carcinoma (HCC)Biliary Tract Cancer (BTC)

Locations

The City of Hope National Medical Center

Duarte, California 91010

United States

Hoag Memorial Hospital

Newport Beach, California 92263

United States

Mass General Brigham Cancer Institute

Boston, Massachusetts 02114

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States