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RecruitingInterventionalPhase 1

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

NCT ID: NCT07197554Sponsor: SEED Therapeutics, Inc.Last updated: 2026-06-02

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.

Arms & interventions

  • DrugST-01156

    ST-01156 is an orally administered degrader of RBM39, a protein frequently upregulated in cancer

Outcome measures

Primary

  • Part 1: Dose Escalation

    To characterize the safety, tolerability, and adverse event (AE) profile of escalating doses of ST-01156 administered for 5 consecutive days followed by 2 days without study drug administration every 7 days, with a cycle defined as 28 days (4 weeks).

    Time frame: First 28 days of treatment

  • Part 1: Dose Escalation

    To identify the maximum tolerated dose (MTD) or maximum administered dose (MAD), and to recommend a dose for subsequent studies (recommended Phase 2 dose \[ RP2D\]) of ST-01156 on a daily oral schedule for 5 consecutive days out of every 7 days with a cycle defined as 28 days (4 weeks).

    Time frame: Duration of treatment period

Secondary

  • Part 1: Dose Escalation

    Time frame: First 28 days of treatment

  • Part 1: Dose Escalation

    Time frame: Baseline and every 6 weeks thereafter until disease progression

Eligibility criteria

Sex: AllAge: 16 Years and olderHealthy volunteers: No
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.

Study locations (6)

The City of Hope National Medical Center

Duarte, California, 91010

Recruiting
Kathryn Zurcher · Contact
Daneng Li · Principal Investigator

Hoag Memorial Hospital

Newport Beach, California, 92263

Recruiting
Holland Orndorff · Contact
Alain Mita · Principal Investigator

Mass General Brigham Cancer Institute

Boston, Massachusetts, 02114

Recruiting
Kristina Goodwin · Contact
Gregory Cote · Principal Investigator

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Suzanne George, MD · Principal Investigator

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Pri Wartanian · Contact
Robert Maki · Principal Investigator

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Kofi Effa Ababio · Contact
Jordi Rodon Ahnert · Principal Investigator