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Recruiting Phase 1

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

NCT07197554 · tracked via the Priya Life Science USA tracker
Sponsor
SEED Therapeutics, Inc
Phase
Phase 1
Started
2025-12-01
Last updated
2026-10-27

Condition(s) studied

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

Investigational drug(s) / intervention(s)

ST-01156

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

Study summary

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

Eligibility

Sex
ALL
Min age
16 Years
Max age
—
Healthy 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.

Primary outcome measure(s)

  • Part 1: Dose Escalation — First 28 days of treatment
    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).
  • Part 1: Dose Escalation — Duration of treatment period
    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).

Trial sites (6)

FacilityCityRegionStatus
The City of Hope National Medical Center Duarte California Recruiting
Hoag Memorial Hospital Newport Beach California Recruiting
Mass General Brigham Cancer Institute Boston Massachusetts Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07197554 on ClinicalTrials.gov ↗ ← All trials in the USA