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Clinical trial Recruiting at 6 sites Phase 1 Interventional Ages 16 and up

ST-01156, a drug that degrades RBM39, for advanced solid cancers

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

Run by SEED Therapeutics, Inc. · NCT07197554 · Data updated 2026-11-12

This trial will test whether ST-01156 is safe and shows early anti-cancer activity in adults (and some teens with Ewing sarcoma) who have advanced or metastatic solid tumors like liver, biliary tract, or Ewing sarcoma.

Quick facts

PhasePhase 1
Study typeInterventional
Ages16 Years and up
SexAll
Enrollment171 (estimated)
SponsorSEED Therapeutics, Inc.
Industry-sponsored
Locations6 sites (Duarte, California and 5 other locations)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedDecember 31, 2029
Study endsDecember 31, 2029
Registry record updatedOctober 27, 2026
Trial IDNCT07197554 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults (≥18 years) or adolescents ≥16 with Ewing sarcoma, unresectable or metastatic solid tumors, measurable disease, ECOG ≤2, and adequate organ function who have completed required washout from prior therapies.

Probably not a fit

Patients with active untreated brain metastases, recent radiotherapy or recent systemic anticancer therapy, poor organ function, or tumors without a biological rationale for RBM39 targeting are less likely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/1b, open-label, multicenter dose-escalation study gives participants ST-01156, a small-molecule degrader of RBM39, to determine safety, tolerability, pharmacokinetics, and early anticancer activity. Part 1 uses a dose-escalation design to identify the maximum tolerated dose and/or recommended Phase 2 dose. Participants must have measurable or evaluable advanced unresectable or metastatic solid tumors and meet organ function and performance-status requirements. The protocol includes screening, regular safety and imaging assessments, and pharmacokinetic sampling at planned timepoints.

Why it matters

Potential benefit: If successful, ST-01156 could become a new treatment option for patients whose tumors depend on RBM39, offering tumor control where other therapies have failed.

How similar studies have gone: RBM39-directed degradation is an emerging and relatively novel approach: related molecular-glue degraders have shown early signals in cancer but RBM39-specific clinical efficacy remains largely unproven.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.