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Phase 1/1B Study of ST-01156 for Advanced Solid Tumors

This study is testing a new oral medicine called ST-01156 for people with advanced solid tumors, including Ewing Sarcoma, liver cancer (Hepatocellular Carcinoma), and bile duct cancer (Biliary Tract Cancer). ST-01156 works by degrading (breaking down) a protein called RBM39, which is often found in higher amounts in cancer cells. The main goals are to find out how safe ST-01156 is, what side effects it might cause, and to see if it shows any early signs of helping to treat these cancers. You might be able to join if you are at least 16 years old (for certain cancers) or 18 years old, and have a solid tumor that has spread or cannot be removed by surgery. The study is currently not recruiting, as its status is unclear.

Study design
This is a Phase 1/1B study, meaning it's an early-stage trial to test safety and dosage. It plans to enroll 171 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes during the first 28 days of treatment and for the duration of the treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07197554

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

Recruiting
PHASE1Ages 16+InterventionalTreatment
SEED Therapeutics, Inc.
~171 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:ST-01156

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Dose Escalation
Measured over First 28 days of treatment
+1 more outcome measured

Conditions

Advanced Solid Tumors
Ewing Sarcoma
Hepatocellular Carcinoma (HCC)
Biliary Tract Cancer (BTC)

Explore related trials

Endometrial CarcinomaEwing SarcomaHepatocellular CarcinomaMalignant neoplasm of biliary tractSolid Neoplasm

Where it's being run

6 sites across 4 states
California2
Massachusetts2
New York1
Texas1

Who to contact

Dr. Eric Rowinsky Chief Medical Officer
[email protected]
(908) 883-0647
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Part 1: Dose EscalationFirst 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 EscalationDuration 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).