Recruiting
Phase 1

ST-01156

Sponsor:

SEED Therapeutics, Inc.

Code:

NCT07197554

Conditions

Advanced Solid Tumors

Ewing Sarcoma

Hepatocellular Carcinoma (HCC)

Biliary Tract Cancer (BTC)

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

ST-01156

Study Details

Brief summary:

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

Conditions

Advanced Solid Tumors

Ewing Sarcoma

Hepatocellular Carcinoma (HCC)

Biliary Tract Cancer (BTC)

Study ID

NCT07197554

Start date

Dec 1, 2025

Status verified date

May, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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 Design

Enrollment

171 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

ST-01156, administered orally once daily for 5 consecutive days followed by 2 days without study drug administration every 7 days

Interventions

ST-01156

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

Primary outcome measure

  • Part 1: Dose Escalation [ Time Frame: First 28 days of treatment ]
  • Part 1: Dose Escalation [ Time Frame: Duration of treatment period ]

Central Contacts and Locations

Central contacts

Dr. Eric Rowinsky Chief Medical Officer

(908) 883-0647erowinsky@oncodrugs.com

Locations

The City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Kathryn Zurcher

626-218-3029kzurcher@coh.org

Principal Investigator:

Daneng Li

Hoag Memorial Hospital

Recruiting

Newport Beach, California, United States, 92263

Contacts

Holland Orndorff

949-764-7110Holland.Orndorff@hoag.org

Principal Investigator:

Alain Mita

Mass General Brigham Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Kristina Goodwin

617-643-6256kgoodwin@mgh.harvard.edu

Principal Investigator:

Gregory Cote

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Suzanne George

877-338-7425Suzanne_George@dfci.harvard.edu

Principal Investigator:

Suzanne George, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Pri Wartanian

210-685-2159wartant@mskcc.org

Principal Investigator:

Robert Maki

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Kofi Effa Ababio

346-725-3989KEAbabio@mdanderson.org

Principal Investigator:

Jordi Rodon Ahnert

More Information

Sponsor

SEED Therapeutics, Inc.

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • cancer
  • solid tumors
  • RBM39
  • RBM39 degrader
  • metastatic solid malignancies
  • Ewing sarcoma
  • Hepatocellular carcinoma
  • HCC
  • Biliary tract carcinoma
  • endometrial carcinoma
  • Adolescents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SEED Therapeutics, Inc. on 2026-06-02.