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

NCT ID: NCT07197554

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2029-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

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

Group Type EXPERIMENTAL

ST-01156

Intervention Type DRUG

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

Interventions

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ST-01156

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SEED Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The City of Hope National Medical Center

Duarte, California, United States

Site Status RECRUITING

Hoag Memorial Hospital

Newport Beach, California, United States

Site Status RECRUITING

Mass General Brigham Cancer Institute

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status NOT_YET_RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Dr. Eric Rowinsky Chief Medical Officer

Role: CONTACT

Phone: (908) 883-0647

Email: [email protected]

Facility Contacts

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Kathryn Zurcher

Role: primary

Holland Orndorff

Role: primary

Other Identifiers

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ST-01156-101

Identifier Type: -

Identifier Source: org_study_id