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ST-01156

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |BeyondSpring, Inc.|Last Updated: Feb 18, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment171

FDA Designations

ORPHAN_DRUGBREAKTHROUGH_THERAPY

Clinical trial landscape

ST-01156 · 1 trial · 4 indications

Phase 1 1
NCT07197554A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid MalignanciesAdvanced Solid Tumors
RECRUITING171 Analytics
PHASE1RECRUITING
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

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).

Secondary Endpoints

Part 1: Dose Escalation
First 28 days of treatment
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

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

Interventions

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

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

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 an...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about ST-01156

What is ST-01156 used for?

ST-01156 is an investigational small molecule being studied for the treatment of advanced solid tumors, including Ewing sarcoma, hepatocellular carcinoma (HCC), and biliary tract cancer (BTC). It is currently in Phase 1 clinical development and has not been approved by the FDA.

What does ST-01156 target?

ST-01156 is a small molecule RBM39 degrader. It works by degrading the RBM39 protein, which is involved in RNA splicing and cancer cell survival. This mechanism is being evaluated in patients with advanced solid malignancies.

Who is developing ST-01156?

ST-01156 is being developed by BeyondSpring, Inc., a biopharmaceutical company listed on NASDAQ under the ticker BYSI. The company is conducting a Phase 1/1B clinical trial of the drug in the United States.

What phase is ST-01156 in?

ST-01156 is in Phase 1 clinical development. It is currently being evaluated in a Phase 1/1B study that is recruiting patients with advanced solid tumors. The drug has not been approved by the FDA and remains investigational.

What clinical trials is ST-01156 in?

ST-01156 is being studied in a single active clinical trial, NCT07197554, titled 'A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies.' The trial is recruiting 171 participants in the United States and is not randomized or blinded.

Is ST-01156 the same as any other drug?

ST-01156 is a distinct investigational compound developed by BeyondSpring, Inc. It is a small molecule RBM39 degrader and is not known to be the same as any other marketed drug. It has received orphan drug and breakthrough therapy designations from the FDA.