Advanced Solid TumorsPhase 1NCT07197554
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
A Phase 1 study testing ST-01156 in people with Advanced Solid Tumors and Ewing Sarcoma, run by SEED Therapeutics, Inc. at 6 sites in United States.
Trial summary
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Advanced Solid Tumors, Ewing Sarcoma, Hepatocellular Carcinoma (HCC)
- What is being tested?
- ST-01156
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Dec 2025to 31 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Mass General Brigham Cancer Institute
Boston, Massachusetts, 02114
Kristina Goodwin, 617-643-6256, kgoodwin@mgh.harvard.edu
Gregory Cote
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Suzanne George, 877-338-7425, Suzanne_George@dfci.harvard.edu
Suzanne George, MD
- Recruiting
The City of Hope National Medical Center
Duarte, California, 91010
Kathryn Zurcher, 626-218-3029, kzurcher@coh.org
Daneng Li
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Kofi Effa Ababio, 346-725-3989 ext. 53989, KEAbabio@mdanderson.org
Jordi Rodon Ahnert
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Pri Wartanian, 210-685-2159, wartant@mskcc.org
Robert Maki
- Recruiting
Hoag Memorial Hospital
Newport Beach, California, 92263
Holland Orndorff, 949-764-7110, Holland.Orndorff@hoag.org
Alain Mita
About this study
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
Read the detailed description
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
- Advanced Solid Tumors, Ewing Sarcoma, Hepatocellular Carcinoma (HCC), Biliary Tract Cancer (BTC)
- Being tested
- ST-01156
- Keywords
- cancer, solid tumors, RBM39, RBM39 degrader, metastatic solid malignancies, Ewing sarcoma, Hepatocellular carcinoma, HCC, Biliary tract carcinoma, endometrial carcinoma, Adolescents
- Medical subject headings
- Sarcoma, Ewing, Carcinoma, Hepatocellular, Biliary Tract Neoplasms, Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST-01156Drug
ST-01156 is an orally administered degrader of RBM39, a protein frequently upregulated in cancer
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | ST-01156, administered orally once daily for 5 consecutive days followed by 2 days without study drug administration every 7 days Receives: Drug: ST-01156 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Dose Escalation
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).
Measured: First 28 days of treatment
Part 1: Dose Escalation
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).
Measured: Duration of treatment period
Secondary outcomes (2)
Part 1: Dose Escalation
To characterize the pharmacokinetics (PK) of ST-01156 administered on a daily oral schedule for 5 consecutive days every 7 days with cycle defined as 28 days (4 weeks). PK parameters will include area under the concentration-time curve (AUC), maximum observed concentration (Cmax), and time to observe maximum observed concentration (Tmax).
Measured: First 28 days of treatment
Part 1: Dose Escalation
To detect preliminary evidence of antitumor activity in select advanced cancers where strong preclinical evidence of the anticancer activity of RBM39 degradation is strongest including:
- Adults or adolescents with ES following disease progression or intolerance to therapeutics of reasonable likelihood of conferring clinical benefit.
- aHCC following disease progression or intolerance to appropriate standard therapy for advanced disease.
- KRASm solid malignancy of any type - locally advanced or unresectable solid malignancy following disease progression or intolerance to therapeutics or reasonable likelihood of conferring clinical benefit.
- BTC, endometrial carcinoma, solid malignancies with pathogenic somatic or germline mutations in BCRA1/2 or HRR genes (BRCA1/2, PALB2, RAD51C, RAD51D, ATM, BARD1, BLM, BRIP 1, CDK12,FANCA, FANCC, FANCD2, FANCE, FANCF, FANCM, MRE11A, NBN (NBS1), RAD50, RAD51B and others as confirmed by a Clinical Laboratory Improvement Amendments [CLIA]-certified m
Measured: Baseline and every 6 weeks thereafter until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Dec 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SEED Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197554
- Sponsor's protocol ID
- ST-01156-101
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT07197554
- Acronym / sponsor ID
- ST-01156-101
- Conditions
- Advanced Solid Tumors, Ewing Sarcoma, Hepatocellular Carcinoma (HCC), Biliary Tract Cancer (BTC)
- Keywords
- cancer, solid tumors, RBM39, RBM39 degrader, metastatic solid malignancies, Ewing sarcoma, Hepatocellular carcinoma, HCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- SEED Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: ST-01156ST-01156, administered orally once daily for 5 consecutive days followed by 2 days without study drug administration every 7 days |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST-01156ST-01156 is an orally administered degrader of RBM39, a protein frequently upregulated in cancer | Drug | Dose Escalation |
Primary outcome
Part 1: Dose Escalation
Time frame: 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).
Part 1: Dose Escalation
Time frame: Duration 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).
2 secondary outcomes
Part 1: Dose Escalation
Time frame: First 28 days of treatment
Part 1: Dose Escalation
Time frame: Baseline and every 6 weeks thereafter until disease progression
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ST-01156 in people with Advanced Solid Tumors and Ewing Sarcoma, run by SEED Therapeutics, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Eric Rowinsky Chief Medical Officer ((908) 883-0647, erowinsky@oncodrugs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Dose Escalation (time frame: First 28 days of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.