A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid … (NCT07197554) | Clinical Trial Compass
RecruitingPhase 1
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
United States171 participantsStarted 2025-12-01
Plain-language summary
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is Phase 1, which means they're still figuring out the right dose and basic safety — given that, what is known so far about the risks of ST-01156, and how does that uncertainty compare to the standard treatment options available to me right now?
2My specific cancer is listed as one of the conditions — Ewing sarcoma, HCC, or biliary tract cancer — but this is a broad solid tumor study, so does this trial actually make sense for my particular diagnosis and situation, or would a more targeted study be a better fit?
3Since this is a dose-escalation study, does that mean I could be enrolled at a lower, potentially less effective dose early on, and how would that affect my care if the treatment isn't working at that level?
4ST-01156 works by degrading a protein called RBM39, which is a pretty novel mechanism — do my tumor's genetic or molecular characteristics make me a candidate where this approach might be more or less likely to be relevant?
5What would my treatment schedule and monitoring look like if I joined this trial, and if my disease progresses while I'm on it, what options would still be available to me afterward?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.