Clinical Trials in the USA / NCT07197554
Recruiting
Phase 1
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
NCT07197554 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Advanced Solid TumorsEwing SarcomaHepatocellular Carcinoma (HCC)Biliary Tract Cancer (BTC)
Investigational drug(s) / intervention(s)
ST-01156
ST-01156: ST-01156 is an orally administered degrader of RBM39, a protein frequently upregulated in cancer
Study summary
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
Eligibility
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.
Primary outcome measure(s)
- 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). - Part 1: Dose Escalation — 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).
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| The City of Hope National Medical Center | Duarte | California | Recruiting |
| Hoag Memorial Hospital | Newport Beach | California | Recruiting |
| Mass General Brigham Cancer Institute | Boston | Massachusetts | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07197554 on ClinicalTrials.gov ↗ ← All trials in the USA