A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
Purpose
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
Conditions
- Advanced Solid Tumors
- Ewing Sarcoma
- Hepatocellular Carcinoma (HCC)
- Biliary Tract Cancer (BTC)
Eligibility
- Eligible Ages
- Over 16 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose Escalation |
ST-01156, administered orally once daily for 5 consecutive days followed by 2 days without study drug administration every 7 days |
|
Recruiting Locations
Mass General Brigham Cancer Institute
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- SEED Therapeutics, Inc.
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.