A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
SEED Therapeutics, Inc.
Summary
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
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.
Eligibility
- Age range
- 16+ years
- Sex
- All
- 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…
Interventions
- DrugST-01156
ST-01156 is an orally administered degrader of RBM39, a protein frequently upregulated in cancer
Locations (6)
- The City of Hope National Medical CenterDuarte, California
- Hoag Memorial HospitalNewport Beach, California
- Mass General Brigham Cancer InstituteBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- Memorial Sloan Kettering Cancer CenterNew York, New York
- The University of Texas MD Anderson Cancer CenterHouston, Texas