A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
Summary
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.
Arms & interventions
- DrugST-01156
ST-01156 is an orally administered degrader of RBM39, a protein frequently upregulated in cancer
Outcome measures
Primary
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).
Time frame: 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).
Time frame: Duration of treatment period
Secondary
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
Eligibility criteria
Study locations (6)
The City of Hope National Medical Center
Duarte, California, 91010
Hoag Memorial Hospital
Newport Beach, California, 92263
Mass General Brigham Cancer Institute
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030