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A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
Trial Status: active
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07197554.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Approved
Name Not Available
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.