RecruitingPhase 1NCT07197554

A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies

Sponsor

SEED Therapeutics, Inc.

Enrollment

171 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies

Min Age: 16 Years

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.

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.