NCT07197554 A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
| NCT ID | NCT07197554 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | SEED Therapeutics, Inc. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 171 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2029-12-31 |
Trial Parameters
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Brief Summary
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
Eligibility Criteria
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 administratio