Trial NCT07197554
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
- Phase
- Phase 1
- Sponsor
- SEED Therapeutics, Inc.
- Conditions
- Advanced Solid Tumors; Ewing Sarcoma; Hepatocellular Carcinoma (HCC); Biliary Tract Cancer (BTC)
- Ages
- 16+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Performance status
* 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 stableBrain metastases
* 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.
Restrictions found (2)
- Brain metastasesConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG ≤ 2
Show in the text
Recruiting in Massachusetts
- Mass General Brigham Cancer Institute · Boston, Suffolk County
- Dana Farber Cancer Institute · Boston, Suffolk County