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

SEED Therapeutics, Inc.

Status and phase

Enrolling

Phase 1

Conditions

Advanced Solid Tumors

Biliary Tract Cancer (BTC)

Ewing Sarcoma

Hepatocellular Carcinoma (HCC)

Treatments

Drug: ST-01156

Study type

Interventional

Funder types

Industry

Identifiers

NCT07197554

ST-01156-101

Details and patient eligibility

About

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

Full 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.

Enrollment

171 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.