NCT07197554

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 171 (estimated)
• Sponsor: SEED Therapeutics, Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Advanced Solid Tumors
• Ewing Sarcoma
• Hepatocellular Carcinoma (HCC)
• Biliary Tract Cancer (BTC)

Interventions

Type	Name	Description
DRUG	ST-01156	ST-01156 is an orally administered degrader of RBM39, a protein frequently upregulated in cancer

Timeline

• Start date: 2025-12-01
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2025-09-29
• Last updated: 2026-02-18

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study