Actively Recruiting
Phase 11B Study of ST-01156, an Oral RBM39 Protein Degrader, for Advanced Solid Tumors
Led by SEED Therapeutics, Inc. · Updated on 2026-06-02
171
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ST-01156, an oral small molecule that degrades RBM39, in patients with advanced solid tumors, including Ewing Sarcoma, hepatocellular carcinoma, and biliary tract cancer. This Phase 11b study aims to assess the safety, tolerability, pharmacokinetics, and preliminary anticancer activity of ST-01156. The trial also seeks to find the maximum tolerated dose and recommended Phase 2 dose for this treatment. The study is conducted in two parts, with Part 1 focusing on dose escalation. Participants will receive ST-01156 orally once daily for 5 consecutive days followed by 2 days without treatment each week. The dose will be gradually increased to evaluate safety and determine the best dose for further study. During the trial, participants will undergo regular assessments including evaluation of tumor lesions using RECIST v1.1 criteria and monitoring of organ function and performance status. Researchers will monitor safety and treatment effects during the first 28 days and throughout the treatment period. Follow-up exams will continue every 6 weeks until disease progression or treatment discontinuation. Participants may be followed for up to several years to assess long-term outcomes and adverse effects.
CONDITIONS
Brief Title
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older on the day of consent, except adolescents with Ewing Sarcoma or other relevant malignancies aged 16 years or older
- Has a metastatic or locally advanced solid tumor that cannot be surgically removed
- Has at least one measurable or evaluable tumor lesion according to RECIST v1.1
- Has an ECOG performance status of 2 or less at screening
- Has adequate organ function as defined by the study protocol
You will not qualify if you...
- Received radiotherapy within 2 weeks prior to treatment
- Has known active central nervous system metastases or carcinomatous meningitis
- Received any anticancer therapy or investigational agent within 14 days or 5 half-lives, whichever is shorter
- Had major surgery within 28 days before starting study treatment
- Has unresolved toxicities from prior anticancer therapies except alopecia and peripheral neuropathy
- Previously treated with an RBM39 inhibitor or degrader
Research Team
D
Dr. Eric Rowinsky Chief Medical Officer
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