A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors

This is a Phase 1, first-in-human (FIH), open-label, multicenter study designed to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of SHY-ONC6 in participants with advanced or metastatic solid tumors who have progressed on or are intolerant to standard therapies. The study will consist of 2 parts: a dose escalation part (Phase 1a) and a dose expansion part (Phase 1b).

NCT Number	NCT07705334
Lead Sponsor	SHY Therapeutics
Conditions	Advanced or Metastatic Solid Tumors, Triple Negative Breast Cancer (TNBC), HR+ Breast Cancer, Colon Cancer, Gastric Cancer, Hepatecellular Carcinoma, NSCLC (Advanced Non-small Cell Lung Cancer), Mesothelioma +3 more
Enrollment	30 participants
Start Date	2026-06-24
Primary Completion	2027-05-15 (estimated)
Study Completion	2028-05-15 (estimated)
Updated on ClinicalTrials.gov	2026-08-10