A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors
Key facts
- Where
- Houston, San Antonio, and Scottsdale, United StatesSee the 3 sites
- Phase
- Phase 1
Where in United States
- The University of Texas MD Anderson Cancer CenterHouston, United StatesTaking people
- NEXT OncologySan Antonio, United StatesTaking people
- HonorHealth Research InstituteScottsdale, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- SHY Therapeutics
- Trial code
- NCT07705334
- Record updated
- 22 October 2026
- Original description
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).Read full original descriptionShow less
A Phase 1 Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SHY-ONC6 in Participants 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).
Inclusion: Male or female ≥18 years of age; Life expectancy >3 months; ECOG performance status 0-1; Histologically/cytologically confirmed advanced or metastatic solid tumors that have progressed on or are intolerant/unsuitable for standard therapies. Eligible tumor types: TNBC, HR+ breast cancer, colon cancer, gastric cancer, HCC, NSCLC (adeno and squamous), mesothelioma, pancreatic cancer, HRPC, soft tissue sarcoma; other tumor types after Medical Monitor discussion. Stable CNS metastases ≥4 weeks post-radiotherapy and off steroids ≥14 days are permitted; ≥1 measurable lesion per RECIST v1.1 (prostate cancer with bone-only disease and elevated PSA assessed by PCWG3); Accessible tumor for biopsy; Adequate organ/bone marrow function; Willingness and ability to provide informed consent; Negative serum pregnancy test and use of effective contraception through 90 days after last dose for women of childbearing potential; Male participants must use barrier contraception or abstinence and not donate sperm through 90 days after last dose.
Exclusion: Concurrent anti-cancer treatment; Recent radiotherapy, systemic anti-tumor therapy, other investigational therapy without appropriate washout; Major surgery ≤4 weeks pre-dose; Persistent toxicities from prior anti-cancer therapy (exceptions apply); Unable to comply with prohibited concomitant medication restrictions; High-risk cardiovascular disease; Active infection requiring systemic treatment within 2 weeks pre-dose; Unable to swallow tablets or conditions affecting GI absorption; Any medical or psychiatric disorders affecting compliance and/or interpretation of study results; Clinically significant corneal disease; Active HBV (HBV-DNA >ULN), HCV (HCV-RNA >ULN), or HIV (well-controlled HIV with CD4 ≥350 cells/µL and undetectable viral load permitted); AIDS-defining opportunistic infection within 12 months; History of another malignancy (with standard exceptions for in situ disease, non-melanoma skin cancers, and remission ≥2 years); Compromised pulmonary function within 6 months pre-dose ; Pregnancy or breastfeeding.