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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 22, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- SHY Therapeutics
- Interventions being studied
- Drug: SHY-ONC6
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- High-risk cardiovascular disease.
- Concurrent anti-cancer treatment.
- Active infection requiring systemic treatment within 2 weeks pre-dose.
- History of another malignancy (with standard exceptions for in situ disease, non-melanoma skin cancers, and remission ≥2 years).
- 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.
- Compromised pulmonary function within 6 months pre-dose .
- Pregnancy or breastfeeding.
- Recent radiotherapy, systemic anti-tumor therapy, other investigational therapy without appropriate washout.
- Major surgery ≤4 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.
- Persistent toxicities from prior anti-cancer therapy (exceptions apply)
- Clinically significant corneal disease.
- Unable to comply with prohibited concomitant medication restrictions.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- HonorHealth Research InstituteScottsdale, Arizona
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- NEXT OncologySan Antonio, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 22, 2026. Always confirm current availability with the study team.