A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors
Sponsored by SHY Therapeutics
About this study
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).
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).
Where this study is enrolling (2)
- I'm interested
HonorHealth Research Institute
Scottsdale, Arizona
- Call 877-632-6789
The University of Texas MD Anderson Cancer Center
Houston, Texas
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Who can participate
Inclusion criteria
- ✓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 criteria
- ✕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.
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Trial data sourced from ClinicalTrials.gov.