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New treatment option for Advanced or Metastatic Solid Tumors
Official title A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT07705334
What this study is testing
What is SHY-ONC6?
SHY-ONC6 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced or metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- ≥1 measurable lesion per RECIST v1.1 (prostate cancer with bone-only disease and elevated PSA assessed by PCWG3).
You likely can't join if
- 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)...
- Compromised pulmonary function within 6 months pre-dose .
See the full eligibility 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...
- ≥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.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Houston, Texas, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.