NCT07705334 A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors
| NCT ID | NCT07705334 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | SHY Therapeutics |
| Condition | Advanced or Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-06-29 |
| Primary Completion | 2027-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-06-29 with a primary completion date of 2027-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07705334 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced or Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07705334 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07705334 currently recruiting?
Yes, NCT07705334 is actively recruiting participants. Contact the research team at shyonc6@shytherapeutics.com for enrollment information.
Where is the NCT07705334 trial being conducted?
This trial is being conducted at Denver, United States, Houston, United States, San Antonio, United States.
Who is sponsoring the NCT07705334 clinical trial?
NCT07705334 is sponsored by SHY Therapeutics. The trial plans to enroll 30 participants.