A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors

Official record

Identifier

NCT07705334

Recruiting locations

country

United States

Interventions studied

SHY-ONC6

Lead sponsor

SHY Therapeutics

Target enrolment

30 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Recruiting

First posted

Jul 15, 2026

Last updated on the registry

Sep 18, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Gastric Cancer