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A Study of SHY-ONC6 for Advanced Solid Tumors

This study is testing a new drug called SHY-ONC6 in adults with advanced or metastatic (spread to other parts of the body) solid tumors, including certain types of breast cancer, colon cancer, and gastric cancer. You might be able to join if your cancer has gotten worse despite standard treatments or if you can't tolerate those treatments. The main goals are to find out how safe SHY-ONC6 is, what side effects it causes, and the highest dose that can be given safely. Researchers will also look for early signs that the drug might be working against the cancer. You would take SHY-ONC6 by mouth once a day in 21-day cycles until your disease gets worse or side effects become too much.

Study design
This is a Phase 1, open-label (meaning everyone knows what treatment is being given) study, designed to be the first time SHY-ONC6 is tested in humans. It plans to enroll about 30 participants.
What's involved
Participants will receive SHY-ONC6 orally once daily in 21-day cycles. Treatment continues until you withdraw, have unacceptable side effects, or your disease progresses.
Compensation
Not stated in the trial record.
Follow-up
Adverse events and serious adverse events will be collected for 30 days after your last dose of the study drug.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07705334

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
SHY Therapeutics
~30 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:SHY-ONC6

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose-Limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs)
Measured over Dose-limiting toxicities assessed from first dose through Day 21 of Cycle 1 (each cycle is 21 days). Adverse events and serious adverse events collected from first dose through 30 days after last dose.
+2 more outcomes measured

Conditions

Advanced or Metastatic Solid Tumors
Triple Negative Breast Cancer (TNBC)
HR+ Breast Cancer
Colon Cancer
Gastric Cancer
Hepatecellular Carcinoma
NSCLC (Advanced Non-small Cell Lung Cancer)
Mesothelioma
Pancreatic Carcinoma Metastatic
Hormone Refractory Prostate Cancer
Soft Tissue Sarcomas

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NCT07705334

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • HonorHealth Research Institute

    Scottsdale, Arizonano site contact published

    Recruiting

  • NEXT Oncology

    San Antonio, Texasno site contact published

    Recruiting

  • SCRI at HCA HealthONE

    Denver, Coloradono site contact published

    Not yet recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texasno site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Medical Monitor
[email protected]
914-543-6110
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Incidence of Dose-Limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs)Dose-limiting toxicities assessed from first dose through Day 21 of Cycle 1 (each cycle is 21 days). Adverse events and serious adverse events collected from first dose through 30 days after last dose.

    Adverse events and serious adverse events graded per NCI CTCAE v6.0; supported by laboratory tests, vital signs, physical examinations, and triplicate 12-lead ECG. Dose-limiting toxicities assessed during Cycle 1 (Days 1 through 21).

  • Maximum Tolerated Dose (MTD)Determined at the end of the Cycle 1 dose-limiting toxicity evaluation period (Cycle 1 is 21 days).

    MTD determined using the BOIN (Bayesian Optimal Interval) design, with a target dose-limiting toxicity rate of 0.30, based on dose-limiting toxicity incidence observed during Cycle 1.

  • Recommended Phase 2 Dose (RP2D)Phase 1a: at the end of Cycle 1 (each cycle is 21 days). Phase 1b: through end of treatment plus a 30-day safety follow-up period.

    Phase 1a: RP2D range determined from dose-limiting toxicity, adverse event, and serious adverse event incidence together with the MTD determination. Phase 1b: RP2D defined by integrated safety, efficacy, pharmacodynamic, and pharmacokinetic data.