RecruitingPhase 1NCT07705334

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

A Phase 1 Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SHY-ONC6 in Participants With Advanced or Metastatic Solid Tumors

Sponsor

SHY Therapeutics

Enrollment

30 participants

Start Date

Jun 29, 2026

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SHY-ONC6 for people with advanced or metastatic solid tumors, colon cancer, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHY-ONC6

Participants receive SHY-ONC6 administered orally once daily in 21-day cycles. SHY-ONC6 will be administered until the participant withdraws from study, experiences unacceptable toxicity or other safety event, or their disease progresses.