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

NCT07705334 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-10

No results posted yet for this study

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).

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

Interventions

DRUG

SHY-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.

Sponsors & Collaborators

  • SHY Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-24
Primary Completion
2027-05-15
Completion
2028-05-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07705334 on ClinicalTrials.gov