Health Trials

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

ConditionsAdvanced or Metastatic Solid TumorsTriple Negative Breast Cancer (TNBC)HR+ Breast CancerColon CancerGastric CancerHepatecellular CarcinomaNSCLC (Advanced Non-small Cell Lung Cancer)MesotheliomaPancreatic Carcinoma MetastaticHormone Refractory Prostate CancerSoft Tissue Sarcomas
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSHY Therapeutics

About this trial

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

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • SHY-ONC6

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

SHY Therapeutics

Lead sponsor

Source ClinicalTrials.gov