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

Part of paid clinical trials in Denver, Colorado.

Sponsor
SHY Therapeutics
Study ID
NCT07705334
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SHY-ONC6 — DRUG
    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.

Study Details

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).

Key Dates

First listed
Jul 15, 2026
Start date
Jun 29, 2026
Status verified
Jul 2026
Primary completion
May 15, 2027
Completion
May 15, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SHY-ONC6
    Participants receive SHY-ONC6 administered orally once daily. Phase 1a, sequential dose levels are evaluated under accelerated titration and BOIN dose-escalation design. In Phase 1b, participants will be evaluated in disease-specific expansion cohorts and receive SHY-ONC6 at the RP2D range identified in Phase 1a.

Primary Outcome Measure

Incidence of Dose-Limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs) [ Time Frame: 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. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
SCRI at HCA HealthONEDenverColorado80218
Gerald Falchook, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Timothy Yap, MBBS, PhD (PRINCIPAL_INVESTIGATOR)
NEXT OncologySan AntonioTexas78229
Ildefonso Rodriguez Rivera, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Denver, CO

By condition
Colorectal cancerGastric cancer
By specialty
OncologyGI oncology
By research site
SCRI at HCA HealthONE· Denver, COThe University of Texas MD Anderson Cancer Center· Houston, TXNEXT Oncology· San Antonio, TX

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