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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 Criteria

  • 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.

Recruiting Locations

NEXT Oncology
San Antonio, Texas 78229

More Details

Status
Recruiting
Sponsor
SHY Therapeutics

Study Contact

Medical Monitor
619-985-2706
shyonc6@shytherapeutics.com

Detailed Description

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.