Advanced 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
Investigational drug(s) / intervention(s)
SHY-ONC6
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.
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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.
Primary outcome measure(s)
Incidence of Dose-Limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs) — 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. Adverse events and serious adverse events graded per NCI CTCAE v6.0; supported by laboratory tests, vital signs, physical examinations, and triplicate 12-lead ECG. Dose-limiting toxicities assessed during Cycle 1 (Days 1 through 21).
Maximum Tolerated Dose (MTD) — Determined at the end of the Cycle 1 dose-limiting toxicity evaluation period (Cycle 1 is 21 days). MTD determined using the BOIN (Bayesian Optimal Interval) design, with a target dose-limiting toxicity rate of 0.30, based on dose-limiting toxicity incidence observed during Cycle 1.
Recommended Phase 2 Dose (RP2D) — Phase 1a: at the end of Cycle 1 (each cycle is 21 days). Phase 1b: through end of treatment plus a 30-day safety follow-up period. Phase 1a: RP2D range determined from dose-limiting toxicity, adverse event, and serious adverse event incidence together with the MTD determination. Phase 1b: RP2D defined by integrated safety, efficacy, pharmacodynamic, and pharmacokinetic data.
Trial sites (4)
Facility
City
Region
Status
HonorHealth Research Institute
Scottsdale
Arizona
Recruiting
SCRI at HCA HealthONE
Denver
Colorado
Not Yet Recruiting
The University of Texas MD Anderson Cancer Center
Houston
Texas
Not Yet Recruiting
NEXT Oncology
San Antonio
Texas
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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