SHY-ONC6: a new anti-cancer drug tested in adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, Phase 1, open-label, multicenter trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of SHY-ONC6 in adults with advanced or metastatic solid tumors. The study includes a dose-escalation part to find a safe dose and a dose-expansion part to further evaluate activity at that dose. Eligible cancers include triple-negative breast cancer, hormone receptor-positive breast cancer, colon cancer, gastric cancer, and other solid tumors that have progressed on standard therapy. Participants must have measurable disease, adequate organ function, and accessible tumor tissue for biopsy. The trial is sponsored by SHY Therapeutics and is conducted at three sites in the United States.

Why it matters

Who can join: the full rules

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.

Where it's running

• HonorHealth Research Institute
  Scottsdale, Arizona, United States Recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• NEXT Oncology
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Medical Monitor
• Email: shyonc6@shytherapeutics.com
• Phone: 914-543-6110

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing MDX2001 for advanced solid tumors

  This study is testing a new drug called MDX2001 to see if it can safely help people with advanced solid tumors like breast or colon cancer.

  Recruiting at 6 sites Phase 1/2 ModeX Therapeutics, An OPKO Health Company · Denver, Colorado and 5 other locations · NCT06239194

• Analyzing solid tumors for HLA loss and collecting T cells for CAR T-cell therapy

  This study is testing how often solid tumors lose a key protein that helps the immune system recognize them, while also collecting T cells from patients with high-risk cancers to prepare for future CAR T-cell therapy.

  Recruiting at 13 sites A2 Biotherapeutics Inc. · Gilbert, Arizona and 15 other locations · NCT04981119

• A resource for collecting cancer data and biospecimens

  This study is creating a resource to collect health information and samples from cancer patients and healthy individuals to help improve cancer prevention and treatment strategies.

  Recruiting at 42 sites University of Nebraska · Greenwood Village, Colorado and 41 other locations · NCT02012699

• Two-part Phase 1/2 test of ODM-212 combined with other cancer treatments

  This trial tests the oral drug ODM-212, given alone or with approved medicines, to see if it helps adults with advanced mesothelioma, pancreatic cancer, or non-small cell lung cancer.

  Recruiting at 23 sites Phase 1/2 Orion Corporation, Orion Pharma · Los Angeles, California and 22 other locations · NCT07563738

• Dose-finding of EXS74539 (REC-4539) in select solid tumors

  This study will try different doses of the experimental drug EXS74539 in adults with select solid tumors to find a safe and tolerable dose.

  Recruiting at 3 sites Phase 1 Exscientia AI Limited · Los Angeles, California and 2 other locations · NCT07517198

• CEA-targeted CAR-T for advanced CEA-positive solid tumors

  This trial will try CEA-targeted CAR-T cell infusions in adults with advanced CEA-positive cancers (such as colorectal, gastric, esophageal, lung, or pancreatic cancer) to see if the treatment is safe and helps control the disease.

  Recruiting Phase 1 Chongqing Precision Biotech Co., Ltd · Hefei, Anhui · NCT07179692

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.