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RecruitingPhase 1

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

A Phase 1 Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SHY-ONC6 in Participants With Advanced or Metastatic Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests SHY-ONC6 in people for the first time to learn about its safety, doses, how the body handles it, and whether it fights cancer. It is for adults with solid tumors that are advanced or have spread, when standard treatments no longer work or cannot be used.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 or older, expected to live more than 3 months, and able to do most daily activities with little or no help.
  • Have cancer confirmed by a tissue or cell test that is advanced or has spread. Standard treatments must have stopped working or be unsuitable. Listed cancers include triple-negative or hormone-sensitive breast cancer; colon, stomach, liver, pancreatic, or hormone-resistant prostate cancer; certain non-small cell lung cancers; mesothelioma (cancer of an organ lining); and soft tissue sarcoma. Other types need discussion with the study’s medical monitor.
  • Have at least one tumor that can be measured and a tumor that can be reached for a tissue sample. Prostate cancer only in the bones may qualify if PSA, a blood marker, is raised.
  • Have organs and bone marrow that work well enough. Bone marrow makes blood cells.
  • Be willing and able to give informed consent, meaning you understand and agree to join.
  • Cancer that has spread to the brain or spinal cord is allowed if stable for at least 4 weeks after radiation and you have been off steroids for at least 14 days.
  • If you can become pregnant, have a negative blood pregnancy test and use effective birth control through 90 days after the last dose.
  • Men must use barrier birth control, such as condoms, or avoid sex, and must not donate sperm through 90 days after the last dose.

Who can't join

  • Have high-risk heart or blood vessel disease, breathing problems within the past 6 months, or serious disease of the cornea, the clear front of the eye.
  • Have an active infection needing treatment throughout the body within 2 weeks before dosing; active hepatitis B or C; or HIV that is not well controlled. Well-controlled HIV is allowed with a CD4 immune cell count of at least 350 and no detectable virus. An AIDS-related infection within 12 months also excludes you.
  • Have a history of another cancer, with exceptions for cancer that has not spread beyond where it started, certain skin cancers, or cancer in remission for at least 2 years.
  • Are receiving another cancer treatment, or have not waited long enough after radiation, cancer medicines, or another study treatment.
  • Had major surgery within 4 weeks before dosing, or still have side effects from past cancer treatment. Some side effect exceptions apply.
  • Are pregnant or breastfeeding.
  • Cannot swallow tablets or have a condition that affects how your stomach or intestines absorb medicine.
  • Have a medical or mental health condition that could affect following study rules or understanding the results, or cannot follow restrictions on other medicines.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (3)

AZ

TX

  • The University of Texas MD Anderson Cancer Center · Houston, TX 77030Timothy Yap, MBBS, PhD · Principal investigatorMore trials in Houston
  • NEXT Oncology · San Antonio, TX 78229Ildefonso Rodriguez Rivera, MD · Principal investigatorMore trials in San Antonio