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Advanced Or Metastatic Solid Tumors / Triple Negative Breast Cancer (TNBC) / SHY-ONC6 · Phase 1 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a first-in-human Phase 1 study of SHY-ONC6, a novel proteasome inhibitor, currently recruiting participants with advanced or metastatic solid tumors. The trial is designed to determine safety, tolerability, maximum tolerated dose, and preliminary anti-tumor activity through a two-part dose escalation and expansion design. No efficacy or safety results are reported in this registry record.
Phase 1, Interventional, Single Group, Open label, Treatment purpose. Advanced or Metastatic Solid Tumors, Triple Negative Breast Cancer (TNBC), HR+ Breast Cancer, Colon Cancer, Gastric Cancer, Hepatecellular Carcinoma, NSCLC (Ad…; age from 18 Years. Intervention: SHY-ONC6. n = 30. 4 sites: United States.
This is a first-in-human Phase 1 study of SHY-ONC6, a novel proteasome inhibitor, currently recruiting participants with advanced or metastatic solid tumors. The trial is designed to determine safety, tolerability, maximum tolerated dose, and preliminary anti-tumor activity through a two-part dose escalation and expansion design. No efficacy or safety results are reported in this registry record.
This is a registry record with no reported results; no safety or efficacy data are available. Primary outcomes are dose-limiting toxicity, adverse events, and preliminary anti-tumor activity; no definitive efficacy endpoint is reported.
This registry record describes an active Phase 1 trial with no reported outcomes. Clinicians should not expect efficacy data from this record. Results, when available, will inform dosing, tolerability profile, and preliminary signal of anti-tumor activity to guide Phase 2 development.
First-in-human Phase 1 trial of a novel proteasome inhibitor designed to evaluate safety, tolerability, and preliminary anti-tumor activity; no results are yet reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
This registry record describes an active Phase 1 trial with no reported outcomes. Clinicians should not expect efficacy data from this record. Results, when available, will inform dosing, tolerability profile, and preliminary signal of anti-tumor activity to guide Phase 2 development.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07705334). This is a study registration, not published results. Lead sponsor: SHY Therapeutics. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Advanced or Metastatic Solid Tumors, Triple Negative Breast Cancer (TNBC), HR+ Breast Cancer, Colon Cancer, Gastric Cancer, Hepatecellular Carcinoma, NSCLC (Advanced Non-small Cell Lung Cancer), Mesothelioma, Pancreatic Carcinoma Metastatic, Hormone Refractory Prostate Cancer, Soft Tissue Sarcomas. Interventions: DRUG: SHY-ONC6. Primary outcome measures: 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.; Maximum Tolerated Dose (MTD) , Determined at the end of the Cycle 1 dose-limiting toxicity evaluation period (Cycle 1 is 21 days).; 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.. Brief 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).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.