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A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors (Luca-1)

10 de julho de 2026 atualizado por: SHY Therapeutics

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

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).

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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).

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • Colorado
      • Denver, Colorado, Estados Unidos, 80218
        • Ainda não está recrutando
        • SCRI at HCA HealthONE
        • Investigador principal:
          • Gerald Falchook, MD
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Ainda não está recrutando
        • The University of Texas MD Anderson Cancer Center
        • Investigador principal:
          • Timothy Yap, MBBS, PhD
      • San Antonio, Texas, Estados Unidos, 78229
        • Recrutamento
        • NEXT Oncology
        • Investigador principal:
          • Ildefonso Rodriguez Rivera, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Incidence of Dose-Limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs)
Prazo: 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).
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)
Prazo: 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.
Determined at the end of the Cycle 1 dose-limiting toxicity evaluation period (Cycle 1 is 21 days).
Recommended Phase 2 Dose (RP2D)
Prazo: 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.
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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Maximum Plasma Concentration (Cmax)
Prazo: Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Maximum observed plasma concentration of study drug.
Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Area Under the Plasma Concentration-Time Curve (AUC)
Prazo: Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Area under the plasma concentration-versus-time curve for study drug.
Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Time to Maximum Plasma Concentration (Tmax)
Prazo: Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Time from dosing to observed maximum plasma concentration of study drug.
Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Terminal Elimination Half-Life (t1/2)
Prazo: Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Terminal elimination half-life of study drug.
Cycle 1 Day 1; Day 2 (24 hours post-dose); Day 8; and pre-dose on Day 15. Pre-dose and post-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Trough Plasma Concentration (Ctrough)
Prazo: Pre-dose on Day 15 of Cycle 1 and pre-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Plasma concentration of study drug immediately prior to the next dose.
Pre-dose on Day 15 of Cycle 1 and pre-dose on Day 1 of subsequent cycles (each cycle is 21 days).
Overall Survival (OS)
Prazo: From first dose until death, withdrawal, loss to follow-up, or study termination, assessed up to an estimated 12 months after last dose of study drug.
Time from first dose until death from any cause.
From first dose until death, withdrawal, loss to follow-up, or study termination, assessed up to an estimated 12 months after last dose of study drug.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1b)
Prazo: From first dose through end of treatment plus a 30-day safety follow-up period.
Adverse events and serious adverse events graded per NCI CTCAE v6.0, collected during Phase 1b.
From first dose through end of treatment plus a 30-day safety follow-up period.
Anti-Tumor Activity - Objective Response Rate
Prazo: Baseline through study completion, an average of 18 months.
Objective response rate defined as the proportion of patients with a confirmed best overall response of either complete response or partial response, as determined per investigator assessment by RECIST v1.1 (PCWG3 for prostate cancer with bone disease).
Baseline through study completion, an average of 18 months.
Anti-Tumor Activity - Best Overall Response (BOR)
Prazo: Baseline through study completion, an average of 18 months.
Best response recorded from first dose until disease progression (complete response, partial response, stable disease, or progressive disease), per RECIST v1.1 (PCWG3 for prostate cancer with bone disease).
Baseline through study completion, an average of 18 months.
Anti-Tumor Activity - Time to Response (TTR)
Prazo: From baseline until first documented response, assessed up to an estimated 18 months.
Time from first dose to first documented complete response (CR) or partial response (PR) per RECIST v1.1 (PCWG3 for prostate cancer with bone disease).
From baseline until first documented response, assessed up to an estimated 18 months.
Anti-Tumor Activity - Duration of Response (DOR)
Prazo: Baseline through study completion, an average of 18 months.
Time from first documented complete response (CR) or partial response (PR) to disease progression or death from any cause, per RECIST v1.1 (PCWG3 for prostate cancer with bone disease).
Baseline through study completion, an average of 18 months.
Anti-Tumor Activity - Progression-Free Survival
Prazo: Baseline through study completion, an average of 18 months.
Time from first dose to first documented disease progression per RECIST v1.1 (PCWG3 for prostate cancer with bone disease) or death from any cause.
Baseline through study completion, an average of 18 months.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

SHY Therapeutics

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

29 de junho de 2026

Conclusão Primária (Estimado)

15 de maio de 2027

Conclusão do estudo (Estimado)

15 de maio de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

1 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de julho de 2026

Primeira postagem (Real)

15 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • SHY-ONC6-101

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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