Um Estudo de ITC-6146RO em Doentes com Cancro Avançado ou Metastático que Falharam a Terapia Padrão
Um Estudo de Fase 1a/b, Aberto, Multicêntrico, Primeiro em Humanos, de Escalação/Expansão de Dose com Múltiplas Coortes para Avaliar a Segurança, Tolerabilidade, Farmacocinética e Eficácia Antitumoral Preliminar de ITC-6146RO em Doentes com Cancro Avançado ou Metastático que Falharam a Terapia Padrão
The study consists of Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, sequential cohorts of subjects will receive escalating doses of ITC-6146RO to determine maximum tolerated dose (MTD) and/or optimal biological dose (OBD).
In Phase 1b, the recommended phase 2 dose (RP2D) chosen from Phase 1a will be evaluated to further investigate safety, tolerability, pharmacokinetic (PK) and anti-tumor efficacy of ITC-6146RO.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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-
Seoul
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Seoul, Seoul, Coréia do Sul, 05505
- Asan Medical Center
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Seoul, Seoul, Coréia do Sul, 06351
- Samsung Medical Center
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Seoul, Seoul, Coréia do Sul, 03722
- Severance Hospital
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Adult males and females aged ≥ 19 years (Korea) or ≥ 18 years (United States)
- Patients must be individuals who have voluntarily agreed to participate in the study after receiving a detailed explanation and fully understanding the nature of the clinical trial, and who have provided written informed consent.
- Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease
- Patients must have at least one evaluable or measurable lesion based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1). However, for patients with prostate cancer, eligibility will be determined based on Prostate Cancer Working Group 3 (PCWG3)
- Patients who have received standard therapies and have no remaining clinically available approved treatment options.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Estimated life expectancy of ≥ 3 months
Exclusion Criteria:
- Inability to comply with study and follow-up procedures
- Patients with a prior history of anticancer therapy before the first dose
- History of another active malignancy within the past 3 years
- Patients with central nervous system metastases, leptomeningeal disease, or spinal cord compression.
- Patients who are currently participating in a clinical trial or have participated in a clinical trial involving a medical device or investigational product within 28 days prior to the first administration of ITC-6146RO
- Has prior treatment with duocarmycin-containing agents
- Pregnancy, lactation, or breastfeeding
- Known Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV) infection with active disease exception of the following conditions.
- Tuberculosis with active disease
- Active infection necessitating systemic therapy
- Prior allogenic bone marrow transplantation or solid organ transplantation
- History of autoimmune disease, treatment with systemic immunosuppressive medications
- Patients with clinically significant pulmonary disease
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Phase 1a/b
The study consists of a Phase 1a dose-escalation part and a Phase 1b dose-expansion part. |
ITC-6146RO will be administered as an intravenous (IV) infusion at protocol-specified dose levels and schedules in Phase 1a (dose escalation) and Phase 1b (dose expansion). |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs)
Prazo: Through study completion (Up to 2 years)
|
Grade 3 and 4 AEs, Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Dose-limiting toxicities (DLTs) and AEs leading to discontinuation of study treatment, Evaluation of all-grade cardiac, renal, and pulmonary AEs , n, (%) |
Through study completion (Up to 2 years)
|
|
Phase 1b (Dose Expansion) Incidence of AEs
Prazo: Through study completion (Up to 2 years)
|
Grade 3 and 4 AEs, TEAEs, SAEs and AEs leading to discontinuation of study treatment, Evaluation of all-grade cardiac, renal, and pulmonary AEs, n, % |
Through study completion (Up to 2 years)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Phase 1a (Dose Escalation) Maximum Tolerated Dose (MTD) or Optimal Biological Dose (OBD) of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
MTD/OBD will be reported as the final selected dose level for further investigation from Phase 1a dose escalation. MTD is determined by DLTs observed during the prespecified DLT observation period, and OBD is determined by meeting prespecified biological activity criteria (as defined in the protocol). |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) After Single-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Plasma AUClast following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) After Single-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Plasma AUCinf following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Maximum Observed Plasma Concentration (Cmax) After Single-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Plasma Cmax following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Terminal Elimination Half-life (t1/2) After Single-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Plasma terminal elimination half-life (t1/2) following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Time to Maximum Observed Plasma Concentration (Tmax) After Single-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Plasma Tmax following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Apparent Clearance (CL) After Single-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Plasma apparent clearance (CL) following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Apparent Volume of Distribution (Vz) After Single-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Plasma apparent volume of distribution (Vz) following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) After Multiple-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Plasma AUClast following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Maximum Observed Plasma Concentration at Steady State (Cmax,ss) After Multiple-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Plasma Cmax,ss (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Trough Plasma Concentration at Steady State (Ctrough,ss) After Multiple-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Plasma Ctrough,ss (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Average Plasma Concentration Over the Dosing Interval at Steady State (Cav,τ) After Multiple-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Plasma Cav,τ (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Terminal Elimination Half-life at Steady State (t1/2,ss) After Multiple-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Plasma terminal elimination half-life at steady state (t1/2,ss) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) After Multiple-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Plasma Tmax,ss (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Apparent Clearance at Steady State (CLss) After Multiple-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Plasma apparent clearance at steady state (CLss) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Apparent Volume of Distribution at Steady State (Vss) After Multiple-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Plasma apparent volume of distribution at steady state (Vss) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Accumulation Ratio After Multiple-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Accumulation ratio (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Peak-to-Trough Fluctuation (PTF) After Multiple-Dose Administration of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Peak-to-trough fluctuation (PTF) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively. |
Through study completion (Up to 2 years)
|
|
Phase 1a (Dose Escalation) Incidence of Anti-Drug Antibodies (ADAs) to ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Percentage of participants with detectable ADAs to ITC-6146RO (ADA-positive) based on a validated immunoassay. |
Through study completion (Up to 2 years)
|
|
Phase 1b (Dose Expansion) Population Pharmacokinetic (PopPK) Parameters of ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
PopPK parameters (e.g.,clearance and volume of distribution) will be estimated using PopPK modeling based on measured ITC-6146RO concentrations. |
Through study completion (Up to 2 years)
|
|
Phase 1b (Dose Expansion) Incidence of Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to ITC-6146RO
Prazo: Through study completion (Up to 2 years)
|
Percentage of participants with detectable ADAs, including NAbs, to ITC-6146RO, as determined by validated immunoassay and neutralization assays (as applicable). |
Through study completion (Up to 2 years)
|
|
Phase 1a/b (Dose Escalation, Dose Expansion) Objective Response Rate (ORR) by Investigator per RECIST v1.1
Prazo: Through study completion (Up to 2 years)
|
ORR will be assessed by the investigator per RECIST v1.1 |
Through study completion (Up to 2 years)
|
|
Phase 1a/b (Dose Escalation, Dose Expansion) Duration of Response (DoR) by Investigator per RECIST v1.1
Prazo: Through study completion (Up to 2 years)
|
DoR will be assessed by the investigator per RECIST v1.1 |
Through study completion (Up to 2 years)
|
|
Phase 1a/b (Dose Escalation, Dose Expansion) Time to Response (TTR) by Investigator per RECIST v1.1
Prazo: Through study completion (Up to 2 years)
|
TTR will be assessed by the investigator per RECIST v1.1 |
Through study completion (Up to 2 years)
|
|
Phase 1a/b (Dose Escalation, Dose Expansion) Progression-Free Survival (PFS) by Investigator per RECIST v1.1
Prazo: Through study completion (Up to 2 years)
|
PFS will be assessed by the investigator per RECIST v1.1 |
Through study completion (Up to 2 years)
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Phase 1b (Dose Expansion) Association Between ITC-6146RO Pharmacokinetic Parameters and Efficacy and Safety Endpoints
Prazo: Through study completion (Up to 2 years)
|
Correlation between ITC-6146RO pharmacokinetic (PK) parameters and selected efficacy, safety, and exploratory endpoints. Efficacy endpoints may include objective response rate (ORR) and progression-free survival (PFS). Associations will be evaluated using appropriate exposure-response analyses. |
Through study completion (Up to 2 years)
|
|
Phase 1a/b (Dose Escalation, Dose Expansion) Overall Survival (OS)
Prazo: Through study completion (Up to 2 years)
|
OS is defined as the time from randomization until death from any cause. |
Through study completion (Up to 2 years)
|
|
Phase 1a/b (Dose Escalation, Dose Expansion) Association Between B7-H3 Expression in Tumor Tissue and Anti-Tumor Efficacy
Prazo: Through study completion (Up to 2 years)
|
Correlation between B7-H3 expression in tumor tissue assessed by immunohistochemistry (IHC) and anti-tumor efficacy endpoints, including objective response rate (ORR) and progression-free survival (PFS). ORR is defined as the proportion of participants with confirmed complete or partial response, and PFS as time to disease progression or death per protocol-defined criteria. Associations will be evaluated using appropriate statistical methods. In participants with metastatic castration-resistant prostate cancer (mCRPC), PSA response rate (≥50% decline from baseline) and time to PSA progression will also be assessed. |
Through study completion (Up to 2 years)
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Processos Patológicos
- Neoplasias por local
- Neoplasias
- Doenças Respiratórias
- Doenças pulmonares
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Processos Neoplásicos
- Neoplasias Pulmonares
- Doenças de pele
- Doenças da mama
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Neoplasias da Mama
- Condições Patológicas, Sinais e Sintomas
- Doenças da Pele e do Tecido Conjuntivo
- Neoplasia Metástase
- Carcinoma pulmonar de células não pequenas
- Neoplasias da Mama Triplo Negativas
Outros números de identificação do estudo
- ITC06P1-P01
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