- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07698613
EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer
BrUOG 438: EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Roxanne Wood, MPH
- Número de telefone: 401-863-3000
- E-mail: roxanne_wood@brown.edu
Estude backup de contato
- Nome: BrUOG
- E-mail: BrUOG@brown.edu
Locais de estudo
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903/02906
- Rhode Island and the Miriam Hospitals (Brown University Health)
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Pathologically confirmed pancreatic adenocarcinoma.
- Clinically staged locally advanced or borderline resectable pancreatic adenocarcinoma.
- Completed neoadjuvant chemotherapy
- Neoadjuvant radiation is allowed
- Planned surgical exploration
- Treatment with ASP-1929 will be at least 4 - 10 weeks after last chemotherapy and radiation.
- Patients with a history of biliary obstruction must have adequate biliary drainage.
Patients meeting the following laboratory criteria for Adequate Organ and Bone Marrow Function:
Platelet Count ≥ 75,000/mm3. Hemoglobin ≥ 8.0 g/dL [NOTE: Participants requiring ongoing transfusions or growth factor support to maintain hemoglobin ≥8.0 g/dL are not eligible] Absolute neutrophil count ≥ 1,000/mm3. [Granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1] Alanine aminotransferase (ALT) ≤ 3×ULN Aspartate aminotransferase (AST) ≤ 3×ULN Total Bilirubin ≤ 1.5×ULN or < 3×ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) Creatinine ≤ 3×ULN
- Age ≥ 18
- ECOG performance status 0-1
- For women of pregnancy potential, a negative pregnancy test within 7 days prior to registration.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Patients with distant metastases.
- Patients with medical co-morbidities that make them not candidates for surgical exploration
- Planned concomitant, non-protocol directed anti-cancer therapy for at least 8 weeks after ASP-1929
- Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable Grade 2.
- History of significant (Grade ≥ 3) cetuximab infusion reactions
- Photosensitizing medications must be discontinued 4 weeks before ASP-1929 PIT treatment, unless medically required.
- No uncontrolled intercurrent illness including but not limited to symptomatic CHF, unstable angina, clinically significant severe cardiac arrhythmia, psychiatric illness or social situations that would limit compliance with study requirements.
- Any other condition which, in the investigator's opinion, deems the patient an unsuitable candidate to receive ASP-1929 and/or be exposed to PIT illumination.
- Women who are pregnant or nursing.
- Patients with concomitant malignancies not expected to cause death within 5 years are eligible.
Plano de estudo
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 |
|---|---|
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Experimental: ASP-1929 PIT
Approximately 24 hours prior to surgery patients will receive ASP-1929, IV over 2 hours, in the outpatient clinic.
ASP-1929 is an EGFR targeting antibody conjugated with a laser-light activable dye IR700.
The following day patients will undergo standard surgical exploration.
Patients found to be inoperable will be treated with the laser device (Alluminox platform) over 5 minutes in the operating room to activate ASP-1929 photoimmunotherapy.
Activation of the IR700 dye with red light (690nm) may result in anticancer activity mediated by immunogenic cell death and necrosis, leading to activation of the immune system.
[Patients who are resectable will undergo resection of their pancreatic cancer and will not receive the laser and their tumor will subsequently be evaluated for EGFR receptor saturation.]
Part 1: There will be a 10-patient safety run-in Part 2: If Part 1 is acceptable, an additional 20 patients will receive PIT to determine preliminary efficacy in a total of 30 patients
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Approximately 24 hours prior to surgery, patients will receive ASP-1929, IV over 2 hours, in the outpatient clinic.
ASP-1929 is an EGFR targeting antibody conjugated with a laser-light activable dye IR700 (IRDye 700DX).
The following day patients will undergo standard surgical exploration.
Those patients found to be inoperable on surgical exploration will be treated with the laser device (Alluminox platform) over 5 minutes in the operating room to activate ASP-1929 photoimmunotherapy.
Activation of the IR700 dye with red light (690nm) may result in anticancer activity mediated by immunogenic cell death and necrosis, leading to activation of the immune system.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of treatment related toxicities grade ≥3
Prazo: From start of treatment to 28 days post surgery
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Part 1 | Safert: The primary endpoint is grade 3 or higher ASP-1929 photoimmunotherapy treatment related toxicity within 28 days of surgery.
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From start of treatment to 28 days post surgery
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Number of Participants Reaching 6 Months Progression Free Survival
Prazo: From start of treatment to 6 months post surgery.
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Part 2 (expansion cohort for efficacy): The primary endpoint of this cohort is 6-month progression free survival.
RECIST version 1.1 will be used to assess for response/progression
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From start of treatment to 6 months post surgery.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
Palavras-chave
Outros números de identificação do estudo
- BrUOG 438
- 1929-IIR-0016 (Outro identificador: Rakuten)
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