A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan in Combination With Fluorouracil, Folinic Acid, and Oxaliplatin (FOLFOX) Compared to Standard of Care in Adult Participants With First-Line Metastatic Pancreatic Ductal Adenocarcinoma

Официальное название

Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan in Combination With FOLFOX Compared to Standard of Care in Subjects With First-Line Metastatic Pancreatic Ductal Adenocarcinoma - AndroMETa-PDAC-288

Обзор

Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. The pancreas is a gland behind the stomach that produces a digestive fluid that is emptied into the intestines through tube shaped ducts. Pancreatic cancer often starts in these ducts. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan when given in combination with fluorouracil, folinic acid, and oxaliplatin (FOLFOX) to treat adult participants with pancreatic ductal cancer. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of pancreatic ductal adenocarcinoma (PDAC). This study will be divided into two phases, with the first phase (Phase 2) treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX. Participants will then be randomized into 3 groups called treatment arms. Two groups will receive telisotuzumab adizutecan with FOLFOX with different optimized doses. One group will receive standard of care (SOC) - fluorouracil, leucovorin, oxaliplatin, and irinotecan. In the second phase (Phase 3), participants will be randomized into 2 arms to receive either the optimal dose of telisotuzumab adizutecan (from the previous phase) with FOLFOLX, or SOC. Approximately 900 participants with PDAC will be enrolled in this study in approximately 200 sites worldwide. Phase 2 includes a dose escalation stage and a dose optimization stage. In the dose escalation stage, participants will receive escalating doses of Intravenous (IV) telisotuzumab adizutecan + FOLFOX. In the dose optimization stage, participants will receive 1 of 2 doses of IV telisotuzumab adizutecan with FOLFOX or SOC. At the start of Phase 3, participants will receive the optimal dose of IV telisotuzumab adizutecan with FOLFOX or SOC. The study will run for a duration of approximately 6 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Вмешательства

• Препарат Telisotuzumab adizutecan
  Intravenous (IV) Infusion
• Препарат Fluorouracil
  IV Infusion
• Препарат Folinic acid/ Leucovorina
  IV Infusion
• Препарат Oxaliplatin
  IV Infusion
• Препарат Irinotecan
  IV Infusion

Первичные конечные точки

• Phase 2 and Phase 3: Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Срок оценки: through study completion, approximately 6 years]
• Phase 3: Overall Survival (OS) [Срок оценки: through study completion, approximately 6 years]

Вторичные конечные точки (11)

• Phase 2 and Phase 3: Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1 [Срок оценки: through study completion, approximately 6 years]
• Phase 2 and Phase 3: Duration Of Response (DoR) assessed by BICR per RECIST v1.1 [Срок оценки: through study completion, approximately 6 years]
• Phase 2 and Phase 3: Clinical Benefit (CB) assessed by BICR per RECIST v1.1 [Срок оценки: through study completion, approximately 6 years]
• Phase 2 : Overall Survival [Срок оценки: through study completion, approximately 6 years]
• Phase 3: Change from baseline and time to deterioration in scale of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - Core 30-item (EORTC QLQ-C30) [Срок оценки: through study completion, approximately 6 years]
• Phase 3: Change from baseline and time to deterioration in scale of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - Pancreatic Cancer Module (EORTC QLQ-PAN26) [Срок оценки: through study completion, approximately 6 years]
• Phase 3: Change in Selected items of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Срок оценки: through study completion, approximately 6 years]
• Phase 3: Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G) [Срок оценки: through study completion, approximately 6 years]
• Phase 3: Change in Selected items of Patient Global Impression of Severity (PGIS) [Срок оценки: through study completion, approximately 6 years]
• Phase 3: Change in Selected items of Patient Global Impression of Change (PGIC) [Срок оценки: through study completion, approximately 6 years]
• Phase 3: Change from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) [Срок оценки: through study completion, approximately 6 years]

Критерии участия

Критерии включения

• Have unresectable, metastatic histologically- or cytologically-confirmed adenocarcinoma of the pancreas
• Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
• Must consent to provide archived or recently obtained tumor tissue during Screening
• Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Критерии исключения

• Have prior systemic therapy, surgery, or radiation (except palliative radiation) in the unresectable, locally advanced or metastatic setting
• Prior c-MET targeting therapy
• History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan, including a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
• Prior bone marrow transplant, solid organ transplant, or previous clinical diagnosis of tuberculosis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• University of Chicago Medical Center /ID# 279460 — Chicago
• City Of Hope - Chicago /ID# 279814 — Zion
• Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279853 — Grand Rapids
• Texas Oncology - Northeast Texas /ID# 280417 — Tyler
• Virginia Cancer Specialists - Fairfax /ID# 280415 — Fairfax

Австралия · 5 центров

• Tamworth Hospital /ID# 280099 — North Tamworth
• Prince Of Wales Hospital - Randwick /ID# 280085 — Randwick
• Monash Health - Monash Medical Centre - Clayton /ID# 280076 — Clayton
• Austin Hospital /ID# 280283 — Melbourne
• Fiona Stanley Hospital /ID# 280079 — Murdoch

Израиль · 4 центра

• The Chaim Sheba Medical Center /ID# 279408 — Ramat Gan
• Tel Aviv Sourasky Medical Center /ID# 279414 — Tel Aviv
• Rambam Health Care Campus- Haifa /ID# 279409 — Haifa
• Hadassah Medical Center-Hebrew University /ID# 279411 — Jerusalem

Тайвань · 3 центра

• Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 279735 — Kaohsiung City
• China Medical University Hospital /ID# 279725 — Taichung
• Taipei Veterans General Hospital /ID# 279726 — Taipei

Италия · 1 центр

• Azienda Ospedaliero Universitaria Pisana /ID# 285773 — Pisa

Япония · 1 центр

• The Cancer Institute Hospital Of JFCR /ID# 280140 — Koto-ku

South Korea · 1 центр

• Seoul National University Hospital /ID# 280191 — Seoul

Великобритания · 1 центр

• Oxford University Hospital NHS Trust /ID# 279764 — Oxford

Идентификаторы

NCT: NCT07490301 · M25-288 · 2025-522563-15-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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