Badanie oceniające dożylny (IV) telisotuzumab adizutecan w skojarzeniu z fluorouracylem, kwasem folinowym i oksaliplatyną (FOLFOX) w porównaniu ze standardowym leczeniem u dorosłych uczestników z przerzutowym gruczolakorakiem przewodowym trzustki w pierwszej linii leczenia
Faza 2/3 otwarte, randomizowane badanie Telisotuzumabu Adizutecanu w skojarzeniu z FOLFOX w porównaniu ze standardem leczenia u pacjentów z przerzutowym rakiem przewodowym trzustki w pierwszej linii leczenia - AndroMETa-PDAC-288
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.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 2
- Faza 3
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: ABBVIE CALL CENTER
- Numer telefonu: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Lokalizacje studiów
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Victoria
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Melbourne, Victoria, Australia, 3084
- Rekrutacyjny
- Austin Hospital /ID# 280283
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Haifa, Izrael, 3109601
- Rekrutacyjny
- Rambam Health Care Campus- Haifa /ID# 279409
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Jerusalem, Izrael, 91120
- Rekrutacyjny
- Hadassah Medical Center-Hebrew University /ID# 279411
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Tel Aviv
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Ramat Gan, Tel Aviv, Izrael, 5265601
- Rekrutacyjny
- The Chaim Sheba Medical Center /ID# 279408
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Tel Aviv, Tel Aviv, Izrael, 6423906
- Rekrutacyjny
- Tel Aviv Sourasky Medical Center /ID# 279414
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Tokyo
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Koto-ku, Tokyo, Japonia, 135-8550
- Rekrutacyjny
- The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 280140
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, Korea Południowa, 03080
- Rekrutacyjny
- Seoul National University Hospital /ID# 280191
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Lisbon, Portugalia, 1649-035
- Rekrutacyjny
- Unidade Local de Saude de Santa Maria /ID# 279884
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Lisbon District
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Lisbon, Lisbon District, Portugalia, 1400-038
- Rekrutacyjny
- Fundacao Champalimaud /ID# 279881
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Connecticut
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New Haven, Connecticut, Stany Zjednoczone, 06511
- Rekrutacyjny
- Smilow Cancer Center At Yale-New Haven /ID# 279780
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60637
- Rekrutacyjny
- University of Chicago Medical Center /ID# 279460
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Zion, Illinois, Stany Zjednoczone, 60099
- Rekrutacyjny
- City Of Hope - Chicago /ID# 279814
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Michigan
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Grand Rapids, Michigan, Stany Zjednoczone, 49503
- Rekrutacyjny
- Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279853
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Missouri
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St Louis, Missouri, Stany Zjednoczone, 63110
- Rekrutacyjny
- Washington University /ID# 279890
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Ohio
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Cleveland, Ohio, Stany Zjednoczone, 44106
- Rekrutacyjny
- UH Seidman Cancer Center /ID# 279602
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Rekrutacyjny
- University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 280038
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Texas
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Tyler, Texas, Stany Zjednoczone, 75702
- Rekrutacyjny
- Texas Oncology - Northeast Texas /ID# 280417
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Virginia
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Fairfax, Virginia, Stany Zjednoczone, 22031
- Rekrutacyjny
- Virginia Cancer Specialists - Fairfax /ID# 280415
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Kaohsiung City, Tajwan, 807
- Rekrutacyjny
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 279735
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Taichung, Tajwan, 40447
- Rekrutacyjny
- China Medical University Hospital /ID# 279725
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Taipei, Tajwan, 112
- Rekrutacyjny
- Taipei Veterans General Hospital /ID# 279726
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Oxfordshire
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Oxford, Oxfordshire, Zjednoczone Królestwo, OX3 7LE
- Rekrutacyjny
- Oxford University Hospital NHS Trust /ID# 279764
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Ph 2: Dose Escalation Telisotuzumab Adizutecan + FOLFOX
Participants will receive Telisotuzumab Adizutecan + fluorouracil, folinic acid, and oxaliplatin (FOLFOX) until doses for optimization are determined, as part of an approximately 2 year study period. |
IV Infusion Intravenous (IV) Infusion IV Infusion IV Infusion |
|
Eksperymentalny: Ph 2: Dose Optimization Telisotuzumab Adizutecan+FOLFOX Dose A
Participants will receive Telisotuzumab Adizutecan+FOLFOX Dose A as part of the approximately 2 year study duration. |
IV Infusion Intravenous (IV) Infusion IV Infusion IV Infusion |
|
Eksperymentalny: Ph 2: Dose Optimization Telisotuzumab Adizutecan+FOLFOX Dose B
Participants will receive Telisotuzumab Adizutecan+FOLFOX Dose B as part of the approximately 2 year study duration. |
IV Infusion Intravenous (IV) Infusion IV Infusion IV Infusion |
|
Aktywny komparator: Ph 2: Dose Optimization Standard of Care (SOC) mFOLFIRINOX
Participants will receive SOC (fluorouracil, leucovorin, oxaliplatin, and irinotecan) as part of the approximately 2 year study duration. |
IV Infusion IV Infusion IV Infusion IV Infusion |
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Eksperymentalny: Ph 3: Telisotuzumab Adizutecan RP3D + FOLFOX
Participants will receive Telisotuzumab Adizutecan recommended Phase 3 dose (RP3D) + FOLFOX as part of an approximately 2 year study period. |
IV Infusion Intravenous (IV) Infusion IV Infusion IV Infusion |
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Aktywny komparator: Ph 3: SOC mFOLFIRINOX
Participants will receive SOC (fluorouracil, leucovorin, oxaliplatin, and irinotecan) as part of the approximately 2 year study duration. |
IV Infusion IV Infusion IV Infusion IV Infusion |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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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
Ramy czasowe: through study completion, approximately 6 years
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OR is defined as participants achieving a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR per RECIST v1.1. |
through study completion, approximately 6 years
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Phase 3: Overall Survival (OS)
Ramy czasowe: through study completion, approximately 6 years
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OS is defined as the time from date of randomization to the death from any cause. |
through study completion, approximately 6 years
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Phase 2 and Phase 3: Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1
Ramy czasowe: through study completion, approximately 6 years
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PFS is defined as the time from the date of randomization or date of first dose of study treatment to the first occurrence of radiographic progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first. |
through study completion, approximately 6 years
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Phase 2 and Phase 3: Duration Of Response (DoR) assessed by BICR per RECIST v1.1
Ramy czasowe: through study completion, approximately 6 years
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DoR is defined as time from the initial response of Complete Response or Partial Response assessed by BICR per RECIST v1.1 to the first occurrence of radiographic progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first. |
through study completion, approximately 6 years
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Phase 2 and Phase 3: Clinical Benefit (CB) assessed by BICR per RECIST v1.1
Ramy czasowe: through study completion, approximately 6 years
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CB is defined as a participant achieving best overall response of confirmed CR or confirmed PR, or SD (with a minimum duration of 24 weeks) assessed by BICR per RECIST v1.1. |
through study completion, approximately 6 years
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Phase 2 : Overall Survival
Ramy czasowe: through study completion, approximately 6 years
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OS is defined as the time from the date of randomization or date of first dose of study treatment to the event of death from any cause |
through study completion, approximately 6 years
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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)
Ramy czasowe: through study completion, approximately 6 years
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The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much). |
through study completion, approximately 6 years
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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)
Ramy czasowe: through study completion, approximately 6 years
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The EORTC QLQ-PAN is a PDAC-specific module and consists of 26 questions assessing pancreatic cancer- and treatment-related symptoms and impact, including 7 scales, and 10 single items, All questions employ a one week recall period, and each item is assessed on a Likert scale from 1 (not at all) to 4 (very much). |
through study completion, approximately 6 years
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Phase 3: Change in Selected items of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Ramy czasowe: through study completion, approximately 6 years
|
The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in patients participating in cancer clinical trials. PRO-CTCAE includes 124 items representing 78 symptomatic toxicities drawn from the Common Terminology Criteria for Adverse Events (CTCAE). PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. All questions employ a 7-day recall period and are scored from 0 to 4 (or 0/1 for absent/present). |
through study completion, approximately 6 years
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Phase 3: Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G)
Ramy czasowe: through study completion, approximately 6 years
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The FACT GP5 item ("I am bothered by side effects of treatment") is used to assess overall treatment tolerability in patients by assessing the overall side effect impact on patients. This item is rated on a 5- point Likert scale from 0="not at all" to 4="very much." |
through study completion, approximately 6 years
|
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Phase 3: Change in Selected items of Patient Global Impression of Severity (PGIS)
Ramy czasowe: through study completion, approximately 6 years
|
The PGIS scale asks the participant to assess the severity of their PDAC symptoms over the past 7 days and employs a 5-point response scale ranging from "None" to "Very Severe". |
through study completion, approximately 6 years
|
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Phase 3: Change in Selected items of Patient Global Impression of Change (PGIC)
Ramy czasowe: through study completion, approximately 6 years
|
The PGIC scale assesses patients' perceptions of change in their PDAC symptoms since the start of treatment in the study and employs a 7-point response scale ranging from "Much Better" to "Much worse". |
through study completion, approximately 6 years
|
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Phase 3: Change from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L)
Ramy czasowe: through study completion, approximately 6 years
|
The EQ-5D-5L is a generic preference instrument that has been validated in numerous cancer populations. The EQ-5D-5L consists of 2 components: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The EQ VAS records the participant's self-rated health on a vertical VAS where 100 represents "The best health you can imagine" and 0 represents "The worst health you can imagine." |
through study completion, approximately 6 years
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: ABBVIE INC., AbbVie
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Organiczne chemikalia
- Związki heterocykliczne, 1-ring
- Związki heterocykliczne
- Związki heterocykliczne, 2-ring
- Związki heterocykliczne, sterowanie stopieniem
- Campptothecin
- Alkaloidy
- Enzymy i koenzymy
- Kompleksy koordynacyjne
- Pirymidyn
- FormylTetrahydrofolates
- Tetrahydrofolety
- Kwas foliowy
- Pterins
- Perydyny
- Uracyl
- Pirymidynony
- Koenzymy
- Oksaliplatyna
- Irynotekan
- Fluorouracyl
- Leukoworyna
Inne numery identyfikacyjne badania
- M25-288
- 2025-522563-15-00 (Inny identyfikator: EU CT)
- 2025 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Ramy czasowe udostępniania IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Kryteria dostępu do udostępniania IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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