Pancreatic Ductal Adenocarcinoma, Pancreatobiliary Cancers
Conditions
Keywords
Pancreatobiliary Cancers, Pancreatic Ductal Adenocarcinoma, PDAC, Telisotuzumab Adizutecan, Cancer
Brief summary
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 goal of this study is to evaluate the safety and efficacy of telisotuzumab adizutecan in combination with gemcitabine and nab-paclitaxel in adult participants with pancreatobiliary cancers. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of pancreatobiliary cancers. In Substudy 1, participants will be randomized into two groups. One group will receive different doses of telisotuzumab adizutecan with gemcitabine. The other group will receive standard of care (SOC) - gemcitabine and nab-paclitaxel. Approximately 168 participants will be enrolled in this study in approximately 50 sites worldwide. Substudy 1 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 + Gemcitabine. In the dose optimization stage, participants will receive 1 of 2 doses of IV telisotuzumab adizutecan with Gemcitabine or SOC. The study will run for a duration of approximately 3 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.
Interventions
DRUGTelisotuzumab Adizutecan
Intravenous (IV) Infusion
DRUGGemcitabine
Intravenous (IV) Infusion
DRUGNab-Paclitaxel
Intravenous (IV) Infusion
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1. * Resolution of any acute clinically significant treatment-related toxicity from prior therapy to Grade \<= 1 prior to study entry (except for alopecia of any grade). * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Exclusion criteria
* Prior cellular-Mesenchymal Epithelial Transition (c-MET) protein 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. * Has had major surgery or significant traumatic injury within 28 days prior to randomization/enrollment, or anticipation of the need for major surgery during the course of study intervention. Placement of biliary stent/tube is permitted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to approximately 3 years | OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR per RECIST v1.1. |
| Number of Participants with Adverse Events (AEs) | Up to approximately 3 years | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1 | Up to approximately 3 years | 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. |
| Duration Of Response (DoR) assessed by BICR per RECIST v1.1 | Up to approximately 3 years | 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. |
| Clinical Benefit (CB) assessed by BICR per RECIST v1.1 | Up to approximately 3 years | 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. |
| Overall Survival (OS) | Up to approximately 3 years | 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 |
Countries
Canada, China, United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed