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[M25-288] 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

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

Yamagishi Chika

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Contact for Patients and HCP

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Recruiting

April. 08, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- 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.

- 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.

Both

Pancreatic ductal adenocarcinoma

Drug: Telisotuzumab adizutecan Intravenous (IV) Infusion
Drug: Irinotecan IV Infusion
Drug: Fluorouracil IV Infusion
Drug: Folinic acid/ Leucovorina IV Infusion
Drug: Oxaliplatin IV Infusion

- 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
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. [Time Frame: through study completion, approximately 6 years]
- Phase 3: Overall Survival (OS)
OS is defined as the time from date of randomization to the death from any cause. [Time Frame: through study completion, approximately 6 years]

- Phase 2 and Phase 3: Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1
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. [Time Frame: through study completion, approximately 6 years]
- Phase 2 and Phase 3: Duration Of Response (DoR) assessed by BICR per RECIST v1.1
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. [Time Frame: through study completion, approximately 6 years]
- Phase 2 and Phase 3: Clinical Benefit (CB) assessed by BICR per RECIST v1.1
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. [Time Frame: through study completion, approximately 6 years]
- Phase 2 : Overall Survival (OS)
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. [Time Frame: 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)
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). [Time Frame: 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)
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). [Time Frame: 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)
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). [Time Frame: through study completion, approximately 6 years]
- Phase 3: Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G)
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." [Time Frame: through study completion, approximately 6 years]
- Phase 3: Change in Selected items of Patient Global Impression of Severity (PGIS)
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". [Time Frame: through study completion, approximately 6 years]
- Phase 3: Change in Selected items of Patient Global Impression of Change (PGIC)
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". [Time Frame: through study completion, approximately 6 years]
- Phase 3: Change from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L)
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." [Time Frame: through study completion, approximately 6 years]

+81-3-3520-0111

April. 08, 2026

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvieclinicaltrials.com/hcp/data-sharing/

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