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Telisotuzumab Adizutecan and FOLFOX Combination for Pancreatic Ductal Cancer

Study Aim

This study aims to evaluate the effectiveness of Telisotuzumab Adizutecan in combination with FOLFOX for the treatment of Pancreatic Ductal Cancer, focusing on overall response to the treatment and overall survival rate.

What is being tested

Telisotuzumab adizutecan

+ Fluorouracil

+ Folinic acid/ Leucovorina

Drug

Who is being recruted

Over 18 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2 & 3

Interventional

Study Start: June 2026

See protocol details

Summary

Principal SponsorAbbVie

Study ContactABBVIE CALL CENTER

Last updated: March 25, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 3, 2026

Actual date on which the first participant was enrolled.

This study focuses on a specific type of cancer called pancreatic ductal adenocarcinoma, which starts in the ducts of the pancreas, an organ located behind the stomach. The main goal is to evaluate the safety and effectiveness of an investigational drug, Telisotuzumab Adizutecan, when used in combination with a standard treatment called FOLFOX for adults with this type of cancer. The study is important as it aims to find a new treatment option that could potentially improve care for those diagnosed with pancreatic ductal adenocarcinoma. The study is divided into two phases. In the first phase, participants will receive increasing doses of Telisotuzumab Adizutecan along with FOLFOX. They will then be divided into three groups, with two groups receiving different doses of the investigational drug with FOLFOX, and one group receiving the standard care. In the second phase, participants will be divided into two groups, receiving either the optimal dose of Telisotuzumab Adizutecan with FOLFOX, or the standard care. Throughout the study, participants will attend regular visits at a hospital or clinic, where the effects of the treatment will be checked through medical assessments, blood tests, questionnaires, and side effect evaluations.

Official TitlePhase 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

NCT07490301

Principal SponsorAbbVie

Study ContactABBVIE CALL CENTER

Last updated: March 25, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

900 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

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

4 exclusion criteria prevent from participating

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Group II

Experimental

Participants will receive Telisotuzumab Adizutecan+FOLFOX Dose A as part of the approximately 2 year study duration.

Group III

Experimental

Participants will receive Telisotuzumab Adizutecan+FOLFOX Dose B as part of the approximately 2 year study duration.

Group IV

Experimental

Participants will receive Telisotuzumab Adizutecan recommended Phase 3 dose (RP3D) + FOLFOX as part of an approximately 2 year study period.

Group 5

Active Comparator

Participants will receive SOC (fluorouracil, leucovorin, oxaliplatin, and irinotecan) as part of the approximately 2 year study duration.

Group 6

Active Comparator

Participants will receive SOC (fluorouracil, leucovorin, oxaliplatin, and irinotecan) as part of the approximately 2 year study duration.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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Recruiting soonNo study centers