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
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
2 other identifiers
interventional
900
5 countries
9
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2026
Longer than P75 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2026
CompletedFirst Posted
Study publicly available on registry
March 24, 2026
CompletedStudy Start
First participant enrolled
April 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2031
June 12, 2026
June 1, 2026
5.1 years
March 13, 2026
June 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
through study completion, approximately 6 years
Secondary Outcomes (11)
Phase 2 and Phase 3: Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1
through study completion, approximately 6 years
Phase 2 and Phase 3: Duration Of Response (DoR) assessed by BICR per RECIST v1.1
through study completion, approximately 6 years
Phase 2 and Phase 3: Clinical Benefit (CB) assessed by BICR per RECIST v1.1
through study completion, approximately 6 years
Phase 2 : Overall Survival
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)
through study completion, approximately 6 years
- +6 more secondary outcomes
Study Arms (6)
Ph 2: Dose Escalation Telisotuzumab Adizutecan + FOLFOX
EXPERIMENTALParticipants 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.
Ph 2: Dose Optimization Telisotuzumab Adizutecan+FOLFOX Dose A
EXPERIMENTALParticipants will receive Telisotuzumab Adizutecan+FOLFOX Dose A as part of the approximately 2 year study duration.
Ph 2: Dose Optimization Telisotuzumab Adizutecan+FOLFOX Dose B
EXPERIMENTALParticipants will receive Telisotuzumab Adizutecan+FOLFOX Dose B as part of the approximately 2 year study duration.
Ph 2: Dose Optimization Standard of Care (SOC) mFOLFIRINOX
ACTIVE COMPARATORParticipants will receive SOC (fluorouracil, leucovorin, oxaliplatin, and irinotecan) as part of the approximately 2 year study duration.
Ph 3: Telisotuzumab Adizutecan RP3D + FOLFOX
EXPERIMENTALParticipants will receive Telisotuzumab Adizutecan recommended Phase 3 dose (RP3D) + FOLFOX as part of an approximately 2 year study period.
Ph 3: SOC mFOLFIRINOX
ACTIVE COMPARATORParticipants will receive SOC (fluorouracil, leucovorin, oxaliplatin, and irinotecan) as part of the approximately 2 year study duration.
Interventions
Intravenous (IV) Infusion
IV Infusion
IV Infusion
IV Infusion
IV Infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (9)
Texas Oncology - Northeast Texas /ID# 280417
Tyler, Texas, 75702, United States
Tamworth Hospital /ID# 280099
North Tamworth, New South Wales, 2340, Australia
Prince Of Wales Hospital - Randwick /ID# 280085
Randwick, New South Wales, 2031, Australia
Monash Health - Monash Medical Centre - Clayton /ID# 280076
Clayton, Victoria, 3168, Australia
Fiona Stanley Hospital /ID# 280079
Murdoch, Western Australia, 6150, Australia
Tel Aviv Sourasky Medical Center /ID# 279414
Tel Aviv, Tel Aviv, 6423906, Israel
Rambam Health Care Campus- Haifa /ID# 279409
Haifa, 3109601, Israel
The Cancer Institute Hospital Of JFCR /ID# 280140
Koto-ku, Tokyo, 135-8550, Japan
China Medical University Hospital /ID# 279725
Taichung, 40447, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2026
First Posted
March 24, 2026
Study Start
April 30, 2026
Primary Completion (Estimated)
June 1, 2031
Study Completion (Estimated)
June 1, 2031
Last Updated
June 12, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.