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

ClinicalTrials.gov ID: NCT07490301

Public ClinicalTrials.gov record NCT07490301. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 4:29 AM EDT

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07490301
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: AbbVie; Industry
Enrollment: 900 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 29, 2026
Primary completion: May 31, 2031
Completion: May 31, 2031
Last update posted: Aug 31, 2026

2026 – 2031

United States locations

U.S. sites: 8
U.S. states: 7
U.S. cities: 8

Facility	City	State	ZIP	Site status
University of Chicago Medical Center /ID# 279460	Chicago	Illinois	60637	Recruiting
City Of Hope - Chicago /ID# 279814	Zion	Illinois	60099	Recruiting
Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279853	Grand Rapids	Michigan	49503	Recruiting
Washington University /ID# 279890	St Louis	Missouri	63110	Recruiting
UH Seidman Cancer Center /ID# 279602	Cleveland	Ohio	44106	Recruiting
University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 280038	Philadelphia	Pennsylvania	19104	Recruiting
Texas Oncology - Northeast Texas /ID# 280417	Tyler	Texas	75702	Recruiting
Virginia Cancer Specialists - Fairfax /ID# 280415	Fairfax	Virginia	22031	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07490301, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 31, 2026 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07490301 live on ClinicalTrials.gov.

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