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NCT07490301 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 900
- Enrollment target
NCT07490301 is a Phase 2 study that is actively recruiting participants, run by AbbVie. The registered enrollment target is 900 participants.
The verdict
NCT07490301, a Phase 2 study, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 900 participants
- Enrollment target
Study 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 c
Interventions
- DRUG Fluorouracil
- DRUG Oxaliplatin
- DRUG Irinotecan
- DRUG Telisotuzumab adizutecan
- DRUG Folinic acid/ Leucovorina
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2026-04-30 |
| Est. Completion | 2031-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07490301
The ClinicalTrials.gov registry entry for NCT07490301 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Fluorouracil is the first listed.
NCT07490301 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07490301 about?
NCT07490301 is a clinical study titled "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". 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 ...
What is the current status of trial NCT07490301?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 900 participants. The study started on 2026-04-30. Estimated completion is 2031-06.
What interventions are being tested in trial NCT07490301?
The interventions under investigation include: Fluorouracil (DRUG), Oxaliplatin (DRUG), Irinotecan (DRUG), Telisotuzumab adizutecan (DRUG), Folinic acid/ Leucovorina (DRUG).
Who is sponsoring clinical trial NCT07490301?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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