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 (NCT07490301)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Chicago Medical Center /ID# 279460 — Chicago, Illinois
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (22 Sites)
- University of Chicago Medical Center /ID# 279460 — Chicago, Illinois
- City Of Hope - Chicago /ID# 279814 — Zion, Illinois
- Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279853 — Grand Rapids, Michigan
- Washington University /ID# 279890 — St Louis, Missouri
- Texas Oncology - Northeast Texas /ID# 280417 — Tyler, Texas
- Virginia Cancer Specialists - Fairfax /ID# 280415 — Fairfax, Virginia
- Tamworth Hospital /ID# 280099 — North Tamworth, New South Wales
- Prince Of Wales Hospital - Randwick /ID# 280085 — Randwick, New South Wales
- Monash Health - Monash Medical Centre - Clayton /ID# 280076 — Clayton, Victoria
- Austin Hospital /ID# 280283 — Melbourne, Victoria
- Fiona Stanley Hospital /ID# 280079 — Murdoch, Western Australia
- The Chaim Sheba Medical Center /ID# 279408 — Ramat Gan, Tel Aviv
- Tel Aviv Sourasky Medical Center /ID# 279414 — Tel Aviv, Tel Aviv
- Rambam Health Care Campus- Haifa /ID# 279409 — Haifa,
- Hadassah Medical Center-Hebrew University /ID# 279411 — Jerusalem,
- Azienda Ospedaliero Universitaria Pisana /ID# 285773 — Pisa,
- The Cancer Institute Hospital Of JFCR /ID# 280140 — Koto-ku, Tokyo
- Seoul National University Hospital /ID# 280191 — Seoul, Seoul Teugbyeolsi
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 279735 — Kaohsiung City,
- China Medical University Hospital /ID# 279725 — Taichung,
- Taipei Veterans General Hospital /ID# 279726 — Taipei,
- Oxford University Hospital NHS Trust /ID# 279764 — Oxford, Oxfordshire
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Pancreatic Ductal Adenocarcinoma
- Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma — Phoenix, Arizona
- A Study of Pembrolizumab and Olaparib for People With Metastatic Pancreatic Ductal Adenocarcinoma and Homologous Recombination Deficiency or Exceptional Treatment Response to Platinum-Based Therapy — Middletown, New Jersey
- Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC) — Basking Ridge, New Jersey
- BXCL701 and Pembrolizumab in Patients With Metastatic Pancreatic Ductal Adenocarcinoma — Washington D.C., District of Columbia
- Phase I Study of Cosibelimab and Balixafortide in Metastatic Pancreatic Ductal Adenocarcinoma — Los Angeles, California
- MK2 Inhibitor in Combination With mFOLFIRINOX for Untreated Metastatic Pancreatic Ductal Adenocarcinoma — St Louis, Missouri
Explore by condition: All Metastatic Pancreatic Ductal Adenocarcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.