Telisotuzumab Adizutecan with Gemcitabine and Nab-Paclitaxel in Pancreatobiliary Cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study evaluates the safety and potential effectiveness of telisotuzumab adizutecan given with gemcitabine, with or without nab-paclitaxel, in adults with pancreatobiliary cancers. In Substudy 1, participants are randomized to receive different doses of telisotuzumab adizutecan plus gemcitabine versus the standard of care regimen of gemcitabine plus nab-paclitaxel, with a dose escalation/optimization portion. About 168 participants will be enrolled across roughly 50 sites worldwide, with primary focus on those whose disease is measurable by RECIST v1.1 and who meet specified performance-status criteria. Key exclusions include prior c-MET targeting therapy and history of certain lung diseases. The trial is sponsored by AbbVie and conducted at sites in the U.S. and Israel.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1.
* Resolution of any acute clinically significant treatment-related toxicity from prior therapy to Grade \<= 1 prior to study entry (except for alopecia of any grade).
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.

Exclusion Criteria:

* Prior cellular-Mesenchymal Epithelial Transition (c-MET) protein 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.
* Has had major surgery or significant traumatic injury within 28 days prior to randomization/enrollment, or anticipation of the need for major surgery during the course of study intervention. Placement of biliary stent/tube is permitted.

Where it's running

• Hattiesburg Clinic /ID# 281952
  Hattiesburg, Mississippi, United States Recruiting
• The Chaim Sheba Medical Center /ID# 281618
  Ramat Gan, Tel Aviv, Israel Recruiting
• Hadassah Medical Center-Hebrew University /ID# 281620
  Jerusalem, Israel Recruiting
• Kanagawa Cancer Center /ID# 281899
  Yokohama, Kanagawa, Japan Recruiting
• Osaka International Cancer Institute /ID# 281900
  Osaka, Osaka, Japan Recruiting
• National Cancer Center Hospital /ID# 281870
  Chuo-Ku, Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.