A Study to Assess Adverse Events and Change in Disease Activity With Treatment Combinations With Telisotuzumab Adizutecan in Adults Participants With Pancreatobiliary Cancers

NCT07769502 · tracked via the Priya Life Science Japan tracker

Sponsor

AbbVie

Phase

Phase 2

Started

2026-08-17

Last updated

2026-09-22

Condition(s) studied

Pancreatobiliary CancersPancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

Telisotuzumab Adizutecan →Gemcitabine →Nab-Paclitaxel →

Telisotuzumab Adizutecan: Intravenous (IV) Infusion

Gemcitabine: Intravenous (IV) Infusion

Nab-Paclitaxel: Intravenous (IV) Infusion

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 goal of this study is to evaluate the safety and efficacy of telisotuzumab adizutecan in combination with gemcitabine and nab-paclitaxel in adult participants with pancreatobiliary cancers.

Telisotuzumab adizutecan is an investigational drug being developed for the treatment of pancreatobiliary cancers. In Substudy 1, participants will be randomized into two groups. One group will receive different doses of telisotuzumab adizutecan with gemcitabine. The other group will receive standard of care (SOC) - gemcitabine and nab-paclitaxel. Approximately 168 participants will be enrolled in this study in approximately 50 sites worldwide.

Substudy 1 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 + Gemcitabine. In the dose optimization stage, participants will receive 1 of 2 doses of IV telisotuzumab adizutecan with Gemcitabine or SOC. The study will run for a duration of approximately 3 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 — Up to approximately 3 years
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR per RECIST v1.1.
Number of Participants with Adverse Events (AEs) — Up to approximately 3 years
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Trial sites (6)

Facility	City	Region	Status
The Chaim Sheba Medical Center /ID# 281618	Ramat Gan	Tel Aviv	Recruiting
Hadassah Medical Center-Hebrew University /ID# 281620	Jerusalem	Israel	Recruiting
Kanagawa Cancer Center /ID# 281899	Yokohama	Kanagawa	Recruiting
Osaka International Cancer Institute /ID# 281900	Osaka	Osaka	Recruiting
National Cancer Center Hospital /ID# 281870	Chuo-Ku	Tokyo	Recruiting
China Medical University Hospital /ID# 281981	Taichung	Taiwan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07769502 on ClinicalTrials.gov ↗ ← All trials in Japan