RecruitingPhase 2NCT07769502

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

A Phase 2, Open-Label, Master Protocol Study to Evaluate Safety and Efficacy of Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Pancreatobiliary Cancers (AndroMETa-118)


Sponsor

AbbVie

Enrollment

168 participants

Start Date

Aug 17, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Gemcitabine, a drug called Nab-Paclitaxel, and others for people with pancreatic ductal adenocarcinoma and pancreatobiliary cancers. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTelisotuzumab Adizutecan

Intravenous (IV) Infusion

DRUGGemcitabine

Intravenous (IV) Infusion

DRUGNab-Paclitaxel

Intravenous (IV) Infusion


Locations(5)

The Chaim Sheba Medical Center /ID# 281618

Ramat Gan, Tel Aviv, Israel

Hadassah Medical Center-Hebrew University /ID# 281620

Jerusalem, Israel

Kanagawa Cancer Center /ID# 281899

Yokohama, Kanagawa, Japan

National Cancer Center Hospital /ID# 281870

Chuo-Ku, Tokyo, Japan

China Medical University Hospital /ID# 281981

Taichung, Taiwan

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NCT07769502


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