RecruitingPhase IIEN originalPancreatic cancer

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Ogólny stan zdrowia pacjenta pozwala na uczestnictwo w badaniu (skala wydolności 0 lub 1)
  • •Objawy uboczne z poprzedniego leczenia ustąpiły lub są minimalne
  • •Widoczny nowotwór można zmierzyć badaniami obrazowymi

✗ Disqualifies

  • •Poprzednie leczenie lekami skierowanymi na białko c-MET
  • •Historia chorób płuc (zwłaszcza włóknięcia płuc) wymagająca leczenia sterydami lub aktywna choroba płuc
  • •Duża operacja lub poważne urazy w ciągu ostatnich 4 tygodni przed rozpoczęciem badania

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
September 22, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (6)

The Chaim Sheba Medical Center /ID# 281618

Ramat Gan, Israel

Hadassah Medical Center-Hebrew University /ID# 281620

Jerusalem, Israel

Kanagawa Cancer Center /ID# 281899

Yokohama, Japan

Osaka International Cancer Institute /ID# 281900

Osaka, Japan

National Cancer Center Hospital /ID# 281870

Chuo-Ku, Japan

China Medical University Hospital /ID# 281981

Taichung, Taiwan

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/22/2026.

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