NCT07769502RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 168 (estimated)
- First submitted
- 13 Aug 2026
- Start date
- 17 Aug 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- AbbVie
- Diseases
- Pancreatic cancer
- NCT number
- NCT07769502
- EU CT number
- 2025-524801-33-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 168
- From 17 Aug 2026 to the primary completion date, Sept 2028
- 7 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hadassah Medical Center-Hebrew University /ID# 281620 Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| The Chaim Sheba Medical Center /ID# 281618 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| National Cancer Center Hospital /ID# 281870 Coordinator of this site? Confirm its status | Chuo-Ku | Japan | Recruiting |
| Osaka International Cancer Institute /ID# 281900 Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Kanagawa Cancer Center /ID# 281899 Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| China Medical University Hospital /ID# 281981 Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| Hattiesburg Clinic /ID# 281952 Coordinator of this site? Confirm its status | Hattiesburg | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.