Pancreatobiliary CancersPhase 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 study testing Telisotuzumab Adizutecan, Gemcitabine and Nab-Paclitaxel in people with Pancreatobiliary Cancers and Pancreatic Ductal Adenocarcinoma, run by AbbVie at 7 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatobiliary Cancers, Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Telisotuzumab Adizutecan, Gemcitabine and Nab-Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 17 Aug 2026to Sep 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 4 countries
Japan3 sites, 3 recruiting
- Recruiting
National Cancer Center Hospital /ID# 281870
Chuo-Ku, Tokyo, 104-0045
- Recruiting
Osaka International Cancer Institute /ID# 281900
Osaka, Osaka, 5418567
- Recruiting
Kanagawa Cancer Center /ID# 281899
Yokohama, Kanagawa, 241-8515
Israel2 sites, 2 recruiting
- Recruiting
Hadassah Medical Center-Hebrew University /ID# 281620
Jerusalem, 91120
- Recruiting
The Chaim Sheba Medical Center /ID# 281618
Ramat Gan, Tel Aviv, 5265601
United States1 site, 1 recruiting
- Recruiting
Hattiesburg Clinic /ID# 281952
Hattiesburg, Mississippi, 39401
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital /ID# 281981
Taichung, 40447
About this study
Official title: 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)
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.
Read more
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.
- Being tested
- Telisotuzumab Adizutecan, Gemcitabine, Nab-Paclitaxel
- Keywords
- Pancreatobiliary Cancers, Pancreatic Ductal Adenocarcinoma, PDAC, Telisotuzumab Adizutecan, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telisotuzumab AdizutecanDrug
Intravenous (IV) Infusion
GemcitabineDrug
Intravenous (IV) Infusion
Nab-PaclitaxelDrug
Intravenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| SS1: Dose Escalation: Telisotuzumab Adizutecan + Gemcitabine | Experimental | Participants will receive Telisotuzumab Adizutecan + Gemcitabine until doses for optimization are determined. as part of an approximately 3 year study period. Receives: Drug: Telisotuzumab Adizutecan; Drug: Gemcitabine |
| SS1:DoseOptimization:TelisotuzumabAdizutecan+Gemcitabine DoseA | Experimental | Participants will receive Telisotuzumab Adizutecan Dose A + Gemcitabine as part of the approximately 3 year study duration. Receives: Drug: Telisotuzumab Adizutecan; Drug: Gemcitabine |
| SS1:DoseOptimization:TelisotuzumabAdizutecan+GemcitabineDoseB | Experimental | Participants will receive Telisotuzumab Adizutecan Dose B + Gemcitabine as part of the approximately 3 year study duration. Receives: Drug: Telisotuzumab Adizutecan; Drug: Gemcitabine |
| SS1: Dose Optimization: Standard of Care (SOC) | Active comparator | Participants will receive gemcitabine and nab-paclitaxel as part of the approximately 3 year study duration. Receives: Drug: Gemcitabine; Drug: Nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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.
Measured: Up to approximately 3 years
Number of Participants with Adverse Events (AEs)
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.
Measured: Up to approximately 3 years
Secondary outcomes (4)
Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1
PFS is defined as the time from the date of randomization or date of first dose of study treatment to the first occurrence of radiographic progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first.
Measured: Up to approximately 3 years
Duration Of Response (DoR) assessed by BICR per RECIST v1.1
DoR is defined as time from the initial response of Complete Response or Partial Response assessed by BICR per RECIST v1.1 to the first occurrence of radiographic progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first.
Measured: Up to approximately 3 years
Clinical Benefit (CB) assessed by BICR per RECIST v1.1
CB is defined as a participant achieving best overall response of confirmed CR or confirmed PR, or SD (with a minimum duration of 24 weeks) assessed by BICR per RECIST v1.1.
Measured: Up to approximately 3 years
Overall Survival (OS)
OS is defined as the time from the date of randomization or date of first dose of study treatment to the event of death from any cause
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start17 Aug 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatobiliary CancersStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769502
- Sponsor's protocol ID
- M26-118
- Other IDs
- 2025-524801-33-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 13 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.