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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07769502
- Acronym / sponsor ID
- M26-118
- Keywords
- Pancreatobiliary Cancers, Pancreatic Ductal Adenocarcinoma, PDAC, Telisotuzumab Adizutecan, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SS1: Dose Escalation: Telisotuzumab Adizutecan + Gemcitabine | Experimental | Drug: Telisotuzumab Adizutecan, Drug: GemcitabineParticipants will receive Telisotuzumab Adizutecan + Gemcitabine until doses for optimization are determined. as part of an approximately 3 year study period. |
| SS1:DoseOptimization:TelisotuzumabAdizutecan+Gemcitabine DoseA | Experimental | Drug: Telisotuzumab Adizutecan, Drug: GemcitabineParticipants will receive Telisotuzumab Adizutecan Dose A + Gemcitabine as part of the approximately 3 year study duration. |
| SS1:DoseOptimization:TelisotuzumabAdizutecan+GemcitabineDoseB | Experimental | Drug: Telisotuzumab Adizutecan, Drug: GemcitabineParticipants will receive Telisotuzumab Adizutecan Dose B + Gemcitabine as part of the approximately 3 year study duration. |
| SS1: Dose Optimization: Standard of Care (SOC) | Active comparator | Drug: Gemcitabine, Drug: Nab-PaclitaxelParticipants will receive gemcitabine and nab-paclitaxel as part of the approximately 3 year study duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telisotuzumab AdizutecanIntravenous (IV) Infusion | Drug | SS1: Dose Escalation: Telisotuzumab Adizutecan + Gemcitabine, SS1:DoseOptimization:TelisotuzumabAdizutecan+Gemcitabine DoseA, SS1:DoseOptimization:TelisotuzumabAdizutecan+GemcitabineDoseB |
| GemcitabineIntravenous (IV) Infusion | Drug | SS1: Dose Escalation: Telisotuzumab Adizutecan + Gemcitabine, SS1: Dose Optimization: Standard of Care (SOC), SS1:DoseOptimization:TelisotuzumabAdizutecan+Gemcitabine DoseA, SS1:DoseOptimization:TelisotuzumabAdizutecan+GemcitabineDoseB |
| Nab-PaclitaxelIntravenous (IV) Infusion | Drug | SS1: Dose Optimization: Standard of Care (SOC) |
Primary outcome
Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: 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)
Time frame: 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.
4 secondary outcomes
Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1
Time frame: Up to approximately 3 years
Duration Of Response (DoR) assessed by BICR per RECIST v1.1
Time frame: Up to approximately 3 years
Clinical Benefit (CB) assessed by BICR per RECIST v1.1
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: 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.
Related trials for Pancreatobiliary Cancers
RecruitingObservational study
Iconographic Registry of Pancreatobiliary Endoscopy Procedures
Pancreas Neoplasm, Cancer of Pancreas
RecruitingObservational study
Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception (SHERLOCK)
Breast Cancer, Lung Cancer
Recruiting
Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers
Stage IV Esophageal Adenocarcinoma, Stage IV Esophageal Squamous Cell Carcinoma
Active, not recruitingObservational study
Integrated Molecular Profiling in Advanced Cancers Trial
Breast Cancer, Non-small Cell Lung Cancer
Recruiting
Ultra-High Resolution Optical Coherence Tomography in Detecting Micrometer Sized Early Stage Pancreatic Cancer in Participants With Pancreatic Cancer
Pancreatic Carcinoma, Pancreatic Intraductal Papillary Mucinous Neoplasm, Pancreatobiliary-Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan, Israel, United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: Up to approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.