A Phase 2 interventional study of Telisotuzumab Adizutecan and Gemcitabine in Pancreatobiliary Cancers and Pancreatic Ductal Adenocarcinoma, sponsored by AbbVie. Recruiting at 7 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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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.
10,824 studies on the registry are indexed under Neoplasms; 2,325 are open to participants now.
This study's planned enrollment of 168 is above the median of 60 across 7,706 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →AbbVie is the lead sponsor of 977 studies on the registry; 136 are open to participants now.
Of its 358 completed or terminated interventional studies of FDA-regulated products, 215 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumor measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumor visible on a scan does not by itself rule you out.
The standard rules for measuring tumors on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumor 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumor measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumor visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumors on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumor 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Telisotuzumab Adizutecan + Gemcitabine until doses for optimization are determined. as part of an approximately 3 year study period.
Drug: Telisotuzumab Adizutecan · Drug: Gemcitabine
Participants will receive Telisotuzumab Adizutecan Dose A + Gemcitabine as part of the approximately 3 year study duration.
Drug: Telisotuzumab Adizutecan · Drug: Gemcitabine
Participants will receive Telisotuzumab Adizutecan Dose B + Gemcitabine as part of the approximately 3 year study duration.
Drug: Telisotuzumab Adizutecan · Drug: Gemcitabine
Participants will receive gemcitabine and nab-paclitaxel as part of the approximately 3 year study duration.
Drug: Gemcitabine · Drug: Nab-Paclitaxel
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Intravenous (IV) Infusion
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.
Time frame: 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.
Time frame: Up to approximately 3 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Up to approximately 3 years
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Sep 2028, 25 months after the start.
Of 179 industry-sponsored phase 2 interventional studies under Neoplasms, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 68. This study's planned 25 months is below that.
Counting every sponsor, half of 514 studies reached it within 52 months; a quarter within 33 and three quarters within 92.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Telisotuzumab adizutecan