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Clinical Trials in the USA / NCT07769502
Recruiting Phase 2

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

NCT07769502 · tracked via the Priya Life Science USA tracker
Sponsor
AbbVie
Phase
Phase 2
Started
2026-08-17
Last updated
2026-10-13

Condition(s) studied

Pancreatobiliary CancersPancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

Telisotuzumab Adizutecan →Gemcitabine →Nab-Paclitaxel →

Telisotuzumab Adizutecan: Intravenous (IV) Infusion

Gemcitabine: Intravenous (IV) Infusion

Nab-Paclitaxel: Intravenous (IV) Infusion

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 — 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) — 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.

Trial sites (7)

FacilityCityRegionStatus
Hattiesburg Clinic /ID# 281952 Hattiesburg Mississippi Recruiting
The Chaim Sheba Medical Center /ID# 281618 Ramat Gan Tel Aviv Recruiting
Hadassah Medical Center-Hebrew University /ID# 281620 Jerusalem Israel Recruiting
Kanagawa Cancer Center /ID# 281899 Yokohama Kanagawa Recruiting
Osaka International Cancer Institute /ID# 281900 Osaka Osaka Recruiting
National Cancer Center Hospital /ID# 281870 Chuo-Ku Tokyo Recruiting
China Medical University Hospital /ID# 281981 Taichung Taiwan Recruiting

More AbbVie trials in the USA

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Study of ABBV-142 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Idiopathic Pulmonary Fibrosis Recruiting
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Safety and Tolerability Study of Oral ABBV-744 Tablet Alone or in Combination With Oral Ruxolitinib Tablet or Oral Navitoclax Tablet in Adult Participants With Myelofibrosis Active, not recruiting

Other trials for the same condition

PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC) Recruiting
A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer Recruiting
Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor Active, not recruiting
A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors Recruiting
Evaluating LINFU™: A Noninvasive Method for Collecting Pancreatic Cells for the Early Detection of Pancreatic Cancer Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07769502 on ClinicalTrials.gov ↗ ← All trials in the USA