Recruiting
Phase 2

Telisotuzumab Adizutecan, Gemcitabine, Nab-Paclitaxel

Sponsor:

AbbVie

Code:

NCT07769502

Conditions

Pancreatobiliary Cancers

Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telisotuzumab Adizutecan

Gemcitabine

Nab-Paclitaxel

Study Details

Brief 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.

Conditions

Pancreatobiliary Cancers

Pancreatic Ductal Adenocarcinoma

Study ID

NCT07769502

Start date

Aug 17, 2026

Status verified date

Oct, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SS1: Dose Escalation: Telisotuzumab Adizutecan + Gemcitabine

Participants will receive Telisotuzumab Adizutecan + Gemcitabine until doses for optimization are determined. as part of an approximately 3 year study period.

experimental: SS1:DoseOptimization:TelisotuzumabAdizutecan+Gemcitabine DoseA

Participants will receive Telisotuzumab Adizutecan Dose A + Gemcitabine as part of the approximately 3 year study duration.

experimental: SS1:DoseOptimization:TelisotuzumabAdizutecan+GemcitabineDoseB

Participants will receive Telisotuzumab Adizutecan Dose B + Gemcitabine as part of the approximately 3 year study duration.

active comparator: SS1: Dose Optimization: Standard of Care (SOC)

Participants will receive gemcitabine and nab-paclitaxel as part of the approximately 3 year study duration.

Interventions

Telisotuzumab Adizutecan

Intravenous (IV) Infusion

Gemcitabine

Intravenous (IV) Infusion

Nab-Paclitaxel

Intravenous (IV) Infusion

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 ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 3 years ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Hattiesburg Clinic /ID# 281952

Recruiting

Hattiesburg, Mississippi, United States, 39401

More Information

Sponsor

AbbVie

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Pancreatobiliary Cancers
  • Pancreatic Ductal Adenocarcinoma
  • PDAC
  • Telisotuzumab Adizutecan
  • Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by AbbVie on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.