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

AbbVie

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Pancreatobiliary Cancers; Pancreatic Ductal Adenocarcinoma

Treatments: Drug: Telisotuzumab Adizutecan; Drug: Gemcitabine; Drug: Nab-Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT07769502

M26-118

2025-524801-33-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 4 patient groups

SS1: Dose Escalation: Telisotuzumab Adizutecan + Gemcitabine

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine

Drug: Telisotuzumab Adizutecan

SS1:DoseOptimization:TelisotuzumabAdizutecan+Gemcitabine DoseA

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine

Drug: Telisotuzumab Adizutecan

SS1:DoseOptimization:TelisotuzumabAdizutecan+GemcitabineDoseB

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine

Drug: Telisotuzumab Adizutecan

SS1: Dose Optimization: Standard of Care (SOC)

Active Comparator group

Description:

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

Treatment:

Drug: Nab-Paclitaxel

Drug: Gemcitabine