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

NCT07769502 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: M26-1182025-524801-33-002025
• Study Type: interventional
• Target: 168
• Locations: 3 countries
• Sites: 6

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to approximately 3 years

Secondary Outcomes (4)

• Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1

  Up to approximately 3 years

• Duration Of Response (DoR) assessed by BICR per RECIST v1.1

  Up to approximately 3 years

• Clinical Benefit (CB) assessed by BICR per RECIST v1.1

  Up to approximately 3 years

• Overall Survival (OS)

  Up to approximately 3 years

Study Arms (4)

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.

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.

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.

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.

Drug: Gemcitabine; Drug: Nab-Paclitaxel

Interventions

Telisotuzumab Adizutecan DRUG

Intravenous (IV) Infusion

SS1: Dose Escalation: Telisotuzumab Adizutecan + Gemcitabine; SS1:DoseOptimization:TelisotuzumabAdizutecan+Gemcitabine DoseA; SS1:DoseOptimization:TelisotuzumabAdizutecan+GemcitabineDoseB

Gemcitabine DRUG

Intravenous (IV) Infusion

SS1: Dose Escalation: Telisotuzumab Adizutecan + Gemcitabine; SS1: Dose Optimization: Standard of Care (SOC); SS1:DoseOptimization:TelisotuzumabAdizutecan+Gemcitabine DoseA; SS1:DoseOptimization:TelisotuzumabAdizutecan+GemcitabineDoseB

Nab-Paclitaxel DRUG

Intravenous (IV) Infusion

SS1: Dose Optimization: Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (6)

The Chaim Sheba Medical Center /ID# 281618

Ramat Gan, Tel Aviv, 5265601, Israel

RECRUITING

Hadassah Medical Center-Hebrew University /ID# 281620

Jerusalem, 91120, Israel

RECRUITING

Kanagawa Cancer Center /ID# 281899

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Osaka International Cancer Institute /ID# 281900

Osaka, Osaka, 5418567, Japan

RECRUITING

National Cancer Center Hospital /ID# 281870

Chuo-Ku, Tokyo, 104-0045, Japan

RECRUITING

China Medical University Hospital /ID# 281981

Taichung, 40447, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: August 17, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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/

Locations

IL (2); JP (3); TW (1)