Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07769502

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pancreatobiliary Cancers Neoplasms Pancreatic Ductal Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Chaim Sheba Medical Center /ID# 281618, Ramat Gan, Tel Aviv, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telisotuzumab Adizutecan

Drug

Intravenous (IV) Infusion

Gemcitabine

Drug

Intravenous (IV) Infusion

Nab-paclitaxel

Drug

Intravenous (IV) Infusion

Primary outcomes

  1. 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

    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.

  2. Number of Participants with Adverse Events (AEs)

    Time frame: 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.

Secondary outcomes

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

    Time frame: Up to approximately 3 years

    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.

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

    Time frame: Up to approximately 3 years

    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.

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

    Time frame: Up to approximately 3 years

    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.

  4. Overall Survival (OS)

    Time frame: Up to approximately 3 years

    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

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 2, Open-Label, Master Protocol Study to Evaluate Safety and Efficacy of Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Pancreatobiliary Cancers (AndroMETa-118)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 18, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.