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

Part of paid clinical trials in Buffalo, New York.

Sponsor
AbbVie
Study ID
NCT07769502
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telisotuzumab Adizutecan — DRUG
    Intravenous (IV) Infusion
  • Gemcitabine — DRUG
    Intravenous (IV) Infusion
  • Nab-Paclitaxel — DRUG
    Intravenous (IV) Infusion

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Sep 22, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer Institute /ID# 284461BuffaloNew York14263-

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By specialty
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By research site
Roswell Park Cancer Institute· Buffalo, NY

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