Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
Conditions
Keywords
Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, ABBV-400, ABBV-181, Budigalimab, Telisotuzumab Adizutecan
Brief summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan (ABBV-400) is given in combination with Fluorouracil, Leucovorin, and a programmed cell death receptor 1 (PD1) inhibitor Budigalimab. The combination (AFLB) will be given to adult participants to treat locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEA). Telisotuzumab Adizutecan (ABBV-400) and Budigalimab are investigational drugs being developed for the treatment of mGEA. Fluorouracil and Leucovorin are drugs approved for the treatment of mGEA. This study will be divided into two stages, with the first stage treating participants with increasing doses of ABBV-400 within the AFLB regimen until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into groups called treatment arms where one group will receive Budigalimab and FOLFOX (Fluorouracil, Leucovorin, and Oxaliplatin) . A further two treatment groups will receive AFLB, but with two optimized doses of ABBV-400 to allow for the best dose to be studied in the future. Approximately 180 adult participants with mGEA will be enrolled in the study in 51 sites worldwide. In the dose escalation stage, participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan (ABBV-400) within the AFLB regimen until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage, participants will receive FOLFOX or receive AFLB, but with one of two optimized doses of ABBV-400. The study will run for a duration of approximately 6 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.
Interventions
Intravenous (IV) Infusion
DRUGBudigalimab
IV Infusion
DRUGFluorouracil
IV Infusion; IV Injection
DRUGLeucovorin
IV Infusion; IV Injection
DRUGOxaliplatin
IV Infusion
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have inoperable, advanced or metastatic histologically- or cytologically confirmed gastric, gastroesophageal junction, or esophageal adenocarcinoma. * Have measurable disease determined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * Human epidermal growth factor receptor 2 (HER2) negative disease, defined as immunohistochemistry (IHC) (0, or 1+) or fluorescence in situ hybridization (FISH) negative. * Known programmed death ligand 1 (PD-L1) status at screening, or availability of tumor tissue for central PD-L1 testing prior to enrollment.
Exclusion criteria
* Have prior systemic therapy in the locally advanced, unresectable, or metastatic setting. * History of clinically significant, intercurrent lung-specific illnesses including, but not limited to those listed in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) as Assessed by Investigator | Through Study Completion, Approximately 6 Years | PFS is defined as the time from the first dose of study drug to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by investigator or death from any cause, whichever occurs earlier. |
| Percentage of Participants with Objective Response (OR) as Assessed by Investigator | Through Study Completion, Approximately 6 Years | OR is defined as confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator per RECIST version 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Disease Control (DC) as Assessed by Investigator | Through Study Completion, Approximately 6 Years | DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) (with a minimum duration of 14 weeks) based on RECIST, version 1.1 as determined by the investigator. |
| Duration of Response (DOR) as Assessed by Investigator | Through Study Completion, Approximately 6 Years | DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST version 1.1 as determined by investigator or death from any cause, whichever occurs first. |
| Overall Survival (OS) | Through Study Completion, Approximately 6 Years | OS is defined as the time from first dose of study drug to the event of death from any cause. |
Countries
Belgium, Canada, China, Germany, Israel, Japan, Puerto Rico, Spain, Taiwan, United Kingdom, United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
CONTACTABBVIE CALL CENTER
Outcome results
None listed