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Trial Title:
A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) ABBV-400 in Combination With IV Fluorouracil, Leucovorin, and Budigalimab in Adult Participants With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
NCT ID:
NCT06628310
Condition:
Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Esophageal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Leucovorin
Oxaliplatin
Fluorouracil
Conditions: Keywords:
Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Esophageal Adenocarcinoma
ABBV-400
ABBV-181
Budigalimab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
ABBV-400
Description:
Intravenous (IV) Infusion
Arm group label:
Stage 1: Dose Escalation ABBV-400
Arm group label:
Stage 2 Arm 1: Dose Optimization ABBV-400 Dose A
Arm group label:
Stage 2 Arm 2: Dose Optimization ABBV-400 Dose B
Intervention type:
Drug
Intervention name:
Budigalimab
Description:
IV Infusion
Arm group label:
Stage 1: Dose Escalation ABBV-400
Arm group label:
Stage 2 Arm 1: Dose Optimization ABBV-400 Dose A
Arm group label:
Stage 2 Arm 2: Dose Optimization ABBV-400 Dose B
Arm group label:
Stage 2 Arm 3: Dose Optimization Standard of Care (SOC)
Other name:
ABBV-181
Intervention type:
Drug
Intervention name:
Fluorouracil
Description:
IV Infusion; IV Injection
Arm group label:
Stage 1: Dose Escalation ABBV-400
Arm group label:
Stage 2 Arm 1: Dose Optimization ABBV-400 Dose A
Arm group label:
Stage 2 Arm 2: Dose Optimization ABBV-400 Dose B
Arm group label:
Stage 2 Arm 3: Dose Optimization Standard of Care (SOC)
Intervention type:
Drug
Intervention name:
Leucovorin
Description:
IV Infusion; IV Injection
Arm group label:
Stage 1: Dose Escalation ABBV-400
Arm group label:
Stage 2 Arm 1: Dose Optimization ABBV-400 Dose A
Arm group label:
Stage 2 Arm 2: Dose Optimization ABBV-400 Dose B
Arm group label:
Stage 2 Arm 3: Dose Optimization Standard of Care (SOC)
Other name:
Folinic Acid
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
IV Infusion
Arm group label:
Stage 2 Arm 3: Dose Optimization Standard of Care (SOC)
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 ABBV-400 is given in combination with Fluorouracil, Leucovorin, and
a programmed cell death receptor 1 (PD1) inhibitor (Budigalimab) (AFLB) to adult
participants to treat locally advanced unresectable or metastatic gastric,
gastroesophageal junction, or esophageal adenocarcinoma (mGEA).
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 fluorouracil, leucovorin, and oxaliplatin
(FOLFOX). 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 ABBV-400 within the AFLB regimen until the dose reached is tolerable and
expected to be efficacious. In the dose optimization stage participants will be receive
FOLFOX or receive AFLB, but with one of two optimized doses of ABBV-400The 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.
Criteria for eligibility:
Criteria:
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 local or 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 8, 2024
Completion date:
October 6, 2030
Lead sponsor:
Agency:
AbbVie
Agency class:
Industry
Source:
AbbVie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06628310
https://www.abbvieclinicaltrials.com/study/?id=M24-977
