AbbVie
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.
Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Esophageal Adenocarcinoma
ABBV-400
Budigalimab
Fluorouracil
Leucovorin
Oxaliplatin
PHASE2
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 180 participants |
| Masking : | QUADRUPLE |
| Primary Purpose : | TREATMENT |
| Official Title : | A Phase 2 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Leucovorin, and Budigalimab as First-Line Treatment in Subjects With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (AndroMETa-GEA-977) |
| Actual Study Start Date : | 2024-12-13 |
| Estimated Primary Completion Date : | 2030-10 |
| Estimated Study Completion Date : | 2030-10 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
City of Hope National Medical Center /ID# 268690
Duarte, California, United States, 91010
RECRUITING
City of Hope Orange County Lennar Foundation Cancer Center /ID# 272630
Irvine, California, United States, 92618
RECRUITING
UCLA - Santa Monica /ID# 270024
Santa Monica, California, United States, 90404
RECRUITING
Hattiesburg Clinic /ID# 268572
Hattiesburg, Mississippi, United States, 39401
RECRUITING
Millennium Research & Clinical Development /ID# 268540
Houston, Texas, United States, 77090
RECRUITING
Beijing Cancer Hospital /ID# 268455
Beijing, Beijing, China, 100142
RECRUITING
Union Hospital - Tongji Medical College /ID# 268796
Wuhan, Hubei, China, 430022
RECRUITING
The first Affiliated Hospital, Zhejiang University School of Medicine /ID# 268782
Hangzhou, Zhejiang, China, 310003
RECRUITING
Soroka Medical Center /ID# 268301
Be's sheva, Headers, Israel, 8410101
RECRUITING
Tel Aviv Sourasky Medical Center /ID# 267755
Tel Aviv, Tel-Aviv, Israel, 6423906
RECRUITING
Shaare Zedek Medical Center /ID#
Jerusalem, Israel, 9103102
RECRUITING
Hadassah Medical Center-Hebrew University /ID# 267753
Jerusalem, Israel, 91120
RECRUITING
National Cancer Center Hospital East /ID# 268083
Mr. Kashiwa, Chiba, Japan, 277-8577
RECRUITING
Shizuoka Cancer Center /ID# 268123
Summary-gun, Shizuoka, Japan, 411-8777
RECRUITING
National Cancer Center Hospital /ID# 268648
C-Ku, Tokyo, Japan, 104-0045
RECRUITING
The Cancer Institute Hospital Of JFCR /ID# 268656
Small talk, Tokyo, Japan, 135-8550
RECRUITING
Pan American Center for Oncology Trials /ID# 268833
Rio Piedras, Puerto Rico, 00935
RECRUITING
National Taiwan University Hospital /ID# 267666
Taipei City, Taipei, Taiwan, 100
RECRUITING
Medical University Chunng-Hospital.
composed, Taiwan, 807
RECRUITING
China Medical University Hospital /ID# 267667
Taichung, Taiwan, 404
RECRUITING
Taipei Veterans General Hospital /ID# 267664
Taipei City, Taiwan, 112
RECRUITING
Linkou Chang Gung Memorial Hospital /ID# 267668
Taoyuan City, Taiwan, 333