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NCT06628310 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Esophageal Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT06628310 is a Phase 2 study of Esophageal Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma that is actively recruiting participants, run by AbbVie. The registered enrollment target is 180 participants, below the 304-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 17 states.
The verdict
NCT06628310, a Phase 2 study of Esophageal Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
Study 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
Conditions Studied
Interventions
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Telisotuzumab Adizutecan
- DRUG Budigalimab
- DRUG Oxaliplatin
Study Locations (20)
California
- City of Hope National Medical Center /ID# 268690 - Duarte
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 272630 - Irvine
- UCLA - Santa Monica /ID# 270024 - Santa Monica
Quebec
- Centre Hospitalier de l'Université de Montréal (CHUM) /ID# 268763 - Montreal
- Jewish General Hospital /ID# 268413 - Montreal
Florida
- AdventHealth Orlando /ID# 268561 - Orlando
Mississippi
- Hattiesburg Clinic /ID# 268572 - Hattiesburg
North Carolina
- Duke University Medical Center /ID# 268186 - Durham
Texas
- Millennium Research & Clinical Development /ID# 268540 - Houston
Antwerpen
- Algemeen Ziekenhuis klina /ID# 268754 - Brasschaat
Vlaams-Brabant
- Universitair Ziekenhuis Leuven /ID# 269957 - Leuven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2024-12-13 |
| Est. Completion | 2030-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06628310
The ClinicalTrials.gov registry entry for NCT06628310 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 43 other Esophageal Adenocarcinoma trials with a reported enrollment target (41% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Esophageal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Fluorouracil is the first listed.
NCT06628310 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, Quebec, Florida.
Frequently Asked Questions
What is clinical trial NCT06628310 about?
NCT06628310 is a clinical study titled "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". 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 d...
What is the current status of trial NCT06628310?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2024-12-13. Estimated completion is 2030-10.
What conditions does trial NCT06628310 study?
This clinical trial studies the following conditions: Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma.
What interventions are being tested in trial NCT06628310?
The interventions under investigation include: Fluorouracil (DRUG), Leucovorin (DRUG), Telisotuzumab Adizutecan (DRUG), Budigalimab (DRUG), Oxaliplatin (DRUG).
Who is sponsoring clinical trial NCT06628310?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06628310 being conducted?
This trial has 20 study locations across California, Florida, Mississippi, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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