Viewing Study NCT06628310



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06628310
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-10-03

Brief 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
Sponsor: None
Organization: None

Study Overview

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
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: AndroMETa-GEA
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 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None