Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Zev A. Wainberg, MD (ucla)
Headshot of Zev A. Wainberg
Zev A. Wainberg

Description

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.

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)

Keywords

Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, ABBV-400, ABBV-181, Budigalimab, Adenocarcinoma, Esophageal Neoplasms, Leucovorin, Oxaliplatin, Fluorouracil

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCLA - Santa Monica /ID# 270024 accepting new patients
    Los Angeles California 90404 United States
  • City of Hope Orange County Lennar Foundation Cancer Center /ID# 272630 accepting new patients
    Irvine California 92618 United States
  • City of Hope National Medical Center /ID# 268690 accepting new patients
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Zev A. Wainberg, MD (ucla)
    Zev Wainberg, M.D., holds the Estelle, Abe, and Marjorie Sanders Chair in Cancer Research.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info
ID
NCT06628310
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 180 study participants
Last Updated