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

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT06628310
Phase
PHASE2
Status
Recruiting
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Conditions

  • Esophageal Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telisotuzumab Adizutecan — DRUG
    Intravenous (IV) Infusion
  • Budigalimab — DRUG
    IV Infusion
  • Fluorouracil — DRUG
    IV Infusion; IV Injection
  • Leucovorin — DRUG
    IV Infusion; IV Injection
  • Oxaliplatin — DRUG
    IV Infusion

Study Details

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 the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Key Dates

Start date
Dec 13, 2024
Status verified
Mar 2026
Primary completion
Oct 31, 2030
Completion
Oct 31, 2030

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Stage 1: Dose Escalation ABBV-400
    Participants will receive escalating doses of telisotuzumab adizutecan (ABBV-400) in combination with a fixed dose of fluorouracil, leucovorin and budigalimab as part of the approximately 6 year study duration.
  • Experimental: Stage 2 Arm 1: Dose Optimization ABBV-400 Dose A
    Participants will receive telisotuzumab adizutecan (ABBV-400) dose A in combination with a fixed dose of fluorouracil, leucovorin and budigalimab as part of the approximately 6 year study duration.
  • Experimental: Stage 2 Arm 2: Dose Optimization ABBV-400 Dose B
    Participants will receive telisotuzumab adizutecan (ABBV-400) dose B in combination with a fixed dose of fluorouracil, leucovorin and budigalimab as part of the approximately 6 year study duration.
  • Experimental: Stage 2 Arm 3: Dose Optimization Standard of Care (SOC)
    Participants will receive a fixed dose of leucovorin (folinic acid), fluorouracil, oxaliplatin (FOLFOX) and budigalimab as part of the approximately 6 year study duration.

Primary Outcome Measure

Progression-Free Survival (PFS) as Assessed by Investigator [ Time Frame: Through Study Completion, Approximately 6 Years ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
City of Hope National Medical Center /ID# 268690DuarteCalifornia91010-
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 272630IrvineCalifornia92618-
UCLA - Santa Monica /ID# 270024Santa MonicaCalifornia90404-
AdventHealth Orlando /ID# 268561OrlandoFlorida32803-
City Of Hope - Atlanta. /ID# 280646NewnanGeorgia30265-
Hattiesburg Clinic /ID# 268572HattiesburgMississippi39401-
Duke University Medical Center /ID# 268186DurhamNorth Carolina27710-
Millennium Research & Clinical Development /ID# 268540HoustonTexas77090-

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City of Hope National Medical Center· Duarte, CACity of Hope - Orange County Lennar Foundation Cancer Center· Irvine, CAUCLA - Santa Monica· Santa Monica, CAAdventHealth Orlando· Orlando, FLCity Of Hope - Atlanta.· Newnan, GAHattiesburg Clinic· Hattiesburg, MS

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