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

Phase 2

Recruiting

• Conditions: Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Esophageal Adenocarcinoma
• Interventions: Drug: ABBV-400; Drug: Budigalimab; Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin

• Registration Number: NCT06628310
• Lead Sponsor: AbbVie

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 loc...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-04
• Status Verified: 2024-12
• Study Start: 2024-12-13
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-18
• Primary Completion: 2030-10
• Study Completion: 2030-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Name	Time	Method
Progression-Free Survival (PFS) as Assessed by Investigator	Through Study Completion, Approximately 6 Years	PFS is defined as the time from the first dose of study drug to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by investigator or death from any cause, whichever occurs earlier.
Percentage of Participants with Objective Response (OR) as Assessed by Investigator	Through Study Completion, Approximately 6 Years	OR is defined as confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator per RECIST version 1.1.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Disease Control (DC) as Assessed by Investigator	Through Study Completion, Approximately 6 Years	DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) (with a minimum duration of 16 weeks) based on RECIST, version 1.1 as determined by the investigator.
Duration of Response (DOR) as Assessed by Investigator	Through Study Completion, Approximately 6 Years	DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST version 1.1 as determined by investigator or death from any cause, whichever occurs first.
Overall Survival (OS)	Through Study Completion, Approximately 6 Years	OS is defined as the time from first dose of study drug to the event of death from any cause.

Trial Locations

Locations (5)

City of Hope National Medical Center /ID# 268690; 🇺🇸 Duarte, California, United States

Hattiesburg Clinic /ID# 268572; 🇺🇸 Hattiesburg, Mississippi, United States

Millennium Research & Clinical Development /ID# 268540; 🇺🇸 Houston, Texas, United States

China Medical University Hospital /ID# 267667; 🇨🇳 Taichung, Taiwan

Taipei Veterans General Hospital /ID# 267664; 🇨🇳 Taipei City, Taiwan