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Evaluating a new treatment for advanced gastric and esophageal cancer

A Phase 2 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan 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)

Phase 2 Interventional AbbVie · NCT06628310

This study is testing a new treatment combining ABBV-400 with other medications to see if it helps adults with advanced stomach and esophageal cancer feel better and improve their condition.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionstelisotuzumab, Budigalimab
Locations49 sites (Duarte, California and 48 other locations)
Trial IDNCT06628310 on ClinicalTrials.gov

What this trial studies

This study assesses the safety and effectiveness of ABBV-400 combined with Fluorouracil, Leucovorin, and Budigalimab in adults with locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The trial is divided into two stages, starting with dose escalation of ABBV-400 to determine the optimal tolerable dose. Participants will then be randomized into treatment groups to evaluate the efficacy of the combination therapy. The study aims to provide insights into the adverse events and changes in disease activity associated with this treatment regimen.

Who should consider this trial

Good fit: Ideal candidates include adults with inoperable, advanced, or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma who meet specific health criteria.

Not a fit: Patients who have received prior systemic therapy for their advanced cancer or have significant lung-specific illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced gastric and esophageal cancers.

How similar studies have performed: While this approach involves investigational drugs, similar studies have shown promise in treating advanced cancers, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 central PD-L1 testing prior to enrollment.

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.

Where this trial is running

Duarte, California and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Locally Advanced Unresectable or Metastatic Gastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaEsophageal AdenocarcinomaABBV-400ABBV-181BudigalimabTelisotuzumab Adizutecan
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.