Featured Trial

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

Study Identifier
M24-977
CT.gov Identifier
NCT06628310
EudraCT Identifier
Not available
EUCTIS ID
2024-513008-32
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

The AndroMETa GEA-977 clinical trial is for adults with advanced or metastatic stomach, gastroesophageal junction, or esophageal adenocarcinoma (GEA) that cannot be removed by surgery. The main purpose is to test whether a new drug combination—the experimental drugs telisotuzumab adizutecan (ABBV‑400 or Temab‑A) and budigalimab, and standard chemotherapy (fluorouracil and leucovorin)—is safe and effective as a first treatment option. Participants will be randomly assigned to receive either the new combination or current standard chemotherapy plus budigalimab. Please note that Temab-A and budigalimab are investigational drugs not approved by global regulatory authorities. Safety and efficacy have not been established.

One of the investigational treatments in this study, Temab-A, is a type of antibody-drug conjugate, which targets a specific protein on cells to stop the DNA in cancer cells from replicating. It is being developed to target colorectal cancer, gastroesophageal adenocarcinoma, non-small cell lung cancer, and other solid tumors. The other investigational treatment in this study, budigalimab, is a PD-1 monoclonal antibody (mAb) currently in clinical development for treating solid tumors. Budigalimab has shown preliminary efficacy and a safety profile comparable to other PD-1 inhibitors in non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC).

Medical Condition
  • Gastrointestinal Cancer - General
  • Gastrointestinal Cancer - Esophageal Cancer
    • Study Drug
  • Telisotuzumab Adizutecan
  • Budigalimab
  • Fluorouracil
  • Leucovorin
  • Oxaliplatin
    • Phase
    Phase 2
    Estimated Enrollment
    180 patients

    Participating in our Gastric Cancer, Esophageal Cancer Clinical Trials

    The study is being conducted at multiple hospitals and clinics. Doses of investigational treatment will be given in 28-day cycles, with standard chemotherapy given in 14-day cycles. Participants will have regular clinic visits, blood tests, and imaging scans to monitor their health and the effects of treatment. All study drugs will be administered until the patient meets any criteria for discontinuation. Following the end of treatment, there will be ongoing follow-ups with the patient to monitor safety and outcomes.

    The main outcomes being measured are:

    • How long people live without their cancer getting worse (progression-free survival)
    • How well the cancer responds to treatment
    • What side effects may occur

    The study also looks at overall survival and quality of life.

    Study Participant Requirements

    Sex
    Female & Male
    Age
    18+ years

    Key Inclusion and Exclusion Criteria

    Participants must:

    • Be 18 or older.
    • Have advanced or metastatic stomach, gastroesophageal junction, or esophageal adenocarcinoma that cannot be removed with surgery, and is HER2 negative
    • Have not received any previous systemic treatment for your cancer in the advanced or metastatic stage

    Participants must not:

    • Have a different type of stomach cancer (such as squamous cell or undifferentiated gastric cancer)
    • Have ever received certain targeted therapies (c-MET, PD-1 or PD-L1 inhibitors) before
    • Have a history of serious lung problems, such as interstitial lung disease (ILD) or pneumonitis

    Inclusion and 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.

    Study Locations

    Location
    Status
    Location
    City of Hope National Medical Center /ID# 268690
    Duarte, California, United States, 91010
    Status
    Recruiting
    Location
    City of Hope - Orange County Lennar Foundation Cancer Center /ID# 272630
    Irvine, California, United States, 92618
    Status
    Recruiting
    Location
    UCLA - Santa Monica /ID# 270024
    Santa Monica, California, United States, 90404
    Status
    Recruiting
    Location
    AdventHealth Orlando /ID# 268561
    Orlando, Florida, United States, 32803
    Status
    Recruiting
    Location
    City Of Hope - Atlanta. /ID# 280646
    Newnan, Georgia, United States, 30265
    Status
    Recruiting
    Location
    Hattiesburg Clinic /ID# 268572
    Hattiesburg, Mississippi, United States, 39401
    Status
    Recruiting
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