Study on BHB810 for Advanced Stomach and Gastroesophageal Cancer

Sponsor: BigHat Biosciences, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07529808

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, BHB810, in adults with advanced stomach and gastroesophageal cancer. Participants will receive the drug through an IV every two weeks to see how it affects their body and how well it works against the cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety of BHB810 in adults with advanced stomach and gastroesophageal junction (GEJ) cancer. Researchers will also study how well the drug works, how it moves through the body, and how the body responds to it. Participants will receive BHB810 through an IV infusion every two weeks during the study.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced stomach or gastroesophageal junction (GEJ) cancer that has not responded to standard treatments or for which no standard treatment is available.
  • For certain parts of the study, participants must test positive for CDH17.
  • Must have at least one measurable tumor.
  • Must provide a sample of tumor tissue for testing.
  • Must have adequate organ and bone marrow function as specified in the study protocol.

Exclusion Criteria

  • Recent cancer treatments, such as chemotherapy or targeted therapy, within 4 weeks or 5 half-lives (whichever is shorter) before starting the study.
  • Recent monoclonal antibody therapy within 4 weeks.
  • Recent immune checkpoint inhibitor therapy within 4 weeks.
  • Recent wide-field radiation therapy within 4 weeks or less than 2 weeks for small, targeted radiation.
  • Previous treatment with a CDH17-directed therapy or certain types of drugs called ADCs.
  • Allergic reactions to BHB810 or its ingredients.
  • Heart problems, such as low heart function or certain heart rhythm issues.
  • Pregnant or breastfeeding, or planning to become pregnant.
  • Known or suspected brain or spinal cord cancer spread, unless stable and treated.
  • Current use of certain medications that affect how the body processes drugs.
  • Any condition that could affect safety, compliance, or evaluation of the study drug.

Locations

FACILITYZIPCITYSTATE
NEXT Virginia22031FairfaxVirginia

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