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RecruitingPhase 1 / Phase 2

Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma

Phase 1/2, Open-Label, Multicenter, Dose Escalation and Expansion Study of BHB810 in Participants With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will get an IV infusion of BHB810 every 2 weeks while on study treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests BHB810 in adults with advanced cancer of the stomach or the place where the food pipe meets the stomach. It checks the drug’s safety, how well it works, how it moves through the body, and how the body reacts to it. Participants get the drug through a vein every 2 weeks.

This study is looking at how safe BHB810 is in adults with gastric and gastroesophageal adenocarcinoma (GEJ). The purpose of this study is also to look at: how well the study drug works, how the study drug moves into, through, and out of the body, and how your body reacts to the study drug. Participants will get an IV infusion of BHB810 every 2 weeks while on study treatment.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old or the legal age to consent where the study takes place.
  • Have advanced stomach or gastroesophageal junction cancer confirmed by a tissue test. The cancer must have grown despite treatment, not responded to treatment, or have no standard or available treatment that could cure it.
  • For Phase 1 backfill groups and Phase 2, the tumor must test positive for CDH17 through the study’s testing center. CDH17 is a protein.
  • Some people with other cancers of the digestive system may join the backfill groups and Phase 2.
  • Have at least one tumor that can be measured using the study’s rules.
  • Provide a stored tumor tissue sample. Phase 1 backfill groups and Phase 2 also require a new tissue sample before joining.
  • Have organs and bone marrow that work well enough under the study’s rules.

Who can't join

  • Have had certain cancer treatments too close to the first study dose: chemotherapy or targeted drugs within 4 weeks or 5 drug half-lives, whichever is shorter; antibody drugs or immune checkpoint drugs within 4 weeks; radiation to a large area within 4 weeks; or radiation for symptom relief to tumors not being measured within 2 weeks. A half-life is the time it takes the body to clear half a drug.
  • Have had treatment aimed at CDH17, or an antibody-drug conjugate carrying MMAE or MMAF. These are antibodies linked to cancer-killing drugs.
  • Have a known allergy to BHB810 or any of its ingredients.
  • Have heart pumping strength below 50%, a history of severe heart failure, certain heart rhythm test results or risk factors, or take drugs that can cause certain heart rhythm changes.
  • Are pregnant or breastfeeding, or you or your partner plan to become pregnant.
  • Have known or suspected cancer in the brain, cancer in the tissue around the brain and spinal cord, or pressure on the spinal cord. People with treated brain cancer that is stable may be able to join.
  • Take certain medicines that affect how the body handles drugs within 2 weeks before the first study dose. These include strong CYP3A4 blockers or boosters, Pgp blockers, and drugs sensitive to CYP3A4.
  • Have any condition that could make the study unsafe, make it hard to follow study rules, or affect the study’s results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF. * Histologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on, was nonresponsive to, or for which no standard or available curative therapy exists. * Participants in Phase 1 Backfill Cohorts \& Phase 2 must be CDH17-positive by central testing. * Other gastrointestinal (GI) tumor types may be enrolled in Backfill Cohorts and Phase 2. * At least 1 measurable target lesion at baseline per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) * Provision of FFPE archival tumor tissue. Additional fresh biopsies at screening are required in Phase 1 Backfill Cohorts and Phase 2. * Adequate organ and marrow function as defined in the protocol Exclusion Criteria: * Prior cancer treatment as follows, relative to the first planned dose of trial intervention: * Chemotherapy or targeted therapy withing 4 weeks or 5-halflives (whichever is shorter) * Monoclonal antibody-based therapy (including ADCs) within 4 weeks * Immune checkpoint inhibitors within 4 weeks * Wide-field radiation therapy (\>30% marrow-bearing bones) within 4 weeks or \< 2 weeks of focal palliative radiation to nontarget lesions * Prior treatment with a CDH17-directed therapy or an ADC with an auristatin (MMAE or MMAF) * Known hypersensitivity or allergic reaction to BHB810 or it's excipients * Left ventricular ejection fraction \<50% or history of congestive heart failure Class III/IV * QTc interval \> 470 msec, history of risk factors for Torsade de Pointes, or taking a medication known to prolong QT/QTc * Pregnant or breastfeeding females, or if you or your partner are planning to become pregnant * Known or suspected brain metastases, leptomeningeal disease, or spinal cord compression. Participants with stable, treated brain metastases may be enrolled. * Current treatment with a strong CYP3A4 inhibitor or inducer, Pgp inhibitor, or CYP3A4 sensitive substrate within 2 weeks of first dose of trial intervention * Any condition that may compromise participant safety, compliance, or interfere with the evaluation of the study drug.

Study sites (3)

CA

VA