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

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.