NCT07529808 · BigHat Biosciences, Inc.
Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
BHB810
Every 2 weeks IV administration
Primary outcome measures
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs) per Common Terminology Criteria for Adverse Events v6.0 (CTCAE v6.0)
Time frame: Cycle 1 Day 1 through 30 days after the last dose, an average of 6 months
Investigate the safety and tolerability of BHB810 by evaluation of AEs, SAEs, DLTs, and clinically significant changes safety assessments, like lab tests, vital signs, and other safety assessments Phase 1 (Dose Escalation \& Backfill Cohorts) and Phase 2 (Dose Optimization) DLTs apply to Phase 1 Dose Escalation Cohorts only.
Incidence of participants who have a dose modification of BHB810 due to toxicity
Time frame: Cycle 1 Day 1 through 30 days after the last dose, an average of 6 months
Investigate the safety and tolerability of BHB810 by assessment of dose modifications due to toxicity Phase 1 (Dose Escalation \& Backfill Cohorts)
Overall Response Rate (ORR)
Time frame: Screening through End of Treatment, an average of 6 months
Identify the recommended Phase 2 dose (RP2D) by comparing 2 doses of BHB810 by evaluating the ORR of participants according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Phase 2 (Dose Optimization)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations