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BHB810 for Advanced Gastric and GEJ Adenocarcinoma

This study is testing a drug called BHB810 for adults with advanced gastric (stomach) cancer or gastroesophageal junction (GEJ) adenocarcinoma. These are cancers that have grown or spread, or for which standard treatments are no longer working or available. The main goals are to see how safe BHB810 is, how well your body tolerates it, and how effective it is in treating the cancer. Participants will receive BHB810 through an IV every two weeks. The study will also look at how the drug moves through your body and how your body reacts to it. The study aims to enroll 164 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is designed to enroll 164 participants.
What's involved
Participants will receive BHB810 through an IV infusion every two weeks while on study treatment. The study will monitor for side effects and how the drug affects your body.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for 30 days after the last dose, which is an average of 6 months. Overall Response Rate will be measured from screening through the end of treatment, an average of 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07529808

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
BigHat Biosciences, Inc.
~164 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:BHB810

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over Cycle 1 Day 1 through 30 days after the last dose, an average of 6 months
+2 more outcomes measured

Conditions

Gastric Cancer
Gastric Adenocarcinoma
Gastric (Stomach) Cancer
Gastroesophageal Adenocarcinoma
Gastroesophageal Cancer (GC)
Gastroesophageal Junction (GEJ) Adenocarcinoma
Gastroesophageal Junction (GEJ) Cancer
Gastrointestinal Cancer Metastatic
Gastrointestinal Adenocarcinoma
Gastrointestinal Cancers
Colorectal (Colon or Rectal) Cancer
Pancreatic Cancer
CDH17-positive Advanced Solid Tumors
Advanced Gastric Cancer

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NCT07529808

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • NEXT Virginia

    Fairfax, Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Maybelle De La Rosa
[email protected]
703-783-4518
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial 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)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 toxicityCycle 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)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)