NCT07529808 Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma
| NCT ID | NCT07529808 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | BigHat Biosciences, Inc. |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2026-07-16 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 164 participants in total. It began in 2026-07-16 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Frequently Asked Questions
Who can join the NCT07529808 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07529808 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07529808 currently recruiting?
Yes, NCT07529808 is actively recruiting participants. Visit ClinicalTrials.gov or contact BigHat Biosciences, Inc. to inquire about joining.
Where is the NCT07529808 trial being conducted?
This trial is being conducted at Duarte, United States, Santa Monica, United States, Fairfax, United States.
Who is sponsoring the NCT07529808 clinical trial?
NCT07529808 is sponsored by BigHat Biosciences, Inc.. The trial plans to enroll 164 participants.
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