Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma (NCT07529808) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma
164 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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'…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
Timeframe: Cycle 1 Day 1 through 30 days after the last dose, an average of 6 months
2
Incidence of participants who have a dose modification of BHB810 due to toxicity
Timeframe: Cycle 1 Day 1 through 30 days after the last dose, an average of 6 months
3
Overall Response Rate (ORR)
Timeframe: Screening through End of Treatment, an average of 6 months