Gastric CancerPhase 1/2NCT07529808
Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma
A Phase 1/2 study testing BHB810 in people with Gastric Cancer and Gastric Adenocarcinoma, run by BigHat Biosciences, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastric Adenocarcinoma, Gastric (Stomach) Cancer
- What is being tested?
- BHB810
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jul 2026to Dec 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
City of Hope Duarte
Duarte, California, 91010
Jalene Tangen, 833-917-5715, jtangen@coh.org
Dani Castillo, MD
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Maybelle De La Rosa, 703-783-4518, mdelarosa@nextoncology.com
Alexander Spira, MD
- Not yet recruiting
University of California at Los Angeles
Santa Monica, California, 90404
Rachel Andes, 310-633-8400 ext. 16122, randes@mednet.ucla.edu
Zev Wainberg, MD
About this study
Official title: Phase 1/2, Open-Label, Multicenter, Dose Escalation and Expansion Study of BHB810 in Participants With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
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.
- Conditions
- Gastric Cancer, Gastric Adenocarcinoma, Gastric (Stomach) Cancer, Gastroesophageal Adenocarcinoma, Gastroesophageal Cancer (GC), Gastroesophageal Junction (GEJ) Adenocarcinoma
- Being tested
- BHB810
- Keywords
- Antibody Drug Conjugate (ADC), Monomethyl Auristatin E (MMAE), CDH17 protein
- Medical subject headings
- Stomach Neoplasms, Adenocarcinoma, Neoplasms, Gastrointestinal Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHB810Drug
Every 2 weeks IV administration
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation and Backfill Cohorts | Experimental | Dose escalation and backfill cohorts Receives: Drug: BHB810 |
| Recommended Phase 2 Dose Level 1 (RP2D1) | Experimental | Dose level 1 of 2 prospective recommended phase 2 dose levels Receives: Drug: BHB810 |
| Recommended Phase 2 Dose Level 2 (RP2D2) | Experimental | Dose level 2 of 2 prospective recommended phase 2 dose levels Receives: Drug: BHB810 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: Cycle 1 Day 1 through 30 days after the last dose, an average of 6 months
Incidence of participants who have a dose modification of BHB810 due to toxicity
Investigate the safety and tolerability of BHB810 by assessment of dose modifications due to toxicity
Phase 1 (Dose Escalation \& Backfill Cohorts)
Measured: Cycle 1 Day 1 through 30 days after the last dose, an average of 6 months
Overall Response Rate (ORR)
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)
Measured: Screening through End of Treatment, an average of 6 months
Secondary outcomes (14)
Clinical Benefit Rate (CBR)
Investigate preliminary antitumor activity of BHB810 as assessed by radiological response per RECIST v1.1
Number of participants who achieve stable disease (SD) for at least 6 months, or PR or CR for any duration
Phase 1 (Dose Escalation \& Backfill Cohorts)
Measured: Screening through End of Treatment, an average of 6 months
Duration of Response (DOR)
Investigate preliminary antitumor activity of BHB810 as assessed by radiological response per RECIST v1.1
Time from PR or CR to disease progression
Phase 1 (Dose Escalation \& Backfill Cohorts) Phase 2 (Dose Optimization)
Measured: Screening through End of Treatment or last scan, an average of 6 months
Progression Free Survival (PFS)
Investigate preliminary antitumor activity of BHB810 as assessed by radiological response per RECIST v1.1
Time from first dose to first documented date of progression per RECIST v1.1
Phase 1 (Dose Escalation \& Backfill Cohorts) Phase 2 (Dose Optimization)
Measured: Screening through End of Treatment, an average of 6 months
Overall Survival (OS)
Investigate preliminary antitumor activity of BHB810
Time from first dose to death from any cause
Phase 1 (Dose Escalation \& Backfill Cohorts) Phase 2 (Dose Optimization)
Measured: Screening through End of Study, an average of 10 months
Pharmacokinetics: Area under the concentration-time curve (AUC)
To characterize the PK profile of BHB810 in blood samples
Phase 1 (Dose Escalation \& Backfill Cohorts)
Measured: At protocol defined intervals starting at Cycle 1 Day 1 through End of Treatment, an average of 6 months
Pharmacokinetics: Area under the concentration-time curve from zero to the end of a dosing interval at steady-state (AUC0-tau)
To characterize the PK profile of BHB810 in blood samples
Phase 1 (Dose Escalation \& Backfill Cohorts) Phase 2 (Dose Optimization)
Measured: At protocol defined intervals starting at Cycle 1 Day 1 through End of Treatment, an average of 6 months
Pharmacokinetics: Maximum concentration of BHB810 (Cmax) Phase 1 (Dose Escalation & Backfill Cohorts) Phase 2 (Dose Optimization)
To characterize the PK profile of BHB810 in blood samples
Measured: At protocol defined intervals starting at Cycle 1 Day 1 through End of Treatment, an average of 6 months
Pharmacokinetics: Time to reach maximum drug concentration of BHB810 (Tmax)
To characterize the PK profile of BHB810 in blood samples
Phase 1 (Dose Escalation \& Backfill Cohorts) Phase 2 (Dose Optimization)
Measured: At protocol defined intervals starting at Cycle 1 Day 1 through End of Treatment, an average of 6 months
Pharmacokinetics: Area under the concentration-time curve from zero to infinity (AUC0-inf)
To characterize the PK profile of BHB810 in blood samples
Phase 1 (Dose Escalation \& Backfill Cohorts) Phase 2 (Dose Optimization)
Measured: At protocol defined intervals starting at Cycle 1 Day 1 through End of Treatment, an average of 6 months
Pharmacokinetics: Terminal elimination half-life (t1/2)
To characterize the PK profile of BHB810 in blood samples
Phase 1 (Dose Escalation \& Backfill Cohorts) Phase 2 (Dose Optimization)
Measured: At protocol defined intervals starting at Cycle 1 Day 1 through End of Treatment, an average of 6 months
Pharmacokinetics: Volume of drug distribution during terminal phase (Vz)
To characterize the PK profile of BHB810 in blood samples
Phase 1 (Dose Escalation \& Backfill Cohorts)
Measured: At protocol defined intervals starting at Cycle 1 Day 1 through End of Treatment, an average of 6 months
Pharmacokinetics: Total body clearance of the drug (CL)
To characterize the PK profile of BHB810 in blood samples
Phase 1 (Dose Escalation \& Backfill Cohorts) Phase 2 (Dose Optimization)
Measured: At protocol defined intervals starting at Cycle 1 Day 1 through End of Treatment, an average of 6 months
Pharmacokinetics: Area under the concentration-time curve from zero to last measurable concentration sample time (AUC0-last)
To characterize the PK profile of BHB810 in blood samples
Phase 2 (Dose Optimization)
Measured: At protocol defined intervals starting at Cycle 1 Day 1 through End of Treatment, an average of 6 months
Incidence of antidrug antibodies (ADAs) in blood before and after BHB810 administration
To characterize the ADAs and PK profile of BHB810 in blood samples
Phase 1 (Dose Escalation \& Backfill Cohorts) Phase 2 (Dose Optimization)
Measured: At protocol defined intervals starting at Cycle 1 Day 1 through End of Treatment, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start16 Jul 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 dose escalation with backfill cohorts followed by randomized Phase 2
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BigHat Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529808
- Sponsor's protocol ID
- BHB810-001
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No