A Phase 1/2 interventional study of BHB810 in Gastric Cancer, Gastric Adenocarcinoma and Gastric (Stomach) Cancer, sponsored by BigHat Biosciences, Inc.. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by BigHat Biosciences, Inc. · Phase 1/2, Interventional, and Treatment
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Among 804 studies in Stomach Neoplasms with a site in United States — 157 open to participants now, 239 under way, 12 of them phase 3. Stomach Neoplasms · United States.
Among the 804 studies in Stomach Neoplasms with a site in United States, this one is the 148th largest by planned enrollment of the 686 interventional ones that give a count, is one of 39 that started in 2026, is one of 109 in phase 1/2, reaches primary completion later than 178 of the 238 other live ones, and was the 780th registered.
3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.
Browse Stomach Neoplasms studies →157 of the 804 studies in Stomach Neoplasms with a site in United States are open now. Recruiting first, the newest first:
University of Illinois Chicago · Sites in United States
Ages 18+
Pfizer · Sites in United States
Ages 18+
Sutro Biopharma, Inc. · Sites in United States
Ages 18+
MacroGenics · Sites in United States
Ages 18+
GE Healthcare · Sites in United States, Sweden
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
804 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 380 · Phase 2 338 · Phase 3 45 · Phase 4 10
First in 1992; this study’s year is marked. 39 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 164 is above the median of 66 across 2,500 interventional studies indexed under Stomach Neoplasms.
Median enrollment 53 across the 686 interventional studies, 207 across the 83 observational. Of the 512 that completed or were terminated, 196 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
381 of 804 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with BigHat Biosciences, Inc. as lead sponsor.
BigHat Biosciences, Inc. has 1 study filed under Stomach Neoplasms — fewer than ten, so there is no comparison to draw.
81 of the studies in Stomach Neoplasms with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06532006Phase 3Shanghai Henlius BiotechA Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer | 2027-06-01 |
| NCT07217704Phase 3SOFIEUsing 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer. | 2027-08-30 |
| NCT07814872Harvard Medical School (HMS and HSDM)A Preregistered Multi-Cohort Evaluation of the FATHOM AI System for Molecular Testing Prioritization to Support Clinical Trial Enrollment | 2026-11 |
| NCT05183126University of Michigan Rogel Cancer CenterPharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer | 2026-11 |
| NCT06219941AstraZenecaAZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 | 2026-11-17 |
Add all 81 to your calendar (.ics) → With an account.
Among the 804 studies in Stomach Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Prior cancer treatment as follows, relative to the first planned dose of trial intervention:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose escalation and backfill cohorts
Drug: BHB810
Dose level 1 of 2 prospective recommended phase 2 dose levels
Drug: BHB810
Dose level 2 of 2 prospective recommended phase 2 dose levels
Drug: BHB810
Every 2 weeks IV administration
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.
Time frame: 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)
Time frame: 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)
Time frame: Screening through End of Treatment, an average of 6 months
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At protocol defined intervals starting at Cycle 1 Day 1 through End of Treatment, an average of 6 months
Started Jul 2026 (actual). Primary completion is estimated for Dec 2028, 29 months after the start.
Of 89 industry-sponsored phase 1/2 interventional studies under Stomach Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 109. This study's planned 29 months is below that.
Counting every sponsor, half of 156 studies reached it within 60 months; a quarter within 41 and three quarters within 109.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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