A Phase 1/2 interventional study of BHB810 in Gastric Cancer, Gastric Adenocarcinoma and Gastric (Stomach) Cancer, sponsored by BigHat Biosciences, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by BigHat Biosciences, Inc. · Phase 1/2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Prior cancer treatment as follows, relative to the first planned dose of trial intervention:
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
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