Recruiting
Phase 1
Phase 2

BHB810

Sponsor:

BigHat Biosciences, Inc.

Code:

NCT07529808

Conditions

Gastric Cancer

Gastric Adenocarcinoma

Gastric (Stomach) Cancer

Gastroesophageal Adenocarcinoma

Gastroesophageal Cancer (GC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BHB810

Study Details

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.

Conditions

Gastric Cancer

Gastric Adenocarcinoma

Gastric (Stomach) Cancer

Gastroesophageal Adenocarcinoma

Gastroesophageal Cancer (GC)

Study ID

NCT07529808

Start date

Jul, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

164 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation and Backfill Cohorts

Dose escalation and backfill cohorts

experimental: Recommended Phase 2 Dose Level 1 (RP2D1)

Dose level 1 of 2 prospective recommended phase 2 dose levels

experimental: Recommended Phase 2 Dose Level 2 (RP2D2)

Dose level 2 of 2 prospective recommended phase 2 dose levels

Interventions

BHB810

Every 2 weeks IV administration

Primary outcome measure

  • 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) [ 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 [ Time Frame: Cycle 1 Day 1 through 30 days after the last dose, an average of 6 months ]
  • Overall Response Rate (ORR) [ Time Frame: Screening through End of Treatment, an average of 6 months ]

Central Contacts and Locations

Locations

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Maybelle De La Rosa

703-783-4518mdelarosa@nextoncology.com

Principal Investigator:

Alexander Spira, MD

More Information

Sponsor

BigHat Biosciences, Inc.

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Antibody Drug Conjugate (ADC)
  • Monomethyl Auristatin E (MMAE)
  • CDH17 protein

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BigHat Biosciences, Inc. on 2026-07-08.