Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma

Part of paid clinical trials in Fairfax, Virginia.

Sponsor
BigHat Biosciences, Inc.
Study ID
NCT07529808
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Gastric Cancer
  • CDH17-positive Advanced Solid Tumors
  • Colorectal (Colon or Rectal) Cancer
  • Gastric (Stomach) Cancer
  • Gastric Adenocarcinoma
  • Gastric Cancer
  • Gastroesophageal Adenocarcinoma
  • Gastroesophageal Cancer (GC)
  • Gastroesophageal Junction (GEJ) Adenocarcinoma
  • Gastroesophageal Junction (GEJ) Cancer
  • Gastrointestinal Adenocarcinoma
  • Gastrointestinal Cancer Metastatic
  • Gastrointestinal Cancers
  • Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BHB810 — DRUG
    Every 2 weeks IV administration

Study Details

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.

Key Dates

First listed
Apr 14, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
164 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
NEXT VirginiaFairfaxVirginia22031
Maybelle De La Rosa
[email protected]
703-783-4518
Alexander Spira, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fairfax, VA

By condition
Gastric cancerPancreatic cancer
By specialty
OncologyGI oncology
By research site
NEXT Virginia· Fairfax, VA

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