Health Trials

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

ConditionsGastric CancerGastric AdenocarcinomaGastric (Stomach) CancerGastroesophageal AdenocarcinomaGastroesophageal Cancer (GC)Gastroesophageal Junction (GEJ) AdenocarcinomaGastroesophageal Junction (GEJ) CancerGastrointestinal Cancer MetastaticGastrointestinal AdenocarcinomaGastrointestinal CancersColorectal (Colon or Rectal) CancerPancreatic CancerCDH17-positive Advanced Solid TumorsAdvanced Gastric Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBigHat Biosciences, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • BHB810

Treatment groups

164 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

BigHat Biosciences, Inc.

Lead sponsor

Source ClinicalTrials.gov