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

NCT07529808 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: BHB810-001
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is looking at how safe BHB810 is in adults with gastroesophageal adenocarcinoma (GEA) and other gastrointestinal (GI) cancers. 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); Gastroesophageal Junction (GEJ) Adenocarcinoma; Gastroesophageal Junction (GEJ) Cancer; Gastrointestinal Cancer Metastatic; Gastrointestinal Adenocarcinoma; Gastrointestinal Cancers; Colorectal (Colon or Rectal) Cancer; Pancreatic Cancer; CDH17-positive Advanced Solid Tumors; Advanced Gastric Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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)

  Screening through End of Treatment, an average of 6 months

Secondary Outcomes (14)

• Clinical Benefit Rate (CBR)

  Screening through End of Treatment, an average of 6 months

• Duration of Response (DOR)

  Screening through End of Treatment or last scan, an average of 6 months

• Progression Free Survival (PFS)

  Screening through End of Treatment, an average of 6 months

• Overall Survival (OS)

  Screening through End of Study, an average of 10 months

• Pharmacokinetics: Area under the concentration-time curve (AUC)

  At protocol defined intervals starting at Cycle 1 Day 1 through End of Treatment, an average of 6 months

Study Arms (3)

Dose Escalation and Backfill Cohorts

EXPERIMENTAL

Dose escalation and backfill cohorts

Drug: BHB810

Recommended Phase 2 Dose Level 1 (RP2D1)

EXPERIMENTAL

Dose level 1 of 2 prospective recommended phase 2 dose levels

Drug: BHB810

Recommended Phase 2 Dose Level 2 (RP2D2)

EXPERIMENTAL

Dose level 2 of 2 prospective recommended phase 2 dose levels

Drug: BHB810

Interventions

BHB810 DRUG

Every 2 weeks IV administration

Dose Escalation and Backfill Cohorts; Recommended Phase 2 Dose Level 1 (RP2D1); Recommended Phase 2 Dose Level 2 (RP2D2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BigHat Biosciences, Inc.: lead

MeSH Terms

Conditions

Stomach Neoplasms; Adenocarcinoma; Neoplasms; Gastrointestinal Neoplasms; Colonic Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1 dose escalation with backfill cohorts followed by randomized Phase 2

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04