Gastric 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
Investigational drug(s) / intervention(s)
BHB810
BHB810: Every 2 weeks IV administration
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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) — Cycle 1 Day 1 through 30 days after the last dose, an average of 6 months 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.
Incidence of participants who have a dose modification of BHB810 due to toxicity — Cycle 1 Day 1 through 30 days after the last dose, an average of 6 months Investigate the safety and tolerability of BHB810 by assessment of dose modifications due to toxicity
Phase 1 (Dose Escalation \& Backfill Cohorts)
Overall Response Rate (ORR) — Screening through End of Treatment, an average of 6 months 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)
Trial sites (1)
Facility
City
Region
Status
NEXT Virginia
Fairfax
Virginia
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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