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164 Participants NeededMy employer runs this trial

BHB810 for Stomach Cancer

Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: BigHat Biosciences, Inc.
Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers
Disqualifiers: Heart failure, Brain metastases, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for adults with advanced stomach or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has not responded to standard treatments, and who have at least one measurable tumor. Participants must have good organ function and provide a tumor sample.

Inclusion Criteria

My cancer tested positive for CDH17.
At least 1 measurable target lesion at baseline per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)
My organ and bone marrow function are within normal limits.
See 4 more

Exclusion Criteria

I have received immune checkpoint inhibitors in the last 4 weeks.
I have received antibody-based therapy in the last 4 weeks.
Known hypersensitivity or allergic reaction to BHB810 or its excipients
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an IV infusion of BHB810 every 2 weeks during the study treatment

6 months
Bi-weekly visits for IV infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • BHB810

Trial Overview

The study is testing BHB810, given by IV every two weeks, to see how safe it is and how well it works in people with advanced gastric or GEJ adenocarcinoma. The trial also studies how the drug moves through the body.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Recommended Phase 2 Dose Level 2 (RP2D2)Experimental Treatment1 Intervention
Group II: Recommended Phase 2 Dose Level 1 (RP2D1)Experimental Treatment1 Intervention
Group III: Dose Escalation and Backfill CohortsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BigHat Biosciences, Inc.

Lead Sponsor

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