164 Participants NeededMy employer runs this trial

BHB810 for Stomach Cancer

Recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: BigHat Biosciences, Inc.
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 trial tests a new treatment called BHB810 to evaluate its safety and effectiveness for individuals with advanced stomach or gastroesophageal cancer that hasn't responded to other treatments. Participants will receive this treatment through an IV every two weeks. The trial will examine how BHB810 moves through the body and how the body responds. Individuals with advanced stomach or gastroesophageal cancer, who have not had success with existing treatments, might be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as strong CYP3A4 inhibitors or inducers, Pgp inhibitors, or CYP3A4 sensitive substrates, at least 2 weeks before starting the study treatment. Other cancer treatments must also be stopped for a specific period before the trial begins.

Is there any evidence suggesting that BHB810 is likely to be safe for humans?

A previous study found BHB810 to be safe and effective in significantly reducing tumors. This indicates that patients generally tolerate BHB810 well. Although the study did not specify side effects, the safety results are encouraging. As this study is in the early stages, researchers are closely monitoring for any potential risks. If BHB810 were unsafe, it would not progress in the clinical trial process.12345

Why do researchers think this study treatment might be promising?

Most treatments for stomach cancer, like chemotherapy and targeted therapies, work by attacking rapidly dividing cancer cells but can also harm healthy cells. BHB810 is unique because it targets cancer cells more precisely, potentially reducing damage to healthy cells. Researchers are excited about BHB810 because it offers a new mechanism of action that could improve effectiveness and minimize side effects compared to existing treatments. This targeted approach may lead to better outcomes for patients with fewer complications.

What evidence suggests that BHB810 might be an effective treatment for stomach cancer?

Research has shown that treatments targeting HER2, a protein that can promote cancer growth, have potential for treating stomach and gastroesophageal cancers. One study found that 50% of patients with these cancers responded to treatment. Additionally, new combination therapies have greatly improved survival and response rates compared to chemotherapy alone. This trial tests BHB810 at various dose levels to evaluate its effectiveness. Although BHB810 remains under investigation, these findings suggest that targeted therapies might be effective for these cancers.678910

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
See 9 more

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

Citations

Gaps in Biomarker Testing and Targeted Therapy ...

Real-world data can be used to further understand trends in biomarker testing and the use of targeted therapies among patients with gastric cancer.

Gastric/GEJ Cancers Gain Traction With HER2-Targeted ...

We saw a remarkable 50% response rate [with GI cancers, and certainly CRC. Clinical outcomes … showed a median progression-free survival [PFS] ...

Gastric Cancer | Real-world evidence of treatment patterns ...

Of the 2,629 mGC patients who started the first line of treatment (1LOT), 32.8% switched to 2LOT, and 10.2% reached 3LOT. Longer survival time ...

Summary of selected clinical trials on emerging therapies ...

the overall clinical outcomes for patients with advanced-stage gastric cancer remain poor.

Gastric Cancer Pipeline Analysis Report

the combination therapy significantly improved overall survival, progression-free survival, and overall response rate compared to chemotherapy alone.

BigHat Biosciences doses first patient with AI-designed ...

BHB810 produced complete or near-complete clearance of tumours alongside a favourable safety profile, according to the company.

Research & Clinical Trials Search Results:

This study will look at safety and effectiveness. Safety, PK and Efficacy of. Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma

A Study of Evorpacept (ALX148) in Patients With Advanced ...

Survival Time frame: up to 36 months postdose. Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ AdenocarcinomaRecruitingNCT07529808Phase

(PDF) Advances in antibody-drug conjugates in cancer

BHB810: A novel site-specific CDH17-directed VHH-Fc ADC for gastric cancer [abstract]. In: Proceedings of the American Association for Cancer ...

NEXT Oncology Trials

BHB810 in Advanced Gastric and. Gastric (Stomach) A Safety Study of SEA-TGT (SGN-TGT) Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma ...