Phase 2 Stomach Cancer Trial, Recruiting NCT07529808 Sponsor: BigHat Biosciences, Inc. Condition: Stomach Cancer
Back to Stomach Cancer

Phase 2 Stomach Cancer Trial, Recruiting

NCT07529808
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years old or older (or meet the legal age of consent where the trial is taking place)
  • You have been diagnosed with advanced stomach cancer or cancer where the stomach meets the esophagus (gastroesophageal junction), confirmed by a lab test, and your cancer has gotten worse, did not respond to standard treatment, or no standard curative treatment is available
  • Your cancer tests positive for a protein called CDH17 (required for certain parts of the trial — confirm with trial site)
  • You have at least one measurable area of cancer that can be tracked on scans at the start of the trial
  • You are able to provide a stored tumor tissue sample; some parts of the trial also require a fresh tissue biopsy taken at the screening stage (confirm with trial site)
  • Your heart, liver, kidneys, and bone marrow are functioning well enough as defined by the trial team

Who may not be able to join:

  • You received chemotherapy or targeted therapy within the past 4 weeks (or within 5 half-lives of the drug, whichever is shorter)
  • You received a monoclonal antibody-based treatment (including a type called ADCs) within the past 4 weeks
  • You received an immune checkpoint inhibitor within the past 4 weeks
  • You received wide-field radiation therapy (covering more than 30% of bone marrow areas) within the past 4 weeks, or focused pain-relief radiation within the past 2 weeks
  • You have previously been treated with a therapy that targets CDH17, or with a specific type of ADC drug containing auristatin (MMAE or MMAF)
  • You have a known allergy or sensitivity to the trial drug (BHB810) or any of its ingredients
  • Your heart's pumping function is below 50%, or you have a history of moderate-to-severe heart failure (Class III or IV)
  • You have an abnormal heart rhythm reading (QTc interval above 470 milliseconds), a history of a specific dangerous heart rhythm problem, or you are taking a medication known to affect heart rhythm
  • You are pregnant, breastfeeding, or you or your partner are planning to become pregnant
  • You have cancer that has spread to the brain or the lining around the brain or spinal cord — although people with brain metastases that have been treated and are stable may still be eligible (confirm with trial site)
  • You are currently taking certain medications that strongly affect how the body processes drugs (strong CYP3A4 inhibitors, inducers, Pgp inhibitors, or CYP3A4 sensitive substrates) within 2 weeks of starting the trial (confirm with trial site)
  • You have any other condition that the trial team believes could affect your safety, your ability to follow the trial requirements, or the accuracy of the results

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
BigHat Biosciences, Inc.
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
1 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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); Incidence of participants who have a dose modification of BHB810 due to toxicity; Overall Response Rate (ORR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov