Phase 2 Stomach Cancer Trial, Recruiting NCT06921837 Sponsor: Bolt Biotherapeutics, Inc. Condition: Stomach Cancer
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Phase 2 Stomach Cancer Trial, Recruiting

NCT06921837
Recruiting Phase 2 🇦🇺 Australian site

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:

  • The cancer must have areas that can be measured using standard imaging assessment tools (confirm with trial site).
  • People with stomach cancer or cancer of the junction between the stomach and oesophagus that has either spread to other parts of the body (Stage 4) or cannot be removed by surgery (Stage 3), confirmed by laboratory testing of tissue samples.
  • People who have already received at least one or two standard treatment options that are available locally, or who were unable to tolerate those standard treatments.
  • For people in the dose escalation part of the trial: if a protein called Claudin 18 has previously been tested in the tumour, a certain minimum level of that protein must be present (confirm with trial site for specific thresholds).
  • The body's major organs (such as kidneys, liver, and heart) must be functioning well enough to safely participate (confirm with trial site for specific requirements).
  • People who agree to have a small tissue sample (biopsy) taken before joining the trial, if it is safe to do so. If a fresh biopsy is not safely possible, a previously collected stored tumour sample may be accepted instead.

Who may not be able to join:

  • People whose cancer has spread to the brain or spinal cord, unless it is causing no symptoms, is considered stable, and has not needed steroid medication for at least 14 days before starting the trial treatment.
  • People with significant heart disease, lung disease, or liver disease.
  • People with an active infection at the time of joining.
  • People with a history of inflammatory eye disease.
  • People who still have side effects remaining from a previous cancer treatment.
  • People who have received another experimental treatment or standard cancer treatment within 28 days before starting the trial treatment, or within a specific timeframe based on how quickly the previous treatment leaves the body — whichever is the shorter period.

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 8 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.

Contact this trial

Principal Investigator: Bolt Clinical Development, Bolt Biotherapeutics

Phone: +1 650 434 8640

Australian sites

AUS Site 2, Darlinghurst, New South Wales
AUS Site 5, Westmead, New South Wales
AUS Site 1, Birtinya, Queensland
AUS Site 4, Clayton, Victoria
AUS Site 3, Heidelberg, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Bolt Biotherapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
26 May 2025
Est. completion
1 May 2027

Where this trial is recruiting

🇦🇺 Australia 🇰🇷 South Korea 🇹🇼 Taiwan

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0; Incidence and nature of AEs considered by the Investigator or Sponsor to be clinically relevant, attributable to study treatment, and meeting dose-limiting toxicity (DLT) criteria

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: 8 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