Phase 1 Stomach Cancer Trial, Recruiting NCT06242470 Sponsor: MacroGenics Condition: Stomach Cancer
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Phase 1 Stomach Cancer Trial, Recruiting

NCT06242470
Recruiting Phase 1 🇦🇺 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:

  • Adults aged 18 or older who are able to give informed consent
  • People whose general health and blood test results meet the required standards set by the trial
  • People who have a stored tumour tissue sample available, or who are able to have a fresh tumour biopsy taken; people for whom a fresh biopsy is not safely possible may still be considered eligible (confirm with trial site)
  • People diagnosed with certain cancers that cannot be removed by surgery, have spread locally, or have spread to other parts of the body — including head and neck squamous cell cancer, oesophageal squamous cell cancer, lung cancer (several types), bladder cancer, sarcoma, endometrial cancer, melanoma, prostate cancer that no longer responds to hormone therapy, breast cancer, ovarian cancer, cervical cancer, colorectal cancer, stomach or gastroesophageal cancer, pancreatic cancer, clear cell kidney cancer, or liver cancer
  • People with measurable disease according to a standard measurement system called RECIST v1.1; people with prostate cancer that no longer responds to hormone therapy but without measurable disease may also be considered eligible
  • People who are willing to use highly effective contraception from the time of joining the trial until 7 months after stopping the study treatment
  • People who are not pregnant and not breastfeeding

Who may not be able to join:

  • People with a medical or psychiatric condition that could affect their ability to receive or follow the planned treatment or study procedures
  • People who have been treated for another cancer within the past 2 years, with some exceptions for certain low-risk cancers such as adequately treated non-melanoma skin cancer, low-grade localised prostate cancer, or carcinoma in situ
  • People with a history of cancer that has spread to the brain or central nervous system, unless it has been treated, is not causing symptoms, is not currently being treated, and has not been getting worse on recent scans — people with a history of cancer spreading to the lining of the brain or spinal cord compression are also not eligible
  • People who have recently received surgery, systemic cancer treatment, immunotherapy, CAR-T cell therapy, or anti-hormonal therapy within timeframes specified by the trial protocol (confirm with trial site)
  • People who have previously received any treatment that specifically targets a protein called B7-H3, or any antibody-drug treatment that uses a topoisomerase-based payload
  • People who have previously had a stem cell transplant (their own or from a donor) or a solid organ transplant
  • People with significant heart, lung, or gastrointestinal conditions
  • People with an active serious infection requiring intravenous treatment within one week before the first dose of the study drug
  • People with a known history of hepatitis B or C infection, or who test positive for certain hepatitis B or C markers
  • People who test positive for HIV or have a history of AIDS
  • People with a history of a primary immune deficiency condition
  • People who have had major surgery or a serious injury within 4 weeks before the first dose of the study drug
  • People with a known allergy or sensitivity to recombinant proteins

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 28 July 2026
Phase 1: approximately ~10% 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: Denise Casey, MD, MacroGenics

Phone: 301-251-5172

Australian sites

ICON Cancer Centre Wesley, Auchenflower, Queensland
ICON Cancer Centre Kurralta Park, Kurralta Park, South Australia
Austin Health- Olivia Newton John Cancer Center, 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 1
Sponsor
MacroGenics
Registry
ClinicalTrials.gov
Start date
6 March 2024
Est. completion
1 May 2028

Where this trial is recruiting

🇦🇺 Australia 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Number of participants with adverse events (AEs) and serious AEs (SAEs), AEs leading to dose delay, AEs leading to dose reduction, AEs leading to treatment discontinuations, AEs meeting criteria for dose limiting toxicity, and AEs of special interest.

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: 28 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