Phase 2 Stomach Cancer Trial, Recruiting NCT05150691 Sponsor: DualityBio Inc. Condition: Stomach Cancer
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Phase 2 Stomach Cancer Trial, Recruiting

NCT05150691
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:

  • People who have been diagnosed with a HER2-positive or HER2-expressing solid tumour (a tumour that has spread or cannot be surgically removed) that has not responded to standard treatment, cannot be tolerated with standard treatment, or for which no standard treatment exists. (Note: one specific group in the trial requires HER2-negative tumours — confirm with trial site.)
  • People who have at least one tumour that can be measured on a scan, using standard measurement guidelines.
  • People who are willing and able to provide signed consent to participate.
  • People who have a general health score of 0 or 1 on the ECOG scale, meaning they are fully active or able to carry out light work (confirm with trial site).
  • People whose heart is pumping at 50% or more of its normal capacity, as measured by a heart scan (echocardiogram or MUGA scan).
  • People whose liver, kidneys, and other organs are functioning well enough to meet the trial's requirements (confirm with trial site for specific values).
  • People who can provide existing HER2 test results, a previously removed tumour sample, or who are willing to have a new tumour biopsy taken for HER2 testing.
  • People with a life expectancy of at least 3 months.

For one specific group in the trial (Part 2, Expansion Group 9), additional criteria apply:

  • People who have been diagnosed with advanced or metastatic endometrial cancer (including certain subtypes: uterine carcinosarcoma or uterine serous papillary carcinoma), whose disease has progressed after receiving at least one prior treatment including platinum-based chemotherapy and an immune checkpoint inhibitor, but who have had no more than three prior lines of treatment for advanced or metastatic disease. (Note: hormone therapy does not count as a qualifying treatment line.)

Who may not be able to join:

  • People who have a history of significant heart failure (classified as moderate to severe) or serious heart rhythm problems that required treatment.
  • People who had a heart attack or unstable chest pain within the 6 months before the trial start date.
  • People whose heart's electrical activity shows a prolonged interval on an ECG (above 450 ms for males or 470 ms for females) (confirm with trial site).
  • People who have a history of clinically significant lung disease.
  • People who have an active, uncontrolled infection currently requiring intravenous antibiotics, antiviral, or antifungal treatment.
  • People who have HIV with AIDS-related illness, or who have an active hepatitis infection.
  • People who have brain metastases (cancer that has spread to the brain) that are currently causing symptoms or are considered active.
  • People who still have side effects from previous cancer treatments that have not recovered to a mild level or returned to their baseline health status.
  • People who are known to have a severe allergy or sensitivity to the trial drug or any of its ingredients.
  • People (in the expansion part of the trial only) who have had more than one type of cancer within the past 3 years — unless the additional cancer was a non-melanoma skin cancer that was fully removed, a cancer that was cured with treatment, or a contralateral breast cancer.

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 19 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

Phone: +1-513-403-8568

Australian sites

Scientia Clinical Research LTD, Randwick, New South Wales
Macquarie Clinical Trials Unit, Sydney, New South Wales
Integrated Clinical Oncology Network Pty Ltd (Icon), South Brisbane, Queensland
Monash Health, Melbourne, 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
DualityBio Inc.
Registry
ClinicalTrials.gov
Start date
31 January 2022
Est. completion
1 April 2026

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China Puerto Rico 🇰🇷 South Korea 🇹🇼 Taiwan 🇺🇸 United States

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

Primary endpoints

Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.; Phase 1: Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0; Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.; Phase 1: Maximum Tolerated Dose (MTD) of DB-1303; Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1303; Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0; Phase 2: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.; Phase 2: Percentage of Objec...

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: 19 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