Phase 2 Stomach Cancer Trial, Recruiting NCT05267626 Sponsor: Aulos Bioscience, Inc. Condition: Stomach Cancer
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Phase 2 Stomach Cancer Trial, Recruiting

NCT05267626
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:

  • Your cancer must be measurable on a CT scan and/or MRI scan using specific medical measurement standards.
  • You may be eligible if you have skin melanoma (cutaneous melanoma) that cannot be surgically removed or has spread to other parts of the body, and your cancer has continued to grow despite previous treatments with certain immunotherapy drugs.
  • If your melanoma has a specific gene change called a BRAF mutation, you must either be unable to take, or have chosen not to take, a specific type of targeted treatment (BRAF+MEK inhibitor).
  • You may be eligible if you have a type of lung cancer (NSCLC) that cannot be removed by surgery, has spread, tests positive for a marker called PD-L1, does not have certain specific gene changes (EGFR or ALK), and has gotten worse during or after treatment with certain immunotherapy drugs.
  • Your cancer must have shown clear signs of growing on scans at least 4 weeks before starting the study drug (confirm with trial site if this requirement may be flexible in your case).
  • A blood marker called LDH must be at or below a certain level (2.5 times the upper limit of normal) — your doctor can check this with a blood test.
  • If you are a woman who could become pregnant, you must have a negative pregnancy test within 72 hours before starting the study drug.
  • Women who could become pregnant must be willing to use two forms of birth control throughout the study and for 60 days (or 5 months if receiving a drug called nivolumab) after the last dose.
  • Male patients whose partners could become pregnant must use barrier contraception from the time they agree to join the study until 60 days after finishing the study drug, and must not donate sperm during this time.
  • If you previously had side effects from immunotherapy drugs, those side effects must have mostly or fully resolved before joining (with an exception for thyroid problems that are well controlled with medication).
  • If you have cancer that has spread to the brain, it must have been treated, you must have had no symptoms for at least 14 days, and you must not currently be receiving any treatment for it (such as steroids above a certain dose, surgery, or radiation).

Who may not be able to join:

  • People with a history of autoimmune diseases may not be eligible, though some conditions are exceptions, including: vitiligo, certain skin conditions not requiring systemic (whole-body) treatment, a past thyroid condition called Graves' disease (if the thyroid has been in a normal range for more than 4 weeks), thyroid underactivity managed with hormone replacement, hair loss (alopecia), or arthritis managed without whole-body medications.
  • People who have had major surgery or a serious injury within 3 weeks before the first dose of the study drug.
  • People who have wounds from surgery or injury that have not yet healed.
  • People who have taken steroid medications (such as prednisone) at doses above 10 mg per day, or other immune-suppressing drugs, within 7 days before starting the study drug (note: steroid creams, eye drops, inhalers, or nasal sprays are allowed).
  • People who have not yet recovered from the side effects of previous cancer treatments (such as chemotherapy or radiation therapy).
  • People who had serious harmful reactions during previous treatment with a drug called IL-2, including events such as bowel perforation, internal bleeding, heart problems, or repeated seizures.
  • People who have had an ongoing inflammatory condition (such as inflammation) lasting 4 weeks or more, or a chronic low-grade inflammation such as lung inflammation caused by radiation, regardless of how long it has been present.
  • People who have a second, separate cancer that has not been in remission for at least 1 year — though some exceptions apply, such as certain skin cancers, early-stage cervical changes, low-risk localised prostate cancer, or cancers that have never needed treatment (confirm with trial site).

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 14 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: James Vasselli, MD, Aulos Bioscience, Inc.

Phone: (707) 758-6776

Australian sites

Southside Cancer Care Centre, Miranda, New South Wales
+61 02 9553 9588
Southern Oncology Clinical Research Unit, Bedford Park, South Australia
+61 4 9167 9039
Monash Health, Clayton, Victoria
+61 3 9076 7467
Peninsula & South Eastern Haematology and Oncology Group, Frankston, Victoria
+61 3 9781 5244
Austin Health, Heidelberg, Victoria
+61 3 9496 9918
The Alfred Hospital, Melbourne, Victoria
+61390766963
Sunshine Hospital, Saint Albans, Victoria
+61 3 8345 6666

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
Aulos Bioscience, Inc.
Registry
ClinicalTrials.gov
Start date
4 April 2022
Est. completion
12 June 2026

Where this trial is recruiting

🇦🇺 Australia 🇺🇸 United States

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

Primary endpoints

Evaluate the safety and tolerability of AU-007; Establish the maximum tolerated dose (MTD) and/or RP2D

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: 14 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