Phase 1 Lung Cancer Trial, Recruiting NCT06515990 Sponsor: Doma Biopharmaceutical(Suzhou)Co., Ltd. Condition: Lung Cancer
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Phase 1 Lung Cancer Trial, Recruiting

NCT06515990
Recruiting Phase 1 🇦🇺 Australian site

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • People who are able to understand the study and are willing to sign a written consent form
  • People who have been confirmed by lab testing to have advanced or metastatic non-small cell lung cancer, gastroesophageal cancer, colorectal cancer, liver cancer (HCC), pancreatic cancer, or head and neck cancer that cannot be cured by surgery or radiation, and has either stopped responding to standard treatments or caused intolerable side effects
  • People who are 18 years of age or older at the time of signing the consent form
  • People whose general physical functioning is rated at a level of 0, 1, or 2 on a standard medical scale used to measure how much cancer affects daily activities (confirm with trial site)
  • People who are expected to live for at least 3 months
  • People whose cancer can be measured on scans according to standard criteria used in cancer research

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have had another active invasive cancer within the past 5 years — although certain exceptions may apply, such as non-invasive cancers (for example, cervical cancer in situ, early-stage melanoma, or early breast cancer) that are fully in remission after treatment, or skin cancers or localised prostate cancer with very low risk of spreading
  • People who have or have had a blood cancer (such as leukaemia or lymphoma)
  • People who have received cancer treatments — including chemotherapy, immunotherapy, hormone therapy, targeted therapy, or biological treatments — within 28 days or 5 half-lives (whichever is shorter) before the first study dose; or who have had wide-field radiation within 28 days, limited palliative radiation within 14 days, or major surgery within 4 weeks of the first dose (some hormone replacement therapies are excepted — confirm with trial site)
  • People who have cancer that started in the brain or has spread to the brain, unless the brain metastases have been treated, are not growing, and the person has been off high-dose steroids for at least 4 weeks
  • People who have a single large tumour mass greater than 7 cm — although exceptions may be considered after discussion with the study's medical team
  • People who have an active, uncontrolled infection that requires intravenous antibiotics, antivirals, or antifungal medications
  • People who have a significant disease affecting the cornea of the eye
  • People whose heart's electrical activity shows a prolonged QT interval on an ECG, who are on medications that prolong the QT interval, or who have a known family history of a heart rhythm condition called long QT syndrome (confirm with trial site)
  • People whose heart pumping function (left ventricular ejection fraction) is below 50% on a heart scan taken within 28 days before the first dose
  • People with a known active hepatitis B or hepatitis C infection — although certain people with well-managed or previously cured hepatitis B or C may still be eligible (confirm with trial site)
  • People with HIV that is not well controlled — people with HIV may be eligible if their virus levels are very low, their immune cell counts are adequate, they have had no serious HIV-related infections in the past 12 months, and their treatment has been stable (confirm with trial site)
  • People from regions where tuberculosis is common will be specifically screened, and those with active tuberculosis will be excluded — people who received a BCG vaccine may need an additional test to confirm they do not have active tuberculosis
  • People who have received a live vaccine within 30 days before the first study dose
  • People who still have unresolved side effects from previous cancer treatments that have not returned to a mild or baseline level — some stable, long-standing mild-to-moderate side effects such as nerve pain, low thyroid function, or blood sugar changes may be considered on a case-by-case basis (confirm with trial site)
  • People who are pregnant, breastfeeding, or planning to become pregnant during the study
  • People of reproductive potential who are unwilling to use effective contraception throughout the study and for 7 months after the last dose (for females) or 4 months after the last dose (for males)

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 31 July 2026

If this is close to home

This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.

  • Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
  • Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
  • Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
  • Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
  • Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14

Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.

Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Contact this trial

Phone: +86 18952761813

Australian sites

Chris O'Brien Lifehouse, Camperdown, New South Wales
Macquarie University Hospital, North Ryde, New South Wales
ICON Cancer Center, South Brisbane, Queensland

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
Doma Biopharmaceutical(Suzhou)Co., Ltd.
Registry
ClinicalTrials.gov
Start date
31 October 2024
Est. completion
1 October 2026

Where this trial is recruiting

🇦🇺 Australia 🇺🇸 United States

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

Primary endpoints

Dose-limiting Toxicities (DLTs) of DM005; Maximum tolerated dose (MTD) for DM005

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: 31 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