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Early Phase 1 Lung Cancer Trial, Not Yet Recruiting
NCT07673419
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 and sign a written consent form.
- People aged 18 to 75 years old at the time of signing the consent form, of any gender.
- People who have been diagnosed with lung cancer that has come back or spread to other parts of the body, confirmed by a tissue or cell sample, and whose cancer has gotten worse on standard treatment or who were unable to tolerate standard treatment.
- People who have at least one area of cancer that can be measured and has not been treated with radiation or other local therapies.
- People who have at least one measurable area of cancer remaining, as defined by standard measurement guidelines (RECIST 1.1).
- People with a general health and activity level rated at 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
- People whose expected survival is more than 3 months.
- People whose blood counts and organ function meet the required levels for the trial.
- People who have no reasons that would prevent them from safely undergoing surgery, bronchoscopy (a procedure to look inside the airways), or procedures through the skin.
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 a severe allergic reaction or sensitivity to any of the drugs or substances used in this study, including certain chemotherapy drugs, contrast dyes used in scans, or ingredients in the study drug GK01 (such as dimethyl sulfoxide).
- People who have received an experimental drug or any anti-cancer treatment within 28 days before the start of a preparatory chemotherapy phase, or within 5 half-lives of their previous medication.
- People who have had major surgery within 28 days before signing the consent form, or who have major surgery planned during the study.
- People whose side effects from previous cancer treatments have not improved to a mild level or returned to their starting level by the time of signing the consent form, except for hair loss or skin darkening.
- People who have had an active infection requiring intravenous antibiotics, antiviral, or antifungal medicines within 4 weeks before signing the consent form or before receiving the first treatment.
- People with a history of, or currently active, autoimmune disease that could come back (such as lupus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, or psoriasis), or people considered at risk of such conditions.
- People who have previously had a bone marrow or organ transplant.
- People with a current or past history of scarring or inflammation in the lung tissue (interstitial lung disease or interstitial pneumonia).
- People with a history of active tuberculosis within the past year (people with a history of tuberculosis more than one year ago may be considered if the medical team confirms there is no current sign of active disease).
- People who have had another type of cancer in the 5 years before the study treatment begins.
- People with significant heart or blood vessel disease.
- People who have had a bleeding episode within 6 months before signing the consent form.
- People with certain metabolic conditions, such as poorly controlled diabetes (with a specific blood sugar marker, HbA1c, at 8.5% or above), or other serious non-cancer-related conditions that could affect safety or make it hard to assess survival.
- People who have cancer that has spread to the brain or spinal cord, or who have a history of central nervous system disorders.
- People who have received a live, weakened, or inactivated vaccine within 28 days before signing the consent form, or who plan to receive one during the screening period.
- People who have been taking steroid medicines at a significant dose (equivalent to 10 mg or more per day of prednisone) or other immune-suppressing medicines within 14 days before tissue collection or during the study.
- People who test positive for hepatitis B surface antigen; people who test negative for that marker but positive for a related hepatitis B antibody and also have detectable hepatitis B virus in their blood; people with active hepatitis C infection; people who test positive for HIV; people with detectable cytomegalovirus (CMV) in their blood; or people who test positive on both types of syphilis tests.
- People who are pregnant or breastfeeding.
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.
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.
Contact this trial
Principal Investigator: Lin Shen, MD，PhD, Peking University Cancer Hospital & Institute
Phone: +86-010-88196561
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
Not Yet Recruiting
Phase
Early Phase 1
Sponsor
Beijing Geekgene Technology Co., LTD
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
1 June 2028
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Safety and Tolerability
Can't join this trial?
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.