Early Phase 1 Lung Cancer Trial, Recruiting NCT07185035 Sponsor: The First Affiliated Hospital with Nanjing Medical University Condition: Lung Cancer
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Early Phase 1 Lung Cancer Trial, Recruiting

NCT07185035
Recruiting Early Phase 1

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:

  • You are willing to take part, have read and signed the consent form, and are able to follow all the steps of the trial
  • You are between 18 and 70 years old (male or female)
  • You have lung nodules where some have already been surgically removed and confirmed as cancerous, but the remaining high-risk nodules cannot be removed with surgery again and other treatments have not worked or are not suitable
  • If a biopsy (tissue sample) could not be done or did not work, your nodule(s) have been identified as likely cancerous through a PET-CT scan

Who may not be able to join:

  • You have a known allergy, sensitivity, or intolerance to any ingredient in the study drug (KN5001), or you have a history of severe allergic reactions
  • You have certain inherited conditions affecting the bone marrow, such as Fanconi syndrome, Kostmann syndrome, Shwachman syndrome, or any similar bone marrow failure condition
  • You have an active or uncontrolled infection that needs intravenous antibiotics, or a serious ongoing viral, bacterial, or fungal infection
  • You have been told you have a serious heart condition classified as grade III or IV heart failure (confirm with trial site)
  • You have a history of epilepsy or other conditions affecting the brain or nervous system
  • You have a history of cancer, unless it was a fully cured skin cancer, cervical pre-cancer, or a cancer that is no longer active (confirm with trial site)
  • You have a significant tendency to bleed, such as gastrointestinal bleeding, a blood clotting disorder, or an enlarged spleen causing related problems
  • You have had unstable chest pain (angina), a heart attack, or symptomatic heart failure in the past 6 months
  • You are pregnant, breastfeeding, or planning to become pregnant within 6 months
  • You have taken part in another clinical trial and received treatment within the past 3 months
  • There is any other reason the trial doctors believe your taking part could put you at risk or affect the trial results (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 2 July 2026
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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Early Phase 1
Registry
ClinicalTrials.gov
Start date
20 September 2025
Est. completion
20 September 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence of all adverse events occurring within 28 days after the first infusion of KN5001

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: 2 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