Phase 1 Lung Cancer Trial, Recruiting NCT05544240 Sponsor: Williams Cancer Foundation Condition: Lung Cancer
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Phase 1 Lung Cancer Trial, Recruiting

NCT05544240
Recruiting 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:

  • Adults aged 18 or older at the time of signing the consent form
  • People who are willing to give written consent and agree to follow the treatment and check-up schedule
  • People with an advanced or spreading solid tumour (confirmed by lab testing) that has stopped responding to standard treatments, or for whom no further standard treatment exists or is available
  • People who have had a heart check-up and received clearance from a heart specialist within two months before the first treatment
  • People who have stopped taking blood thinners (such as heparin or warfarin) at least 5 days before each treatment session
  • People whose side effects from previous cancer treatments have mostly resolved (except hair loss) to a mild level or better
  • People whose cancer can be measured using standard imaging methods (such as CT or MRI scans)
  • People who are able to safely receive general anaesthesia or a lighter form of sedation
  • People with a reasonable level of physical functioning (confirm with trial site for the specific scoring threshold used)
  • Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting the study
  • People taking bone-strengthening medicines (such as bisphosphonates or denosumab) must have been on a stable dose for at least 42 days before the procedure
  • People for whom, in the treating doctor's opinion, no other meaningful life-prolonging treatment option is available
  • People with blood counts, kidney function, and liver function that meet the specific levels required by the trial (confirm exact values with trial site)
  • People who have at least one tumour that can be seen on a PET/CT, CT, ultrasound, or MRI scan and can be reached for injection
  • People (and male participants with female partners who could become pregnant) who are willing to use effective contraception during treatment and for 4 to 5 months after the last dose

Who may not be able to join:

  • People who have another active or recently treated cancer (within the last 3 years), not counting certain common skin cancers
  • People who have had major surgery within the past 28 days and have not yet adequately recovered
  • People who currently have an active infection (including tuberculosis) that requires treatment
  • People who have a history of, or currently have, a non-infectious lung inflammation condition that required steroid treatment
  • People who have received a live vaccine within 30 days before enrolling
  • People who are currently in, or have recently been in, another clinical trial or have used an experimental medical device within the past 4 weeks
  • People whose tumour size or spread is considered too great for safe or effective treatment, as determined by the lead doctor in consultation with the sponsor's medical team
  • People whose cancer has spread only to areas just beneath the skin surface
  • People with serious heart conditions, such as severe heart failure, unstable chest pain, or serious irregular heart rhythms, or a history of heart failure
  • People with fluid build-up around the lungs or in the abdomen that requires immediate treatment
  • People with a history of autoimmune disease, except for an underactive thyroid
  • People with any condition that weakens the immune system, whether present from birth or developed over time
  • People with an active COVID-19 infection, or who test positive for COVID-19 the day before or on the day of planned treatment
  • People with active hepatitis B infection (those with chronic hepatitis B may still be considered if their viral load is undetectable on suppressive treatment — confirm with trial site)
  • People with hepatitis C infection that has not been treated and cleared, unless currently on treatment with an undetectable viral load
  • People with uncontrolled diabetes, unstable or untreated heart rhythm problems, severe allergic sensitivities, or any other condition that the lead doctor considers would make participation unsafe or interfere with the study

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 16 July 2026
Phase 1: approximately ~10% 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: Jason Williams, MD, Williams Cancer Institute

Phone: (954) 530-4606

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
Williams Cancer Foundation
Registry
ClinicalTrials.gov
Start date
1 February 2023
Est. completion
31 July 2025

Where this trial is recruiting

🇲🇽 Mexico

Primary endpoints

Antitumor activity

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: 16 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