Phase 1 Lung Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People with an advanced or metastatic solid tumour (a cancer that has spread or cannot be surgically removed) that has stopped responding to available treatments, and for whom no standard curative treatment exists.
• For some parts of the trial, people with specific cancer types or genetic changes may be considered — including triple negative breast cancer (TNBC), small cell lung cancer (SCLC), or solid tumours with certain gene alterations (called RB1 or CDKN2A/B loss, or Rb protein loss of function).
• People whose cancer can be measured on scans using standard criteria (called RECIST v1.1).
• People aged 18 or older (for early parts of the trial); people aged 12 or older and weighing at least 40 kg may be considered for the later expansion part of the trial.
• People who are well enough to carry out light activity and care for themselves (a score of 0 or 1 on a standard health performance scale; younger patients are assessed using age-appropriate scales).
• People with a life expectancy of more than 12 weeks.
• People who are able to have a fresh tissue sample (biopsy) taken, if it is medically safe to do so (adults only in the expansion part).
• People who are able to swallow capsules by mouth.
• People whose kidney function, liver function, and blood counts meet minimum levels required by the trial (confirm specific values with the trial site).
• Women who could become pregnant must agree to use two forms of contraception during the trial and for four months after the last dose, or commit to abstinence; this requirement does not apply to women who are post-menopausal or who have had certain procedures that prevent pregnancy.
• Men must be sterile or agree to use a reliable form of contraception (condoms with spermicide) or abstinence during the trial and for four months after the last dose.
• Women who could become pregnant must have a negative pregnancy test before starting the trial.
• People who have signed a consent form approved by an ethics committee before any trial-related procedures begin (for patients aged 12–17, a parent or legal guardian must also sign, and an age-appropriate assent form may be required).
• For the food effect cohort only: people who are able to eat a standardised high-fat, high-calorie or low-fat meal within 25 minutes.

Who may not be able to join:

• People who have recently received certain cancer treatments before the trial start date — including targeted therapy (within 8 days or a specific timeframe based on the drug), other systemic anti-cancer treatment (within 14 days), radiation therapy (within 28 days, or 14 days for palliative radiation), immunotherapy (within 28 days), or major surgery (within 28 days).
• People who still have significant side effects (grade 2 or higher) from previous cancer treatment, apart from hair loss or skin pigmentation changes (some exceptions may be considered by the trial team).
• People with cancer that has spread to the brain or is pressing on the spinal cord, unless it has been treated, is not causing symptoms, and has been stable without increasing medication for at least four weeks.
• People who have previously been treated with the trial drug, CID-078.
• People with a known allergy or sensitivity to CID-078 or similar drugs.
• People with a history of a lung condition called interstitial lung disease, or who currently show signs of active interstitial lung disease (people with mild, stable lung inflammation from prior cancer treatment may be considered).
• People with a history of severe heart failure (Class III or IV) or serious heart rhythm problems requiring treatment.
• People whose heart electrical activity shows a specific abnormality on an ECG (a QTc interval greater than 470 milliseconds).
• People currently taking medications known to affect heart rhythm in a particular way, or who have certain risk factors for a serious heart rhythm condition called Torsade de Pointes, such as severe low potassium or a family history of long QT syndrome (exceptions may be considered by the trial team).
• Women who are pregnant or breastfeeding.
• People who have had another primary cancer within the past two years, unless it was a minor skin cancer or early-stage cervical cancer that has been fully treated.
• People with conditions that prevent the body from properly absorbing medications taken by mouth, such as severe nausea and vomiting, certain bowel surgeries, or malabsorption disorders.
• People with serious uncontrolled illnesses, including uncontrolled heart, lung, liver or kidney disease, untreated HIV, active tuberculosis, unstable angina, heart rhythm problems, or mental health or social situations that would make it difficult to follow the trial requirements.
• People with uncontrolled hormone (endocrine) conditions, unless the treating doctor considers them stable and well managed (people with stable hormone conditions on replacement therapy may be considered).
• People with active Hepatitis B infection (those who become eligible after treatment with antiviral medication may be able to be re-screened — confirm with the trial site).
• People with active Hepatitis C infection.
• People with a history of HIV or AIDS who do not meet specific requirements around immune cell counts, freedom from certain infections in the past year, current HIV treatment, and HIV viral load levels (confirm details with the trial site).
• People currently taking certain strong medications that significantly affect how the body processes drugs (known as strong CYP3A4 inhibitors or inducers, Pgp inhibitors, or CYP3A4 sensitive substrates) within 14 days or a specified timeframe before starting the trial.
• People with active bleeding disorders.
• People who have previously had a solid organ transplant (such as a kidney, liver, or heart transplant).
• People who the treating doctor believes would be unable or unwilling to follow the trial procedures.
• People with any other condition or illness that the treating doctor believes could affect their safety or interfere with evaluating the trial drug.

Important: Always verify eligibility with the trial site directly before applying.