Phase 2 Thyroid Cancer Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older.
• People diagnosed with a type of lung cancer called non-small cell lung cancer (NSCLC) that has a specific gene change called an "Exon 14 skipping mutation," where the cancer cannot be surgically removed or has spread, and who have not yet received a MET inhibitor treatment (first-line or previously treated groups available).
• People with any solid tumour (excluding brain tumours that started in the brain) that has a gene change called "MET amplification," who have not responded to or could not tolerate standard treatments, and who have not previously received a MET inhibitor.
• People with NSCLC that has both "MET amplification" and a normal (wild-type) EGFR gene, who have not previously received a MET inhibitor.
• People with NSCLC that has an EGFR gene mutation and has developed resistance to their current EGFR-blocking treatment due to MET amplification, who are currently on an EGFR-blocking therapy and willing to take the study drug as an add-on treatment.
• People with any solid tumour (excluding brain tumours that started in the brain) that has a gene change called a "MET fusion," who have not responded to or could not tolerate standard treatments, and who have not previously received a MET inhibitor.
• People with primary brain tumours that have specific MET gene changes (including MET fusion, Exon 14 skipping mutations, or MET amplification), whose neurological symptoms have been stable on a steady or reducing steroid dose for at least 2 weeks before starting the trial.
• People with any solid tumour that has a normal MET gene but shows overexpression of both HGF and MET proteins, who have not responded to or could not tolerate standard treatments, and who have not previously received a MET inhibitor.
• People who have a measurable area of disease that can be tracked on scans, assessed within 28 days before starting treatment.
• People with a general health performance rating of 0 or 1 on the ECOG scale (a measure of how well a person can carry out daily activities); for primary brain tumour patients, a score of 70 or above on a similar scale (KPS).
• People with adequate organ function and adequate heart function as assessed by the trial site.
• People whose previous cancer treatments were finished at least 30 days (or 5 half-lives of that treatment, whichever is shorter) before starting the study drug, and any side effects from prior treatment have resolved sufficiently.
• Women who are not able to become pregnant, are post-menopausal, or have a negative pregnancy test at screening.
• People with brain metastases (cancer that has spread to the brain) or leptomeningeal disease (cancer spread around the brain and spinal cord) that is treated or untreated but causing no symptoms are eligible (confirm with trial site).
• People with a life expectancy of at least 3 months from the start of treatment.
• People able to provide a tumour tissue sample (either stored or freshly taken, if safe) or a blood-based sample for laboratory testing to confirm the relevant gene changes.
• People who have no major surgery planned within 4 weeks of starting the study drug.

Who may not be able to join:

• People with a known allergy or sensitivity to the study drug (APL-101) or its ingredients.
• People whose cancer has certain other known gene mutations or changes (such as ALK, ROS1, RET, NTRK, KRAS, or BRAF), except in specific lung cancer groups defined by the trial site.
• People currently using or planning to use another experimental treatment or herbal medicines during the trial.
• People with an active, uncontrolled bacterial, viral, or fungal infection, or another serious active illness that the trial doctor considers too risky for participation.
• People with a life-threatening illness, serious organ dysfunction, or other significant health conditions that could affect safety or interfere with how the study drug works in the body.
• People who have had unstable chest pain (angina) or a heart attack within the past year, have an unstable heart rhythm requiring treatment, have a history of a specific inherited heart condition affecting heart rhythm, or are taking medications known to affect heart rhythm.
• People with active hepatitis C or hepatitis B infection with high viral levels not being managed with antiviral treatment, or people with HIV who are not medically stable and controlled on their medication.
• People with significant mental illness or active alcohol or substance use that the trial doctor believes would make it difficult to safely follow the trial requirements.
• People who are unable to swallow tablets or capsules whole.
• People with significant stomach or bowel conditions that could affect how the body absorbs the study drug.
• Women who are currently breastfeeding.
• People who have had another cancer within the past 3 years, unless it was a specific type considered cured or very unlikely to return (such as certain skin cancers, treated cervical cancer in situ, certain bladder or thyroid cancers, or treated prostate cancer — confirm with trial site).
• People who are unable or unwilling to stop taking certain medications that are known to interact with the study drug, at least 5 half-lives before starting treatment (unless a safe substitute medication can be used).
• People with an active COVID-19 infection.
• People with brain metastases that are causing symptoms or neurological instability, or who need an increased steroid dose to manage brain disease (those on a stable steroid dose for at least 2 weeks before starting treatment may be considered).

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