Phase 1 Oesophageal 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:

• People who have a solid tumour (cancer) that has spread to other parts of the body or cannot be removed by surgery, confirmed by a laboratory test on a tissue or cell sample.
• People whose cancer can be measured on scans according to a standard set of medical criteria (RECIST v1.1), as assessed by the trial doctor.
• People whose cancer has continued to grow or spread after trying all standard available treatments for their advanced cancer.
• People who are generally well enough to carry out light activity and care for themselves (a fitness level rated 0 or 1 on a standard medical scale).
• People whose heart, liver, kidneys, and blood counts are functioning at levels defined in the trial protocol.

For Part 2 of the trial only, additional criteria apply:

• People with a type of lung cancer called squamous non-small cell lung cancer (sqNSCLC), with or without certain specific gene mutations (NRF2 and/or CUL3).
• People with advanced sqNSCLC whose cancer has stopped responding to, or continued growing after, a platinum-based chemotherapy combination and an immunotherapy drug.
• People with advanced head and neck squamous cell carcinoma (a type of cancer affecting the head and neck area) who have previously received platinum-based chemotherapy, immunotherapy (where relevant based on tumour characteristics), and a targeted therapy called an anti-EGFR agent.
• People with advanced squamous cell carcinoma of the oesophagus who have previously received platinum-based chemotherapy and immunotherapy (where relevant based on tumour characteristics).
• People whose cancer has a known specific genetic driver mutation (such as certain EGFR mutations or ALK rearrangements) must have received and progressed on the appropriate targeted treatment for that mutation.
• People whose cancer is known to overproduce a protein called HER2 must have received and progressed on the appropriate targeted treatment.

Who may not be able to join:

• People whose cancer is known to have a specific type of mutation in a gene called KEAP1 (a nonsense or frameshift mutation at any position), as this mutation is not expected to respond to the trial drug VVD-130037.
• People who still have side effects from previous cancer treatment that are rated moderate or above (Grade 2 or higher on a standard medical scale) and have not yet resolved.
• People who are currently taking, or have previously taken, anti-seizure (anti-epileptic) medications to treat or prevent seizures.
• People who have a history of seizures, or a medical condition that may increase the risk of seizures.
• People who have had cancer spread to the brain or spinal cord, or have a history of spinal cord compression.
• People with high blood pressure that remains uncontrolled even with medical treatment.
• People with certain risk factors for abnormal heart rhythms or a prolonged QT interval (a specific electrical measurement of the heart), as defined in the trial protocol (confirm with trial site).
• People with a history of certain heart conditions, including: significant heart failure, unstable chest pain (angina), new chest pain that started within the past 6 months, a heart attack within the past 6 months, or a clinically significant irregular heart rhythm within the past 6 months.
• (Combination Expansion Cohort only) People who previously had a severe (Grade 3 or 4) reaction to immunotherapy that caused them to stop that treatment.
• (Combination Expansion Cohort only) People with a history of non-infectious lung inflammation (pneumonitis) or scarring of the lung tissue (interstitial lung disease), including cases caused by drugs or radiation that required steroid treatment, or people who currently show signs of active lung inflammation.

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