Phase 1 Kidney 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 aged 18 or older who have been diagnosed with advanced or metastatic kidney cancer (with a specific cell type called "clear cell") that has been confirmed through a tissue or cell sample, and who have already received at least one immunotherapy drug (a PD-1/PD-L1 checkpoint inhibitor) and at least one targeted therapy drug (a tyrosine kinase inhibitor).
• People whose cancer showed signs of getting worse during or after their most recent treatment — or, if someone received two or more prior treatments, they may be eligible even without progression if they had to stop treatment due to side effects.
• People whose kidney tumour tissue (either from the original tumour or a biopsy of a spread site) shows a specific protein called CAIX present on at least 50% of cells, confirmed through laboratory testing of stored tissue samples.
• People who have at least one area of cancer that can be measured on a scan, according to standard measurement guidelines.
• People who are generally well enough to carry out light activity and care for themselves (assessed using a standard medical scale where a score of 0 or 1 is required).
• People whose blood counts, liver function, and kidney function meet specific minimum levels as determined by blood tests (confirm specific values with the trial site).
• People whose blood clotting results fall within an acceptable range, or who are on a stable dose of blood-thinning medication (such as low molecular weight heparin or a direct oral anticoagulant) for at least two weeks before joining.
• People whose heart is pumping adequately, confirmed by a heart scan showing the left side of the heart is working at 45% capacity or above.
• People with a past hepatitis B or C infection, as long as the virus is currently undetectable in their blood.
• People with a history of significant mental health conditions, provided the treating doctor determines they are fully able to understand the study and its risks.
• People who are willing and able to use effective contraception during the study and for 90 days after the last dose — specific requirements apply depending on sex and reproductive status (confirm full details with the trial site).
• People who are able to understand the study and are willing to sign a written consent form.
• People who are willing to take part in a 15-year follow-up monitoring programme after receiving the study treatment.

Who may not be able to join:

• People who have had another cancer requiring active treatment within the past two years, with some exceptions for certain early-stage, low-risk, or fully treated skin, cervical, breast, or prostate cancers (confirm with trial site).
• People who have had major surgery or serious injury within the four weeks before joining, or who are expected to need major surgery within four weeks after receiving the treatment.
• People with a recent history of serious heart problems — such as unstable chest pain, heart attack, significant heart failure, or dangerous blood vessel conditions — that required hospitalisation within the six months before consenting, or other poorly controlled heart conditions.
• People with active or symptomatic cancer that has spread to the brain or the lining around the brain, or brain metastases larger than 1.5 cm, or those who have received brain radiation within seven days of joining — though people with previously treated and stable brain metastases that have been stable for at least four weeks without swelling and without needing steroid medication (or on only a very low dose) may still be considered.
• People with active autoimmune diseases that currently require systemic treatment with immune-suppressing or disease-modifying drugs, or steroid doses greater than the equivalent of 10 mg of prednisone per day — with some exceptions for replacement therapies and inhaled or locally applied treatments.
• People currently taking systemic steroid medication at a dose greater than the equivalent of 10 mg of prednisone per day.
• People who have previously received an organ transplant or bone marrow/stem cell transplant from another person.
• People who have previously received any form of CAR T-cell therapy.
• People who have previously been treated with any experimental therapy specifically targeting the CAIX or ENPP3 proteins.
• People who have had a serious infection requiring hospitalisation within the four weeks before joining, or who have an ongoing infection currently requiring antibiotic or antiviral treatment.
• People who are pregnant, as the study drug may harm an unborn baby.
• People who are breastfeeding or plan to breastfeed during the study.
• People who are still experiencing ongoing side effects (grade 2 or higher) from previous cancer treatments that could make it harder to monitor new side effects or to participate fully in the study.
• People with any medical, surgical, or psychiatric condition — or laboratory result — that the treating doctor believes could interfere with the study, increase health risks, or make participation not in the person's best interest.

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