Phase 2 Kidney 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 diagnosed with Wilms tumor or desmoplastic small round cell tumor (DSRCT), confirmed by a tissue sample either at the time of original diagnosis or at relapse
• For the first phase of the trial (Part A): children aged 2 years up to (but not including) 12 years old at the time of joining
• For the second phase, Wilms tumor group (Part B1): patients under 18 years old (initially limited to ages 12–17; younger children may be allowed after early phase results are confirmed)
• For the second phase, DSRCT group (Part B2): patients aged 12 to 39 years (younger patients may be allowed after early phase results are confirmed)
• Wilms tumor patients whose cancer has come back or stopped responding to treatment, meeting at least one of these conditions: relapse after treatment with four or more chemotherapy drugs; relapse with a high-risk tumour type (anaplasia or blastemal predominant); or more than one relapse
• DSRCT patients whose cancer has come back or stopped responding to treatment
• People whose cancer can be measured on scans, according to a standard medical measurement system
• People who have already received standard initial treatment (chemotherapy combined with either radiation or surgery)
• People who are in good general health, able to carry out normal daily activities with no or minimal limitations (confirm with trial site for how this is assessed based on age)
• People who have recovered from side effects of previous cancer treatments and have waited the required time since their last treatment (the exact waiting period depends on the type of treatment received — confirm with trial site)
• People who have not had any previous treatments that specifically target HER2 (a protein on cancer cells)
• People who had surgery at least 14 days before joining
• People whose blood counts meet minimum levels: white blood cell count, platelet count, and haemoglobin all above specified thresholds (confirm with trial site for exact values)
• People whose kidneys are working well enough, based on a kidney function test result
• People whose liver function test results are within acceptable ranges
• People whose blood protein (albumin) level is at or above a minimum level
• People whose blood clotting results are within acceptable ranges
• People whose heart is pumping strongly enough, confirmed by a heart scan done within 28 days before joining
• People whose heart rhythm (measured by an ECG) does not show a specific type of prolongation
• People whose blood oxygen level on room air is above 93%
• People with a seizure condition may be eligible if their seizures are well controlled on medication and have not increased in the past 7 days
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months
• People (or their parents or legal guardians) who are able to give written consent to participate

Who may not be able to join:

• People who are pregnant, planning to become pregnant, or currently breastfeeding
• People of childbearing or reproductive potential who are not willing to use two effective forms of contraception during the study and for at least 7 months after the last dose (for females) or 4 months (for males)
• Male patients who are not willing to avoid donating or freezing sperm during the study and for at least 4 months after the last dose
• Female patients who are not willing to avoid donating eggs during the study and for at least 7 months after the last dose
• People currently taking corticosteroid medications whose dose has not been stable or decreasing for at least 7 days before joining (or at least 14 days if used for immune-related side effects from prior treatment)
• People currently taking part in another clinical trial involving an experimental drug
• People currently receiving other cancer treatments
• People taking medications to prevent graft-versus-host disease after a bone marrow transplant (such as cyclosporine or tacrolimus)
• People who have taken chloroquine or hydroxychloroquine within the past 14 days
• People who have received a live or weakened vaccine within 30 days before joining
• People who have previously received a solid organ transplant (such as a kidney or liver transplant)
• People who have had a heart attack within the past 180 days, or who have moderate to severe heart failure symptoms, or who have had recent blood test results suggesting a heart attack
• People with certain serious congenital (present from birth) heart conditions, including single ventricle defects or other significant structural heart problems (confirm with trial site for full list)
• People who have a build-up of fluid around the lungs, in the abdomen, or around the heart that needs to be drained
• People who have spinal cord compression or active brain metastases that are causing symptoms or require treatment with steroids or anti-seizure medication
• People with a known history of severe allergic reactions to the study drug (DS-8201a) or to related antibody treatments
• People with an uncontrolled infection or a surgical wound that has not healed
• People with a known history of substance misuse or significant psychological conditions that a doctor believes could interfere with safe participation in the trial
• People with breathing difficulties caused by lung disease, including severe asthma, severe COPD, blood clots in the lungs within the past three months, or previous surgical removal of a lung
• People with a history of lung inflammation (interstitial lung disease or pneumonitis) that required steroid treatment, or who currently have this condition, or where it cannot be ruled out on scans
• People with inherited (genetic) lung conditions such as cystic fibrosis
• People with autoimmune, connective tissue, or inflammatory conditions (such as rheumatoid arthritis or sarcoidosis) where there is known or suspected lung involvement
• People with an active immune system deficiency condition
• People with hepatitis B or C where the virus is detectable in the blood
• People who, in the treating doctor's judgement, may not be able to safely follow the monitoring requirements of the study

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