Phase 2 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:

• Adults aged 18 or older with a solid tumour cancer that has spread or cannot be surgically removed, and that has continued to grow or come back after standard treatments, cannot be tolerated with standard treatments, or has no standard treatment available.
• People who have at least one tumour that can be measured on a scan, according to standard medical measurement guidelines (confirm with trial site for specific tumour types such as brain tumours or prostate cancer with bone-only disease).
• People with a life expectancy of at least 3 months.
• People who are still relatively well and able to carry out daily activities, as rated on a standard medical scale (ECOG performance score of 0 or 1).
• People whose heart is pumping well enough, confirmed by a heart scan done within 28 days before joining (heart pumping function of at least 50%).
• People whose organs (such as kidneys, liver, and blood cells) are functioning adequately, confirmed by blood tests done within 7 days before starting treatment.
• People who have waited a sufficient period of time after their last cancer treatment before starting this trial.
• People who are willing to provide an existing tumour tissue sample, or have a new biopsy taken, to measure certain proteins — note that no minimum level of the B7-H3 protein is required to join.
• People who are able to understand and sign the informed consent form and agree to follow the study requirements.
• People of childbearing or reproductive potential who agree to use effective contraception during the study and for at least 4 months (for males) or 7 months (for females) after the last dose of the study drug.
• Males who agree not to freeze or donate sperm from the start of screening until at least 4 months after the final dose.
• Females who agree not to donate or retrieve eggs for personal use from the start of screening until at least 7 months after the final dose.
• People with small cell lung cancer (SCLC, specific cohort only) who have advanced or metastatic disease not suitable for curative surgery or radiation, and who have previously received at least one platinum-based chemotherapy regimen, and who have not previously received irinotecan, topotecan, or similar drugs.
• People with non-small cell lung cancer (NSCLC, specific cohort only) who have advanced or metastatic disease not suitable for curative surgery or radiation, and who have previously received certain standard chemotherapy and/or immunotherapy treatments (and targeted therapy if a relevant gene change was present in their tumour).
• People with oesophageal squamous cell cancer (ESCC, specific cohort only) who have advanced or metastatic disease not suitable for curative surgery or radiation, and who have received at least one prior treatment for their cancer.
• People with castrate-resistant prostate cancer (CRPC, specific cohort only) with confirmed spread of the cancer, very low testosterone levels, and disease that has continued to grow, who have previously received docetaxel chemotherapy and a hormone-based therapy.
• People with melanoma (specific cohort only) with advanced unresectable or metastatic melanoma that cannot be treated with local therapy, who have previously received certain immunotherapy drugs, and if the tumour has a BRAF gene mutation, have also received a relevant targeted therapy.
• People with liver cancer (HCC, specific cohort only) with a confirmed diagnosis (certain rare subtypes are not eligible), who have received one or two prior systemic treatment regimens, whose disease progressed during or after immunotherapy, and who have satisfactory liver function as measured by a standard scoring system.
• People with cervical cancer (specific cohort only) with recurrent or metastatic cervical cancer of certain cell types, who have experienced disease progression during or after standard chemotherapy combinations (which may or may not have included bevacizumab and/or immunotherapy, depending on what is standard in their location), and who have received one or two prior treatment regimens for their recurrent or metastatic disease.
• People with other solid tumour cancers (specific cohort only) who have a confirmed solid tumour diagnosis and whose disease has progressed after at least one standard treatment — note that the trial site is required to inform patients about other available treatment options before consenting.
• People with head and neck squamous cell cancer (HNSCC, specific cohorts only, not including nasopharyngeal cancer) whose cancer has spread or returned and is considered incurable by local treatments, and who have previously received standard treatment.
• People with rare tumour types (specific cohort only) with a confirmed diagnosis, whose disease has progressed after at least one standard treatment — note that the trial site is required to inform patients about other available treatment options before consenting.
• People with castrate-resistant prostate cancer who have previously received lutetium-177 treatment (specific cohort only), with confirmed low testosterone levels and progressive disease.
• People with castrate-resistant prostate cancer who have not previously received taxane chemotherapy (specific cohorts only), with confirmed low testosterone levels and progressive disease.
• People with platinum-resistant ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (specific cohort only) of certain tissue types, who have received between one and three prior treatment regimens and whose disease has progressed on the most recent treatment.
• People with hormone-sensitive prostate cancer that has not responded well to hormone therapy (specific cohort only), with confirmed advanced or metastatic disease on imaging, who have received hormone therapy plus enzalutamide or abiraterone for at least 4 months with a poor response based on PSA levels.
• For a specific drug interaction (DDI) cohort only: people expected to be on the study treatment for at least 2.5 months and who are able to temporarily stop taking certain other medications that may interact with the study drug.

Who may not be able to join:

• People who have previously been treated with a therapy that specifically targets the B7-H3 protein.
• People who have previously received an antibody-drug conjugate that uses a topoisomerase inhibitor (for example, trastuzumab deruxtecan).
• People with a history of moderate to severe heart failure, or a serious heart rhythm problem requiring treatment.
• People who have had a heart attack or unstable chest pain (angina) within the past 6 months.
• People with a certain type of abnormal heart rhythm measurement (prolonged QTcF interval) on an ECG.
• People currently taking medications known to cause abnormal heart rhythm (QT prolongation), unless carefully managed in discussion with the trial sponsor.
• People with a history of certain lung conditions such as non-infectious lung inflammation, lung scarring (pulmonary fibrosis), or severe radiation-related lung damage, or who show signs of these conditions on a scan at the time of screening.
• People with significant underlying lung problems, including a blood clot in the lungs within the past 3 months, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, or those who require supplemental oxygen.
• People with significant bowel or digestive problems, including a history of bowel fistula requiring long-term intravenous nutrition, bowel dysfunction requiring long-term tube feeding, or a bowel blockage or perforation that had not resolved within 6 months before joining.
• People with untreated or incompletely treated varicose veins in the oesophagus or stomach that are bleeding or at high risk of bleeding, or who have had such a bleeding event within the past 6 months (applies to liver cancer patients only).
• People whose cancer has spread to involve major airways or large blood vessels.
• People with uncontrolled fluid build-up around the lungs, in the abdomen, or around the heart that required drainage within 2 weeks before joining.
• People with autoimmune, connective tissue, or inflammatory conditions (such as rheumatoid arthritis or sarcoidosis) where there is known or suspected involvement of the lungs.
• People with an active uncontrolled infection that requires intravenous antibiotic, antiviral, or antifungal treatment.
• People with a known HIV infection.
• People with active viral hepatitis of any type — although people with chronic hepatitis B with a very low viral load who are on or willing to take antiviral treatment may still be eligible (confirm with trial site), and people who have had hepatitis C and completed curative treatment with an undetectable viral load may also be eligible (confirm with trial site).
• Women who are breastfeeding (including those willing to temporarily stop breastfeeding), or who are pregnant.
• People with untreated or actively symptomatic cancer spread to the brain or spinal cord, or those who require steroid or anti-seizure medications to control symptoms from brain metastases — people whose treated brain metastases are no longer causing symptoms and no longer require these medications may be eligible if enough time has passed since radiotherapy (confirm with trial site).
• People who still have significant side effects from previous cancer treatments that have not returned to a mild or baseline level (hair loss is excepted); people with ongoing moderate side effects such as nerve damage may be considered on a case-by-case basis.
• People who have had more than one primary cancer diagnosis within the past 3 years, with some exceptions such as certain treated skin cancers, early-stage cancers that were fully treated, or other solid tumours that were curatively treated.
• People with substance use issues or other medical conditions that, in the investigator's judgement, would make participation unsafe or interfere with the study.
• People with a known allergy or sensitivity to the study drug or any of its ingredients.
• People who, in the investigator's judgement, are considered unsuitable for any other reason.
• For the drug interaction (DDI) cohort only: people who cannot take lopinavir, ritonavir, or itraconazole orally, or for whom these medications are medically contraindicated.

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