Phase 2 Bladder 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 are willing and able to sign a consent form before any study procedures begin
• People with advanced cancer that cannot be removed by surgery or cured by radiation, and whose cancer falls into one of the following types:
• People with skin (cutaneous) melanoma — including acral (affecting palms or soles) or non-acral types — that has been confirmed by laboratory testing, and whose disease has continued to grow or spread after at least one prior treatment using an anti-PD-1 or anti-PD-L1 immunotherapy; those whose melanoma has a BRAF gene mutation must also have received and progressed on a BRAF/MEK inhibitor treatment
• People with squamous cell carcinoma of the head and neck (affecting the mouth, throat, voice box, or lower throat area — but not the nasopharynx, nasal cavity, sinuses, or unknown primary locations) that has progressed after one or more — but fewer than three — prior systemic treatments, including at least one anti-PD-1/PD-L1 therapy and at least one platinum-based chemotherapy
• People with stomach (gastric) or gastroesophageal junction (GEJ) cancer confirmed by laboratory testing to be HER2-negative, who have progressed after at least two prior treatments including platinum-based chemotherapy, with or without anti-PD-1 therapy (this is the third-line or later gastric cancer group)
• People with stomach or GEJ cancer confirmed to be HER2-negative, who have progressed after only one prior systemic treatment that included a 5-FU-based chemotherapy (this is the second-line gastric cancer group)
• People with high-grade serous cancer of the ovaries, fallopian tubes, or peritoneum (the lining of the abdomen), whose disease progressed at least four weeks but less than six months after their last dose of platinum-based chemotherapy in the advanced or metastatic setting
• People with cancer of the cervix (squamous, adenosquamous, or adenocarcinoma type) that has returned or persisted, and who have progressed after at least one prior systemic treatment in the recurrent or metastatic setting
• People with cancer of the uterine lining (endometrial cancer or carcinosarcoma, of any subtype), who have progressed after at least one — but no more than three — prior treatments that included platinum-based chemotherapy and an anti-PD-1/PD-L1 therapy
• People with advanced or metastatic cancer of the bladder, kidney pelvis, ureter, or urethra (urothelial carcinoma — small cell or neuroendocrine types not included), who have progressed after at least one — and no more than three — prior treatments that included an anti-PD-1/PD-L1 therapy, and at least one treatment of chemotherapy or enfortumab vedotin
• People with squamous cell carcinoma of the esophagus, confirmed by testing, who have progressed after two prior treatments including platinum-based chemotherapy with or without anti-PD-1 therapy
• People with pancreatic cancer (adenocarcinoma type) that cannot be surgically removed or has spread, who have progressed after one prior treatment in the advanced or metastatic setting
• People with castration-resistant prostate cancer (cancer that continues to grow despite very low testosterone levels), confirmed as adenocarcinoma without small cell or neuroendocrine features, with testosterone levels below 50 ng/dL, who have progressed after at least one newer hormonal therapy (such as abiraterone, enzalutamide, apalutamide, or darolutamide) and at least one taxane-based chemotherapy
• People with non-squamous non-small cell lung cancer (NSCLC) that has spread or cannot be removed by surgery, with no known targetable gene mutations (such as EGFR, ALK, BRAF, KRAS, RET, ROS1, MET, NTRK, HER2), who have progressed after receiving an anti-PD-1/PD-L1 therapy and platinum-based chemotherapy
• People with breast cancer confirmed to be HER2-negative and hormone receptor-positive (ER and/or PR positive), whose HER2 and hormone receptor results were tested from a tumour sample taken during the metastatic stage, who have received exactly one line of chemotherapy for metastatic breast cancer and have progressed on or after a CDK 4/6 inhibitor combined with endocrine (hormone) therapy
• People who have at least one tumour that can be measured by CT or MRI scan (prostate cancer patients with cancer only in the bones may still be eligible — confirm with trial site)
• People who are able to provide a tumour tissue sample taken from a lesion that has not been previously irradiated — either an archived sample taken after the most recent treatment progressed, or a newly collected sample taken during the screening period
• People who are in good general health, able to carry out light activity and care for themselves (rated 0 or 1 on a standard medical scale called the ECOG performance status)

Who may not be able to join:

• People with HER2-positive gastric or GEJ cancer, as classified by standard laboratory guidelines
• People with nasopharyngeal cancer (cancer starting at the back of the nose)
• People with mucosal melanoma (melanoma arising from mucous membranes) or uveal melanoma (melanoma of the eye)
• People with a history of non-infectious interstitial lung disease (ILD) — a type of lung inflammation — that required steroid treatment, or who currently have or may have ILD or pneumonitis (lung inflammation) that cannot be ruled out on imaging at screening
• People with serious breathing difficulties caused by other lung conditions, as assessed by the treating doctor
• People currently taking corticosteroids (such as prednisone) at more than 10 mg per day, or any other immune-suppressing medication, before the start of treatment — note that inhaled, topical, or locally injected steroids, as well as bronchodilators (inhalers), may still be acceptable
• People who have previously been treated with an anti-HER3 antibody or an antibody-drug conjugate (ADC) containing an exatecan-based topoisomerase I inhibitor (for example, trastuzumab deruxtecan)
• People who have had another active cancer diagnosed within the past three years — exceptions include adequately treated non-melanoma skin cancer, adequately treated early-stage cervical cancer, or other cancers that were fully cured
• People with severe or uncontrolled health conditions (such as active serious infections or uncontrolled bleeding), significant mental health or social circumstances, substance use concerns, or other factors that the treating doctor believes would make participation high risk or make it difficult to follow the study requirements
• People who have previously received a topoisomerase-1 inhibitor medication (such as irinotecan) for advanced or metastatic disease

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