Phase 1 Ovarian 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 are able to understand the study and have signed a consent form before any study procedures begin.
• Adults aged 18 years or older.
• People who have been confirmed (through tissue or cell testing) to have advanced solid tumours — including platinum-resistant ovarian cancer (also covering fallopian tube and primary peritoneal cancers), non-small cell lung cancer, testicular cancer, or other solid tumours — where standard treatments have not worked, were not tolerated, or no standard treatment exists.
• People who have at least one tumour that can be measured using standard imaging criteria (confirm with trial site).
• People whose general physical functioning is rated at 0 or 1 on a standard cancer performance scale, meaning they are fully active or have only minor limitations in physical activity (confirm with trial site).
• People who are expected to survive for 3 months or longer.
• For the first part of the trial: People who have tumour tissue available (either stored or freshly collected) for a specific protein test called CLDN6. For the second part of the trial: People whose tumour tissue has tested positive for the CLDN6 protein through a laboratory test (confirm with trial site).
• People whose blood, liver, kidney, and heart function meet specific laboratory standards set by the trial, as assessed by a doctor (confirm with trial site).
• Women who could become pregnant must have a negative pregnancy test within 7 days before the first dose, must not be breastfeeding, and must agree to use highly effective contraception from the start of the trial until 6 months after the last dose.
• Women who cannot become pregnant — for example, those who have had a hysterectomy, had both ovaries removed, or had both fallopian tubes removed — are also eligible.
• Women who have gone through menopause, defined as having had no periods for 1 year or more.
• Men who have had a vasectomy, or who agree to use highly effective contraception and not donate sperm from the start of the trial until 6 months after the last dose.

Who may not be able to join:

• People who have received certain cancer treatments too recently before the trial starts — including chemotherapy, targeted therapy, hormone therapy, or herbal cancer medicines within 2 weeks; biological treatments such as antibodies or antibody-drug conjugates within 4 weeks (or 5 half-lives, whichever is shorter); or certain slower-acting chemotherapy agents within 6 weeks (confirm with trial site).
• People who have had certain types of radiation therapy too recently — including full-dose radiotherapy within 4 weeks, brain radiotherapy within 4 weeks, palliative radiotherapy within 2 weeks, or radioactive drug treatments within 8 weeks before starting the trial.
• People who have previously received any anti-cancer treatment that specifically targets the CLDN6 protein.
• People who still have side effects from previous cancer treatments rated above a mild level, except for hair loss or hormone-related issues that can be managed with replacement therapy.
• People who have an active or uncontrolled infection requiring antibiotic, antiviral, or antifungal treatment within 2 weeks before starting the trial.
• People who have cancer that has spread to the membranes around the brain or spinal cord, or who have brain or spinal cord metastases that are causing symptoms or are not controlled. People with small, symptom-free brain metastases may be considered only if those metastases have been treated and are stable, and certain medication conditions are also met (confirm with trial site).
• People who have uncontrolled fluid build-up around the lungs, abdomen, or heart, unless the fluid is stable and symptom-free under specific conditions (confirm with trial site).
• People who have had another cancer requiring treatment within the past 5 years, with some exceptions such as certain skin cancers, early-stage cervical changes, papillary thyroid cancer, early breast changes, or other cancers with a good outlook that have been treated and have not returned within 5 years (confirm with trial site).
• People who have a history of active or ongoing eye conditions affecting the cornea or surface of the eye, or other significant eye diseases that could interfere with monitoring of eye-related side effects.
• People who have a significant pre-existing lung disease — such as interstitial lung disease, non-infectious lung inflammation, pulmonary fibrosis, or severe radiation-related lung damage — that causes symptoms or requires treatment.
• People with serious or unstable heart conditions, including a history of heart failure, unstable chest pain or heart attack within the past 6 months, certain irregular heart rhythms within 6 months that are still unstable, or specific electrical abnormalities of the heart that could pose a risk (confirm with trial site).
• People who have had a stroke or mini-stroke within 6 months before the first dose.
• People with high blood pressure that remains uncontrolled despite treatment (above specific levels set by the trial), or uncontrolled diabetes despite treatment.
• People with an active hepatitis B infection based on specific blood test results (confirm with trial site).
• People with an active hepatitis C infection based on specific blood test results (confirm with trial site).
• People with a known history of HIV infection or AIDS.
• People who have had major surgery within 2 weeks before the first dose.
• People who have taken part in another clinical trial involving an investigational treatment within 28 days or 5 half-lives (whichever is shorter) before starting this trial.
• People with a known allergic reaction to any component of the study drug, including eribulin or its ingredients.
• Women who are pregnant or breastfeeding.
• People who have any other significant medical condition or history that, in the opinion of the treating doctor, could pose a safety risk or interfere with the trial (confirm with trial site).

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