Phase 2 Ovarian 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 who are 18 years of age or older.
• People (or their legal representative) who are able to give written agreement to take part before any study procedures begin.
• People who have been confirmed through a tissue or cell sample to have one of the following advanced cancers, depending on which group (cohort) they are being considered for:
  • Group A: Kidney cancer (that has spread or cannot be removed) after trying at least two prior treatments including a targeted therapy and an immunotherapy; prostate cancer that no longer responds to hormone treatment, after trying a second-generation hormone drug and a taxane chemotherapy; head and neck cancer that cannot be cured by surgery or radiation and has worsened after platinum-based chemotherapy and/or immunotherapy; or lung cancer (non-small cell) that no longer responds to standard treatment or for which no standard treatment is available.
  • Group B: Bowel cancer (colorectal) that no longer responds to standard treatment or for which no standard treatment is available; prostate cancer that no longer responds to hormone treatment, after trying a second-generation hormone drug and a taxane chemotherapy; lung cancer (non-small cell) that no longer responds to standard treatment or for which no standard treatment is available; uterine (endometrial) cancer that no longer responds to standard treatment or for which no standard treatment is available; or ovarian cancer that no longer responds to standard treatment or for which no standard treatment is available.
  • Group C: One or more of the cancer types listed in Groups A and B, to be confirmed after the trial team reviews earlier data.
• People whose general health and ability to carry out daily activities is rated at a 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People who have measurable signs of their cancer on scans, as assessed by the trial site (people with prostate cancer that cannot be measured on scans may still be considered if their PSA level is 2.0 ng/mL or higher and the trial sponsor approves).
• People whose cancer has not responded to standard treatment, or for whom no suitable standard treatment is available.
• People who agree to a tumour tissue sample (biopsy) at the start of the trial, with some exceptions — if the biopsy site is considered moderate or high risk, sponsor approval may allow enrolment without a new biopsy; or a stored tissue sample taken within the past 6 months (without any treatment in between) may be accepted instead.
• People whose blood counts and bone marrow function meet the required minimum levels (confirm with trial site for exact values).
• People whose liver function test results are within the required range (confirm with trial site for exact values).
• People whose kidney function is within the required range (confirm with trial site for exact values).
• Women who could potentially become pregnant must have a negative pregnancy test within 1 week before starting treatment, and must use a highly effective form of contraception or avoid heterosexual activity for the entire time on the study and for 120 days after the last dose.
• Male participants must agree to use highly effective contraception.
• People who are able to attend all required study visits and follow all study procedures.
• People who are able to swallow capsules.

Who may not be able to join:

• People who have had major surgery within the 4 weeks before the screening visit.
• People who currently have active cancer spread to the brain or spinal fluid lining; however, people who have already been treated for brain metastases (by radiation or surgery), are neurologically stable, and are no longer taking steroid medicines at treatment doses may still be considered.
• People who have had radiotherapy within 2 weeks before starting the study treatment, or who have not fully recovered from radiation side effects (a shorter waiting period may apply for limited palliative radiation to areas outside the brain).
• People who have received cancer treatment within 4 weeks before starting the study (a shorter 2-week gap may be accepted for some fast-acting drugs); all treatment-related side effects must have settled to a mild or absent level.
• People who are living with HIV.
• People who currently have active hepatitis B infection and have not been on antiviral treatment for at least 4 weeks with an undetectable virus level (those who meet these treatment conditions may still be considered).
• People who have a history of hepatitis C infection unless their virus level is undetectable at screening and they have completed curative antiviral treatment at least 4 weeks before enrolment.
• People who are currently taking immune-suppressing medicines (such as corticosteroids at 10 mg prednisone daily or equivalent, or similar drugs), except where steroids are used to replace a hormone the body cannot make.
• People who need to take medicines that strongly affect the way the body processes certain drugs (known as strong CYP3A4, 2C9, or 2C19 inhibitors or inducers — confirm with trial site for specific drug names).
• People who need to take medicines that reduce stomach acid, such as proton pump inhibitors or H2 blockers (common antacid tablets may be allowed at specific times around dosing — confirm with trial site).
• People who have an active bacterial, fungal, or viral infection at the time of screening (people taking preventive antimicrobial medicines may still be considered if all other criteria are met).
• People who have received a live vaccine within 6 weeks before the first dose (mRNA COVID-19 vaccines are allowed).
• People whose heart's electrical activity (a measurement called QTcF) is above a certain level on an ECG reading, unless they have a specific type of electrical conduction difference in the heart (right or left bundle branch block).
• People who have had stomach or bowel surgery, or have a condition that may affect how the body absorbs medicines (such as gastric bypass surgery or removal of part of the stomach).
• People who are pregnant or breastfeeding.
• People who have another active cancer at the same time, other than certain limited skin cancers or early-stage localised cancers (confirm with trial site for specifics).
• People with a history of a serious lung condition involving scarring or inflammation (interstitial lung disease), or lung inflammation caused by radiation that required steroid treatment.
• People who have had a stomach ulcer or bleeding in the digestive tract within the past 6 months before screening.
• People who have had a stroke, unstable chest pain, heart attack, or serious heart rhythm problem requiring medicine or a medical device within the past 6 months before screening.
• People with an unstable or serious uncontrolled medical condition (such as unstable heart or lung function, uncontrolled diabetes, or abnormal blood test results) that the trial doctor believes would put the person at too much risk.

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