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 information, sign a consent form, and are willing to follow the study requirements
• People who are female and aged 21 years or older (for sites in Singapore)
• People who have been diagnosed with advanced or spreading ovarian cancer that has been confirmed by laboratory testing, and whose cancer either returned within 6 months of their last platinum-based chemotherapy, or for whom platinum-based chemotherapy is no longer considered an option by their treating doctor
• People whose tumours have been tested and shown to be a specific type called MSS/pMMR (meaning the tumour's DNA repair system is working normally), confirmed through standard laboratory testing
• People whose cancer has been confirmed to be getting worse, based on scans and other assessments done at the screening visit
• People who have at least one area of cancer that can be measured on scans, according to standard measurement guidelines
• People whose general physical health and ability to carry out daily activities falls within an acceptable range as rated by their doctor (called ECOG performance status 0 to 2)
• People who are expected to live for at least 3 months at the time of screening
• People whose blood tests show that their kidneys, liver, blood cells, and clotting system are all functioning adequately at the time of screening
• People whose bone density scan (DEXA scan) shows a T-score greater than -1, or who have mild bone thinning (called osteopenia, with a T-score between -1 and -2.5) — those with osteopenia would receive calcium and vitamin D supplements during the study
• People who are able to swallow the study tablets, or who have a carer who can help them take the medication each day
• People who have a negative pregnancy test at the time of screening (applies to those who could become pregnant)
• People who are able to provide tumour tissue samples before and after treatment, unless the tumour is not safely reachable (confirm with trial site)

Who may not be able to join:

• People who have received cancer treatment, including immunotherapy, within the past 4 weeks, or whose side effects from such treatment have not settled down sufficiently
• People who have taken another experimental drug within the past 4 weeks or five half-lives of that drug (whichever is longer)
• People who have another active cancer, or had a different cancer within the last 3 years (some minor treated skin cancers or cervical conditions may be exceptions — confirm with trial site)
• People who have cancer that has spread to the brain or spinal cord, unless it was treated at least 8 weeks ago, has been stable since, and no steroids have been needed for at least 4 weeks
• People who have had radiation therapy within the past 4 weeks (or limited radiation within the past 2 weeks), or whose radiation side effects have not settled down sufficiently
• People who have had radiation directed at the spine or pelvis, or combined chemotherapy and radiation to pelvic organs, within the past 6 months, or whose side effects from this have not settled down
• People who have a history of certain lung conditions, including interstitial lung disease, sarcoidosis, silicosis, pulmonary fibrosis, or lung inflammation caused by an allergic or immune reaction
• People who have received certain bone-strengthening medications (bisphosphonates or denosumab) for osteoporosis or high calcium levels within the past 6 months
• People who have severe bone thinning (osteoporosis), defined as a T-score below -2.5 on a DEXA scan
• People who have a history of bone fractures that occurred without a significant injury, particularly in the spine, hip, pelvis, or wrist
• People whose spine scans show moderate or severe compression fractures in the vertebrae
• People with a specific blood marker of bone breakdown (β-CTX) above a certain level after fasting, unless it can be brought back into the acceptable range with bone-protective treatment (confirm with trial site)
• People whose thyroid-stimulating hormone level is below the normal range at screening
• People whose vitamin D levels are too low at screening (unless levels can be corrected before the study begins — confirm with trial site)
• People who have cancer that has spread to the bones at the time of screening
• People who have a bone metabolism disorder such as overactive parathyroid glands, Paget's disease of bone, or softening of the bones (osteomalacia)
• People who cannot receive bone-protective medication (denosumab or zoledronic acid) as required by the study
• People who have been taking steroid tablets or infusions at a significant daily dose for 4 weeks or more within the past 12 weeks
• People who have an active autoimmune disease that has required ongoing medical treatment within the past 2 years (routine hormone replacement or low-dose steroids for gland problems are not included in this)
• People who are able to become pregnant and are not using a highly effective form of contraception throughout the study and for 12 weeks after finishing treatment
• People who are currently pregnant or breastfeeding
• People who have had a major operation within the past 4 weeks, or who have not fully recovered from surgery
• People who have a history of a heart rhythm condition called long QT syndrome, or whose heart rhythm test (ECG) shows an abnormally long QT interval at screening
• People who have a known significant bleeding or clotting disorder
• People who have been taking blood-thinning medications such as heparin or warfarin within the past 4 weeks (some types of blood thinners may be permitted — confirm with trial site)
• People who have serious or unstable health conditions such as heart failure, uncontrolled high blood pressure, uncontrolled diabetes, significant heart rhythm problems, or other major ongoing medical conditions
• People who have a known history of HIV, or currently active hepatitis B or C infection (some exceptions may apply — confirm with trial site), or other active serious infections
• People who have previously had gastric bypass surgery
• People who have a wound that is not healing, or inflammation of blood vessels (vasculitis)
• People who have previously received a treatment that blocks the same biological pathway (Wnt-β-catenin) that this study drug targets
• People who are unwilling or unable to follow the study requirements
• People who are unable to provide tumour tissue samples, unless an exception is approved by the lead study investigator
• People who have received certain white blood cell or red blood cell stimulating injections within the past 4 weeks
• People who have an active infection currently being treated with antibiotics, antifungal, or antiviral medicines within the past 2 weeks (those on preventive antibiotics only may still be considered — confirm with trial site)
• People who have received a live vaccine within the past 28 days (certain flu vaccines may be permitted — confirm with trial site)

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