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:

• Women aged 18 or older who have advanced, returning, or spread ovarian cancer, endometrial cancer, or triple-negative breast cancer of specific types confirmed by laboratory testing of tumour tissue
• People whose tumour tissue shows a protein called FRα on at least 5% of tumour cells, confirmed by a specific laboratory test
• People with ovarian cancer whose cancer returned or progressed within 6 months of their last platinum-based chemotherapy treatment
• People who have tried previous cancer treatments, progressed on them, and for whom no other approved treatment is currently considered appropriate by the treating doctor
• People whose cancer can be measured on a CT or MRI scan taken within 28 days before starting the trial treatment
• People with no signs of bowel blockage
• People who are reasonably well and active in daily life (a medical rating scale called ECOG score of 0 or 1)
• People who, in the doctor's opinion, have an estimated life expectancy of more than 3 months
• People whose blood counts, immune system, kidney function, and liver function all meet specific healthy ranges confirmed by blood tests
• People who have recovered from most side effects of prior chemotherapy (minor ongoing side effects such as hair loss or mild nerve problems may be acceptable)
• People with no significant heart or lung disease
• People with no active or recent serious autoimmune disease (some mild autoimmune conditions such as vitiligo, type 1 diabetes, or thyroid conditions managed with hormone replacement may be acceptable)
• People who test negative on a specific allergy-related blood test called a basophil activation test (BAT) before starting treatment
• People who test negative on a pregnancy test (two negative tests required during the screening period for those who could become pregnant)
• People who are able and willing to use two forms of contraception throughout the trial and for 6 months after the last dose, if they could become pregnant (oral or injectable contraception alone is not sufficient)
• People who are willing and able to follow all trial visits and assessments as required
• People who are willing to protect their skin from UV light, sunbathing, and solariums during the trial and for 4 weeks after the last dose

Who may not be able to join:

• People with certain types of ovarian tumours that do not originate from the lining of the ovary, fallopian tube, or peritoneum (such as germ cell tumours or sarcomas)
• People who have had fluid build-up around the lungs or abdomen requiring drainage within 28 days before starting treatment, or who have an ongoing drain in place for this
• People taking certain medications including beta-blockers (in some cases), full-dose tricyclic antidepressants, or MAOIs, which cannot be safely paused before starting treatment
• People with a history of throat swelling (laryngeal oedema), poorly controlled or high-risk asthma, or severe allergic reactions (anaphylaxis)
• People with a history of parasitic worm infections within the past 5 years
• People with an elevated baseline level of a blood marker called serum tryptase, or a positive basophil activation test result
• People who have received other systemic cancer treatments within 28 days before starting the trial treatment
• People receiving any other cancer treatment, chemotherapy, anti-cancer hormonal therapy, or radiation therapy at the same time as the trial treatment (some exceptions apply, confirm with trial site)
• People who received radiation therapy within 14 days before starting the trial (some local palliative radiotherapy may be permitted, confirm with trial site)
• People taking long-term or high-dose steroid or immune-suppressing medications within 14 days before starting treatment
• People who received a live vaccine within 28 days before starting treatment or who would need one during the trial or within 5 months after the last dose
• People who have had a bone marrow transplant from a donor or a solid organ transplant
• People who have previously tested positive for HIV
• People with a history of interstitial lung disease or active lung inflammation
• People with a known allergy to any ingredient in the trial drug (MOv18 IgE)
• People who test positive for hepatitis B or C
• People with uncontrolled ongoing infections, serious psychiatric illness, or other uncontrolled medical conditions
• People with serious heart problems in the past 12 months, including heart attack, unstable angina, uncontrolled abnormal heart rhythm, heart failure, or certain abnormal heart electrical readings
• People currently taking medications known to affect the heart's electrical activity in a specific way (QT/QTc prolongation)
• People who have had a fever of 38°C or higher within 3 days before starting treatment
• People with active or recent brain or spinal cord metastases, or a brain tumour
• People who have had a serious illness or major surgery within 4 weeks before starting treatment
• People who are currently breastfeeding
• People with another current or recent cancer diagnosis, with some exceptions for certain early-stage or skin cancers that have been fully treated (confirm with trial site)
• People who are under legal guardianship
• People who are close family members of the trial investigators, trial staff, or the company sponsoring the trial
• People with any other condition that, in the doctor's opinion, would make participation unsafe or affect the trial results

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