Status:
RECRUITING
Investigating Idetrexed and Olaparib in Patients With Ovarian Cancer
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Collaborating Sponsors:
Algok Bio Inc.
Conditions:
High Grade Serous Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
Two drugs called Idetrexed and olaparib are being evaluated. Idetrexed is a type of drug called an "aFR-targeted thymidylate synthase inhibitor". Idetrexed has been designed to selectively target canc...
Eligibility Criteria
Inclusion
- Histologically or cytologically proven high grade serous ovarian cancer refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient.
- Measurable (as defined by RECIST v1.1) or evaluable (based on tumour markers) disease.
- Life expectancy of at least 12 weeks.
- World Health Organisation (WHO) performance status of 0-1 (Appendix 1 of Protocol).
- Haematological and biochemical indices within the ranges shown in Protocol section 4.1.1). These measurements must be performed within one week (Day -7 to Day 1) prior to the patient's first dose of IMP.
- Normal (no clinically significant abnormalities) 12-lead ECG, QTcF interval \<470 ms
- Pulmonary function test FVC of \>70%, DLCOc (DLCO corrected for Hb) of \>60%.
- 18 years or over.
- Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.
- For dose expansion patients only, they must have medium to high α-folate receptor expression according to the Ventana FOLR1-2.1 IHC assay.
Exclusion
- Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C) and 4 weeks for investigational medicinal products) before treatment.
- Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator and the DDU should not exclude the patient.
- Patients with new brain metastases. Patients with treated (surgically excised or irradiated) and stable brain metastases are eligible as long as the treatment was at least 4 weeks prior to initiation of study drug and brain MRI within 2 weeks of initiation of study drug is negative for new metastases.
- Patients with pulmonary metastases.
- History of thoracic radiation or other history likely to create pre-existing lung disease
- Presence of significant clinical ascites and/or pleural effusions.
- Female patients of child-bearing potential (or are already pregnant or lactating). However, those patients who have a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one effective form plus a barrier method) \[oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom\] or agree to sexual abstinence (see Protocol Section 16.5 - Appendix 5), effective from signing the consent form, throughout the trial and for six months afterwards are considered eligible.
- Major thoracic or abdominal surgery from which the patient has not yet recovered.
- Patients with sub-acute bowel obstruction.
- Organ transplant patients.
- At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
- Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- Patients with history of QT prolongation, clinically significant VT, VF, heart block, MI within 1 year, CHF NYHA Class III or IV, unstable angina, angina within 6 months, or other evidence of clinically significant coronary artery disease/
- Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I/Ib study of Idetrexed and Olaparib. Participation in an observational trial would be acceptable.
- Inability to tolerate Olaparib.
- Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
- Confirmed, current COVID-19 infection.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06976892
Start Date
August 1 2025
End Date
December 1 2029
Last Update
August 13 2025
Active Locations (3)
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1
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
2
Royal Marsden Hospital - Drug Development Unit
Sutton, London, United Kingdom, SM2 5NG
3
Velindre Cancer Centre
Cardiff, Wales, United Kingdom