RecruitingPhase 1NCT06976892

Investigating Idetrexed and Olaparib in Patients With Ovarian Cancer

A Phase I/Ib Trial of Idetrexed (Alpha Folate Receptor Targeted Thymidylate Synthase Inhibitor) in Combination With Olaparib (a PARP Inhibitor) at Different Doses in Patients With Ovarian Cancer (IDOL)


Sponsor

Institute of Cancer Research, United Kingdom

Enrollment

33 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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 cancer cells that have a protein called folate receptor on the surface of cancer cells. Thymidylate synthase is key to cancer cells for creating new DNA when they multiply. Blocking the action of thymidylate synthase with a drug like Idetrexed may therefore stop cancers from growing by damaging DNA in cancer cells. Olaparib is a type of drug called a "PARP inhibitor". It prevents cells repairing DNA damage. This leads to cells dying. Combining Idetrexed and olaparib should increase the number of cancer cells dying, especially those cells that have a lot of folate receptors. Cancer cells with a high number of folate receptors should be targeted more than normal healthy cells.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — idetrexed and olaparib — in people with advanced ovarian cancer that has stopped responding to standard treatments. Idetrexed targets a protein called folate receptor, while olaparib is a PARP inhibitor that blocks cancer cell repair. **You may be eligible if...** - You have been diagnosed with high-grade serous ovarian cancer confirmed by biopsy - Your cancer has stopped responding to conventional treatment, or no standard treatment is available - You have measurable disease or rising tumor markers - You are 18 or older - Your lungs and breathing tests are within acceptable ranges - Your cancer expresses medium to high levels of a protein called alpha-folate receptor (for the expansion phase of the study) **You may NOT be eligible if...** - You have received chemotherapy, radiation, or immunotherapy in the past 4 weeks - You have new or untreated brain tumors - You have cancer that has spread to the lungs - You have had previous radiation to the chest, or other conditions that affect lung function - You have significant ongoing side effects from previous treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDose Level 2 (starting dose)

Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 300 mg P.O. (days1-7, 15-21)

DRUGDose Level 1

Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 200 mg P.O. (days1-7, 15-21)

DRUGDose Level -1

Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 150 mg P.O. (days1-7, 15-21)

DRUGDose Level 3

Idetrexed: 12 mg/m2 I.V. (days 1 \& 8) Olaparib: 200 mg P.O. (days1-7, 15-21)

DRUGMaximum Tolerated Dose

MTD of Olaparib in combination with idetrexed established from Dose Escalation


Locations(3)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

Royal Marsden Hospital - Drug Development Unit

Sutton, London, United Kingdom

Velindre Cancer Centre

Cardiff, Wales, United Kingdom

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NCT06976892


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