NCT06976892

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Institute of Cancer Research, United Kingdom · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High Grade Serous Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Dose Level 2 (starting dose)	Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 300 mg P.O. (days1-7, 15-21)
DRUG	Dose Level 1	Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 200 mg P.O. (days1-7, 15-21)
DRUG	Dose Level -1	Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 150 mg P.O. (days1-7, 15-21)
DRUG	Dose Level 3	Idetrexed: 12 mg/m2 I.V. (days 1 \& 8) Olaparib: 200 mg P.O. (days1-7, 15-21)
DRUG	Maximum Tolerated Dose	MTD of Olaparib in combination with idetrexed established from Dose Escalation

Timeline

• Start date: 2025-08-01
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2025-05-16
• Last updated: 2025-08-13

Locations

3 sites across 1 country: United Kingdom