High Grade Serous Ovarian CancerPhase 1IDOLNCT06976892
Investigating Idetrexed and Olaparib in Patients With Ovarian Cancer
A Phase 1 study testing Dose Level 2 (starting dose), Dose Level 1 and Dose Level -1 in people with High Grade Serous Ovarian Cancer, run by Institute of Cancer Research, United Kingdom at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Grade Serous Ovarian Cancer
- What is being tested?
- Dose Level 2 (starting dose), Dose Level 1 and Dose Level -1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Aug 2025to Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Zachariou, Ph.D. contact
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Addenbrooke's Hospital
Cambridge, Cambridgeshire
Joo Ern Ang, jooern.ang1@nhs.net
- Not yet recruiting
Velindre Cancer Centre
Cardiff, Wales
Amy E Quinton, amy.quinton@wales.nhs.uk
- Recruiting
Royal Marsden Hospital - Drug Development Unit
Sutton, London, SM2 5NG
Prof Udai Banerji, MBBS MD DNB PhD FRCP, udai.banerji@icr.ac.uk
About this study
Official title: 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)
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
- Being tested
- Dose Level 2 (starting dose), Dose Level 1, Dose Level -1, Dose Level 3, Maximum Tolerated Dose
- Keywords
- Ovarian Cancer, idetrexed, olaparib
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose Level 2 (starting dose)Drug
Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 300 mg P.O. (days1-7, 15-21)
Dose Level 1Drug
Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 200 mg P.O. (days1-7, 15-21)
Dose Level -1Drug
Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 150 mg P.O. (days1-7, 15-21)
Dose Level 3Drug
Idetrexed: 12 mg/m2 I.V. (days 1 \& 8) Olaparib: 200 mg P.O. (days1-7, 15-21)
Maximum Tolerated DoseDrug
MTD of Olaparib in combination with idetrexed established from Dose Escalation
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Patients may be assigned one of four dose levels for the combination of idetrexed and Olaparib:
* Dose Level 2 (starting dose): 9 mg/m2 idetrexed administered intravenously on days 1 and 15 of each cycle; 300 mg Olaparib administered orally twice per day on days 1-7 and 15-21.
* Dose Level 1: 9 mg/m2 idetrexed administered intravenously on days 1 and 15 of each cycle; 200 mg Olaparib administered orally twice per day on days 1-7 and 15-21.
* Dose Level -1: 9 mg/m2 idetrexed administered intravenously on days 1 and 15 of each cycle; 150 mg Olaparib administered orally twice per day on days 1-7 and 15-21.
* Dose Level 3: 12 mg/m2 idetrexed administered intravenously on days 1 and 15 of each cycle; 200 mg Olaparib administered orally twice per day on days 1-7 and 15-21. Receives: Drug: Dose Level 2 (starting dose); Drug: Dose Level 1; Drug: Dose Level -1; Drug: Dose Level 3 |
| Dose Expansion | Experimental | Only patients expressing high levels of alpha-folate receptor on their tumours will be eligible. The maximum tolerated dose of Olaparib in combination with idetrexed, based on safety and efficacy data from Dose Escalation, will inform the dose carried forward to Dose Expansion. Receives: Drug: Maximum Tolerated Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propose a recommended dose/schedule for Phase II evaluation of the combination of Idetrexed and Olaparib
Endpoint: Maximum tolerated dose/ schedule (MTD) of the combination of Idetrexed and Olaparib based on dose-limiting toxicities (DLT) with target acceptable DLT rate of 25%, and the Recommended Phase II dose (RP2D) and schedule (Dose Escalation only).
Measured: End of Cycle 2 (each cycle is 28 days)
Assess the safety and toxicity profile of Idetrexed and Olaparib
Endpoint: determining causality of each adverse event to Idetrexed and Olaparib and grading severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Dose Escalation and Dose Expansion).
Measured: End of Cycle 6 (each cycle is 28 days)
Evaluate the preliminary anti-tumour activity of the combination of Idetrexed and Olaparib in alpha folate receptor overexpressing high grade serous ovarian cancer
Endpoint: Objective response rate by the occurrence of Best Overall Response (BOR) per RECIST 1.1 criteria (Dose Expansion only).
Measured: Until patient withdraws due to radiological progression, or begins new line of therapy.
Secondary outcomes (3)
Evaluate antitumour activity of the combination of Idetrexed and Olaparib
Endpoint: Progression Free Survival (PFS).
Measured: From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Evaluate the preliminary anti-tumour activity of the combination of Idetrexed and Olaparib in ovarian cancer irrespective of alpha folate receptor expression status
Objective response rate.
Measured: From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
CA125 responses
Measurement of CA125 levels.
Measured: From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade Serous Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Up to 4 dose levels of Olaparib in combination with Idetrexed will be explored. Dose Escalation will use a flexible TIme To Event Continual Reassessment Method (TITE-CRM) including time-to-toxicity analysis to account for dose-limiting toxicities that may arise outside the initial DLT period (2 cycles). The TITE-CRM was proposed to handle the problem of long trial duration in Phase 1 trials due to late-onset toxicities. By combining a "backfilling" feature with TITE-CRM, the aim is to significantly shorten trial duration while maintaining a good assessment of the Maximum Tolerated Dose and Recommended Phase 2 Dose. The latter will consider not only the DLT outcomes, but also other parameters including activity and patient tolerability, as well as biomarker response during dose expansion. The proposed trial design ensures that the study has the advantages of both speed and efficiency. PLEASE NOTE: INTRA-PATIENT DOSE ESCALATION IS NOT PERMITTED ON THIS STUDY.
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Algok Bio Inc.
- Responsible party
- Sponsor
- Investigators
- Professor Udai Banerji, Principal investigator, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976892
- Sponsor's protocol ID
- CCR5978
- Other IDs
- 1008393
- Acronym
- IDOL
- Status last verified
- Aug 2025
- First submitted
- 3 Apr 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06976892
- Acronym / sponsor ID
- IDOL / CCR5978
- Conditions
- High Grade Serous Ovarian Cancer
- Keywords
- Ovarian Cancer, idetrexed, olaparib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Algok Bio Inc.
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Up to 4 dose levels of Olaparib in combination with Idetrexed will be explored. Dose Escalation will use a flexible TIme To Event Continual Reassessment Method (TITE-CRM) including time-to-toxicity analysis to account for dose-limiting toxicities that may arise outside the initial DLT period (2 cycles). The TITE-CRM was proposed to handle the problem of long trial duration in Phase 1 trials due to late-onset toxicities. By combining a "backfilling" feature with TITE-CRM, the aim is to significantly shorten trial duration while maintaining a good assessment of the Maximum Tolerated Dose and Recommended Phase 2 Dose. The latter will consider not only the DLT outcomes, but also other parameters including activity and patient tolerability, as well as biomarker response during dose expansion. The proposed trial design ensures that the study has the advantages of both speed and efficiency. PLEASE NOTE: INTRA-PATIENT DOSE ESCALATION IS NOT PERMITTED ON THIS STUDY.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: Dose Level 2 (starting dose), Drug: Dose Level 1, Drug: Dose Level -1, Drug: Dose Level 3Patients may be assigned one of four dose levels for the combination of idetrexed and Olaparib: * Dose Level 2 (starting dose): 9 mg/m2 idetrexed administered intravenously on days 1 and 15 of each cycle; 300 mg Olaparib administered orally twice per day on days 1-7 and 15-21. * Dose Level 1: 9 mg/m2 idetrexed administered intravenously on days 1 and 15 of each cycle; 200 mg Olaparib administered orally twice per day on days 1-7 and 15-21. * Dose Level -1: 9 mg/m2 idetrexed administered intravenously on days 1 and 15 of each cycle; 150 mg Olaparib administered orally twice per day on days 1-7 and 15-21. * Dose Level 3: 12 mg/m2 idetrexed administered intravenously on days 1 and 15 of each cycle; 200 mg Olaparib administered orally twice per day on days 1-7 and 15-21. |
| Dose Expansion | Experimental | Drug: Maximum Tolerated DoseOnly patients expressing high levels of alpha-folate receptor on their tumours will be eligible. The maximum tolerated dose of Olaparib in combination with idetrexed, based on safety and efficacy data from Dose Escalation, will inform the dose carried forward to Dose Expansion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 Escalation |
| Dose Level 1Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 200 mg P.O. (days1-7, 15-21) | Drug | Dose Escalation |
| Dose Level -1Idetrexed: 9 mg/m2 I.V. (days 1 \& 8) Olaparib: 150 mg P.O. (days1-7, 15-21) | Drug | Dose Escalation |
| Dose Level 3Idetrexed: 12 mg/m2 I.V. (days 1 \& 8) Olaparib: 200 mg P.O. (days1-7, 15-21) | Drug | Dose Escalation |
| Maximum Tolerated DoseMTD of Olaparib in combination with idetrexed established from Dose Escalation | Drug | Dose Expansion |
Primary outcome
Propose a recommended dose/schedule for Phase II evaluation of the combination of Idetrexed and Olaparib
Time frame: End of Cycle 2 (each cycle is 28 days)
Endpoint: Maximum tolerated dose/ schedule (MTD) of the combination of Idetrexed and Olaparib based on dose-limiting toxicities (DLT) with target acceptable DLT rate of 25%, and the Recommended Phase II dose (RP2D) and schedule (Dose Escalation only).
Assess the safety and toxicity profile of Idetrexed and Olaparib
Time frame: End of Cycle 6 (each cycle is 28 days)
Endpoint: determining causality of each adverse event to Idetrexed and Olaparib and grading severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Dose Escalation and Dose Expansion).
Evaluate the preliminary anti-tumour activity of the combination of Idetrexed and Olaparib in alpha folate receptor overexpressing high grade serous ovarian cancer
Time frame: Until patient withdraws due to radiological progression, or begins new line of therapy.
Endpoint: Objective response rate by the occurrence of Best Overall Response (BOR) per RECIST 1.1 criteria (Dose Expansion only).
3 secondary outcomes
Evaluate antitumour activity of the combination of Idetrexed and Olaparib
Time frame: From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Evaluate the preliminary anti-tumour activity of the combination of Idetrexed and Olaparib in ovarian cancer irrespective of alpha folate receptor expression status
Time frame: From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
CA125 responses
Time frame: From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Zachariou, Ph.D. contact
Professor Udai Banerji principal investigator
Institute of Cancer Research, United Kingdom
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dose Level 2 (starting dose), Dose Level 1 and Dose Level -1 in people with High Grade Serous Ovarian Cancer, run by Institute of Cancer Research, United Kingdom at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Cowley, Ph.D. (+44 20 3437 6927, idol@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propose a recommended dose/schedule for Phase II evaluation of the combination of Idetrexed and Olaparib (time frame: End of Cycle 2 (each cycle is 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.