NCT04669002

EP0057 in Combination With Olaparib in Advanced Ovarian Cancer

Phase 2 Study to Evaluate the Safety & Efficacy of EP0057 in Combination With Olaparib in Advanced Ovarian Cancer Patients Who Have: Cohort 1 - Platinum Resistant Disease; Cohort 2 - Had at Least 1 Prior Line of Therapy Which Must Include at Least 1 Line of Platinum-based Chemotherapy Followed by PARP Inhibitor Maintenance

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Ellipses Pharma · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

EP0057-201 is a Phase 2A/B adaptive design study. Phase 2A will test EP0057 in combination with Olaparib and Phase 2B, the randomised part of the study, will test EP0057 in combination with Olaparib against SOC chemotherapy. When EP0057 is combined with Olaparib, it is envisaged that the combination should improve therapeutic responses in the recurrent ovarian cancer disease setting. EP0057 is an investigational nanoparticle-drug conjugate administered intravenously. The rationale for developing EP0057 is to enable selective entry of EP0057 into tumour tissue and as a result create preferential accumulation of EP0057, and therefore of the payload Camptothecin, to translate into maximum tumour cell killing.

Detailed description

EP0057-201 is an adaptive Phase 2A/B study in patients with advanced ovarian cancer. Phase 2A Phase 2A will be comprised of 2 single-arm treatment cohorts: Cohort 1 will explore EP0057 in combination with Olaparib in patients with advanced platinum resistant ovarian cancer (see inclusion criteria for definition of platinum resistant) who have received no more than 1 prior line of therapy which must be platinum-based chemotherapy (n\~=30) Cohort 2 will explore EP0057 in combination with Olaparib in patients with advanced ovarian cancer who have received at least 1 prior line of therapy which must include at least 1 line of platinum-based chemotherapy followed by a PARP inhibitor as maintenance treatment as their last treatment regimen (n\~=30) It is anticipated that up to approximately 60 patients (approximately 30 patients per cohort) will be enrolled into Phase 2A. Both treatment cohorts will open in parallel and patients will be enrolled into each cohort concurrently. At the end of Phase 2A, the Safety Review Committee will guide the decision to initiate 1 or both cohorts in Phase 2B, or terminate further recruitment into the study. Phase 2B Phase 2B will be comprised of 2 treatment cohorts, each randomised versus SOC. One or both cohorts may be opened concurrently to recruitment: Cohort 1 will explore EP0057 in combination with Olaparib compared with SOC chemotherapy (TBC) in patients with advanced platinum resistant ovarian cancer who have received no more than 1 prior line of therapy which must be platinum-based chemotherapy (n=\~132) Cohort 2 will explore EP0057 in combination with Olaparib compared with SOC chemotherapy (TBC) in patients with advanced ovarian cancer who have received at least 1 prior line of therapy which must include at least 1 line of platinum-based chemotherapy followed by a PARP inhibitor as maintenance treatment as their last therapy (n=\~192) It is anticipated that \~324 patients will be enrolled into Phase 2B. Both treatment cohorts may open in parallel and patients may be enrolled into each cohort concurrently.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	EP0057	EP0057 is an investigational nanoparticle-drug conjugate with a Camptothecin payload, that is administered intravenously
DRUG	Olaparib tablets	Olaparib is a PARP inhibitor (poly \[adenosine diphosphate-ribose\] polymerase inhibitor)

Timeline

• Start date: 2020-12-14
• Primary completion: 2023-02-17
• Completion: 2023-05-05
• First posted: 2020-12-16
• Last updated: 2023-08-02

Locations

21 sites across 3 countries: United States, Hungary, United Kingdom

Regulatory

• FDA-regulated drug study