NCT05942300

CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

Phase I Trial of CPI-0209 in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Lan Coffman · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical trial using CPI-0209 in combination with Carboplatin chemotherapy followed by CPI-0209 maintenance in patients with platinum sensitive, recurrent ovarian cancer.

Detailed description

Clinically, there is a critical need for improved therapies in ovarian cancer. There has been recent success with maintenance therapy in ovarian cancer with both PARP inhibitors and bevacizumab approved in the up-front maintenance setting and in the recurrent, platinum sensitive maintenance setting. However, it is unclear what treatment should be used post-PARPi or bevacizumab maintenance. Additionally, the benefit derived from bevacizumab maintenance therapy is modest with generally a few month improvement in progression free survival. Further, there is emerging evidence that after progression on a PARPi, there is decreased response to platinum-based therapy. This provides a critical unmet need to enhance platinum response, particularly after previous maintenance therapy. This also provides a large group of patients who could potentially benefit from EZH2 targeting agents to block stromal-mediated chemotherapy resistance and metastasis. This study aims to investigate whether CPI-0209 will enhance ovarian cancer sensitivity to platinum-based chemotherapy and prolong the disease free interval after completion of chemotherapy by blocking stromal mediated chemotherapy resistance, metastasis promotion and ovarian cancer growth.

Conditions

• Recurrent Ovarian Cancer

Interventions

Type	Name	Description
DRUG	CPI-0209	A second-generation EZH2 inhibitor that has been designed to achieve comprehensive anti-cancer target coverage through extended on-target residence time.
DRUG	carboplatin	Carboplatin is a chemotherapy drug that contains the metal platinum. It stops or slows the growth of cancer cells and other rapidly growing cells by damaging their DNA.

Timeline

• Start date: 2024-01-30
• Primary completion: 2026-11-01
• Completion: 2028-12-31
• First posted: 2023-07-12
• Last updated: 2025-06-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study