A Study of CPI-0209 in Patients with Advanced Solid Tumors and Lymphomas (CPI 0209)
Recruiting
18-99 years
Female
Phase
1/2
1 Location
Brief description of study
First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor of EZH2.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Advanced ovarian clear cell carcinoma; recurrent, metastatic, or unresectable endometrial carcinoma
-
Age: Between 18 Years - 99 Years
-
Gender: Female
Inclusion Criteria:
Phase 1
Eligible Phase 1 patients are adults who have a confirmed locally advanced or metastatic tumors (solid tumors or lymphoma) that have relapsed following standard therapy or progressed through standard therapy or who have a disease for which no standard effective therapy exists.
Phase 2:
- Life expectancy of ≥ 12 weeks
- ECOG 0-1
- Adequate bone marrow function
- Adequate renal function
- Adequate liver function
- For Cohort M2, the following criteria should be considered:
- Histologically confirmed advanced ovarian clear cell carcinoma
- Known ARID1A mutation (by NGS testing)
- Received at least 1 line of platinum-based chemotherapy and must have received bevacizumab as part of any line of treatments unless contraindicated or locally not approved or locally not accessible
- Measurable disease per RECIST 1.1
- Patient must have disease progression after previously receiving effective and available standard of care treatment for clear cell ovarian cancer per local clinical practice
For Cohort M3, the following criteria should be considered:- Histologically or cytologically confirmed recurrent, metastatic, or unresectable endometrial carcinoma
- Known ARID1A mutation (by NGS testing)
- Received at least 1 line of platinum-based regimen in recurrent/metastatic setting
- Documented microsatellite instability (MSI)-high or deficient mismatch repair (dMMR) or patients who have non-dMMR/microsatellite stable tumors should have received an anti-PD-1 or anti-PD-L1 agent alone or in combination with the approved agents as applicable, as part of their prior treatments unless considered not eligible, contraindicated or if not locally approved
- Brachytherapy is allowed if completed >12 weeks before the first dose of study drug
- Measurable disease per RECIST 1.1
- Patients must have previously received effective and available standard of care treatment options for endometrial cancer per local clinical practice unless these are contraindicated
Updated on
01 Aug 2024.
Study ID: 850931
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