Endometrial Cancer Clinical Trial
Official title:
A Phase 1/2 Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas
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.
Emerging evidence suggests that EZH2 is overexpressed in many cancer types and has a pivotal role in disease progression. This is a Phase 1/2, open-label, multi-center, FIH study designed to evaluate the safety and tolerability and preliminary clinical activity of CPI-0209, an EZH2/1 inhibitor as monotherapy in patients with advanced solid tumors and lymphomas. Phase 1 is composed of a CPI-0209 Dose Escalation period in patients with advanced tumors and aims to determine maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of CPI-0209 as monotherapy in patients with advanced tumors. Phase 2 is planned to evaluate safety and tolerability and antitumor activity of CPI-0209 in six disease-specific cohorts (M1 to M6). Patients in Cohorts M1, M2, M3, M5, and M6 will be enrolled at 10 to 29 patients per cohort, using a Simon 2-stage design. Cohort M4 will enroll up to 20 patients with lymphoma in a single-stage. The primary aim of Phase 2 part of the study is to evaluate the antitumor activity of CPI-0209, and characterize the safety and tolerability of CPI-0209 as monotherapy in patients with selected tumors. In Phase 2, two additional doses are planned to be evaluated in cohorts M2 and M3 in 2 stages: Stage 2a and Stage 2b. In Stage 2a approximately 20 patients will be enrolled per cohort and will be randomized 1:1 to receive 2 prespecified dose levels of CPI-0209 once daily. When protocol criteria for initiating Stage 2b will be fulfilled after completion of Stage 2a, then Stage 2b will be opened for enrolment of additional 10 patients in one or both dose arms in each of the two cohorts. Thus, up to 40 patients per cohort (M2 and M3) could be enrolled. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05796518 -
Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
|
N/A | |
| Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
| Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06463028 -
Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, Serabelisib With Paclitaxel, and Paclitaxel Alone in Patients With Advanced/Recurrent Endometrial Cancer
|
Phase 2 | |
| Recruiting |
NCT06036836 -
Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)
|
Phase 2 | |
| Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
| Completed |
NCT03820024 -
MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback
|
N/A | |
| Active, not recruiting |
NCT05082025 -
Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations
|
Phase 2 | |
| Active, not recruiting |
NCT00587886 -
Estrogen, Diet, Genetics and Endometrial Cancer
|
||
| Completed |
NCT05378152 -
Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity
|
N/A | |
| Suspended |
NCT05124743 -
HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
|
||
| Recruiting |
NCT03876860 -
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis
|
N/A | |
| Recruiting |
NCT04569773 -
Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer
|
||
| Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
| Not yet recruiting |
NCT06366347 -
ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab
|
Phase 2 | |
| Not yet recruiting |
NCT06073184 -
Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
|
Phase 2 | |
| Not yet recruiting |
NCT05998798 -
Revealing Engagement Patterns Among Endometrial Cancer Patients
|
||
| Terminated |
NCT02907073 -
Positron Emission Tomography (PET) Imaging Studies With NIS Reporter
|
Phase 1/Phase 2 | |
| Completed |
NCT02413606 -
ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More?
|
N/A |