Status:
UNKNOWN
Navtemadlin (KRT-232) With or Without Anti-PD-1/Anti-PD-L1 for the Treatment of Patients With Merkel Cell Carcinoma
Lead Sponsor:
Kartos Therapeutics, Inc.
Conditions:
Merkel Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Merkel Cell Carcinoma (MCC) who have failed treatment with at least one anti-PD-1 or ant...
Eligibility Criteria
Inclusion
- For Cohort 1, 3 and 4 patients must have failed treatment with at least one PD-1 inhibitor or PD-L1 inhibitor for metastatic MCC
- For Cohort 2, patients must not have received any anti-PD-1 or anti-PD-L1 therapy
- For Cohort 3, patients must not have received any prior chemotherapy
- For Cohort 4, patients must have received at least one prior line of chemotherapy
- ECOG performance status of 0 to 1
- Histologically confirmed MCC. Disease must be measurable, with at least 1 measurable lesion by RECIST 1.1
- MCC expressing p53WT based on any CLIA or test approved by local health authority or a validated test (Cohort 1 and 2)
- MCC expressing p53WT based Central Lab test (Cohort 3 and 4)
- Adequate hematological, hepatic, and renal functions
Exclusion
- For Cohort 2, subjects must not have autoimmune disease, medical conditions requiring systemic immunosuppression, prior stem cell transplant, or active infection with HBV or HCV.
- Patients previously treated with MDM2 antagonist therapies or p53-directed therapies
- History of major organ transplant
- Patients with known central nervous system (CNS) metastases that are previously untreated
- Grade 2 or higher QTc prolongation (\>480 milli-seconds per NCI-CTCAE criteria, version 5.0)
Key Trial Info
Start Date :
March 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT03787602
Start Date
March 19 2019
End Date
August 1 2025
Last Update
March 2 2023
Active Locations (51)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
Miami Cancer Institute
Miami, Florida, United States, 33176
3
Moffitt
Tampa, Florida, United States, 33612
4
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60612