A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients who are Anti-PD-1 or Anti-PD-L1 Treatment Naïve

Kartos Therapeutics, Inc.0 sites175 target enrollmentOctober 21, 2021

Conditionsp53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC)MedDRA version: 21.1Level: LLTClassification code 10064025Term: Merkel cell carcinomaSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsBavencio

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC)
Sponsor: Kartos Therapeutics, Inc.
Enrollment: 175
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 21, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Kartos Therapeutics, Inc.

Eligibility Criteria

Inclusion Criteria

•1\. For Cohorts 1, 3 and 4, subjects must have failed treatment with at least one PD\-1 inhibitor or PD\-L1 inhibitor for metastatic MCC
•2\. For Cohort 2, subjects must not have received any anti\-PD\-1 or anti\-PD\-L1 treatments for metastatic MCC
•3\. For Cohort 3, subjects must not have received any prior chemotherapy.
•4\. For Cohort 4, subjects must have received at least 1 line of prior chemotherapy
•5\. Adults \= 18 years of age and willing to provide written informed consent
•6\. ECOG performance status of 0 to 1
•7\. Histologically confirmed MCC. Disease must be measurable, with at least 1 measurable lesion by RECIST criteria, version 1\.1
•8\. For Cohorts 1 and 2: MCC expressing p53WT based on any CLIA or FDA approved sequencing test or by a test approved by the local health authority or, if not available, by a validated test. For Cohort 2, subjects may be enrolled and treated with avelumab monotherapy before p53WT status is known
•9\. For Cohorts 3 and 4: MCC expressing p53WT based on Central Laboratory testing
•10\. Fresh or archival tumor tissue must be submitted for biomarker assessment.

Exclusion Criteria

•1\. 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
•2\. Concurrent anticancer treatment such as chemotherapy, cytoreductive therapy, immune therapy, or cytokine therapy within 28 days or approximately 5 half\-lives, whichever is shorter, prior to the first dose of KRT\-232
•3\. Radiation therapy within 2 weeks prior to the first dose of KRT\-232
•4\. Toxicity from prior radiation therapy that has not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI\-CTCAE) Grade 0 or Grade 1 (with the exception of Grade 2 alopecia)
•5\. Participation in another interventional clinical trial within the past 4 weeks of the first dose of KRT 232 (participation in observational studies is permitted)
•6\. Patients previously treated with MDM2 antagonist therapies or p53\-directed therapies
•7\. Women who are pregnant or breastfeeding
•8\. History of major organ transplant
•9\. Subjects with known central nervous system (CNS) metastases that are previously untreated
•10\. Uncontrolled intercurrent illness including, but not limited to, acute hepatitis A; known history of human immunodeficiency virus (HIV)\-positive; clinically significant cardiac disease (New York Heart Association Class III or IV); symptomatic congestive heart failure; unstable angina pectoris; ventricular arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements