A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT)M erkel 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 - KRT-232-103 study

Kartos Therapeutics, Inc.0 sites8 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•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. Failure is defined as any
•subject whose disease has progressed (by RECIST criteria) or those who are
•intolerant to PD\-1 inhibitor or PD\-L1 inhibitor treatment. Any PD\-1 inhibitor
•or PD\-L1 inhibitor may have been used at any time in the past, with no limit or
•minimum duration required.
•2\. For Cohort 2, subjects must not have received any anti\-PD\-1 or
•anti\-PD\-L1therapy.
•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

•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)

Not specified