Moffitt Cancer Center: Clinical Trial 20254

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Clinical Trial 20254

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT03787602

Phase: Phase II
Prinicipal Investigator: Brohl, Andrew

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

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 Naive

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 anti-PD-L1 immunotherapy. Inhibition of MDM2 is a novel mechanism of action in MCC.

Objective

To determine the objective response rate (ORR) in subjects with p53WT MCC who have failed anti-PD-1 or anti-PDL-1 immunotherapy Secondary Objectives: To determine duration of response (DoR) - To determine progression-free survival (PFS) - To determine overall survival (OS) - To determine the pharmacokinetic/ pharmacodynamic (PK/PD) profile of KRT-232 - To determine KRT-232 safety and tolerability

Treatments

Therapies

Therapy (NOS)

Medications

Avelumab (); KRT-232 (); MSB00100718C (Avelumab)

Inclusion Criteria

Inclusion Criteria:

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 FDA approved test

Patients must have failed (i.e., relapsed or were refractory to) treatment with at least one PD-1 inhibitor or PD-L1 inhibitor for MCC

Fresh or archival tumor tissue must be submitted for biomarker assessment. Archival tissue samples must have been obtained from biopsy performed ≤ 2 years before the date of signing the informed consent for this study. Adequate hematological, hepatic, and renal function within 14 days prior to the first dose of KRT-232: (a) Hematologic: ANC ≥1.0 × 109/L in the absence of growth factors during the prior 7 days; platelet count ≥100 × 109/L (b) Hepatic: total bilirubin ≤2.0 times the upper limit of normal (ULN), unless Gilbert's Syndrome; aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) ≤2.5 ULN (c) Renal: estimated creatinine clearance >30 mL/min by Cockcroft Gault.

Exclusion Criteria

Exclusion Criteria:

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

Radiation therapy within 2 weeks prior to the first dose of KRT-232

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)

Participation in another interventional clinical trial within the past 4 weeks of the first dose of KRT-232

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

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.