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This Study Evaluates KRT-232, a Novel Oral Small Molecule Inhibitor of MDM2, for the Treatment of Patients With (p53WT) Merkel Cell Carcinoma Who Have Failed Anti-PD-1/ PD-L1 Immunotherapy

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ClinicalTrials.gov Identifier: NCT03787602
Recruitment Status : Recruiting
First Posted : December 26, 2018
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
Kartos Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 6, 2018
First Posted Date  ICMJE December 26, 2018
Last Update Posted Date December 30, 2019
Actual Study Start Date  ICMJE March 19, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
To determine the objective response rate (ORR) in subjects with p53WT MCC who have failed anti-PD-1 or anti-PDL-1 immunotherapy [ Time Frame: 42 days ]
The proportion of patients achieving a CR or PR as determined by RECIST 1.1 after 2 cycles of treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
  • To determine the duration of response (DoR) [ Time Frame: 1 year after last subject enrolled ]
    Time from documentation of response (CR or PR as determined by RECIST 1.1) until disease progression
  • To determine Progression-free survival (PFS) [ Time Frame: 1 year after last subject enrolled ]
    Time from initial treatment until disease progression
  • To determine overall survival (OS) [ Time Frame: 1 year after last subject enrolled ]
    Time from initial treatment until death from any cause
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE This Study Evaluates KRT-232, a Novel Oral Small Molecule Inhibitor of MDM2, for the Treatment of Patients With (p53WT) Merkel Cell Carcinoma Who Have Failed Anti-PD-1/ PD-L1 Immunotherapy
Official Title  ICMJE A Phase 2, Open-Label, Study 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
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 anti-PD-L1 immunotherapy. Inhibition of MDM2 is a novel mechanism of action in MCC.

This study is Phase 2, Open-Label, Study of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Merkel Cell Carcinoma
Intervention  ICMJE Drug: KRT-232
KRT-232, administered by mouth
Study Arms  ICMJE
  • Experimental: Experimental: Stage 1, Arm 1b
    KRT-232 240mg by mouth once daily for Days 1-5, off treatment for Days 6-28 (28-day cycles)
    Intervention: Drug: KRT-232
  • Experimental: Experimental: Stage 1, Arm 2b
    KRT-232 180mg by mouth once daily for Days 1-5, off treatment for Days 6-28 (28-day cycles)
    Intervention: Drug: KRT-232
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 26, 2019)
46
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2018)
27
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

    1. Hematologic: ANC ≥1.0 × 109/L in the absence of growth factors during the prior 7 days; platelet count ≥100 × 109/L
    2. 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
    3. Renal: estimated creatinine clearance >30 mL/min by Cockcroft Gault:

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: John Mei 650-542-0136 jmei@kartosthera.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03787602
Other Study ID Numbers  ICMJE KRT-232-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kartos Therapeutics, Inc.
Study Sponsor  ICMJE Kartos Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kartos Therapeutics, Inc.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP