Clinical Trials /

Safety of SNK01 in Subjects With Pathologically Confirmed Metastatic and/or Unresectable Cancer Refractory to Conventional Therapy

NCT03941262

Description:

The purpose of the study is to evaluate the safety and preliminary efficacy of SNK01 (autologous natural killer cell), as a single agent and in combination with avelumab or pembrolizumab, for the treatment of subjects with advanced and/or metastatic refractory cancer that has failed three or more prior lines of conventional standard of care therapy.

Related Conditions:
  • Cancer
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety of SNK01 in Subjects With Pathologically Confirmed Metastatic and/or Unresectable Cancer Refractory to Conventional Therapy
  • Official Title: Phase 1, Open-Label, Safety Study of Escalating Doses of Ex Vivo Expanded, Autologous Natural Killer Cells in Patients With Pathologically Confirmed Cancer Refractory to Conventional Therapy

Clinical Trial IDs

  • ORG STUDY ID: SNK01-US01
  • NCT ID: NCT03941262

Conditions

  • Refractory Cancer
  • Metastatic Cancer
  • Recurrent Cancer
  • Unresectable Carcinoma
  • Solid Tumor, Adult
  • Advanced Cancer
  • Advanced Solid Tumor

Interventions

DrugSynonymsArms
SNK01Cohort 1 - Low dose SNK01
AvelumabBavencioCohort 4 - SNK01 with avelumab
PembrolizumabKeytrudaCohort 4 - SNK01 with pembrolizumab

Purpose

The purpose of the study is to evaluate the safety and preliminary efficacy of SNK01 (autologous natural killer cell), as a single agent and in combination with avelumab or pembrolizumab, for the treatment of subjects with advanced and/or metastatic refractory cancer that has failed three or more prior lines of conventional standard of care therapy.

Trial Arms

NameTypeDescriptionInterventions
Cohort 1 - Low dose SNK01ExperimentalSNK01 (low dose) administered once a week for five weeks.
  • SNK01
Cohort 2 - Medium dose SNK01ExperimentalSNK01 (medium dose) administered once a week for five weeks.
  • SNK01
Cohort 3 - High dose SNK01ExperimentalSNK01 (high dose) administered once a week for five weeks.
  • SNK01
Cohort 4 - SNK01 with avelumabExperimentalSNK01 (high dose) administered in combination with avelumab once every two weeks (14-day cycle) for five cycles.
  • SNK01
  • Avelumab
Cohort 4 - SNK01 with pembrolizumabExperimentalSNK01 (high dose) administered in combination with pembrolizumab once every three weeks (21-day cycle) for five cycles.
  • SNK01
  • Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Voluntary written informed consent signed by patient, obtained prior to study
             enrollment.

          -  Males and females ages 18 to 75 years, inclusive.

          -  Pathologically confirmed diagnosis of refractory cancer that has failed three or more
             prior lines of conventional standard of care therapy.

          -  Diagnosed with any histologically confirmed malignancy whose disease is confirmed to
             be metastatic and/or unresectable for which standard curative or beneficial treatments
             are no longer effective.

          -  Eastern Cooperative Oncology Group (ECOG) performance status <2.

          -  At least 4 weeks since any prior systemic therapy (excluding corticosteroid therapy)
             to treat the underlying malignancy (standard or investigational).

          -  At least 2 weeks since prior palliative radiotherapy.

          -  Adequate bone marrow function:

               -  Neutrophils: 2.0-8.0 K/uL

               -  Platelet Count: 140-440 K/uL

               -  Hemoglobin: 10.0-18.0 g/dL

               -  No ongoing transfusion requirements

          -  Adequate hepatic function:

               -  Serum total bilirubin < 1.5 x upper limit of normal (ULN)

               -  Serum albumin ≥ 3.0 g/dL

               -  Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN

               -  International normalized ratio (INR) ≤ 1.5 x ULN

          -  Adequate renal function with creatinine ≤ 2.0 mg/dL.

          -  Patients with central nervous system (CNS) metastasis amenable to stereotactic surgery
             and/or uncontrolled primary brain tumors.

          -  Negative pregnancy test for women of childbearing potential and use of effective
             contraception (hormonal or barrier method of birth control) during study.

        Exclusion Criteria:

          -  Pregnant and/or lactating females.

          -  Life expectancy of less than three months.

          -  Currently being treated by "biological therapy" as defined by the National Cancer
             Institute (example: checkpoint inhibitors, adoptive cell transfer, monoclonal
             antibodies, treatment vaccines, cytokines, Bacillus Calmette-Guerin (BCG), chimeric
             antigen receptor T cell therapy (CAR-T), and natural killer cell therapy).

          -  Patients tested positive for hepatitis B and/or C surface antigen.

          -  High fever or any active or unresolved infection, including human immunodeficiency
             virus (HIV) positive.

          -  Autoimmune disease requiring therapy; immunodeficiency, or any disease process
             requiring immunosuppressive therapy.

          -  Prior clinical trial requiring patient to receive an investigational drug within two
             weeks of enrollment.

          -  Congestive heart failure, unstable angina or other underlying cardiac disease; history
             of thrombosis currently requiring anticoagulation.

          -  Mental or psychological illness preventing cooperation with treatment, efficacy
             evaluations, or unable to understand the informed consent process.

          -  Adult subjects who lack capacity to consent for themselves and for whom consent must
             be provided by a legally authorized representative.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:To assess the safety profile
Time Frame:Up to 6 months
Safety Issue:
Description:Assessed by the incidence and severity of dose limiting toxicity (DLT) and other adverse events graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 5.0, or the cytokine release syndrome revised grading system.

Secondary Outcome Measures

Measure:To assess clinical objective response rate (ORR) of SNK01 in patients with refractory cancer
Time Frame:Up to 12 months
Safety Issue:
Description:Objective response rate (ORR) is defined by the percentage of subjects who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
Measure:To assess clinical objective response rate (ORR) of SNK01 in combination with avelumab in patients with refractory cancer
Time Frame:Up to 12 months
Safety Issue:
Description:Objective response rate (ORR) is defined by the percentage of subjects who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
Measure:To assess clinical objective response rate (ORR) of SNK01 in combination with pembrolizumab in patients with refractory cancer
Time Frame:Up to 12 months
Safety Issue:
Description:Objective response rate (ORR) is defined by the percentage of subjects who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:NKMax America, Inc.

Trial Keywords

  • Natural killer cell
  • NK cell
  • Expanded natural killer cell
  • Immunotherapy
  • Cancer
  • Metastatic cancer
  • Advanced solid tumor
  • Refractory cancer
  • Recurrent cancer
  • Unresectable carcinoma
  • Solid tumor
  • Neoplasms

Last Updated

July 18, 2020