Clinical Trials /

NL-201 in Patients With Relapsed or Refractory Cancer

NCT04659629

Description:

The primary purpose of this study is to understand the safety of NL-201 when given intravenously as monotherapy in patients with advanced cancer to evaluate tolerability and to identify a recommended dose and schedule for further testing.

Related Conditions:
  • Kidney Carcinoma
  • Malignant Solid Tumor
  • Skin Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: NL-201 in Patients With Relapsed or Refractory Cancer
  • Official Title: A First-in-Human Phase 1 Study of NL-201 in Patients With Relapsed or Refractory Cancer

Clinical Trial IDs

  • ORG STUDY ID: NL201-101
  • NCT ID: NCT04659629

Conditions

  • Solid Tumor
  • Advanced Solid Tumor

Interventions

DrugSynonymsArms
NL-201Part 1: NL-201 Dose Escalation

Purpose

The primary purpose of this study is to understand the safety of NL-201 when given intravenously as monotherapy in patients with advanced cancer to evaluate tolerability and to identify a recommended dose and schedule for further testing.

Detailed Description

      Patients will have tests and exams to see if they are eligible for the clinical trial.

      If eligible, the patient will receive NL-201 treatment by vein. Tumor response to treatment
      will be assessed every 6 weeks for 12 weeks, and every 12 weeks thereafter until disease
      progression.

      Patients will be able to receive study treatment as long as it is tolerated and there is
      evidence of clinical benefit. Safety follow- up will occur within 7 days after the last dose
      of NL-201. Patients will then enter long-term follow-up until starting a subsequent therapy.
    

Trial Arms

NameTypeDescriptionInterventions
Part 1: NL-201 Dose EscalationExperimentalNL-201 given by intravenous administration testing ascending doses and two different schedules.
  • NL-201
Part 2: NL201 Expansion CohortsExperimentalNL-201 given by intravenous administration in indication specific cohorts at a dose and schedule determined in Part 1.
  • NL-201

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with measurable disease

          -  Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  At least 6 weeks from any prior nitrosurea or mitomycin C therapy; at least 4 weeks
             from any other prior chemotherapy or checkpoint inhibitor; at least 2 weeks from any
             kinase inhibitor

          -  Patients with relapsed or refractory advanced solid tumor, other than prostate cancer,
             who have progressed, not tolerated or are ineligible for all approved lines of therapy

          -  Part 2 Only: Patients with kidney and skin cancer who have failed at least 1 line of
             systemic therapy

        Exclusion Criteria:

          -  Prostate Cancer

          -  Any serious medical condition or laboratory abnormality or psychiatric condition or
             any other significant or unstable concurrent medical illness (in the opinion of the
             Investigator) would preclude protocol adherence or would make the safety of the study
             drug difficult to assess

          -  Known or suspected SARS-CoV-2 infection, unless patient tests negative for SARS-CoV-2
             within the Screening period

          -  History of solid organ transplant or bone marrow transplant

          -  Prior CAR-T or allogeneic cellular therapy

          -  Prior IL-2-based cancer therapy

          -  Ongoing systemic immunosuppressive therapy

          -  Concurrent therapy with any other investigational agent, vaccine, or device.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Recommended phase 2 dose (RP2D) for NL-201
Time Frame:Up to Day 33
Safety Issue:
Description:Evaluation of tolerability of NL-201 as measured by number of subjects with dose limiting toxicities (DLTs)

Secondary Outcome Measures

Measure:Best Objective Response according to RECIST version 1.1
Time Frame:Up to 36 months
Safety Issue:
Description:Based on Investigator assessment of radiographic imaging
Measure:Objective Response Rate (ORR) according to RECIST version 1.1
Time Frame:Up to 36 months
Safety Issue:
Description:Based on Investigator assessment of radiographic imaging
Measure:Progression-Free Survival (PFS) according to RECIST version 1.1
Time Frame:Up to 36 months
Safety Issue:
Description:Based on Investigator assessment of radiographic imaging
Measure:Duration of Response (DOR) according to RECIST version 1.1
Time Frame:Upto 36 months
Safety Issue:
Description:Based on Investigator assessment of radiographic imaging
Measure:Pharmacokinetic (PK) profile of NL-201 by half-life (t1/2)
Time Frame:Up to 24 Months
Safety Issue:
Description:Prespecified timepoints in serum before and after dosing with NL-201.
Measure:Pharmacokinetic (PK) profile of NL-201 by area under the plasma concentration time curve (AUC)
Time Frame:Up to 24 months
Safety Issue:
Description:Prespecified timepoints in serum before and after dosing with NL-201.
Measure:Pharmacokinetic (PK) profile of NL-201 by maximum observed plasma concentration (Cmax)
Time Frame:Up to 24 months
Safety Issue:
Description:Prespecified timepoints in serum before and after dosing with NL-201.
Measure:Pharmacokinetic (PK) profile of NL-201 by volume of distribution (Vd)
Time Frame:Up to 24 Months
Safety Issue:
Description:Prespecified timepoints in serum before and after dosing with NL-201.
Measure:Immunogenicity of NL-201
Time Frame:Up to 24 months
Safety Issue:
Description:Anti-drug antibodies in serum during and after treatment with NL-201

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Neoleukin Therapeutics, Inc.

Trial Keywords

  • Cancer
  • NL-201
  • NL201-101
  • Phase 1
  • Immunotherapy
  • Cytokine

Last Updated

April 6, 2021