Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

NL-201 in Patients With Relapsed or Refractory Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04659629
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Neoleukin Therapeutics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Advanced Solid Tumor Drug: NL-201 Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First-in-Human Phase 1 Study of NL-201 in Patients With Relapsed or Refractory Cancer
Actual Study Start Date : April 26, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Experimental: Part 1: NL-201 Dose Escalation
NL-201 given by intravenous administration testing ascending doses and two different schedules.
Drug: NL-201
NL-201 is a de novo protein therapeutic.

Experimental: Part 2: NL201 Expansion Cohorts
NL-201 given by intravenous administration in indication specific cohorts at a dose and schedule determined in Part 1.
Drug: NL-201
NL-201 is a de novo protein therapeutic.




Primary Outcome Measures :
  1. Recommended phase 2 dose (RP2D) for NL-201 [ Time Frame: Up to Day 33 ]
    Evaluation of tolerability of NL-201 as measured by number of subjects with dose limiting toxicities (DLTs)

  2. Recommended dose schedule for NL-201 [ Time Frame: Up to Day 33 ]
    Evaluation of tolerability of NL-201 as measured by number of subjects with dose limiting toxicities (DLTs)

  3. Incidence of treatment-emergent adverse events [ Time Frame: Up to Day 33 ]
    Rate of adverse events in patients with advanced solid tumors

  4. Severity of treatment-emergent adverse events [ Time Frame: Up to Day 33 ]
    Rate of adverse event grades in patients with advanced solid tumors


Secondary Outcome Measures :
  1. Best Objective Response according to RECIST version 1.1 [ Time Frame: Up to 36 months ]
    Based on Investigator assessment of radiographic imaging

  2. Objective Response Rate (ORR) according to RECIST version 1.1 [ Time Frame: Up to 36 months ]
    Based on Investigator assessment of radiographic imaging

  3. Progression-Free Survival (PFS) according to RECIST version 1.1 [ Time Frame: Up to 36 months ]
    Based on Investigator assessment of radiographic imaging

  4. Duration of Response (DOR) according to RECIST version 1.1 [ Time Frame: Upto 36 months ]
    Based on Investigator assessment of radiographic imaging

  5. Pharmacokinetic (PK) profile of NL-201 by half-life (t1/2) [ Time Frame: Up to 24 Months ]
    Prespecified timepoints in serum before and after dosing with NL-201.

  6. Pharmacokinetic (PK) profile of NL-201 by area under the plasma concentration time curve (AUC) [ Time Frame: Up to 24 months ]
    Prespecified timepoints in serum before and after dosing with NL-201.

  7. Pharmacokinetic (PK) profile of NL-201 by maximum observed plasma concentration (Cmax) [ Time Frame: Up to 24 months ]
    Prespecified timepoints in serum before and after dosing with NL-201.

  8. Pharmacokinetic (PK) profile of NL-201 by volume of distribution (Vd) [ Time Frame: Up to 24 Months ]
    Prespecified timepoints in serum before and after dosing with NL-201.

  9. Immunogenicity of NL-201 [ Time Frame: Up to 24 months ]
    Anti-drug antibodies in serum during and after treatment with NL-201


Other Outcome Measures:
  1. Flow cytometry analysis of immune cells in blood [ Time Frame: Up to 36 months ]
    Based on appropriate assay

  2. Serum measurements of inflammatory cytokine levels [ Time Frame: Up to 36 months ]
    Based on appropriate assay

  3. Analysis of immune characteristics of the tumor microenvironment [ Time Frame: Up to 36 months ]
    Based on appropriate assay

  4. Estimate additional measures of anti-tumor activity of NL- 201 per iRECIST criteria [ Time Frame: Up to 36 months ]
    Based on Investigator assessment of imaging



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04659629


Contacts
Layout table for location contacts
Contact: Mary Lessig 800-718-4951 clinicaltrials@neoleukin.com

Locations
Layout table for location information
United States, Arizona
Mayo Clinic Scottsdale/ Phoenix Not yet recruiting
Phoenix, Arizona, United States, 85054
Principal Investigator: Cassandra Moore, MD         
United States, Florida
Mayo Clinic Jacksonville Not yet recruiting
Jacksonville, Florida, United States, 32224
Principal Investigator: Winston Tan, MD         
United States, Minnesota
Mayo Clinic Rochester Not yet recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Brian Costello, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Parth Patel         
United States, Oregon
Providence Cancer Center Oncology and Hematology Care Clinic Recruiting
Portland, Oregon, United States, 97213
Contact: Kim Sutliffe         
United States, Texas
UT- MD Anderson Recruiting
Houston, Texas, United States, 77230
Contact: Andrew Nguyen         
United States, Washington
Seattle Cancer Care Alliance Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Erin Shaw         
Australia, New South Wales
St Vincents Hospital Recruiting
Sydney, New South Wales, Australia
Contact: Robert Kent         
Principal Investigator: Anthony Joshua, MD         
Australia, Victoria
Olivia Newton-John Cancer Wellness & Research Centre Recruiting
Heidelberg, Victoria, Australia
Contact: Sarah Healy         
Principal Investigator: Andrew Weickhardt, MD         
Canada, Ontario
UHN - Princess Margaret Cancer Center Not yet recruiting
Toronto, Ontario, Canada, M5G1Z5
Contact: Stephanie Zantinge         
Sponsors and Collaborators
Neoleukin Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: Umut Ulge, MD, PhD Neoleukin
Layout table for additonal information
Responsible Party: Neoleukin Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04659629    
Other Study ID Numbers: NL201-101
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neoleukin Therapeutics, Inc.:
Cancer
NL-201
NL201-101
Phase 1
Immunotherapy
Cytokine
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms