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History of Changes for Study: NCT04659629
NL-201 in Patients With Relapsed or Refractory Cancer
Latest version (submitted August 30, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 2, 2020 None (earliest Version on record)
2 March 1, 2021 Study Status
3 April 5, 2021 Contacts/Locations and Study Status
4 April 26, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
5 May 25, 2021 Study Status and Contacts/Locations
6 August 26, 2021 Contacts/Locations and Study Status
7 September 30, 2021 Contacts/Locations and Study Status
8 November 29, 2021 Contacts/Locations and Study Status
9 February 9, 2022 Arms and Interventions, Contacts/Locations, Outcome Measures, Study Design, Study Description, Study Status, Eligibility, Conditions and Sponsor/Collaborators
10 August 30, 2022 Contacts/Locations and Study Status
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Study NCT04659629
Submitted Date:  December 2, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: NL201-101
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
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2020
Overall Status: Not yet recruiting
Study Start: December 2020
Primary Completion: May 2023 [Anticipated]
Study Completion: December 2024 [Anticipated]
First Submitted: November 9, 2020
First Submitted that
Met QC Criteria:
December 2, 2020
First Posted: December 9, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
December 2, 2020
Last Update Posted: December 9, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Neoleukin Therapeutics, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
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.

Open or close this module Conditions
Conditions: Solid Tumor
Advanced Solid Tumor
Keywords: Cancer
NL-201
NL201-101
Phase 1
Immunotherapy
Cytokine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 120 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Mary Lessig
Telephone: 800-718-4951
Email: clinicaltrials@neoleukin.com
Study Officials: Umut Ulge, MD, PhD
Study Director
Neoleukin
Locations: United States, New York
NYU Lagone Health
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Contact:Contact: Erin Frederickson
United States, Oregon
Providence Cancer Center Oncology and Hematology Care Clinic
Portland, Oregon, United States, 97213
Contact:Contact: Tara Foote
United States, Texas
UT- MD Anderson
Houston, Texas, United States, 77230
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Contact:Contact: Erin Shaw
Australia, New South Wales
St Vincents Hospital
Sydney, New South Wales, Australia
Contact:Contact: Robert Kent
Australia, Victoria
Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg, Victoria, Australia
Contact:Contact: Sarah Healy
Canada, Ontario
UHN - Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G1Z5
Contact:Contact: Stephanie Zantinge
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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