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.
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
Drug | Synonyms | Arms |
---|
NL-201 | | Part 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
Name | Type | Description | Interventions |
---|
Part 1: NL-201 Dose Escalation | Experimental | NL-201 given by intravenous administration testing ascending doses and two different schedules. | |
Part 2: NL201 Expansion Cohorts | Experimental | NL-201 given by intravenous administration in indication specific cohorts at a dose and schedule determined in Part 1. | |
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: | Recruiting |
Lead Sponsor: | Neoleukin Therapeutics, Inc. |
Trial Keywords
- Cancer
- NL-201
- NL201-101
- Phase 1
- Immunotherapy
- Cytokine
Last Updated
May 26, 2021