NL-201 in Patients With Relapsed or Refractory Cancer

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neoleukin Therapeutics, Inc.

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.