NL-201 in Patients With Relapsed or Refractory Cancer

Overview

About this study

The 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Brian Costello, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Cassandra Moore, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Winston Tan, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
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CLS-20522599

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