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Closed (no longer recruiting)Last updated: 11 April 2024

This phase I trial is trying to understand how safe a new cancer immunotherapy is for the treatment of patients with advanced cancer that have not responded to or are unable to receive other treatmentA First-in-Human Phase 1 Study of NL-201 in Patients With Relapsed or Refractory Cancer

Clinical summary


This is a dose escalation and expansion trial. Eligible patients will receive NHL-201 intravenously, testing ascending doses and two different schedules. Tumour response to treatment will be assessed every 6-weeks for 12 weeks, and every 12 weeks thereafter until disease progression. Patients enrolled in the expansion phase of this trial will receive NHL-201 intravenously at a dose and schedule determined in the escalation phase.


This trial is treating patients with advanced solid cancer (in part 1), including kidney cancer and skin cancer (in part 2).


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Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Neoleukin Therapeutics, Inc.

Scientific Title

A First-in-Human Phase 1 Study of NL-201 in Patients With Relapsed or Refractory Cancer



  • 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
  • Part 1 Only: 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
  • Part 3 Only: Patients with solid tumors who have received ≥ 1 prior line of therapy for advanced or metastatic disease
  • Part 4 Only: Patients with diagnosed target disease OR previously received pembrolizumab


  • 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.
  • Part 3 and 4 Only: History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Part 3 and 4 Only: Known additional cancer that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone curative resection are eligible.


  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.


  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.