Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
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.
Conditions
This trial is treating people with advanced solid cancer (in part 1), including kidney cancer and skin cancer (in part 2)
Eligibility
Inclusion
- 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
Exclusion
- 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.
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Neoleukin Therapeutics, Inc.
Scientific Title
A First-in-Human Phase 1 Study of NL-201 in Patients With Relapsed or Refractory Cancer
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