NL-201 Monotherapy and in Combination With Pembrolizumab in Patients With Relapsed or Refractory Cancer
Completed · Phase 1
Conditions studied: Solid Tumor, Advanced Solid Tumor
In brief
Parts 1 and 2 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. In Part 1, there will be backfill cohorts at certain Data Monitoring Committee (DMC)-cleared dose levels and schedules to collect pharmacokinetic (PK), pharmacodynamic (PD) and response data in certain tumor types or to explore additional pre-medication regimens. Parts 3 and 4 The primary purpose of this study is to understand the safety of NL-201 in combination with pembrolizumab when both drugs are given intravenously in patients with advanced cancer, to evaluate tolerability, and to identify a recommended dose and schedule for further testing.
Key facts
- Study ID
- NCT04659629
- Run by
- Neurogene Inc.
- People needed
- 59
- Starts
- 2021-04-26
- Expected to finish
- 2024-08-15
- Last updated by the study team
- 2024-10-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 chimeric antigen receptor T-cell (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.
Where it is running
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Providence Cancer Center Oncology and Hematology Care Clinic — Portland, Oregon, United States
- UT- MD Anderson — Houston, Texas, United States
- Seattle Cancer Care Alliance — Seattle, Washington, United States
- Melanoma Institute Australia — Sydney, New South Wales, Australia
- St Vincents Hospital — Sydney, New South Wales, Australia
- Olivia Newton-John Cancer Wellness & Research Centre — Heidelberg, Victoria, Australia
- UHN - Princess Margaret Cancer Center — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.