NL-201 in Patients With Relapsed or Refractory Cancer

Official Title

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

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.

Trial Description

Primary Outcome:

• Recommended phase 2 dose (RP2D) for NL-201
• Recommended dose schedule for NL-201
• Incidence of treatment-emergent adverse events
• Severity of treatment-emergent adverse events

Secondary Outcome:

• Best Objective Response according to RECIST version 1.1
• Objective Response Rate (ORR) according to RECIST version 1.1
• Progression-Free Survival (PFS) according to RECIST version 1.1
• Duration of Response (DOR) according to RECIST version 1.1
• Pharmacokinetic (PK) profile of NL-201 by half-life (t1/2)
• Pharmacokinetic (PK) profile of NL-201 by area under the plasma concentration time curve (AUC)
• Pharmacokinetic (PK) profile of NL-201 by maximum observed plasma concentration (Cmax)
• Pharmacokinetic (PK) profile of NL-201 by volume of distribution (Vd)
• Immunogenicity of NL-201

Patients will have tests and exams to see if they are eligible for the clinical trial. If eligible, the patient will receive NL-201 treatment by vein. Tumour response to treatment will be assessed every 6 weeks for 12 weeks, and every 12 weeks thereafter until disease progression. Patients will be able to receive study treatment as long as it is tolerated and there is evidence of clinical benefit. Safety follow- up will occur within 7 days after the last dose of NL-201. Patients will then enter long-term follow-up until starting a subsequent therapy.

View this trial on ClinicalTrials.gov