A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumours

Official Title

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumours

Summary:

This is a multicentre, open-label, first-in-human Phase 1 study evaluating the anti-programmed death receptor 1 (anti-PD-1) antibody TSR-042 in patients with advanced solid tumours who have limited available treatment options. The study will be conducted in 2 parts: dose escalation and cohort expansion. The cohort expansion may include various tumour types, including endometrial, Non-Small Cell Lung cancer, and MSI-H solid tumours.

Trial Description

Primary Outcome:

  • To evaluate the safety and tolerability of TSR-042 in patients with advanced solid tumours and determine the recommended Phase 2 dose (RP2D) and schedule
  • To evaluate the antitumour activity of TSR-042 in patients with advanced solid tumours, in terms of objective response rate (ORR) and duration of response (DOR)
Secondary Outcome:
  • To evaluate the immunogenicity of TSR-042
  • To determine the pharmacokinetic profile of TSR-042
  • Immune-related disease control rate (irDCR), duration of response (irDOR) and overall response rate (irORR) based on Investigators' assessment using irRECIST
  • Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST
  • Overall Survival (OS)
  • Patient reported outcome (European Quality of Life scale, 5-Dimensions (EQ-5D-5L)
  • Patient reported outcome (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30))

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society