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 multi-centre, open-label, first-in-human Phase 1 study evaluating the anti-programmed death receptor 1 (anti-PD-1) antibody dostarlimab (also known as 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 non-endometrial deficient mismatch repair (dMMR)/microsatellite instability-high (MSI-H) solid tumours.

Trial Description

Primary Outcome:

  • To evaluate the safety and tolerability of dostarlimab in patients with advanced solid tumours and determine the recommended Phase 2 dose (RP2D) and schedule.
  • Evaluate antitumour activity of dostarlimab in patients with recurrent or advanced mismatch repair deficient/microsatellite instability-high cancers, including dMMR/MSI-H endometrial and non-endometrial dMMR/MSI-H cancers, as to objective response rate
  • Evaluate antitumour activity of dostarlimab in patients with recurrent or advanced mismatch repair deficient/microsatellite instability-high cancers, including dMMR/MSI-H endometrial and non-endometrial dMMR/MSI-H cancers, as to duration of response
  • To evaluate the antitumour activity of dostarlimab in patients with recurrent or advanced mismatch repair proficient (MMR-proficient)/microsatellite stable (MSS) endometrial cancer, in terms of objective response rate (ORR).
  • To evaluate the antitumour activity of dostarlimab in patients with recurrent or advanced mismatch repair proficient (MMR-proficient)/microsatellite stable (MSS) endometrial cancer, in terms of duration of response (DOR).
  • To evaluate the antitumour activity of dostarlimab in patients with non-small cell lung cancer (NSCLC), in terms of immune-related objective response rate (irORR).
Secondary Outcome:
  • To evaluate the immunogenicity of dostarlimab
  • To assess Area Under the Curve (AUC)
  • To assess Minimum Concentration (Cmin)
  • To assess Maximum Concentration (Cmax)
  • To assess Volume of Distribution (Vz)
  • To assess Clearance (CL)
  • To assess AUC at steady state (AUCss)
  • To assess Cmin at steady state (Cmin,ss)
  • To assess Cmax at steady state (Cmax,ss)
  • To evaluate disease control rate (DCR)
  • To evaluate immune-related disease control rate (irDCR)
  • To evaluate duration of response (DOR)
  • To evaluate immune-related duration of response (irDOR)
  • To evaluate overall response rate (ORR)
  • To evaluate overall immune-related response rate (irORR)
  • Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST
  • Overall Survival (OS)

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society