Sym021 in Combination With Either Sym022 or Sym023 in Patients With Advanced Solid Tumour Malignancies

Official Title

An Exploratory, Open-label, Multicentre Phase 1b Trial to Evaluate Safety and Efficacy of Sym021 (Anti-PD-1) in Combination With Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3) in Patients With Advanced Solid Tumour Malignancies

Summary:

This study will evaluate the preliminary efficacy of the 2 combinations (Sym021+Sym022 and Sym021+Sym023) in each tumour type under study by assessing ORRs per Investigator assessment using Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1. This study will also evaluate the safety and tolerability profile of the 2 combinations (Sym021+Sym022 and Sym021+Sym023)

Trial Description

Primary Outcome:

  • To evaluate the preliminary efficacy of the 2 combinations (Sym021+Sym022 and Sym021+Sym023) in each tumour type under study by assessing ORRs per Investigator assessment using Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
  • To evaluate the incidence, severity, and relationship of (S)AEs collected from administration of the first dose of study drug until 30 days after the last dose of the 2 combinations (Sym021+Sym022 and Sym021+Sym023)
  • To evaluate the AEs leading to dose interruption, dose delays, and permanent treatment stop of the 2 combinations (Sym021+Sym022 and Sym021+Sym023)
Secondary Outcome:
  • Peak Plasma Concentration (Cmax) of the 2 combinations (Sym021+Sym022 and Sym021+Sym023)
  • To confirm the RP2D of each combination
  • Evaluation of duration of response.
  • To evaluate the immunogenicity of each drug in the combinations
  • Area under the plasma concentration versus time curve (AUC) of the 2 combinations (Sym021+Sym022 and Sym021+Sym023)
  • Time to reach maximum concentration (Tmax) of the 2 combinations (Sym021+Sym022 and Sym021+Sym023)
  • Trough concentration (Ctrough) of the 2 combinations (Sym021+Sym022 and Sym021+Sym023)
  • Evaluation of Progression-Free Survival (PFS) (the PFS rate at 6 months will additionally be evaluated in patients with SCLC)
  • Evaluation of Disease Control Rate (DCR), defined as CR, PR, or stable disease (SD) ≥6 months
  • Evaluation of Objective Response Rate (ORR) per Investigator assessment (based on Immunotherapeutics Response Evaluation Criteria in Solid Tumours [iRECIST])
  • Evaluation Overall Survival (OS)
The study will evaluate safety and efficacy in participant with small cell lung cancer, urothelial cancer and bladder cancer who have developed resistance to prior anti-PD1 or anti-PD-L1 therapy and in patient with cholangiocarcinoma who have received at least 1 line of standard of care therapy and have progressed on it. Per 22nd of December 2020 recruitment for small cell lung cancer, urothelial cancer and bladder cancer has temporarily stopped due to strategy considerations. Recruitment for cholangiocarcinoma is still open. Per May 2021 recruitment into the trial is temporarily halted. Symphogen wish to halt recruitment during the first planned interim analysis as the recruitment is faster than expected and therefore many patient could be enrolled before the results of the interim analysis is known. A protocol amendment has been submitted 23rd of April to FDA including changes for the temporarily halt in recruitment during interim analysis.

View this trial on ClinicalTrials.gov

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Resources

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