Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Biliary Tract Carcinomas

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) or Sym023 and Irinotecan in Patients With Recurrent Advanced Biliary Tract Carcinomas

Summary:

The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinoma by assessing overall response rates (ORRs) per Investigator assessment using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 The study will also evaluate the safety and tolerability profile of the 3 combinations

Trial Description

Primary Outcome:

  • To evaluate the preliminary efficacy of the combinations Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan in patients with biliary tract carcinoma (BTC) by assessing overall response rates (ORRs) per Investigator assessment using RECISTv.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 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irrinotecan)
  • To evaluate the AEs leading to dose interruption, dose delays, and permanent treatment stop of the 3 combinations (Sym021+Sym022 and Sym021+Sym023 and Sym021+Sym023 +irinotecan)
Secondary Outcome:
  • Peak plasma (irinotecan) and serum( mAbs) Concentration (Cmax) of the 3 combinations (Sym021+Sym022 and Sym021+Sym023 and Sym021+Sym023+irinotecan)
  • Area under the serum concentration versus time curve (AUC) of the 3 combinations (Sym021+Sym022 and Sym021+Sym023 and Sym021+Sym023+ irinotecan)
  • Time to reach maximum concentration (Tmax) of the 3 combinations (Sym021+Sym022 and Sym021+Sym023 and Sym021+Sym023+irinotecan)
  • Trough concentration (Ctrough) of the 3 combinations (Sym021+Sym022 and Sym021+Sym023 and Sym021+Sym023 + irinotecan)
  • Plasma concentration for irinotecan and its metabolite in the combination Sym021+Sym023+ Irinotecan
  • To confirm the RP2D of each combination
  • Evaluation of Duration of Response (DOR)
  • Evaluation of Progression-Free Survival (PFS)
  • Evaluation of Disease Control Rate (DCR), defined as CR, PR, or stable disease (SD) ≥6 months
  • Evaluation of duration of response.
  • Evaluation of Objective Response Rate (ORR) per Investigator assessment (based on Immunotherapeutics Response Evaluation Criteria in Solid Tumours [iRECIST])
  • Evaluation Overall Survival (OS)
  • Evaluation of immunogenicity of each drug in the combinations
The study will evaluate safety and efficacy in patients with biliary tract tumours who have progressed on one prior line of gemcitabine and platinum-based chemotherapy in the metastatic setting. The trial is set up as 2 sub-studies. Sub-study 1 is composed of 2 investigational combination treatment arms (Sym021+Sym022 [Arm A] and Sym021+Sym023 [Arm B]). Sub-study 2, is composed of one investigational combination treatment arm: Sym021+Sym023+irinotecan. A safety lead-in phase is included to assess tolerability of the combination. A Study Safety Team will review clinical and laboratory safety data and will make decisions regarding the continued enrollment after the safety lead-in phase. August 2021 : Based upon results from a recent per protocol Interim Analysis (IA) it is has been decided as of 3rd of August 2021 to stop further enrollment into Sub-study 1 Arm A (Sym021+Sym022). Future patients will be allocated to either Sub-study 1 Arm B (Sym021+Sym023) or Sub-study 2 (Sym021+Sym023+irinotecan).

View this trial on ClinicalTrials.gov

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Resources

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