Evaluation of SAR408701 in Patients With Advanced Solid Tumours

Official Title

A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumour Activity of SAR408701 in Patients With Advanced Solid Tumours

Summary:

Primary Objectives: - To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy to patients with advanced solid tumours (Escalation Phase). - To assess efficacy according to Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1) (Expansion Phase). Secondary Objectives: - To characterize the overall safety profile of SAR408701. - To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential circulating derivatives. - To identify the recommended phase 2 dose (RP2D) of SAR408701. - To assess the potential immunogenicity of SAR408701.

Trial Description

Primary Outcome:

  • Number of dose limiting adverse events
  • Assessment of overall response rate using standard imaging and RECIST 1.1 criteria
Secondary Outcome:
  • Number of treatment emergent adverse events
  • Maximum concentration (Cmax)
  • Time to reach maximum concentration (tmax)
  • Trough plasma concentrations (Ctrough)
  • Area under the plasma concentration curve versus time curve between 0 and 14 days (AUC0-14day)
  • Mean systemic clearance (CL)
  • Clearance at steady state (CLss)
  • Accumulation ratio (Rac) on AUC0-14day and Cmax
  • Detection of the development of anti-SAR408701 antibody
The study duration for an individual patient will start from the signature of the informed consent, will include a period to assess eligibility (screening period) of up to approximately 4 weeks (28 days), a treatment period and an end-of-treatment visit around 30 days following the last administration of study drug, and at least one follow-up visit after the end-of-treatment visit. Additional follow-up visit may be required until resolution or stabilization of adverse events (at least 30 days). Additional tests for immunogenicity will be done at Day 60. Treatment may continue until precluded by toxicity, progression, or upon patient's request. If the patient stops study treatment for reason other than disease progression, follow-up visit will be performed every 3 months until disease progression or initiation of another anti-tumour treatment or death, whichever comes first.

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