A Phase I Study of IAG933 in Patients With Advanced Mesothelioma and Other Solid Tumours

Official Title

An Open-label, Multi-centre, Phase I Study of Oral IAG933 in Adult Patients With Advanced Mesothelioma and Other Solid Tumours

Summary:

The purpose of this study is to characterize the safety and tolerability of IAG933 in patients with mesothelioma, NF2/LATS1/LATS2 mutated tumours and tumours with functional YAP/TAZ fusions and to identify the maximum tolerated dose and/or recommended dose.

Trial Description

Primary Outcome:

  • Number of patients with adverse events and serious adverse events
  • Incidence of dose limiting toxicities during the first treatment cycle (dose escalation only)
  • Number of patients with dose interruptions and dose changes
Secondary Outcome:
  • Overall response rate (ORR)
  • Disease control rate (DCR)
  • Progression free survival (PFS)
  • Duration of response (DOR)
  • Overall survival (OS) (dose expansion only)
  • Minimum serum concentration (Cmin) (dose escalation only)
  • Maximum serum concentration (Cmax)
  • Time to reach Cmax (Tmax)
  • Area under the curve (AUC)
  • Half life (T1/2) (dose escalation only)
  • Accumulation ratio (Racc) (dose escalation only)
This is a phase I, open-label, multi-centre study of IAG933 as a single agent consisting of a dose escalation part, followed by a dose expansion part. The escalation part will characterize the safety and tolerability. After the determination of the recommended dose/maximum tolerated dose, dose expansion will assess the preliminary anti-tumour activity in defined patient populations and further assess the safety and tolerability at RD/MTD.

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