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


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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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society