Study of JDQ443 in Patients With Advanced Solid Tumours Harboring the KRAS G12C Mutation

Official Title

A Phase Ib/II Open-label, Multi-centre Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumours Harboring the KRAS G12C Mutation

Summary:

This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and spartalizumab) in advanced solid tumour patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumour activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose.

Trial Description

Primary Outcome:

  • Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment
  • Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
  • Dose Escalation: Frequency of dose interruptions and reductions, by treatment
  • Dose Escalation: Dose intensity by treatment
  • Dose Expansion: Overall response rate (ORR) per RECIST v1.1, by treatment
Secondary Outcome:
  • Dose Escalation and Expansion: ORR per RECIST v1.1
  • Dose Escalation and Expansion: Best Overall Response (BOR) per RECIST v1.1
  • Dose Escalation and Expansion: Progression-free survival (PFS) per RECIST v1.1, Overall Survival (OS)
  • Dose Escalation and Expansion: Duration of Response (DOR) per RECIST v1.1
  • Dose Escalation and Expansion: Disease Control Rate (DCR) per RECIST v1.1
  • Dose Escalation and Expansion: Plasma or serum concentration vs time profiles (AUC) by treatment
  • Dose Escalation and Expansion: Plasma concentration (Cmax) by treatment
  • Dose Escalation and Expansion: Time to achieve Cmax (Tmax) by treatment
  • Dose Escalation and Expansion: Antidrug antibody (ADA) incidence by treatment
  • Dose Expansion: Frequency of dose interruptions and reductions, by treatment
  • Dose Expansion: Dose intensity by treatment
  • Dose Expansion: Incidence and severity of AEs and SAEs by treatment

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