Program Status
Active, not recruitingPhase
Phase 1 Phase 2Prior Immunotherapy Allowed
YesCRC-directed Trial
NoDrugs
Atezolizumab, IpatasertibTags
MSI-H/ MMRd, MSS/ MMRpComments
In dose escalation part A, solid tumours, might include CRC
In part B, only patients with solid tumours with hyperactivation of PI3K pathway will be admitted (eg known activating mutations in PIK3CA, AKT1, AKT2) or PTEN loss
Ipatasertib: AKT inhibitor
Atezolizumab: anti PD-L1, immunotherapy
Location | Location Status |
---|---|
United Kingdom | |
Royal Marsden Hospital NHS Foundation Trust Sutton, Surrey SM2 5PT |
Active, not recruiting |
Inclusion Criteria
Inclusion Criteria:
1. PART A1: Patients with histologically or cytologically confirmed malignant advanced solid tumours refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient;
PART A2: Patients with advanced glioblastoma with potentially surgically resectable disease.
PART B1: Patients with histologically or cytologically confirmed malignant advanced solid tumours, refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient, with somatic mutations or other aberrations predicted to result in a hyperactivated PI3K-AKT pathway (eg activating mutations in PIK3CA, AKT1, AKT2) or PTEN loss (assessed by immunohistochemistry (IHC) (n=12).
PART B2: Patients with histologically or cytologically confirmed malignant castrate refractory prostate cancer, refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient, with PTEN loss confirmed by immunohistochemistry H-score 1.5 times ULN then Calculated creatinine clearance <1.5 times ULN
≥ 50 mL/min (uncorrected value)
Coagulation INR < 1.5 APTT <1.5x ULN (except for potentially resectable glioblastoma patients enrolled onto the surgical resection arms where the APTT should be