A Trial of Ipatasertib in Combination With Atezolizumab

Program Status

Active, not recruiting

Phase

Phase 1 Phase 2

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

No

Drugs

Atezolizumab, Ipatasertib

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

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

NCT ID

NCT03673787

Date Trial Added

2018-09-17

Updated Date

2025-05-14