A study evaluating the safety, preliminary efficacy and pharmacokinetics of ipatasertib in combination with atezolizumab and docetaxel in participants with mCRPC previously treated with second-generation AR (Androgen Receptor)-targeted therapy. The study consists of two parts: \[1\] Part A: Safety run-in cohort of approximately 12 participants; \[2\] Part B: Expansion cohort of approximately 38 participants. All participants in this study will continue to be treated until progression of disease, loss of clinical benefit, unacceptable toxicity or withdrawal of consent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Ipatasertib will be administered at a dose of 400 mg, as per the dosing schedule described above.
Atezolizumab will be administered at a fixed dose of 1200 mg, as per the dosing schedule described above.
Docetaxel will be administered at a dose of 75 mg/m\^2, as per the dosing schedule described above.
HOPITAL JEAN MINJOZ; Oncologie
Besançon, France
Centre Val Aurelle Paul Lamarque; Radiotherapie
Montpellier, France
Hopital d'Instruction des Armees de Begin
Saint-Mandé, France
Gustave Roussy
Villejuif, France
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, Italy
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain
Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie
Chur, Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zurich, Switzerland
Percentage of Participants with Adverse Events (AEs)
Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Time frame: Up to 35 months
Confirmed Prostate Specific Antigen (PSA) Response
Defined as the proportion of participants with a reduction in their PSA levels of 50% or more from baseline, confirmed by a second evaluation at least 3 weeks later
Time frame: Up to 35 months
Overall Response Rate (ORR) (In participants presenting with measurable visceral disease or measurable extrapelvic adenopathy at baseline)
Defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions \>= 4 weeks apart, as determined by the Investigator according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1)
Time frame: Up to 35 months
Time to PSA Progression
Time frame: Up to 35 months
radiographic Progression-Free Survival (rPFS)
Assessed according to the Prostate Cancer Working Group 3 (PCWG3) criteria
Time frame: Up to 35 months
Overall Survival (OS) (median OS and landmark survival at 12, 18 and 24 months)
Time frame: Up to 35 months
Documented Objective Response (DOR) (In participants presenting with measurable visceral disease or measurable extrapelvic adenopathy at baseline)
Defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Time frame: Up to 35 months
Clinical Benefit Rate (CBR) (In participants presenting with measurable visceral disease or measurable extrapelvic adenopathy at baseline)
Defined as the proportion of participants who have an objective response (a CR or a PR) or stable disease for at least 27 weeks, as determined by the Investigator according to RECIST v1.1 and PCWG3 criteria
Time frame: Up to 35 months
Plasma Concentrations (ng/mL) of Ipatasertib and G-037720 at pre-specified timepoints
Time frame: Up to 35 months
Serum Concentrations (ng/mL) of Atezolizumab at pre-specified timepoints
Time frame: Up to 35 months
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab
Time frame: Up to 35 months
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