A Study Evaluating Single-agent Inavolisib and Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers
NCT Number: NCT06496568
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: PIK3CA-Mutated Cancers
Interventions: DRUG: Inavolisib|DRUG: Atezolizumab
Sponsor: Hoffmann-La Roche
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-12-11
Completion Date: 2025-06-11
Locations: University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35249, United States|Moores Cancer Center at UC San Diego Health, La Jolla, California, 92093, United States|California Cancer Associates for Research & Excellence, Inc., San Marcos, California, 92069, United States|Vanderbilt-Ingram Cancer Ctr, Nashville, Tennessee, 37232, United States|BC Cancer Vancouver Centre, Vancouver, British Columbia, V5Z 4E6, Canada|Princess Margaret Cancer Center, Toronto, Ontario, M5G 2M9, Canada|Jewish General Hospital, Montreal, Quebec, H3T 1E2, Canada|Seoul National University Hospital, Seoul, 03080, Korea, Republic of|Samsung Medical Center, Seoul, 06351, Korea, Republic of

Summary:
The purpose of the study is to assess the safety and efficacy of inavolisib as a single-agent and in combination with atezolizumab in participants with phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform (PIK3CA)-mutated cancers, including previously treated head and neck squamous cell carcinoma (HNSCC).

Primary Outcome Measures: Percentage of Participants with Select Treatment-related Toxicities (TRT) in Arm B, Day 1 of Cycle 1 to Day 3 of Cycle 2 (each cycle = 21 days)|Percentage of Participants with Adverse Events (AEs) and serious adverse events (SAEs), From baseline up to approximately 3 years
Secondary Outcome Measures: Objective Response Rate (ORR), Every 9 weeks from Day 1 of Cycle 1 during the first 2 years, and every 12 weeks thereafter until disease progression or initiation of another anti-cancer therapy whichever occurs first (up to approximately 3 years)|Best Objective Response (BOR), Every 9 weeks from Day 1 of Cycle 1 during the first 2 years, and every 12 weeks thereafter until disease progression or initiation of another anti-cancer therapy whichever occurs first (up to approximately 3 years)|Duration of Response (DOR), Every 9 weeks from Day 1 of Cycle 1 during the first 2 years, and every 12 weeks thereafter until disease progression or initiation of another anti-cancer therapy whichever occurs first (up to approximately 3 years)|Clinical Benefit Rate (CBR), Every 9 weeks from Day 1 of Cycle 1 during the first 2 years, and every 12 weeks thereafter until disease progression or initiation of another anti-cancer therapy whichever occurs first (up to approximately 3 years)|Progression-free Survival (PFS), Every 9 weeks from Day 1 of Cycle 1 during the first 2 years, and every 12 weeks thereafter until disease progression or initiation of another anti-cancer therapy whichever occurs first (up to approximately 3 years)|Plasma Concentration of Inavolisib in Arm A, Predose and 3 hours post-dose on Day 1 of Cycle 1 and 2 and at predose on Day 1 of Cycle 3 (each cycle = 21 days)|Area Under the Concentration-time Curve (AUC) of Inavolisib in Arm A, Predose and 3 hours post-dose on Day 1 of Cycle 1 and 2 and at predose on Day 1 of Cycle 3 (each cycle = 21 days)|Maximum Plasma Concentration (Cmax) of Inavolisib in Arm A, Predose and 3 hours post-dose on Day 1 of Cycle 1 and 2 and at predose on Day 1 of Cycle 3 (each cycle = 21 days)|Minimum Plasma Concentration (Cmin) of Inavolisib in Arm A, Predose and 3 hours post-dose on Day 1 of Cycle 1 and 2 and at predose on Day 1 of Cycle 3 (each cycle = 21 days)|Plasma Concentration of Inavolisib in Arm B, Predose and 3 hours post-dose on Day 1 of Cycle 1 and 2 and Predose on Day 1 of Cycle 3 (each cycle = 21 days)|AUC of Inavolisib in Arm B, Predose and 3 hours post-dose on Day 1 of Cycle 1 and 2 and Predose on Day 1 of Cycle 3 (each cycle = 21 days)|Cmax of Inavolisib in Arm B, Predose and 3 hours post-dose on Day 1 of Cycle 1 and 2 and Predose on Day 1 of Cycle 3 (each cycle = 21 days)|Cmin of Inavolisib in Arm B, Predose and 3 hours post-dose on Day 1 of Cycle 1 and 2 and Predose on Day 1 of Cycle 3 (each cycle = 21 days)