Toxicities
DLTs, stomach pain, diarrhea, rash, pain
ADVERSE EVENT
For Arm A, 3 patients developed DLT (1 grade 3 diarrhea, 1 grade 3 stomach pain, and 1 persistent grade 2 diarrhea) leading to dose delay (less than 75% planned ipatasertib dosing) (DLTs within the first cycle (representing 5 unique patients).

Adverse events at RP2D per CTCAE 5.0 (


As previously mentioned, of the 10 patients in Arm A, 3 had DLTs including 2 patients with grade 2-3 diarrhea and 1 patient with grade 3 stomach pain within the first 28-day cycle, which led to de–escalation to dose -1 with ipatasertib (300 mg daily). Of the 12 patients in Arm B, 1 had grade 3 maculopapular rash in cycle 1, which led to dose delay of ipatasertib (<75% completion) during the first 28 days. Of the 6 patients in Arm C, 1 had grade 3 maculopapular rash attributed to atezolizumab. After appropriate treatment, both patients with maculopapular rash had resolution of rash (Median (range) of cycles completed was 4 (2-15), including 4 (2-7) for Arm A, 4 (2-15) for Arm B, and 6 (2-10) for Arm C. A total of 11 (39%) had dose delay, including 4 (40%) in Arm A, 6 (50%) in Arm B, and 1 (17%) in Arm C. Ten (36%) had dose reduction, including 6 (60%) in Arm A, 3 (25%) in Arm B, and 1 (17%) in Arm C. The RP2D for Arm A was ipatasertib 300 mg daily, carboplatin AUC2 and paclitaxel 80 mg m