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Association details:
Biomarker:PIK3CB mutation
Cancer:Solid Tumor
Drug:Bavencio (avelumab) (PD-L1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1026MO - Phase Ib dose escalation study of novel immunogenic cell death (ICD) inducer PT-112 plus PD-L1 inhibitor avelumab in solid tumours

Published date:
09/18/2020
Excerpt:
A 3+3 design was used to determine the recommended phase II dose (RP2D) for PT-112 (28-day cycle IV days 1, 8, 15) with avelumab 800 mg (days 1 and 15) in pts with progressing solid tumors, with no available effective therapy (Tx). Previous ICI Tx was allowed...Two CRPC pts responded: one with durable improved PSA and bone metastases, PFS 11.4 months (150mg/m2, MSI stable); another with confirmed RECIST partial response (66% reduction), PSA reduction (94%), bone scan improvement, and ongoing PFS 9.5 months (200 mg/m2, PIK3CBmut and PTEN loss, prior ICI Tx). 4 of 18 total CRPC pts had reductions in PSA ≥50%; 15 of 18 in alkaline phosphatase.
Secondary therapy:
PT-112
Trial ID: