Therapy Detail

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Therapy Name GDC-0077
Synonyms
Therapy Description

GDC-0077 inhibits PIK3CA, with selectivity for mutant PIK3CA over wild-type PIK3CA, potentially resulting in increased apoptosis and decreased growth of PIK3CA-mutant tumors (AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 156).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
GDC-0077 RO7113755|RG6114|GDC0077|GDC 0077|inavolisib PIK3CA inhibitor 21 GDC-0077 inhibits PIK3CA, with selectivity for mutant PIK3CA over wild-type PIK3CA, potentially resulting in increased apoptosis and decreased growth of PIK3CA-mutant tumors (AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 156).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PIK3CA E453Q PIK3CA H1047R breast cancer sensitive GDC-0077 Preclinical - Cell culture Actionable In a preclinical study, breast epithelial cells expressing PIK3CA E453Q and PIK3CA H1047R in cis demonstrated increased sensitivity to growth inhibition by GDC-0077 treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). 31699932
PIK3CA mutant breast cancer predicted - sensitive GDC-0077 Preclinical - Pdx & cell culture Actionable In a preclinical study, GDC-0077 inhibited proliferation and induced apoptosis in PIK3CA-mutant breast cancer cell lines in culture, and induced apoptosis and tumor regression in PIK3CA-mutant breast cancer cell line and patient-derived xenograft models (AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 156). detail...
PIK3CA E545K breast cancer sensitive GDC-0077 Preclinical - Cell line xenograft Actionable In a preclinical study, GDC-0077 treatment led to tumor regression in an ESR1 (ER)-positive breast cancer cell line xenograft model harboring PIK3CA E545K (PMID: 34544753). 34544753
PIK3CA E545K colon cancer sensitive GDC-0077 Preclinical - Cell culture Actionable In a preclinical study, GDC-0077 treatment led to decreased cell viability in a colon cancer cell line expressing PIK3CA E545K in culture (PMID: 34544753). 34544753
PIK3CA E545K PIK3CA E726K breast cancer sensitive GDC-0077 Preclinical - Cell culture Actionable In a preclinical study, breast epithelial cells expressing PIK3CA E545K and PIK3CA E726K in cis demonstrated increased sensitivity to growth inhibition by GDC-0077 treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). 31699932
PIK3CA E726K PIK3CA H1047R breast cancer sensitive GDC-0077 Preclinical - Cell culture Actionable In a preclinical study, breast epithelial cells expressing PIK3CA E726K and PIK3CA H1047R in cis demonstrated increased sensitivity to growth inhibition by GDC-0077 treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). 31699932
PIK3CA E545K PIK3CA M1043L breast cancer sensitive GDC-0077 Preclinical - Cell culture Actionable In a preclinical study, breast epithelial cells expressing PIK3CA E545K and PIK3CA M1043L in cis demonstrated increased sensitivity to growth inhibition by GDC-0077 treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). 31699932
PIK3CA H1047R colon cancer sensitive GDC-0077 Preclinical - Cell culture Actionable In a preclinical study, GDC-0077 treatment led to decreased cell viability in a colon cancer cell line expressing PIK3CA H1047R in culture (PMID: 34544753). 34544753

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05332561 Phase II Olaparib Ipatasertib Sacituzumab govitecan-hziy GDC-0077 Pertuzumab/trastuzumab/hyaluronidase-zzxf Atezolizumab Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE) Not yet recruiting DEU 0
NCT04589845 Phase II Alectinib Ado-trastuzumab emtansine Ipatasertib GDC-0077 Entrectinib Atezolizumab Idasanutlin Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 16
NCT03006172 Phase I GDC-0077 + Letrozole + Palbociclib GDC-0077 Fulvestrant + GDC-0077 GDC-0077 + Letrozole To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer Recruiting USA | GBR | FRA | ESP | CAN 0
NCT04632992 Phase II Ipatasertib Atezolizumab + Capecitabine Entrectinib Atezolizumab + Docetaxel Ado-trastuzumab emtansine + Atezolizumab Capecitabine + Pertuzumab/trastuzumab/hyaluronidase-zzxf Paclitaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf Alectinib GDC-0077 Pertuzumab/trastuzumab/hyaluronidase-zzxf Docetaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf Atezolizumab + Paclitaxel Ado-trastuzumab emtansine + Tucatinib A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response (MyTACTIC) Active, not recruiting USA 0


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