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 18 | 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). |
Filtering
- Case insensitive filtering will display rows where any text in any cell matches the filter term
- Simple literal full or partial string matches
- Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
- Filtering will only apply to rows that are already loaded on the page, filtering has no impact on query parameters
- Use quotes to match a longer phrase which contains spaces "mtor c1483f"
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 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 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 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 | 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 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 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 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 | FRA | ESP | CAN | 1 |
| 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 | FRA | ESP | DEU | CAN | BEL | 18 |
| 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 |
| 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 |
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