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| Therapy Name | OKI-219 + Trastuzumab + Tucatinib |
| Synonyms | |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| OKI-219 | OKI219|OKI 219 | PIK3CA inhibitor 27 | OKI-219 inhibits PIK3CA H1047R, which potentially results in decreased tumor cell proliferation and reduced tumor growth (Mol Cancer Ther (2023) 22 (12_Supplement): B163). | |
| Trastuzumab | Herceptin | Anti HER2 | HER2 (ERBB2) Antibody 79 | Herceptin (trastuzumab) is a monoclonal antibody, which binds ERBB2 (HER2) to induce tumor cellular cytotoxicity (PMID: 17611206). Herceptin (trastuzumab) is FDA approved for HER2-overexpressing (or amplification) breast cancer, gastric adenocarcinoma, and gastroesophageal junction adenocarcinoma (FDA.gov). |
| Tucatinib | Tukysa | ONT-380|ARRY-380|irbinitinib | HER2 Inhibitor 44 | Tukysa (tucatinib) selectivity inhibits ERBB2 (HER2), resulting in decreased proliferation and increased apoptosis in ERBB2 (HER2) expressing tumor cells (PMID: 28053022). Tukysa (tucatinib) in combination with Herceptin (trastuzumab) and Xeloda (capecitabine) is FDA approved for use in patients with advanced unresectable or metastatic ERBB2 (HER2)-positive breast cancer, including patients with brain metastasis, who have received prior anti-HER2 therapies, and in combination with Herceptin (trastuzumab) for patients with RAS wild-type ERBB2 (HER2)-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy (FDA.gov). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT06239467 | Phase I | OKI-219 + Trastuzumab + Tucatinib OKI-219 Fulvestrant + OKI-219 + PF-07220060 Fulvestrant + OKI-219 Fulvestrant + OKI-219 + Ribociclib | First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer (PIKture-01) | Recruiting | USA | ITA | FRA | ESP | BEL | 1 |