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Profile Name | TP53 positive |
Gene Variant Detail | |
Relevant Treatment Approaches |
Molecular Profile | Indication/Tumor Type | Response Type | Relevant Treatment Approaches | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|---|
TP53 positive | Advanced Solid Tumor | predicted - sensitive | p28 | Phase I | Actionable | In a Phase I trial, treatment with p28 was well-tolerated and demonstrated preliminary efficacy in patients with Tp53-positive advanced solid tumors, with complete response in 6% (1/15), partial response in 20% (3/15), and stable disease in 46% (7/15) of patients (PMID: 23449360). | 23449360 | |
TP53 positive | ovarian cancer | predicted - sensitive | NU6027 + Temozolomide | Preclinical - Cell culture | Actionable | In a preclinical study, NU6027 enhanced the efficacy of Temodar (temozolomide) in ovarian cancer cells with mismatch repair activity and positive for TP53 in culture, demonstrating a 50% greater decrease in cell survival compared to Temodar (temozolomide) alone (PMID: 21730979). | 21730979 | |
TP53 positive | Advanced Solid Tumor | sensitive | Serdemetan | Phase I | Actionable | In a Phase I trial, Serdemetan (JNJ-26854165) treatment increased Tp53 expression in tumor and surrogate tissue, resulted in partial response in 1.8% (1/57) and stable disease in 38.6% (22/57) of patients with advanced solid tumors (PMID: 21831953). | 21831953 | |
TP53 positive | breast cancer | sensitive | Serdemetan | Phase I | Actionable | In a Phase I trial, Serdemetan (JNJ-26854165) treatment induced a 102% increase of Tp53 expression in tumor tissue, resulted in partial response in a patient with breast cancer (PMID: 21831953). | 21831953 | |
TP53 positive | Advanced Solid Tumor | sensitive | MVAp53 | Phase I | Actionable | In a phase I study, Ankara (MVAp53) demonstrated safety and efficacy in patients with metastatic colon, gastric and pancreas cancer stained positive for p53 (J Clin Oncol 31, 2013 (suppl; abstr 3089)). | detail... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT03363867 | Phase II | Atezolizumab + Bevacizumab + Cobimetinib | BEACON - ABC in Recurrent Platinum Resistant HGSOC (BEACON) | Recruiting | 1 | |
NCT01042535 | Phase Ib/II | Ad.p53-DC vaccine + Indoximod | Vaccine Therapy and 1-MT in Treating Patients With Metastatic Breast Cancer | Completed | USA | 0 |
NCT03560882 | Phase I | Atorvastatin | A Pilot Trial of Atorvastatin in Tumor Protein 53 (p53) -Mutant and p53 Wild-Type Malignancies | Recruiting | USA | 0 |
NCT02098343 | Phase Ib/II | Carboplatin + Doxorubicin APR-246 + Carboplatin + Doxorubicin | p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246 | Completed | USA | FRA | ESP | DEU | BEL | 3 |
NCT03063203 | Phase II | Decitabine | Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia | Terminated | USA | 0 |