Molecular Profile Detail


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Profile Name CDK12 inact mut
Gene Variant Detail

CDK12 inact mut (loss of function)

Relevant Treatment Approaches Olaparib


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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
CDK12 inact mut prostate cancer sensitive Olaparib Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in CDK12 ( detail...
CDK12 inact mut prostate cancer sensitive Olaparib Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved progression-free survival (PFS, 5.8 vs 3.5 mo, HR=0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, including patients harboring CDK12 mutations (5.09 vs 2.20 mo) (PMID: 32343890; NCT02987543). detail... 32343890 detail...
CDK12 inact mut prostate cancer sensitive Olaparib Olaparib Phase II Actionable In a Phase II (TOPARP-B) trial, Lynparza (olaparib) treatment resulted in a composite overall response rate of 25.0% (5/20) and a RECIST objective response rate of 0% (0/18) in patients with castration-resistant prostate cancer harboring deleterious CDK12 mutations (PMID: 31806540; NCT01682772). 31806540
CDK12 inact mut prostate cancer predicted - sensitive Abiraterone + Niraparib + Prednisone Phase III Actionable In a Phase III trial (MAGNITUDE), Zejula (niraparib) in combination with Zytiga (abiraterone) and Adasone (prednisone) (AAP) significantly improved radiographic progression-free survival (16.5 vs 13.7 mo, HR 0.73, p=0.0217) compared to placebo and AAP in patients with metastatic castration-resistant prostate cancer harboring alterations in homologous recombination repair genes including ATM, BRCA1/2, BRIP1, CHEK2, FANCA, HDAC2, and PALB2 (J Clin Oncol 40, 2022 (suppl 6; abstr 12); NCT03748641). detail...
CDK12 inact mut prostate cancer no benefit Rucaparib Phase II Actionable In a Phase II trial (TRITON2), activity of Rubraca (rucaparib) was limited in the cohort of patients with metastatic castrate-resistant prostate cancer harboring a CDK12 mutation presumed to be inactivating, with no confirmed radiographic responses in 10 evaluable patients and a PSA response in 1 patient with biallelic CDK12 alterations in the overall population of 15 patients, and a clinical benefit rate of 20% (3/15) at 6 months and 7.1% (1/14) at 12 months (PMID: 32086346; NCT02952534). 32086346
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04053322 Phase II Durvalumab + Fulvestrant + Olaparib Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients. (DOLAF) Recruiting FRA 0
NCT03840967 Phase II Niraparib A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma Recruiting USA 0
NCT05071209 Phase Ib/II BAY1895344 Elimusertib for the Treatment of Relapsed or Refractory Solid Tumors Recruiting USA 0
NCT03047135 Phase II Olaparib Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis Recruiting USA 0
NCT02734004 Phase Ib/II Durvalumab + Olaparib Bevacizumab + Durvalumab + Olaparib A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors. (MEDIOLA) Completed USA | FRA 5
NCT04019964 Phase II Nivolumab Nivolumab in Biochemically Recurrent dMMR Prostate Cancer Recruiting USA 0
NCT04985721 Phase II Pamiparib + Tislelizumab A Trial of Pamiparib With Tislelizumab in Patients With Advanced Tumours With Homologous Recombination Repair Defects (IMPARP-HRD) Recruiting 1
NCT04272645 Phase II Abemaciclib + Atezolizumab Abemaciclib Atezolizumab Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer Withdrawn USA 0
NCT04336943 Phase II Durvalumab + Olaparib Durvalumab and Olaparib for the Treatment of Prostate Cancer in Men Predicted to Have a High Neoantigen Load Recruiting USA 0
NCT04826341 Phase Ib/II Berzosertib + Sacituzumab govitecan-hziy A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors Recruiting USA 0
NCT05011383 Phase II Testosterone High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers (VA-BAT) Recruiting USA 0
NCT04104893 Phase II Pembrolizumab A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation (CHOMP) Recruiting USA 0
NCT04019327 Phase Ib/II Talazoparib + Temozolomide A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer Recruiting USA 0
NCT04276376 Phase II Atezolizumab + Rucaparib Efficacy and Safety of the Combination of Rucaparib (PARP Inhibitor) and Atezolizumab (Anti-PD-L1 Antibody) in Patients With DNA Repair-deficient or Platinum-sensitive Solid Tumors (ARIANES) Recruiting FRA 0
NCT04550494 Phase II Talazoparib Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations Recruiting USA 0
NCT04751929 Phase II Abemaciclib + Atezolizumab Atezolizumab Abemaciclib Abemaciclib With or Without Atezolizumab for mCRPC Recruiting USA 0
NCT03786796 Phase II Olaparib Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations (ORCHID) Recruiting USA 0
NCT03810105 Phase II Durvalumab + Olaparib A Study of Olaparib and Durvalumab in Prostate Cancer Active, not recruiting USA 0
NCT04266912 Phase Ib/II Avelumab + Berzosertib Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors Recruiting USA 0
NCT05010096 Phase I BAY1895344 + Copanlisib BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors Withdrawn 0
NCT04983745 Phase II Dostarlimab-gxly + Niraparib Niraparib and Dostarlimab in HRD Solid Tumors (DIDO) Not yet recruiting USA 0
NCT05188508 Phase II Olaparib + Pembrolizumab + Temozolomide Pembrolizumab, Olaparib, and Temozolomide for People With Glioma Recruiting USA 0