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    BIOMARKER:

    CDK12 mutation

    i
    Other names: CDK12, Cyclin Dependent Kinase 12, Cdc2-Related Kinase, Arginine/Serine-Rich, Cell Division Cycle 2-Related Protein Kinase 7, Cell Division Protein Kinase 12, CDC2-Related Protein Kinase 7, Cyclin-Dependent Kinase 12, CRKRS, CRK7, CDC2 Related Protein Kinase 7, HCDK12, CrkRS, CRKR
    Entrez ID:
    51755
    Related biomarkers:
    Mutation
    CNA
    Related tests:
    3d
    NIRADO: Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (clinicaltrials.gov)
    P2, N=51, Terminated, Gustave Roussy, Cancer Campus, Grand Paris | Trial completion date: Dec 2027 --> Feb 2025 | Suspended --> Terminated; Abandon of the partner, GSK
    Trial completion date • Trial termination • Pan tumor • Platinum sensitive
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • ARID1A (AT-rich interaction domain 1A) • PBRM1 (Polybromo 1) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • RAD51 (RAD51 Homolog A) • FANCA (FA Complementation Group A) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • ARID2 (AT-Rich Interaction Domain 2) • BARD1 (BRCA1 Associated RING Domain 1) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • RAD54L (DNA Repair And Recombination Protein RAD54) • DRD (DNA Repair Deficiency)
    |
    HER-2 positive • HER-2 amplification • DDR • CDK12 mutation • CHEK2 mutation • BRIP1 mutation • RAD51C mutation • RAD51D mutation • BARD1 mutation
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    3d
    ARIANES: 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 (clinicaltrials.gov)
    P2, N=130, Terminated, Gustave Roussy, Cancer Campus, Grand Paris | Suspended --> Terminated; Bankruptcy of partner: Clovis
    Trial termination • Pan tumor • Platinum sensitive
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • RAD51 (RAD51 Homolog A) • FANCA (FA Complementation Group A) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • IL2 (Interleukin 2) • RAD51D (RAD51 paralog D) • BARD1 (BRCA1 Associated RING Domain 1) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • RAD54L (DNA Repair And Recombination Protein RAD54) • DRD (DNA Repair Deficiency)
    |
    DDR • CDK12 mutation • CHEK2 mutation • BRIP1 mutation • RAD51C mutation • RAD51D mutation • BARD1 mutation
    |
    Tecentriq (atezolizumab) • Rubraca (rucaparib)
    9d
    MEDIOLA: A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors. (clinicaltrials.gov)
    P1/2, N=264, Active, not recruiting, AstraZeneca | Trial completion date: Sep 2025 --> Sep 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA (Breast cancer early onset)
    |
    HER-2 negative • CDK12 mutation • BARD1 mutation
    |
    Avastin (bevacizumab) • Lynparza (olaparib) • Imfinzi (durvalumab)
    23d
    PARP Inhibitors in Metastatic Castration-resistant Prostate Cancer: Rationale, Mechanisms, and Clinical Applications. (PubMed, Eur Urol Oncol)
    Promising results have led to the approval of several PARPi agents as monotherapy or in combination with ARPIs in selected or unselected patients when chemotherapy is not clinically indicated. However, some questions remain regarding patient selection and treatment sequencing.
    Review • Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PALB2 (Partner and localizer of BRCA2) • CDK12 (Cyclin dependent kinase 12)
    |
    PALB2 mutation • CDK12 mutation
    |
    Lynparza (olaparib) • Talzenna (talazoparib) • Zejula (niraparib) • Xtandi (enzalutamide) • Rubraca (rucaparib) • Xofigo (radium Ra-223 dichloride)
    24d
    Blood-based Genomic Alteration Signature for Predicting Progression-free Survival in De Novo Metastatic Hormone-Sensitive Prostate Cancer: A Real-World Study. (PubMed, Cancer Res Commun)
    The model also showed significant clinical relevance, with bTRPC-positive patients exhibiting shorter survival times under ADT and doublet therapy, although this disparity diminished with triplet therapy. These findings highlight the potential of ctDNA-based gene mutation analysis to guide personalized treatment strategies for mHSPC, offering a non-invasive alternative to tissue-based analyses and improving prognostic accuracy.
    Journal • Real-world evidence
    |
    TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • CDK12 (Cyclin dependent kinase 12)
    |
    TP53 mutation • PTEN mutation • CDK12 mutation
    1m
    CA209-76M: Nivolumab in Biochemically Recurrent dMMR Prostate Cancer (clinicaltrials.gov)
    P2, N=8, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Completed | N=15 --> 8 | Trial completion date: Jan 2026 --> Jul 2025 | Trial primary completion date: Jan 2026 --> Apr 2025
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Tumor mutational burden • dMMR
    |
    TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CDK12 (Cyclin dependent kinase 12)
    |
    MSI-H/dMMR • CDK12 mutation
    |
    Opdivo (nivolumab)
    2ms
    NCI10217: Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations (clinicaltrials.gov)
    P1, N=39, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2026 --> Sep 2026
    Trial completion date
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • RAD51 (RAD51 Homolog A) • FANCA (FA Complementation Group A) • RAD51B (RAD51 Paralog B) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • CD4 (CD4 Molecule) • RAD51D (RAD51 paralog D) • BARD1 (BRCA1 Associated RING Domain 1) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin))
    |
    PIK3CA mutation • PTEN mutation • PALB2 mutation • CDK12 mutation • BARD1 mutation
    |
    Lynparza (olaparib) • Imfinzi (durvalumab) • Aliqopa (copanlisib)
    2ms
    Abemaciclib With or Without Atezolizumab for mCRPC (clinicaltrials.gov)
    P2, N=19, Active, not recruiting, Dana-Farber Cancer Institute | N=75 --> 19
    Enrollment change
    |
    CDK12 (Cyclin dependent kinase 12)
    |
    CDK12 mutation
    |
    Tecentriq (atezolizumab) • Verzenio (abemaciclib)
    2ms
    Biphasic (squamoid) papillary renal cell carcinoma: a distinct molecular and morphologic subtype within the PRCC spectrum. (PubMed, Virchows Arch)
    Targeted NGS revealed MET amplification (2 cases), MET mutation (1 case), NOTCH1 mutations (9 cases), and alterations in MAP2K2, FGFR4, DDR pathway genes (e.g., PMS2, CDK12R44W, RAD51C/D), and chromatin remodeling genes (EZH2, ARID1A). These findings support BPRCC as a distinct subtype of papillary RCC with consistent biphasic morphology, immunophenotypic divergence, and a unique molecular profile enriched for NOTCH, MAPK, and DDR pathway alterations.
    Journal
    |
    MET (MET proto-oncogene, receptor tyrosine kinase) • RB1 (RB Transcriptional Corepressor 1) • ARID1A (AT-rich interaction domain 1A) • NOTCH1 (Notch 1) • CCND1 (Cyclin D1) • FGFR4 (Fibroblast growth factor receptor 4) • CDK12 (Cyclin dependent kinase 12) • MAP2K2 (Mitogen-activated protein kinase kinase 2) • PMS2 (PMS1 protein homolog 2) • CDH1 (Cadherin 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • CA9 (Carbonic anhydrase 9) • TP63 (Tumor protein 63) • GATA3 (GATA binding protein 3) • PAX8 (Paired box 8)
    |
    MET amplification • CDK12 mutation • MET mutation • RAD51C mutation
    2ms
    Leveraging Real-World Data From a Clinicogenomic Database Addresses the Treatment Gap in Patients With High-Grade Serous Ovarian Cancer. (PubMed, JCO Precis Oncol)
    Overall, our study provides evidence that CGP significantly improves the identification of molecular targets in HGSOC, supporting its importance in the clinical practice to provide patients with more therapeutic options.
    Observational data • Retrospective data • Journal • Real-world evidence • BRCA Biomarker • PARP Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • FGFR1 (Fibroblast growth factor receptor 1) • ARID1A (AT-rich interaction domain 1A) • CCNE1 (Cyclin E1) • CDK12 (Cyclin dependent kinase 12) • BRCA (Breast cancer early onset)
    |
    TP53 mutation • PIK3CA mutation • CDK12 mutation • BRCA mutation • TP53 Y220C
    3ms
    Resistance to CDK7 inhibitors directed by acquired mutation of a conserved residue in cancer cells. (PubMed, EMBO J)
    Continuous culturing of prostate cancer cells with Samuraciclib, a non-covalent ATP-competitive CDK7i, led to outgrowth of resistant cells...Consistent with this, mutation of the homologous residue in CDK12 (D819N) or CDK4 (D99N) promoted resistance to drugs that inhibit these CDKs. Our findings reveal a general mechanism for acquired resistance with obvious implications for patients treated with CDK inhibitors.
    Journal
    |
    CDK4 (Cyclin-dependent kinase 4) • CDK12 (Cyclin dependent kinase 12)
    |
    CDK12 mutation
    |
    samuraciclib (CT7001)
    3ms
    The utility of next-generation sequencing in metastatic prostate cancer FNA biopsies. (PubMed, Cancer Cytopathol)
    NGS on cytology material showed diagnostic and therapeutic utility in a subset of patients, with 10 of 46 patients (22%) having a change or potential in therapy based on NGS results.
    Retrospective data • Journal • Next-generation sequencing • BRCA Biomarker
    |
    TP53 (Tumor protein P53) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • AR (Androgen receptor) • RB1 (RB Transcriptional Corepressor 1) • CDK12 (Cyclin dependent kinase 12) • ERG (ETS Transcription Factor ERG) • TMPRSS2 (Transmembrane serine protease 2) • SYP (Synaptophysin) • NKX3-1 (NK3 homeobox 1)
    |
    TP53 mutation • IDH1 mutation • PTEN mutation • CDK12 mutation • RB1 mutation • TMPRSS2-ERG fusion