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    DRUG:

    samuraciclib (CT7001)

    i
    Other names: CT7001, ICEC0942, CT 7001, CT-7001
    Company:
    Carrick Therap
    Drug class:
    CDK7 inhibitor
    Related drugs:
    1m
    CDK7-targeted therapy effectively disrupts cell cycle progression and oncogenic signaling in head and neck cancer. (PubMed, Signal Transduct Target Ther)
    Additionally, CDK7 knockout (KO) and selective inhibitors (YKL-5-124 and samuraciclib) demonstrated potent antitumor activity, effectively suppressing tumor growth in HNSCC patient-derived organoids (PDOs), as well as in both cell line- and patient-derived xenograft (PDX) mouse models with minimal toxicity...These findings highlight CDK7 as a promising therapeutic target for HNSCC. Our study provides strong evidence of the robust antitumor activity of CDK7-selective inhibition in disease-relevant preclinical models, strongly supporting its progression to clinical testing.
    Journal
    |
    CDK7 (Cyclin Dependent Kinase 7)
    |
    samuraciclib (CT7001)
    1m
    C4891024: TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C) (clinicaltrials.gov)
    P1/2, N=11, Active, not recruiting, Pfizer | Trial completion date: Nov 2025 --> Apr 2026 | Trial primary completion date: Nov 2025 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    TP53 mutation
    |
    vepdegestrant (ARV-471) • samuraciclib (CT7001)
    1m
    Functional insight into cyclin-dependent kinase (CDK)7 via chemical inhibition of the priority fungal pathogen Cryptococcus neoformans. (PubMed, mBio)
    The antifungal activity of SY-1365 was also markedly enhanced in combination with membrane-targeting antifungals. Together, our findings highlight CDK7 inhibitors as valuable tools to study CDK7 function in Cn and as potentially promising antifungals in combination with licensed antifungals.
    Journal
    |
    CDK7 (Cyclin Dependent Kinase 7)
    |
    SY-5609 • samuraciclib (CT7001) • mevociclib (SY-1365)
    2ms
    SUMIT-BC: A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants (clinicaltrials.gov)
    P2, N=60, Completed, Carrick Therapeutics Limited | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Aug 2025
    Trial completion • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • CDK4 (Cyclin-dependent kinase 4)
    |
    TP53 mutation • ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    fulvestrant • samuraciclib (CT7001)
    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)
    4ms
    SUMIT-BC: A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Carrick Therapeutics Limited | Trial primary completion date: Jun 2025 --> Mar 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • CDK4 (Cyclin-dependent kinase 4)
    |
    TP53 mutation • ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    fulvestrant • samuraciclib (CT7001)
    9ms
    C4891024: TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C) (clinicaltrials.gov)
    P1/2, N=11, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=67 --> 11 | Trial completion date: Jan 2027 --> Nov 2025 | Trial primary completion date: Jul 2026 --> Nov 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    vepdegestrant (ARV-471) • samuraciclib (CT7001)
    10ms
    SUMIT-ELA: A Study of Samuraciclib and Elacestrant in Participants with Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=49, Active, not recruiting, Carrick Therapeutics Limited | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • CDK4 (Cyclin-dependent kinase 4)
    |
    TP53 mutation • ER positive • HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    |
    Orserdu (elacestrant) • samuraciclib (CT7001)
    10ms
    SUMIT-BC: A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Carrick Therapeutics Limited | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • CDK4 (Cyclin-dependent kinase 4)
    |
    TP53 mutation • ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    fulvestrant • samuraciclib (CT7001)
    10ms
    MORPHEUS BC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (clinicaltrials.gov)
    P1/2, N=316, Recruiting, Hoffmann-La Roche | N=510 --> 316
    Enrollment change
    |
    ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 positive • ER positive
    |
    Herceptin (trastuzumab) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • Kisqali (ribociclib) • ipatasertib (RG7440) • Itovebi (inavolisib) • giredestrant (RG6171) • Pegasys (pegylated interferon α -2a) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • samuraciclib (CT7001)
    10ms
    MORPHEUS BC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (clinicaltrials.gov)
    P1/2, N=510, Recruiting, Hoffmann-La Roche | Trial primary completion date: Apr 2026 --> Nov 2027
    Trial primary completion date
    |
    ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 positive • ER positive
    |
    Herceptin (trastuzumab) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • Kisqali (ribociclib) • ipatasertib (RG7440) • Itovebi (inavolisib) • giredestrant (RG6171) • Pegasys (pegylated interferon α -2a) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • samuraciclib (CT7001)
    11ms
    MORPHEUS BC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (clinicaltrials.gov)
    P1/2, N=510, Recruiting, Hoffmann-La Roche | Trial completion date: Oct 2026 --> Nov 2027
    Trial completion date
    |
    ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 positive • ER positive
    |
    Herceptin (trastuzumab) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • Kisqali (ribociclib) • ipatasertib (RG7440) • Itovebi (inavolisib) • giredestrant (RG6171) • Pegasys (pegylated interferon α -2a) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • samuraciclib (CT7001)