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    DRUG:

    zanzalintinib (XL092)

    i
    Other names: XL092, XL-092, XL 092
    Associations

    News

    Trials
    Company:
    Exelixis
    Drug class:
    Tyrosine kinase inhibitor
    Related drugs:
    Associations

    News

    Trials
    12h
    Morpheus Lung: A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (clinicaltrials.gov)
    P1/2, N=314, Terminated, Hoffmann-La Roche | Completed --> Terminated; Study was closed early as the sponsor decided not to continue development of certain treatment combinations.
    Trial termination
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    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
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    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • docetaxel • Cotellic (cobimetinib) • pemetrexed • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • Repatha (evolocumab) • camonsertib (RP-3500) • cibisatamab (RG7802) • ciforadenant (CPI-444) • zanzalintinib (XL092)
    1d
    Zanzalintinib and MO-03 for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy (clinicaltrials.gov)
    P2, N=34, Not yet recruiting, City of Hope Medical Center
    New P2 trial
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    Cdactin-O (CBM588) • zanzalintinib (XL092)
    3d
    Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03) (clinicaltrials.gov)
    P1/2, N=140, Recruiting, Merck Sharp & Dohme LLC
    Trial initiation date
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    Keytruda (pembrolizumab) • Welireg (belzutifan) • zanzalintinib (XL092)
    7d
    A clinical study of belzutifan and zanzalintinib in people with advanced kidney cancer (MK-6482-034) (2024-516993-31-00)
    P2/3, N=154, Not yet recruiting, Merck Sharp & Dohme LLC
    New P2/3 trial
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    Welireg (belzutifan) • zanzalintinib (XL092)
    20d
    A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034) (clinicaltrials.gov)
    P3, N=758, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
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    Welireg (belzutifan) • zanzalintinib (XL092)
    26d
    Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced/Metastatic Soft-tissue Sarcoma (clinicaltrials.gov)
    P2, N=20, Recruiting, M.D. Anderson Cancer Center | Suspended --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • zanzalintinib (XL092)
    29d
    A Phase 2 Study Of Zanzalintinib For Patients With Recurrent Or Metastatic Olfactory Neuroblastoma (clinicaltrials.gov)
    P2, N=16, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    zanzalintinib (XL092)
    1m
    Y-90 Radioembolization, Durvalumab, Tremelimumab, and Zanzalintinib for the Treatment of Unresectable and Locally-Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, OHSU Knight Cancer Institute
    New P2 trial
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl) • zanzalintinib (XL092)
    1m
    Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced/Metastatic Soft-tissue Sarcoma (clinicaltrials.gov)
    P2, N=20, Suspended, M.D. Anderson Cancer Center | Not yet recruiting --> Suspended
    Trial suspension
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    Keytruda (pembrolizumab) • zanzalintinib (XL092)
    2ms
    Molecular complete response to the RIN protocol (regorafenib, ipilimumab, and nivolumab) in a patient with advanced recurrent metastatic mismatch repair proficient/microsatellite stable (pMMR/MSS) rectal cancer. (PubMed, Ther Adv Med Oncol)
    Rectal cancer recurrence remains a major therapeutic challenge, particularly in patients unresponsive to conventional regimens. While previous studies have demonstrated limited benefit of immunotherapy in this tumor subtype, the present findings suggest an emerging therapeutic opportunity that warrants prospective evaluation to confirm efficacy, explore the mechanistic basis, and identify biomarkers predictive of durable response beyond the absence of liver metastases. More effective combinatorial regimens like zanzalintinib and atezolizumb (STELLAR-303) trial, as well as newer generation of CTLA-4 inhibitors like botensilimab, vilastobart, and muzastotug are showing more promise for patients with MSS colorectal cancers in particular who do not have liver metastases (NLM).
    Journal • Mismatch repair • PD(L)-1 Biomarker • IO biomarker • pMMR
    |
    KRAS (KRAS proto-oncogene GTPase) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    KRAS mutation • KRAS G12D • KRAS G12
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • Stivarga (regorafenib) • botensilimab (AGEN1181) • vilastobart (XTX101) • muzastotug (ADG126) • zanzalintinib (XL092)
    2ms
    A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034) (clinicaltrials.gov)
    P3, N=758, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial
    |
    Welireg (belzutifan) • zanzalintinib (XL092)
    2ms
    NEO COMBAT XL: H&N NEO-COMBAT XL: Neoadjuvant XL-092 (Zanzalintinib) and Pembrolizumab (Keytruda) in Surgically Resectable, HPV Negative Oral Cavity Squamous Cell Carcinoma (OCSCC) (clinicaltrials.gov)
    P2, N=26, Not yet recruiting, UNC Lineberger Comprehensive Cancer Center
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • zanzalintinib (XL092)