zanzalintinib (XL092) / Exelixis 
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  • ||||||||||  zanzalintinib (XL092) / Exelixis
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  STELLAR-001: A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (clinicaltrials.gov) -  Nov 18, 2024   
    P1,  N=325, Active, not recruiting, 
    The abstract will be released to the public on January 21, 2025 at 10:00 PM UTC Trial completion date: Nov 2024 --> May 2027 | Trial primary completion date: Nov 2024 --> Aug 2026
  • ||||||||||  Tecentriq (atezolizumab) / Roche, zanzalintinib (XL092) / Exelixis
    P3 data, Journal, Metastases:  STELLAR-303: randomized phase III study of zanzalintinib (Pubmed Central) -  Jul 23, 2024   
    P3
    Presented is the design of STELLAR-303, a global, phase III, open-label, randomized study evaluating zanzalintinib plus atezolizumab versus regorafenib in patients with non-MSI-H mCRC who progressed during/after or are refractory/intolerant to standard-of-care therapy. The primary end point is overall survival in patients without liver metastases.Clinical Trial Registration: NCT05425940 (ClinicalTrials.gov).
  • ||||||||||  zanzalintinib (XL092) / Exelixis
    Biomarker analysis of zanzalintinib in clear cell renal cell carcinoma from STELLAR-001. (Hall A; Poster Bd #: 240) -  Apr 24, 2024 - Abstract #ASCO2024ASCO_1711;    
    P1
    The reduction in immunosuppressive immune cells and activation of effector immune cells by zanza support the rationale for combining zanza with immune checkpoint inhibitors. Given the small sample sizes, further investigation in larger studies is warranted.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen, zanzalintinib (XL092) / Exelixis
    Preliminary results of a prospective pilot study using CD8 ImmunoPET imaging to evaluate the immune response to radiation therapy (ELIXR) (Exhibit Hall B) -  Sep 27, 2023 - Abstract #SITC2023SITC_1058;    
    P1
    Concurrent therapies included cabozantinib, nivolumab, and an experimental chemotherapy XL092 (table 1)...Conclusions Increase in intratumoral CD8+ T cell activity was observed during RT in mRCC and lymphoma patients. Follow-up may reveal the prognostic implications of visualizing the immunogenic effects of radiation using CD8 ImmunoPET.
  • ||||||||||  MODULE 2: Optimizing the Use of Immune Checkpoint Inhibitors in the Management of mCRC (San Francisco Marriott Marquis, Golden Gate Ballroom, Salon A (B2 Level)) -  Dec 23, 2022 - Abstract #ASCOGI2023ASCO_GI_997;    
    This activity is supported by educational grants from Bayer HealthCare Pharmaceuticals, Exelixis Inc, Lilly, Natera Inc, and Seagen Inc. Key data informing the rational incorporation of pembrolizumab, nivolumab and nivolumab/ipilimumab for microsatellite instability-high/mismatch repair-deficient mCRC Early results with and ongoing investigation of immune checkpoint inhibitors in combination with other systemic approaches (eg, chemotherapy, targeted therapy) for MSI-H/dMMR advanced CRC Biologic rationale for the investigation of immune checkpoint inhibition for microsatellite-stable (MSS) mCRC Clinical activity and safety observed with cabozantinib in combination with anti-PD-1/PD-L1 antibodies among patients with MSS mCRC in early-phase trials (eg, COSMIC-021 cohort 16, CAMILLA cohort 2) Pharmacologic and pharmacodynamic comparison of cabozantinib and XL092 Design, eligibility and efficacy and safety endpoints for the Phase III STELLAR-303 trial comparing XL092/atezolizumab to regorafenib for relapsed/refractory (R/R) MSS mCRC Available data with and ongoing investigation of other immune checkpoint inhibitor-based strategies (eg, lenvatinib/pembrolizumab, regorafenib/pembrolizumab) for MSS mCRC Available data with and ongoing investigation of other immune checkpoint inhibitor-based strategies (eg, lenvatinib/pembrolizumab, regorafenib/pembrolizumab) for patients with MSS mCRC
  • ||||||||||  XL092 / Exelixis
    Preclinical, Journal:  Preclinical characterization of XL092, a novel receptor tyrosine kinase inhibitor of MET, VEGFR2, AXL, and MER. (Pubmed Central) -  Nov 19, 2022   
    Additionally, XL092 promoted M2 to M1 repolarization of macrophages in vitro and inhibited primary human macrophage efferocytosis in a dose-dependent manner. In summary, XL092 was shown to have significant antitumor and immunomodulatory activity in animal models both alone and in combination with immune checkpoint inhibitors, supporting its evaluation in clinical trials.