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- |||||||||| zanzalintinib (XL092) / Exelixis
New P3 trial, Metastases: STELLAR-303: Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer (clinicaltrials.gov) - Jun 21, 2022
P3, N=600, Recruiting, Sponsor: Exelixis
- A phase 1b study (STELLAR-002) of XL092 administered in combination with nivolumab (NIVO) with or without ipilimumab (IPI) or bempegaldesleukin (BEMPEG) in patients (pts) with advanced solid tumors. (Available On Demand; 90a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2530;
P1
Primary efficacy endpoints include objective response rate by investigator per RECIST v1.1 and progression-free survival by blinded independent radiology committee per Prostate Working Group 3 criteria (mCRPC cohort only). The study is currently enrolling pts.
- ||||| XL092 / Exelixis
Very excited to see #XL092 moving forward into multiple histologies, both as mono & CPI. Glad to be a part of this terrific group of investigators including @neerajaiims @VivekSubbiah @AmitaPatnaikMD #ManishSharma @KrisWentzelMD et al. Please stop by our poster at @ASCO #GU22! (Twitter) - Feb 19, 2022
- || Trial completion date, Trial primary completion date: 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) - Feb 16, 2022
P1/2, N=435, Recruiting, Sponsor: Hoffmann-La Roche
The study is currently enrolling pts. Trial completion date: Nov 2023 --> Aug 2025 | Trial primary completion date: Feb 2022 --> Apr 2024
- || Trial primary completion date: 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) - Jan 18, 2022
P1/2, N=435, Recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Nov 2023 --> Aug 2025 | Trial primary completion date: Feb 2022 --> Apr 2024 Trial primary completion date: Jun 2022 --> Feb 2022
- XL092 / Exelixis
A phase 1 first-in-human study of XL092 administered alone or in combination with immune checkpoint inhibitors (ICIs) in patients (pts) with inoperable locally advanced or metastatic solid tumors: Description of genitourinary (GU) expansion cohorts. (In-Person & On Demand | Level 1, West Hall - M5) - Jan 5, 2022 - Abstract #ASCOGU2022ASCO_GU_792;
P1
Pts with advanced urothelial carcinoma will be enrolled in 3 cohorts: (i) pts with ongoing CR/PR/SD after 4-6 cycles of first-line chemotherapy (gemcitabine + cisplatin and/or gemcitabine + carboplatin) will receive XL092 + AVE; (ii) pts with progression on/after prior ICI therapy (=2 prior systemic therapies) will be randomized 1:1 to XL092 + AVE or single-agent XL092; (iii) pts with progression on/after first-line platinum-based chemotherapy will receive XL092 + AVE. The study is currently enrolling pts.
- ||| zanzalintinib (XL092) / Exelixis
New P1 trial: STELLAR-002: Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors (clinicaltrials.gov) - Jan 3, 2022
P1, N=826, Recruiting, Sponsor: Exelixis
- | XL092 / Exelixis
Preclinical, Journal: Identification of the metabolites of XL092 in rat and human by using ultra-high performance liquid chromatography high resolution mass spectrometry. (Pubmed Central) - Oct 15, 2021
CYP3A4 and CYP2D6 were the major enzymes responsible for XL092 metabolism. Taken together, this study for the first time evaluated the in vitro metabolic profiles of XL092 in rat and human, which is of great help for us to investigate the XL092 pharmacokinetic and toxicity assessment and to predict the in vivo human metabolism.
- Bavencio (avelumab) / EMD Serono, Pfizer, Tecentriq (atezolizumab) / Roche
Trial in progress: Phase 1 first-in-human study of XL092 administered alone or in combination with immune checkpoint inhibitors in patients with inoperable locally advanced or metastatic solid tumors (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_451;
P1
The study is open for enrollment. Trial Registration NCT03845166
- XL092 / Exelixis
[VIRTUAL] The tyrosine kinase inhibitor XL092 promotes an immune-permissive tumor microenvironment and enhances the anti-tumor activity of immune checkpoint inhibitors in preclinical models () - Sep 30, 2021 - Abstract #AACRNCIEORTC2021AACR_NCI_EORTC_424;
- || Trial completion date: 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) - Aug 27, 2021
P1/2, N=435, Recruiting, Sponsor: Hoffmann-La Roche
Trial Registration NCT03845166 Trial completion date: Feb 2024 --> Nov 2023
- || zanzalintinib (XL092) / Exelixis
Enrollment change, 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) - Jun 7, 2021
P1, N=800, Recruiting, Sponsor: Exelixis
Trial completion date: Feb 2024 --> Nov 2023 N=425 --> 800 | Trial completion date: May 2022 --> Nov 2024 | Trial primary completion date: May 2022 --> Nov 2023
- || XL092 / Exelixis
$EXEL Cabo is an excellent drug. XL092 potentially better. (Twitter) - Jun 6, 2021
- || Trial completion date, Trial primary completion date: 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) - May 26, 2021
P1/2, N=435, Recruiting, Sponsor: Hoffmann-La Roche
N=425 --> 800 | Trial completion date: May 2022 --> Nov 2024 | Trial primary completion date: May 2022 --> Nov 2023 Trial completion date: Nov 2023 --> Feb 2024 | Trial primary completion date: Feb 2022 --> Jun 2022
- || Trial completion date: 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) - Mar 15, 2021
P1/2, N=380, Recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Nov 2023 --> Feb 2024 | Trial primary completion date: Feb 2022 --> Jun 2022 Trial completion date: Apr 2022 --> Nov 2023
- || zanzalintinib (XL092) / Exelixis
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, PD(L)-1 Biomarker, Metastases: STELLAR-001: A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (clinicaltrials.gov) - Sep 16, 2020
P1, N=425, Recruiting, Sponsor: Exelixis
Trial completion date: Apr 2022 --> Nov 2023 N=151 --> 425 | Trial completion date: Feb 2021 --> May 2022 | Trial primary completion date: Feb 2021 --> May 2022
- Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
[VIRTUAL] XL092, A multi-targeted inhibitor of MET, VEGFR2, AXL and MER with an optimized pharmacokinetic profile (Channel 1) - Sep 7, 2020 - Abstract #AACRNCIEORTC2020AACR_NCI_EORTC_123;
P1
In preclinical studies XL092 showed potent pharmacodynamic inhibition of MET and VEGFR2 phosphorylation, which was associated with significant anti-tumor activity. PK data from the Phase 1 trial of XL092 shows a significantly shorter terminal half-life compared to cabozantinib, consistent with the desired profile.
- | zanzalintinib (XL092) / Exelixis
Enrollment change, Combination therapy, PD(L)-1 Biomarker, Metastases: STELLAR-001: A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (clinicaltrials.gov) - Aug 6, 2019
P1, N=151, Recruiting, Sponsor: Exelixis
PK data from the Phase 1 trial of XL092 shows a significantly shorter terminal half-life compared to cabozantinib, consistent with the desired profile. N=100 --> 151
- | Enrollment change: 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) - Jul 11, 2019
P1/2, N=250, Recruiting, Sponsor: Hoffmann-La Roche
N=100 --> 151 N=410 --> 250
- ||| Enrollment change: 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) - Mar 1, 2019
P1/2, N=410, Recruiting, Sponsor: Hoffmann-La Roche
N=410 --> 250 N=292 --> 410
- ||| zanzalintinib (XL092) / Exelixis
Enrollment open, Combination therapy, PD(L)-1 Biomarker, Metastases: STELLAR-001: A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (clinicaltrials.gov) - Feb 22, 2019
P1, N=100, Recruiting, Sponsor: Exelixis
N=292 --> 410 Not yet recruiting --> Recruiting
- ||| zanzalintinib (XL092) / Exelixis
New P1 trial, Combination therapy, PD(L)-1 Biomarker, Metastases: STELLAR-001: A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (clinicaltrials.gov) - Feb 19, 2019
P1, N=100, Not yet recruiting, Sponsor: Exelixis
- |||| Enrollment open: 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) - Nov 17, 2017
P1/2, N=307, Recruiting, Sponsor: Hoffmann-La Roche
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| New P1/2 trial: 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) - Nov 9, 2017
P1/2, N=307, Not yet recruiting, Sponsor: Hoffmann-La Roche