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type="submit" value="Search trials"> </form></div></div> </nav></header><main id="content" class="mx-1 mx-md-0"> <div class="container-xl px-5"><div class="row"><div class="col-md-9 col-lg-8" role="main" id="main-column"><div id="summary" class="page-header show-jargon-definitions"><div class="h3 alert alert-danger text-center">This study is in progress, not accepting new patients</div><h1 id="summary--title"> A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors </h1><p class="h5 hide-long-content">a study on <span class="comma-list"><span class="comma-list-item"> <a href="../malignant-neoplasm">Malignant Neoplasm</a></span><span class="comma-list-item"> <a href="../kidney-cancer">Kidney Cancer</a></span><span class="comma-list-item"> <a href="../renal-cell-carcinoma">Renal Cell Carcinoma</a></span><span class="comma-list-item"> <a href="../breast-cancer">Breast Cancer</a></span><span class="comma-list-item"> <a href="../hormone-receptor-positive-breast-cancer">Hormone Receptor Positive Breast Cancer</a></span><span class="comma-list-item"> <a href="../metastatic-castration-resistant-prostate">Metastatic Castration-Resistant Prostate Cancer</a></span><span class="comma-list-item"> <a href="../prostate-cancer">Prostate Cancer</a></span><span class="comma-list-item"> <a href="../colorectal-cancer">Colorectal Cancer</a></span><span class="comma-list-item"> <a href="../solid-tumor">Solid Tumor</a></span><span class="comma-list-item"> <a href="../carcinoma">Carcinoma</a></span><span class="comma-list-item"> <a href="../neoplasm">Neoplasms</a></span></span></p></div><div id="trial-details-container"><div id="key-points" class="trial-details-block"><div class="row"> <div class="col"><h2 class="sr-only h3">Summary</h2><dl id="key-points-bullets" class="row"><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Eligibility</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <strong>for people ages 18 years and up</strong> (<a href="#eligibility">full criteria</a>) </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-map-marker fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Location</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <a href="#location"> at San Francisco, California and other locations </a> </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-calendar fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Dates</span></dt><dd class="col-12 col-sm-11 col-lg-10"><div> study started <span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateCreated" datetime="2019-03-20">March 2019</time></span></div><div> completion around <time datetime="2027-05-31">May 2027</time></div><div itemscope itemtype="https://schema.org/WebPage" aria-hidden="true" class="d-none"><meta itemprop="datePublished" content="2019-02-19"></div></dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user-md fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Principal Investigator</span></dt><dd class="col-12 col-sm-11 col-lg-10 comma-list"> by <span class="pi-name comma-list-item"><span><a href="https://profiles.ucsf.edu/rahul.aggarwal" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Rahul Aggarwal</a></span></span></dd></dl></div> <div class="d-none d-md-block col-md-auto" id="pi-photos-block"><figure class="figure"><img class="pi-photo figure-img img-fluid rounded" src="https://researcherprofiles.org/profile/Modules/CustomViewPersonGeneralInfo/PhotoHandler.ashx?NodeID=187808" alt="Headshot of Rahul Aggarwal" loading="lazy"><figcaption class="figure-caption">Rahul Aggarwal</figcaption></figure></div></div></div><div id="description" class="trial-details-block"><h2 class="h3">Description</h2><div class="show-jargon-definitions"><h3 class="h4">Summary</h3><div class="hide-long-content"><p>This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with <a href="../solid-tumor" class="trial--link-to-condition-in-text">advanced solid tumors</a>.</p></div><h3 class="h4">Official Title</h3><p class="hide-long-content">A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors</p><h3 class="h4">Keywords</h3><p class=" hide-long-content"><span> Neoplasm Malignant</span>, <span> <a href="../renal-cell-carcinoma" class="trial--link-to-condition-in-text">Renal Cell Carcinoma</a></span>, <span> Hormone Receptor Positive Breast Carcinoma</span>, <span> Metastatic Castration-resistant <a href="../prostate-cancer" class="trial--link-to-condition-in-text">Prostate Cancer</a></span>, <span> <a href="../colorectal-cancer" class="trial--link-to-condition-in-text">Colorectal Cancer</a></span>, <span> Carcinoma</span>, <span> Breast Neoplasms</span>, <span> Neoplasms</span>, <span> Atezolizumab</span>, <span> Avelumab</span></p></div></div><div id="eligibility" class="trial-details-block show-jargon-definitions"><h2 class="h3">Eligibility</h2><div class="hide-long-content"><div class="row"><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-check-square-o" aria-hidden="true"></i> You can join if… </h3><div><p><strong>Open to people ages 18 years and up</strong></p><ul><li>Cytologically or histologically confirmed <a href="../solid-tumor" class="trial--link-to-condition-in-text">solid tumor</a> that is inoperable locally advanced, metastatic, or recurrent.</li><li>Dose-escalation (single-agent and combination therapy): Subjects with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.</li><li>Expansion Cohort A (ccRCC): Subjects with previously treated advanced RCC with clear cell histology (including those with a sarcomatoid component) who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.</li><li>Expansion Cohorts B and E (nccRCC): Subjects with previously treated advanced RCC with non-clear cell histology who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.</li><li>Expansion Cohorts C and F (HR+ BC): Subjects with breast cancer that is hormone receptor positive (ER+ and/or PR+) and negative for human epidermal growth factor receptor 2 (HER-2) and who have radiographically progressed during or following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.</li><li>Expansion Cohorts D and G (mCRPC): Subjects with metastatic CRPC (adenocarcinoma of the prostate). Neuroendocrine differentiation and other features permitted if adenocarcinoma is the primary histology.</li><li>Expansion Cohort H (CRC): Subjects with histologically confirmed unresectable, locally advanced, or metastatic <a href="../colorectal-cancer" class="trial--link-to-condition-in-text">adenocarcinoma of the colon</a> or rectum, KRAS/NRAS wild-type (confirmed via local testing report) and determined NOT to have <a href="../microsatellite-instability" class="trial--link-to-condition-in-text">microsatellite instability</a> high (MSI-high) or mismatch repair deficient (dMMR) by local testing, who received the following standard of care chemotherapy regimens as prior therapy for metastatic CRC: <ul><li> Fluoropyrimidine, irinotecan and oxaliplatin, with or without an anti-VEGF <a href="../monoclonal-antibody" class="trial--link-to-condition-in-text">monoclonal antibody</a> (bevacizumab)</li><li> Anti-EGFR monoclonal antibody (cetuximab or panitumumab)</li><li> BRAF inhibitor (in combination with cetuximab +/- binimetinib) for subjects with BRAF V600E mutations</li></ul></li><li>Expansion Cohorts: Subjects must have measurable disease per RECIST 1.1.</li><li>Tumor tissue material: <ul><li> Subjects in the non-biomarker cohort provide archival, if available, or fresh tumor tissue if it can be safely obtained.</li></ul></li><li>Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs), including immune-related adverse events (irAEs), related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.</li><li>Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.</li><li>Adequate organ and marrow function.</li><li>Sexually active fertile subjects and their partners must agree to use highly effective methods of <a href="../contraception" class="trial--link-to-condition-in-text">contraception</a>.</li><li>Female subjects of childbearing potential must not be pregnant at screening.</li></ul></div></div><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-ban" aria-hidden="true"></i> You CAN'T join if... </h3><div><ul><li>Prior treatment with XL092 (all cohorts), prior treatment with PD-L1/PD-1 targeting immune checkpoint inhibitor (Cohorts E, F, G, and H only), or prior treatment with regorafenib and/or TAS-102 (Cohort H only).</li><li>Receipt of any type of small molecule kinase inhibitor within 2 weeks before first dose of study treatment.</li><li>Receipt of any type of anticancer antibody, systemic chemotherapy, or hormonal anticancer therapy within 4 weeks before first dose of study treatment.</li><li>Radiation therapy for <a href="../bone-cancer" class="trial--link-to-condition-in-text">bone metastasis</a> within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.</li><li>Known <a href="../brain-cancer" class="trial--link-to-condition-in-text">brain metastases</a> or cranial epidural disease unless adequately treated with <a href="../radiotherapy" class="trial--link-to-condition-in-text">radiotherapy</a> and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.</li><li>Uncontrolled, significant intercurrent or recent illness.</li><li>Concomitant use of certain medications.</li><li>Corrected QT interval calculated by the Fridericia formula (QTcF) > 450 ms for males and > 470 ms for females. Single ECGs are no longer permitted.</li><li>Pregnant or lactating females.</li><li>Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial <a href="../skin-cancer-melanoma" class="trial--link-to-condition-in-text">skin cancers</a>, or localized, low grade tumors deemed cured and not treated with systemic therapy.</li></ul><p>Additional Exclusion Criteria for XL092 + Atezolizumab Combination Therapy Cohorts ONLY:</p><ul><li>Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment.</li><li>Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.</li></ul><p>Additional Exclusion Criteria for XL092 + Avelumab Combination Therapy Cohorts ONLY:</p><ul><li>Active <a href="../autoimmune-disease" class="trial--link-to-condition-in-text">autoimmune disease</a> that might deteriorate when receiving an immunostimulatory agent.</li><li>Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.</li></ul></div></div></div></div></div><div id="location" class="trial-details-block"><h2 class="h3">Locations</h2><ul id="locations-list" class="hide-long-content "><li class="location " itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">Exelixis Clinical Site #66</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> San Francisco</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 94158</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li><li class="location " itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">Exelixis Clinical Site #71</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> Stanford</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 94305</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li></ul></div><div id="pis" class="trial-details-block"><h2 class="h3">Lead Scientist <span class="d-none d-sm-inline">at UCSF</span></h2><ul class="pis-list--only-one-pi"><li class="pi"><span class="pi-name"> <strong> <a href="https://profiles.ucsf.edu/rahul.aggarwal" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Rahul Aggarwal</a> </strong> </span><br> I am a Medical Oncologist within the Division of Hematology/Oncology at the University of California San Francisco. My clinical practice focuses on patients with advanced solid tumor malignancies with a particular emphasis on genitourinary malignancies including prostate, kidney, bladder, and testicular cancer. </li></ul></div><div id="details" class="trial-details-block"><h2 class="h3">Details</h2><dl class="row"><dt class="col-sm-3 text-sm-right">Status</dt><dd class="col-sm-9"> in progress, not accepting new patients </dd><dt class="col-sm-3 text-sm-right">Start Date</dt><dd class="col-sm-9"><time datetime="2019-03-20">March 2019</time></dd><dt class="col-sm-3 text-sm-right">Completion Date</dt><dd class="col-sm-9"><time datetime="2027-05-31">May 2027</time> (estimated)</dd><dt class="col-sm-3 text-sm-right">Sponsor</dt><dd class="col-sm-9">Exelixis</dd><dt class="col-sm-3 text-sm-right">ID</dt><dd class="col-sm-9"> <a href="https://clinicaltrials.gov/study/NCT03845166" class="trial--link-to-clinicaltrials-gov" target="_blank" rel="noopener nofollow" title="ClinicalTrials.gov identifier">NCT03845166</a> </dd><dt class="col-sm-3 text-sm-right">Phase</dt><dd class="col-sm-9">Phase 1 research study</dd><dt class="col-sm-3 text-sm-right">Study Type</dt><dd class="col-sm-9">Interventional</dd><dt class="col-sm-3 text-sm-right">Participants</dt><dd class="col-sm-9">About 325 people participating</dd><dt class="col-sm-3 text-sm-right">Last Updated</dt><dd class="col-sm-9"><span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateModified" datetime="2024-11-15">November 15, 2024</time></span></dd></dl></div><div id="faq" class="trial-details-block d-print-none" role="complementary"><h2 class="h3">Frequently Asked Questions</h2><ul><li><a href="../about/how-clinical-trials-work">How Do Clinical Trials Work?</a></li><li><a href="../about/what-to-expect">What to Expect</a></li><li><a href="../about/who-can-join">Who Can Join</a></li><li><a href="../about/our-researchers">Our Researchers</a></li></ul></div></div> </div><div class="col-md-3 text-center offset-lg-1 d-none d-md-block d-print-none" id="secondary-column"> <div id="sidebar"></div> </div></div> </div> <script type="application/ld+json"> [{"@context":"https://schema.org/","@type":"MedicalTrial","additionalType":"Product","alternateName":"A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors","code":{"@type":"MedicalCode","codeValue":"NCT03845166","codingSystem":"ClinicalTrials.gov"},"description":"This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.","healthCondition":[{"@type":"MedicalCondition","name":"Malignant Neoplasm"},{"@type":"MedicalCondition","name":"Kidney Cancer"},{"@type":"MedicalCondition","name":"Renal Cell Carcinoma"},{"@type":"MedicalCondition","name":"Breast Cancer"},{"@type":"MedicalCondition","name":"Hormone Receptor Positive Breast Cancer"},{"@type":"MedicalCondition","name":"Metastatic Castration-Resistant Prostate Cancer"},{"@type":"MedicalCondition","name":"Prostate Cancer"},{"@type":"MedicalCondition","name":"Colorectal Cancer"},{"@type":"MedicalCondition","name":"Solid Tumor"},{"@type":"MedicalCondition","name":"Carcinoma"},{"@type":"MedicalCondition","name":"Neoplasms"}],"name":"A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors","sameAs":"https://clinicaltrials.gov/study/NCT03845166","sponsor":[{"@type":"Organization","name":"Exelixis"},{"@context":"https://schema.org/","@type":"Person","affiliation":{"@type":"Organization","name":"UCSF"},"description":"I am a Medical Oncologist within the Division of Hematology/Oncology at the University of California San Francisco. 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