[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Exelixis\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":287},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,54,67,98,125,154,182,210,235,261],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100054209","phase-2-a-study-of-zanzalintinib-in-participants-with-recurrent-or-progressive-meningioma-100054209",false,"NCT07428616","A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma","A Phase 2, Single-Arm, Multicenter, Open-Label Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma","STELLAR-201","Key Inclusion Criteria:\n\n* Histologically confirmed World Health Organization (WHO) grade 1, 2, or 3 meningioma.\n* Developed recurrent disease or progressive disease (PD) after receiving standard therapy (for example, surgery and\u002For radiation) or have been deemed ineligible to receive these therapies. At least 1 prior course of meningioma-directed radiotherapy is required, if not contraindicated.\n* Radiologically documented progression of any existing tumor (growth \\> 15% of the bidimensional enhancing tumor within the prior 6 months or appearance of new lesions (including intra and extracranial manifestations).\n* For participants treated with external beam radiation, interstitial brachytherapy, or radiosurgery, an interval ≥ 24 weeks must have elapsed from completion of therapy to initiation of treatment.\n* Measurable disease by RANO meningioma criteria as determined by the investigator, obtained ≤ 14 days prior to initiation of treatment.\n* Karnofsky performance status (KPS) ≥ 60%.\n* Demonstrate adequate organ and marrow function within 14 days of treatment initiation\n\nKey Exclusion Criteria:\n\n* Prior history of hypertensive encephalopathy at any time.\n* Extracranial lesions invading major blood vessels including, but not limited to, inferior vena cava, pulmonary artery, or aorta.\n* Contraindication to magnetic resonance imaging (MRI).\n* Local therapy (surgery and\u002For radiation therapy) is indicated per investigator\n* Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks or 5 half-lives, whichever is shorter, before initiation of treatment. There is no limit on prior systemic therapies\n* Prior Surgery - completed wound healing must occur prior to initiation of treatment; ≥ 8 weeks for major surgery, ≥ 7 days for minor surgery, including stereotactic biopsies.\n* The participant has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders, including uncontrolled hypertension,\n  * Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation,\n  * Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 milliliters \\[mL\\]) of red blood within 12 weeks before initiation of treatment or other history of significant bleeding (eg, intracranial hemorrhage\u002Fbleeding), or\n  * Other clinically significant disorders.\n* Requirement for hemodialysis or peritoneal dialysis.\n* History of solid organ or allogeneic stem cell transplant.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The objective of the study is to evaluate efficacy and safety of zanzalintinib in participants with recurrent or progressive meningioma refractory to standard therapies.",[27],"Meningioma",[27,29,30,31,32,33,34,35,36,37,38,39,40],"Recurrent Meningioma","Progressive Meningioma","Atypical Meningioma","Anaplastic Meningioma","Brain","Zanzalintinib","XL092","Grade 1 Meningioma","Grade 2 Meningioma","Grade 3 Meningioma","Intracranial Neoplasms","Extracranial Meningioma","RECRUITING","2026-07-10",{"date":44,"type":45},"2026-07-13","ACTUAL",{"date":47,"type":45},"2026-05-21",{"date":49,"type":21},"2029-09-30",{"name":51,"class":52},"Exelixis","INDUSTRY",12,{"id":55,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":25,"conditions":58,"keywords":59,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":65,"locationsCount":66},"100625898",{"count":20,"type":21},[24],[27],[27,29,30,31,32,33,34,35,36,37,38,39,40],"2026-06-19",{"date":62,"type":45},"2026-06-24",{"date":47,"type":45},{"date":49,"type":21},{"name":51,"class":52},6,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100589253","phase-1-a-study-of-xb628-alone-and-in-combination-with-zanzalintinib-in-participants-with-recurrent-advanced-or-metastatic-solid-tumors-100589253","NCT06952010","A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors","A Phase 1 Dose Escalation and Expansion Study of XB628 as a Single Agent and in Combination With Zanzalintinib in Participants With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Minimum life expectancy of ≥ 12 weeks.\n* Have a recurrent advanced or metastatic solid tumor that is histologically or cytologically confirmed.\n* Adequate organ and marrow function.\n* Not amenable to curative treatment with surgery or radiation.\n* Received at least 1 line of prior systemic anticancer therapy in the recurrent or metastatic setting.\n* Acceptable alternative therapy was received, refused, intolerable, or no longer effective.\n* Capable of understanding and complying with the protocol requirements and provide signed informed consent according to the protocol and local requirements.\n\nKey Exclusion Criteria\n\n* Primary brain tumors or known active brain metastases.\n* Major surgery (eg, gastrointestinal surgery, removal or biopsy of brain metastasis) within 4 weeks before the first dose of study treatment.\n* Received radiation therapy within 1 week before the first dose of study treatment or clinically relevant ongoing complications from prior radiation therapy.\n* Received prior therapy targeting NK cells (eg, monalizumab).\n* A woman of childbearing potential has a positive serum pregnancy test within 7 days prior to study treatment.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":75,"type":21},303,[77],"PHASE1","This study consists of a Dose-Escalation stage and a Dose Expansion stage. The primary purpose of the dose escalation stage is to determine the maximum tolerated dose (MTD) and\u002For recommended dosage(s) for expansion (RDE\\[s\\]); and the dose expansion stage is to evaluate the preliminary antitumor activity of XB628 as a single agent and in combination with zanzalintinib.",[80,81,82,83],"Solid Tumor","Advanced Solid Tumor","Metastatic Solid Tumor","Immune Sensitive Tumor",[85,86,87,88,89,90,34],"XB628","Solid tumor","Advanced solid tumor","Metastatic solid tumor","Immune sensitive tumor","PD-L1",{"date":62,"type":45},{"date":93,"type":45},"2025-05-01",{"date":95,"type":21},"2027-11-30",{"name":51,"class":52},11,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100557993","phase-1-study-of-xb010-in-subjects-with-solid-tumors-100557993","NCT06545331","Study of XB010 in Subjects With Solid Tumors","A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors","* Age 18 years or older on the day of consent.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n* Adequate organ and marrow function.\n* Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.\n\n  * The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer).\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.",{"count":106,"type":21},396,[77],"This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.",[110,111,112,113,114,115],"Locally Advanced or Metastatic Solid Tumors","Esophageal Squamous Cell Cancer","Head and Neck Squamous Cell Cancer","NSCLC (Non-small Cell Lung Cancer)","Hormone-receptor-positive Breast Cancer","Triple Negative Breast Cancer (TNBC)","2026-06-17",{"date":118,"type":45},"2026-06-22",{"date":120,"type":45},"2024-08-06",{"date":122,"type":21},"2027-10-20",{"name":51,"class":52},20,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100452820","phase-1-study-of-zanzalintinib-in-combination-with-immuno-oncology-agents-in-participants-with-solid-tumors-100452820","NCT05176483","Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors","A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors","STELLAR-002","Key Inclusion Criteria:\n\n* Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.\n* Dose-Escalation Cohorts: Participants 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.\n* Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy.\n\n  * Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose.\n* Expansion Cohort 2 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component.\n\n  * Must have radiographically progressed after a combination therapy consisting of a Programmed Cell Death Protein 1 (PD-1)\u002FProgrammed death-ligand 1 (PD-L1) targeting monoclonal antibody (mAb) with a Vascular endothelial growth factor (receptor) tyrosine kinase inhibitor (VEGFR-TKI) or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy.\n  * Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma.\n* Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate.\n\n  * Must have progressed during or after one novel hormone therapy (NHT) given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC.\n* Expansion Cohort 4 (UC, ICI-naive): Participants with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).\n\n  * Must have progressed during or after prior first-line platinum-based combination therapy, including participants who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence \\\u003C 12 months from the end of last therapy.\n  * Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease.\n* Expansion Cohort 5 (post enfortumab vedotin \\[EV\\] and ICI): Participants with histologically confirmed unresectable, locally advanced or metastatic predominant urothelial carcinoma.\n\n  * Progressive disease following prior EV or ineligible for EV, and progression following prior PD-1\u002FPD-L1 inhibitor or ineligible for PD-1\u002FPD-L1 inhibitor.\n  * Prior receipt of platinum-based therapy allowed but not required.\n  * Prior therapy with other agents allowed but not required.\n* Expansion Cohort 6 (nccRCC): Participants with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary, unclassified RCC, and translocation-associated, Fumarate Hydratase (FH) deficient and Succinate Dehydrogenase (SDH) deficient. Among the eligible histologic subtypes, sarcomatoid features are allowed.\n\n  * No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose.\n* Expansion Cohort 7 (HCC): Participants with locally advanced, or metastatic and\u002For unresectable HCC that is not amenable to curative treatment or locoregional therapy.\n* Expansion Cohort 8 (NSCLC): Participants with Stage IV non-squamous NSCLC with positive PD-L1 expression (tumor proportion score \\[TPS\\] 1-49%) and without prior systemic anticancer therapy for metastatic disease.\n* Expansion Cohort 9 (NSCLC): Participants with Stage IV non-squamous NSCLC who have radiologically progressed following treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease.\n* Expansion Cohort 10 (CRC): Participants with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum.\n* Expansion Cohort 11 (HNSCC): Participant with inoperable, refractory, recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx. PD-L1 combined positive score (CPS) ≥1.\n* Expansion Cohort 12 (ccRCC): Participants with unresectable advance or metastatic RCC with a clear cell component, including participants who also have a sacromatoid feature.\n\n  * Must have received no more than two prior lines of systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma\n* Expansion Cohort 13 and Cohort 14 (ccRCC 1L): Participants with unresectable advanced or metastatic RCC with a clear component, including participants who also have a sacromatoid feature.\n* For all Expansion Cohorts except Cohort 3: Measurable disease per RECIST 1.1 as determined by the Investigator.\n* For Expansion Cohorts 1 - 11 Only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.\n* Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and\u002For stable on supportive therapy.\n* Karnofsky Performance Status (KPS) ≥ 70%.\n* Adequate organ and marrow function.\n* Sexually active fertile participants and their partners must agree to use highly effective methods of contraception.\n* Females of childbearing potential must not be pregnant at screening.\n\nKey Exclusion Criteria:\n\n* For all Dose-Escalation cohorts: Prior treatment with zanzalintinib. For all Expansion Cohorts: Prior treatment with zanzalintinib, nivolumab, ipilimumab or relatlimab with the following exceptions: Prior PD-1\u002FPD-L1, Lymphocyte-activation gene 3 (LAG-3) and cCytotoxic T lymphocyte associated protein 4 (CTLA-4) targeting therapy for locally advanced or metastatic disease is allowed for Cohort 2 (ccRCC), Cohort 5 (UC), Cohort 9 (NSCLC), and Cohort 12 (ccRCC), and prior treatment in the neoadjuvant or adjuvant setting is allowed for Cohort 13 and Cohort 14 (ccRCC 1L).\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC), Cohort 10 (CRC), and Cohort 12: Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC), and Cohort 12: Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment.\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* Prior external radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment, unless otherwise specified.\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.\n* Concomitant anticoagulation with oral anticoagulants, except for specified direct factor Xa inhibitors.\n* Administration of a live, attenuated vaccine within 30 days prior to first dose.\n* Uncontrolled, significant intercurrent or recent illness.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 460 ms for females and \\> 450 ms for males per electrocardiogram (ECG) within 14 days before first dose of study treatment.\n* Participants with inadequately treated adrenal insufficiency.\n* Pregnant or lactating females.\n* Any other active malignancy within two years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* For Cohort 2 (ccRCC, 2L): Receipt of a prior triplet therapy including a VEGFR-TKI, a PD1 targeting mAb, and a CTLA-4 mAb.\n* For Cohort 3 (mCRPC): Receipt of a taxane-based chemotherapy for mCRPC.\n* For Cohort 4 (UC, ICI-naïve): Participants who have had recurrence within the 6 months of completing adjuvant anti-PD-(L)1 treatment.\n* For Cohort 6 (nccRCC, 1L): Participants with chromophobe, renal medullary carcinoma, or pure collecting duct nccRCC.\n* For Cohort 7 (HCC):\n\n  * Documented hepatic encephalopathy (HE) within 6 months before the first dose.\n  * Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization.\n  * Participants who have received any local anticancer therapy including surgery, percutaneous ethanol injection (PEI), radiofrequency ablation (RFA), microwave ablation (MWA), transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to first dose.\n  * Participants with known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma\n* For Cohort 10 (CRC, 2L+): Receipt of prior therapy with regorafenib and\u002For trifluridine + tipiracil (TAS-102).\n* For Cohort 11 (HNSCC): Primary tumor site of the nasopharyngeal area.\n* For Cohorts 1 (ccRCC, 1L), 2 (ccRCC, 2L), 4, 5 (UC), 7 (HCC), 8 (NSCLC 1L PD-L1 low), 9 (NSCLC, 2L+), 10 (CRC, microsatellite stable \\[MSS\\], 2L+), and 11 (HNSCC):\n\n  * Troponin T (TnT) or I (TnI) \\> 2 × institutional upper limit of normal (ULN).\n\nNote: Additional Inclusion and Exclusion criteria may apply.",{"count":134,"type":21},1314,[77],"This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors.\n\nIn the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.",[138,139,140,80,141,142,143,144,145,146],"Renal Cell Carcinoma (RCC)","Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Urothelial Carcinoma (UC)","Hepatocellular Carcinoma (HCC)","Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","Clear Cell Renal Cell Carcinoma (ccRCC)","Non-Clear Cell Renal Cell Carcinoma (nccRCC)",{"date":118,"type":45},{"date":149,"type":45},"2021-12-14",{"date":151,"type":21},"2030-06-28",{"name":51,"class":52},122,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":164,"conditions":165,"keywords":172,"overallStatus":173,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":4},"100639971","phase-3-long-term-extension-study-for-participants-previously-enrolled-in-an-exelixis-sponsored-study-100639971","NCT07620574","Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study","Key Inclusion Criteria:\n\n* Eligible to continue receiving the study treatment in the parent study (that is, has not met parent study discontinuation\u002Fwithdrawal criteria).\n* Continuing to derive clinical benefit from the study treatment at the time of transition from the parent study as assessed by the investigator.\n* Able to comply with the long-term extension study protocol as determined by the investigator.\n* Able to receive the first dose of study treatment in this extension study within the specified treatment interruption window allowed by the parent study.\n\nKey Exclusion Criteria:\n\n* Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study.\n* Study treatment is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant.\n* Treatment with any anticancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this long-term extension study.\n* Permanent discontinuation of all study treatment(s) for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this long-term extension study (if applicable).\n* Concurrent participation in any therapeutic clinical trial (other than the parent study).\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":161,"type":21},5000,[163],"PHASE3","The primary objective of this long-term extension study is to allow continued access to study treatment for eligible participants who are deriving clinical benefit in an Exelixis-sponsored study who do not have access to treatment locally.",[166,138,167,168,141,169,146,170,171],"Cancer","Pancreatic Neuroendocrine Tumors (pNET)","Extra-Pancreatic NET (epNET)","Differentiated Thyroid Cancer (DTC)","Colorectal Cancer","Prostate Cancer",[138,167,168,141,169,146,170],"NOT_YET_RECRUITING","2026-05-27",{"date":176,"type":45},"2026-06-02",{"date":178,"type":21},"2026-05-31",{"date":180,"type":21},"2030-05-31",{"name":51,"class":52},{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":193,"conditions":194,"keywords":197,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},"100588619","phase-2-zanzalintinib-versus-everolimus-in-participants-with-locally-advanced-or-metastatic-neuroendocrine-tumors-100588619","NCT06943755","Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors","A Phase 2\u002F3, Multicenter, Randomized Open-Label Study of Zanzalintinib vs Everolimus in Participants With Previously Treated, Unresectable, Locally Advanced or Metastatic Neuroendocrine Tumors","STELLAR-311","Key Inclusion Criteria:\n\n* Histologically confirmed, locally advanced\u002Funresectable or metastatic, well-differentiated Grade 1, 2, or 3 NETs of pancreatic origin or extra-pancreatic origin.\n* Allowed prior lines of therapy, based on the site of NET and functional status.\n* Documented radiographic disease progression per RECIST 1.1, as assessed by the Investigator based on imaging assessments (computed tomography \\[CT\\] or magnetic resonance imaging \\[MRI\\]) within 12 months before randomization.\n* Measurable disease according to RECIST 1.1 as determined by the Investigator.\n* Archival tumor tissue is required, if available. If archival tumor tissue is not available, a fresh biopsy may be submitted if it can be safely and feasibly obtained. Every attempt should be made to provide tumor tissue.\n\nKey Exclusion Criteria:\n\n* Histologically confirmed neuroendocrine carcinomas (including small cell lung cancer), medullary thyroid cancer, pheochromocytoma, paraganglioma, Merkel cell carcinoma, and mixed neuroendocrine non-neuroendocrine neoplasm (MiNEN).\n* Prior treatment with a vascular endothelial growth factor receptor (VEGFR) -targeting tyrosine kinase inhibitor or a mammalian target of rapamycin (mTOR) inhibitor.\n* Systemic chemotherapy and any liver-directed or other ablative therapy within 4 weeks before randomization.\n* Systemic radionuclide therapy within 6 weeks before randomization.\n* Radiation therapy for bone metastases within 2 weeks, any other radiation therapy, except as indicated above, within 4 weeks before randomization.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":191,"type":21},440,[24,163],"The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.",[195,196],"Pancreatic Neuroendocrine Tumor (pNET)","Extra-Pancreatic Neuroendocrine Tumor (epNET)",[198,199,200],"Metastatic Cancer","Locally Advanced Cancer","Neuroendocrine Tumor (NET)","2026-04-15",{"date":203,"type":45},"2026-04-17",{"date":205,"type":45},"2025-07-21",{"date":207,"type":21},"2029-06",{"name":51,"class":52},80,{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},"100602407","phase-1-a-study-of-xb371-administered-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100602407","NCT07123103","A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors","A Dose Escalation and Expansion Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Minimum life expectancy of ≥ 12 weeks.\n* Recurrent locally advanced or metastatic solid tumors.\n* Adequate end organ and bone marrow function.\n\nKey Exclusion Criteria:\n\n* Primary brain tumors or known active brain metastases, leptomeningeal, or cranial epidural disease.\n* History of interstitial lung disease (ILD) of any grade or history of organizing pneumonia.\n* Has acute ocular infection, acute or chronic ulcerative\u002Fcicatricial condition of conjunctiva or cornea.\n* Known history of immunodeficiency virus (HIV) unless specific criteria are met.\n* Active infection with hepatitis C virus (HCV) defined as positive for HCV antibody.\n* Major surgery within 4 weeks before the first dose of study treatment.\n* Received radiation therapy within 2 weeks before the first dose of study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":218,"type":21},150,[77],"The primary purpose of the study is to characterize the safety and tolerability of XB371. The dose-escalation cohorts and Part B of the expansion cohorts are non-randomized. Part A of the expansion cohorts is randomized.",[222],"Solid Tumors",[224,225],"Advanced Solid Tumors","Metastatic Solid Tumors","2026-02-13",{"date":228,"type":45},"2026-02-17",{"date":230,"type":45},"2025-08-18",{"date":232,"type":21},"2028-02",{"name":51,"class":52},9,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":247,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},"100510932","phase-1-a-phase-1-study-of-xl309-ism3091-alone-and-in-combination-in-participants-with-advanced-solid-tumors-100510932","NCT05932862","A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors","An Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of XL309 (ISM3091) as Single-Agent and Combination Therapy in Patients With Advanced Solid Tumors","Key Inclusion Criteria:\n\n1. Capable of understanding and complying with protocol requirements.\n2. Male or female aged 18 years or older.\n3. Eastern Cooperative Oncology Group performance status 0 or 1.\n4. Adequate bone marrow and organ function.\n5. Participant-disease Characteristics\n\n   Dose-Escalation Stage Single Agent and Combination:\n\n   a) Participants whose tumor progressed on, or who were intolerant to standard therapy, have a disease for which no therapy exists or are not a candidate for these therapies, and have one of the following cancers:\n\n   i. Histologically confirmed locally advanced\u002Fmetastatic human epidermal growth factor receptor-2 (HER2)-negative breast cancer, with deleterious or suspected deleterious breast cancer gene (BRCA)1\u002F2 alteration.\n\n   ii. Histologically confirmed locally advanced\u002Fmetastatic high-grade serous ovarian cancer (HGSOC), including primary peritoneal cancer (PPC) and fallopian tube cancer (FTC).\n\n   iii. Histologically confirmed locally advanced\u002Fmetastatic CRPC, with deleterious or suspected deleterious BRCA1\u002F2 alteration.\n\n   iv. Histologically confirmed locally advanced\u002Fmetastatic pancreatic cancer with deleterious or suspected deleterious BRCA1\u002F2 alteration.\n\n   v. Locally advanced\u002Fmetastatic tumors with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) mutation or homologous recombination deficiency (HRD) phenotype.\n\n   Cohort-Expansion Stage Single Agent and Combination:\n\n   b) HER2-negative breast cancer cohort: participants with histologically confirmed locally advanced\u002Fmetastatic (HER2)-negative breast cancer with alterations in select HRR genes.\n\n   c) Platinum-sensitive HGSOC cohort: participants with histologically confirmed locally advanced\u002Fmetastatic HGSOC, including primary peritoneal cancer (PPC) and fallopian tube cancer (FTC), with positive HRD result using an approved diagnostic, and\u002For alterations in select HRR genes.\n\n   d) mCRPC cohort: participants with metastatic, castration-resistant adenocarcinoma of the prostate with alterations in select HRR genes.\n\n   e) HRRm advanced solid tumors cohort: participants with locally advanced\u002Fmetastatic tumors with alterations in select HRR genes.\n\n   For all participants with solid tumors:\n6. Participants in the Cohort-Expansion Stage must have at least 1 measurable target lesion.\n7. Recovery to baseline or ≤ Grade 1 CTCAE v5 from AE(s) related to any prior treatments.\n\nKey Exclusion Criteria\n\n1. Prior anticancer treatment including:\n\n   1. Small molecule-targeted therapy \\\u003C 5 half-lives from first dose of study treatment, or 3 weeks (whichever is shorter).\n   2. Any antibody therapy \\\u003C 5 half-lives from first dose of study treatment (or 4 weeks since last therapy, whichever is shorter).\n   3. Chemotherapy with nitrosoureas or mitomycin C \\\u003C 6 weeks from first dose of study treatment. Other chemotherapy \\\u003C 3 weeks prior to first dose of study treatment.\n   4. Radiation therapy (including radiofrequency ablation) \\\u003C 1 week prior to initiation of study treatment. Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n2. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.\n3. History of hypersensitivity to any excipient of XL309, or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to XL309.\n4. Lactating or pregnant females.\n5. Clinically relevant cardiovascular disease.\n6. Known history of myelodysplastic syndrome.\n7. Other severe, acute, or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or that may interfere with the interpretation of the study results, and in the judgment of the investigator, would make the participant inappropriate for the study.\n8. Inability or unwillingness to comply with requirement for oral drug administration or presence of a gastrointestinal condition that would preclude adequate absorption of XL309.\n9. Prior treatment with a ubiquitin specific peptidase 1 (USP1) inhibitor.",{"count":243,"type":21},429,[77],"This is a first-in-human (FIH), multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as pharmacokinetics (PK) and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in participants with advanced solid tumors.",[81],[248,171,249,250,251],"Ovarian Cancer","Pancreatic Cancer","Advanced HRRm Solid Tumors","Breast Cancer","2025-08-28",{"date":254,"type":45},"2025-09-05",{"date":256,"type":45},"2024-04-03",{"date":258,"type":21},"2029-08-03",{"name":51,"class":52},16,{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":268,"sex":17,"minAge":18,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":276,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},"100590047","phase-1-pharmacokinetics-pk-and-safety-of-zanzalintinib-in-participants-with-moderate-hepatic-impairment-hi-100590047","NCT06962332","Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)","A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment","Key Inclusion Criteria:\n\n* All Participants:\n\n  * No clinically significant medical history (aside from the HI for participants in the HI group only), physical examination findings, or vital signs, as deemed by the investigator.\n  * A continuous non-smoker or moderate smoker who smokes ≤ 10 cigarettes, ≤ 2 cigars, or ≤2 pipes per day and agree to limit smoking during the confinement period to ≤ 4 cigarettes or ≤1 cigar or pipe per day. Participant must agree to maintain the same smoking status (smoker or non-smoker) from screening and until after the last PK sample collection.\n  * Has not donated blood within 30 days of dosing or plasma within 7 days of dosing and must agree to refrain from blood donation until at least 30 days following dosing.\n* Participants with Moderate HI Only:\n\n  * Adequate bone marrow function, at the screening and dosing visit.\n  * Is classified as having moderate HI by the Child-Pugh classification system (Class B, score of 7 to 9, inclusive) and has a total bilirubin value within the range of \\> 1.5\\* upper limit of normal (ULN) and ≤ 3\\* ULN at the screening and dosing visit.\n  * Has a diagnosis of chronic (\\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency at the screening visit with features of cirrhosis due to any etiology.\n* Healthy Control Participants Only:\n\n  * Age must be within ± 10 years of the mean age of participants with moderate HI. The sex ratio (male\u002Ffemale ratio), and smoking status ratio (smokers\u002Fnon-smokers ratio) must be the same to the sex and smoking status ratio of participants with moderate HI.\n\nKey Exclusion Criteria:\n\n* All Participants:\n\n  * • History of any medical or surgical conditions that would potentially alter absorption, distribution, metabolism, and\u002For excretion of orally administered drugs.\n  * Has or is at risk for major cardiac events or dysfunction.\n* Participants with Moderate HI Only:\n\n  * History of liver or other solid organ transplant.\n  * Fluctuating or rapidly deteriorating hepatic function (the definition of the change of more than 1 Child-Pugh point) within 30 days prior to Day 1, in the opinion of the investigator and Sponsor.\n  * Symptoms or history of Grade 3 or worse degree of encephalopathy within 3 months of dosing.\n  * Clinical evidence of severe ascites at the screening visit or at check in.\n* Healthy Control Participants Only:\n\n  * History or presence of alcohol or drug abuse within the past 2 years prior to dosing.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",true,"75 Years",{"count":124,"type":21},[77],"The primary purpose of this study is to evaluate the plasma PK of zanzalintinib following a single dose in participants with moderate liver dysfunction compared to matched healthy participants with normal liver function.",[274,275],"Hepatic Impairment","Moderate Hepatic Impairment",[34,277],"Pharmacokinetics","2025-06-17",{"date":280,"type":45},"2025-06-22",{"date":282,"type":45},"2025-05-13",{"date":284,"type":21},"2026-04",{"name":51,"class":52},2,""]