[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Ionova Life Sciences Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":135},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,73,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100642404","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-antitumor-activity-of-inv-8989-in-patients-with-advanced-solid-tumors-harboring-kras-g12d-mutations-100642404",false,"NCT07610798","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations","A Phase I\u002FII, Open-Label, Multi-Center, Dose Escalation and Cohort Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations","Inclusion Criteria:\n\n1. Written informed consent obtained.\n2. Adult patients aged ≥ 18 years.\n3. Patients with histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumors harboring the KRAS G12D mutations.\n4. Agree to provide available archived FFPE tumor tissue specimens or voluntarily accept pre-treatment tumor biopsy.\n5. Have RECIST 1.1-defined measurable lesions.\n6. Has a life expectancy of \\> 3 months.\n7. ECOG performance status 0-1.\n8. Adequate marrow, liver and kidney function.\n9. Meet the study's specified contraceptive requirements.\n10. Meet protocol-specified washout period requirements.\n\nExclusion Criteria:\n\n1. Have protocol-defined toxicities within 28 days before the start of study treatment.\n2. Have a second primary malignancy.\n3. Patients with known hypersensitivity to the study drug or any of its components.\n4. Prior history of receiving targeted therapy with specific KRAS G12D inhibitors\u002Fdegraders or pan-RAS inhibitors\u002Fdegraders for KRAS G12D mutation.\n5. Has undergone major surgery within 28 days prior to the first dose of study drug.\n6. Patients with symptomatic brain or leptomeningeal metastases.\n7. Patients with other severe and persistent underlying medical conditions as assessed by the Investigator.\n8. Have protocol-defined clinically significant cardiovascular diseases.\n9. Prolonged QTcF interval.\n10. Patients with dyspnea at rest secondary to complications of advanced malignancy, or requiring continuous oxygen therapy due to other medical conditions.\n11. Patients with active pulmonary tuberculosis (TB).\n12. Patients with a known history of interstitial lung disease (ILD).\n13. Patients with a known history of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n14. Have experienced a severe concurrent infection within 28 days prior to the first dose of study drug.\n15. Patients with congenital or acquired immunodeficiency.\n16. Female patients in pregnancy or lactation period.\n17. Patients with concomitant diseases or conditions deemed by the Investigator likely to interfere with protocol compliance.\n18. Patients unwilling or unable to comply with protocol-specified procedures.","ALL","18 Years",{"count":19,"type":20},178,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-8989 in patients with advanced solid tumors harboring KRAS G12D mutations.",[27,28,29,30,31,32,33],"Advance Solid Tumors","Colon and Rectal Cancer","Non - Small Cell Lung Cancer NSCLC","Pancreatic Adenocarcinoma Advanced or Metastatic","Ovarian Cancer","Endometrial Cancer","Biliary Cancers","RECRUITING","2026-06-07",{"date":37,"type":38},"2026-06-10","ACTUAL",{"date":40,"type":38},"2026-06-01",{"date":42,"type":20},"2029-05",{"name":44,"class":45},"Shenzhen Ionova Life Sciences Co., Ltd.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100562887","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-pharmacodynamics-and-antitumor-activity-of-inv-9956-in-adult-patients-with-advanced-metastatic-castration-resistant-prostate-cancer-100562887","NCT06609005","A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer","A Phase 1 and Phase 2, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Evidence of Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer","Inclusion Criteria:\n\n1. Written informed consent obtained.\n2. Male aged ≥ 18 years.\n3. Histologically confirmed adenocarcinoma of the prostate.\n4. Castration resistant prostate cancer with serum testosterone \\\u003C50 ng\u002FdL.\n5. Metastatic disease.\n6. Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy.\n7. Received at least one prior line of taxane-based chemotherapy and at least one line of hormonal AR targeted therapy (eg, abiraterone, enzalutamide). Patients who have refused or were intolerant to taxane-based chemotherapy may be enrolled.\n8. ECOG performance status 0-1.\n9. Adequate marrow, liver and kidney function.\n10. INR ≤1.5.\n11. Able to swallow study treatment.\n12. Has a life expectancy of \\> 3 months.\n\nExclusion Criteria:\n\n1. Have a medical condition such as Crohn's disease or have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption.\n2. History of pituitary or adrenal dysfunction.\n3. Poorly controlled diabetes mellitus.\n4. Clinically significant abnormality in serum potassium and sodium.\n5. Have a serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and\u002For the Sponsor.\n6. Active or unstable cardio-\u002Fcerebro-vascular disease, including thromboembolic events.\n7. History of congestive heart failure; cardiac disease, myocardial infarction within 6 months prior to enrollment.\n8. Prolonged QTcF interval.\n9. Active infection or other medical condition that would make corticosteroid contraindicated.","MALE",{"count":56,"type":20},84,[23,24],"This is a Phase 1 and Phase 2 study to evaluate the safety and antitumor activity of INV-9956 in adult patients with advanced metastatic Castration Resistant Prostate Cancer.",[60],"Advanced Metastatic Castration Resistant Prostate Cancer",[62,63],"mCRPC","Prostate Cancer","2026-06-02",{"date":66,"type":38},"2026-06-04",{"date":68,"type":38},"2025-01-23",{"date":70,"type":20},"2028-01-17",{"name":44,"class":45},22,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":46},"100640853","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-antitumor-activity-of-inv-6452-in-adult-patients-with-hormone-receptor-positive-human-epidermal-growth-factor-receptor-2-negative-hrher2--advancedmetastatic-breast-cancer-or-locally-advancedmetastatic-solid-tumor-100640853","NCT07612891","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+\u002FHER2-) Advanced\u002FMetastatic Breast Cancer or Locally Advanced\u002FMetastatic Solid Tumor","A Phase 1 and Phase 2, First-in-Human, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+\u002FHER2-) Advanced\u002FMetastatic Breast Cancer or Locally Advanced\u002FMetastatic Solid Tumor","Inclusion Criteria:\n\n1. Written informed consent obtained.\n2. Adult patients aged ≥ 18 years.\n3. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors, who have disease progression following standard-of-care therapy, are intolerant to standard treatment, or have no available standard treatment options (e.g., HR+\u002FHER2- breast cancer, Cyclin E1-overexpressing solid tumors and other solid tumors).\n4. Agree to provide available archived FFPE tumor tissue specimens or voluntarily accept pre-treatment tumor biopsy (Phase Ⅱ).\n5. Have RECIST 1.1-defined measurable lesions.\n6. Has a life expectancy of \\> 3 months.\n7. ECOG performance status 0-1.\n8. Adequate marrow, liver and kidney function.\n9. Meet the study's specified contraceptive requirements.\n\nExclusion Criteria:\n\n1. Have a second primary malignancy.\n2. Patients with primary CNS tumors or CNS metastases with prior local treatment failure.\n3. Have received any anti-tumor therapy or participated in other therapeutic clinical trial within 28 days prior to the first dose of study drug.\n4. Has undergone major surgery within 28 days prior to the first dose of study drug.\n5. Prior anti-tumor therapy-related toxicities have not recovered to protocol-specified grades.\n6. Diagnosed with immunodeficiency or received any form of immunosuppressive therapy within 7 days prior to the first dose.\n7. Patients with other severe and persistent underlying medical conditions as assessed by the Investigator.\n8. Have protocol-defined clinically significant cardiovascular diseases.\n9. Prolonged QTcF interval.\n10. Have any medical conditions likely to impair digestion and absorption of the investigational product.\n11. Patients with poorly managed blood glucose levels and blood pressure.\n12. Clinically significant abnormal serum potassium or sodium as judged by the investigator.\n13. Have experienced a severe concurrent infection 14 days prior to the first dose of study drug.\n14. Confirmed infection with HIV, HBV or HCV.\n15. Are currently receiving any other investigation agent.\n16. Have received prior CDK2 inhibitors.\n17. Patients with known hypersensitivity to the study drug or any of its components.\n18. History of allogenic tissue or solid organ transplant.\n19. Are unwilling or unable to comply with procedures required in this protocol.\n20. Has other severe systemic diseases or for other reasons deemed ineligible for participation in this clinical trial by the investigator.",{"count":81,"type":20},201,[23,24],"This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-6452 in adult patients with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+\u002FHER2-) advanced\u002Fmetastatic breast cancer or locally advanced\u002Fmetastatic solid tumor.",[85,86,87,31,32],"Breast Cancer (Locally Advanced or Metastatic)","Advanced Solid Cancers","Metastatic (Stage IV) Breast Cancer",[89,90,91,92,93,94],"breast cancer","locally advanced solid tumor","metastatic solid tumor","ovarian cancer","endometrial cancer","HR+\u002FHER2-","2026-05-27",{"date":97,"type":38},"2026-05-29",{"date":99,"type":38},"2025-07-04",{"date":101,"type":20},"2028-02-04",{"name":44,"class":45},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":122,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100396514","phase-1-an-open-label-study-of-inv-1120-as-a-single-agent-and-in-combination-with-pembrolizumab-in-adult-patients-with-advanced-solid-tumors-100396514","NCT04443088","An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors","A Phase 1a\u002F1b, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Evidence of Antitumor Activity of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors","KEYNOTE-E12","Inclusion Criteria:\n\n1. Written informed consent, according to local guidelines, signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses;\n2. Patient must be ≥18 years-of-age at the time of signature of the informed consent form (ICF);\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;\n4. Patients with histologically or cytologically confirmed advanced solid tumors which have progressed on or following standard therapy or for which no standard therapy exists;\n5. Patients with life expectancy ≥3 months;\n6. Patients with at least one measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI), according to RECIST v1.1. Tumor lesions that have been irradiated ≥4 weeks before the start of treatment, and have subsequently had documented progression, may be chosen as target lesions in the absence of measurable lesions that have not been irradiated;\n7. Patients whose laboratory data at screening meet the acceptable criteria for bone marrow, liver function and renal function.\n8. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test during screening. A woman is considered of childbearing potential (fertile) following menarche and until becoming postmenopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Postmenopausal women can be included;\n9. Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 3 months following last dose. Medically acceptable contraception includes:\n\n   * Hormonal methods (Needs to have been instituted at least 1 month prior to the first dose of study drug):\n   * Barrier methods:\n   * Abstinence, defined as refraining from sexual intercourse\n10. Male patients must also refrain from donating sperm from the first dose of study drug until 4 months after the last dose of study drug;\n11. Patients must be able to swallow and retain orally administered medication.\n\nExclusion Criteria:\n\n1. History (≤5 years) or current evidence of cancer that is histologically distinct from the cancer under study, except for cervical carcinoma in situ, superficial non-invasive bladder tumors, or curatively treated Stage I non-melanoma skin cancer. Patients with hepatocellular carcinoma will be excluded from Phase 1b dose escalation;\n2. Known serious allergy to investigational drug or excipients (microcrystalline cellulose);\n3. History of severe autoimmune disease (including significant ongoing immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone \\>10 mg\u002Fday or equivalent);\n4. Known malignant central nervous system disease other than neurologically stable, treated brain metastases - defined as metastases having been treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of progression or hemorrhage and off any systemic corticosteroids for at least 4 weeks prior to signing the consent;\n5. History (within 4 weeks of starting treatment) or evidence of active infections (Grade ≥2);\n6. Seropositive status for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at any time before the start of treatment: Testing for seropositive status during screening will be at the discretion of the Investigator in patients without previously reported results;\n7. History or evidence of any severe and\u002For uncontrolled medical conditions or other conditions that, in the opinion of the Investigator and Sponsor, could affect the patient's participation in the study, such as any disorder or surgical procedure that could impact the absorption of study drug from the gastrointestinal tract.\n8. History (≤6 months before the start of treatment) or evidence of any of the following: acute myocardial infarction, unstable angina pectoris, coronary artery bypass graft, cerebrovascular accident, or transient ischemic attack;\n9. Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:\n\n   * Congenital long QT syndrome;\n   * Significant ventricular or supraventricular arrhythmias (patients with sinus arrhythmia or chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible);\n   * LVEF \\\u003C 50% by ECHO or MUGA;\n   * Other clinically significant heart disease such as known congestive heart failure New York Heart Association (NYHA) Class III-IV;\n10. Patients with QT interval ≥470 msec in females and ≥450 msec in males at screening using Fridericia's formula (determined as the mean of 3 QTcF values from the screening triplicate ECG obtained with adequate quality);\n11. Women who are pregnant or breastfeeding.\n12. WOCBP and sexually active fertile men with WOCBP partners who are unwilling or unable to use acceptable contraception method to avoid pregnancy for at least 1 month before the first dose of the study drug, during the study, and for 4 months after the last dose of study drug;\n13. Male patient who plans to father a child while enrolled in this study or within 4 months after the last dose of study drug;\n14. Not recovered from toxicity from prior anticancer therapy to baseline or Grade 1 (except toxicities which are not clinically significant such as alopecia, skin discoloration).\n15. History of an allogeneic bone marrow or solid organ transplant;\n16. Use of systemic anti-cancer agent (except luteinizing hormone-releasing hormone (LHRH) agonists, bisphosphonates and denosumab) or investigational drug ≤28 days or five half-lives whichever is shorter prior to the first dose of study treatment;\n17. Radiation therapy ≤28 days prior to the first dose of study treatment, or likely to require radiation therapy at any time until the 30 days after the last dose of study treatment, except for palliative radiation therapy limited to non-target bone lesions;\n18. Major surgery within 4 weeks before enrollment or surgery with ongoing post-operative complications);\n19. History of transfusion of platelets ≤2 weeks before the start of treatment;\n20. Patients who start erythropoietin or granulocyte-colony stimulating factor (G-CSF), pegfilgrastim, or filgrastim ≤3 weeks before screening;\n21. Patients taking medications known to have a significant risk of causing Torsades de Pointes. Patients who have discontinued any of these medications must have a wash-out period of at least 7 days or at least 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug.\n22. History of use of H2 blockers (\\\u003C24 hours before the first dose of study treatment and during the study) and proton pump inhibitors (\\\u003C5 days before the first dose of study treatment and during the study).\n23. Patients with recent (within past 12 months) history, or are currently being treated for gastroesophageal ulcer.\n\n    The following additional exclusion criteria will apply to patients enrolling in Phase 1b:\n24. Have been discontinued treatment due to a Grade 3 or higher immune-related (irAE) from prior anti-PD-1 or anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137) (only for dose expansion).\n25. Patient is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of administration of investigational products.\n26. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Administration of killed vaccines are allowed.\n27. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n28. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease or radiation pneumonitis.",{"count":112,"type":20},78,[23],"Phase 1, open-label dose-escalation study to determine the MTD of INV-1120 and RP2D, and to assess the DLT of INV-1120 as a single agent or in the combination with pembrolizumab. The safety, tolerability, and PK of INV-1120 as a single agent or in the combination with pembrolizumab will be assessed in adult patients with advanced solid tumors.",[116,117,118,119,120,121],"Cancer","Solid Tumor, Adult","Cancer Metastatic","Solid Carcinoma","Solid Tumor, Unspecified, Adult","Tumor, Solid",[123,124,116,125],"Ionova","Ionova Bio","Oncology","2026-03-16",{"date":128,"type":38},"2026-03-18",{"date":130,"type":38},"2020-06-26",{"date":132,"type":20},"2026-12-31",{"name":44,"class":45},3,""]