[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Voronoi, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,75],{"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":26,"conditions":27,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100053363","phase-1-a-study-of-vrn110755-in-patients-with-egfr-mutant-non-small-cell-lung-cancer-100053363",false,"NCT07699328","A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer","A Phase 1\u002F2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of VRN110755 in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)","REACH-EGFR","Inclusion Criteria:\n\n* Adults aged 18 years or older (19 years or older in the Republic of Korea).\n* Able to understand, sign, and provide written informed consent.\n* Histologically or cytologically confirmed advanced, metastatic, or recurrent predominantly nonsquamous non-small cell lung cancer (NSCLC) with a documented epidermal growth factor receptor (EGFR) mutation.\n* At least one measurable extracranial lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n* Documented EGFR mutation determined by tumor tissue or liquid biopsy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Able to swallow oral capsules and comply with study procedures.\n* Women of childbearing potential must have a negative pregnancy test, must not be breastfeeding, and must agree to use effective contraception during the study and for 7 months after the last safety follow-up visit. Men must agree to use effective contraception during the study and for 6 months after the last safety follow-up visit.\n* No appropriate standard treatment options are available or standard treatment is not considered feasible, in the opinion of the investigator.\n* Participants must meet the disease-specific eligibility criteria for one of the following study groups:\n\n  * Phase 1a\n\n    * NSCLC with EGFR activating, resistant, uncommon, or complex mutations, including but not limited to exon 19 deletion (Del19), L858R, C797S, or other uncommon EGFR mutations.\n    * Radiographic disease progression following at least 2 cycles of prior EGFR tyrosine kinase inhibitor (TKI) therapy or discontinuation of prior EGFR TKI therapy because of toxicity, with no remaining standard therapy expected to provide clinical benefit.\n  * Phase 1b - Cohort A\n\n    * NSCLC with EGFR exon 19 deletion or L858R mutation plus a C797X resistance mutation following disease progression after first-line treatment with a third-generation EGFR TKI (including osimertinib, lazertinib, or aumolertinib).\n  * Phase 1b - Cohort B\n\n    * Treatment-naïve NSCLC with common EGFR mutations.\n  * Phase 1b - Cohort C\n\n    * NSCLC with atypical or uncommon EGFR mutations (including G719X, L861Q, S768I, E709X, R776H, L747S, or combinations of these mutations) previously treated with at least one systemic therapy, including an EGFR TKI, with no remaining standard therapy expected to provide clinical benefit.\n  * Phase 1b - Cohort D\n\n    * Treatment-naïve NSCLC with atypical EGFR mutations.\n\nExclusion Criteria:\n\n* Received an investigational anticancer therapy within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment.\n* Unresolved side effects from previous anticancer therapy greater than Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), except for Grade 2 peripheral neuropathy or alopecia.\n* Pregnant or breastfeeding, or planning to become pregnant during the study.\n* NSCLC with an EGFR or HER2 exon 20 insertion mutation.\n* Another active malignancy within the past 3 years, with the exception of adequately treated cancers considered cured.\n* Inadequate bone marrow, kidney, or liver function based on protocol-defined laboratory criteria.\n* Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of study treatment.\n* Active hepatitis B or hepatitis C infection, or known human immunodeficiency virus (HIV) infection.\n* Receipt of a live vaccine within 4 weeks before the first dose of study treatment.\n* Use of strong or moderate cytochrome P450 (CYP) 3A inhibitors or inducers, certain herbal supplements, or other prohibited medications within the protocol-defined washout period.\n* Major surgery within 4 weeks before the first dose of study treatment or incomplete recovery from major surgery.\n* Receipt of prior anticancer therapy within the protocol-defined washout period, including systemic therapy, immunotherapy, or radiotherapy.\n* Symptomatic or uncontrolled central nervous system (CNS) metastases or spinal cord compression requiring increasing doses of corticosteroids. Participants with treated and stable CNS metastases or asymptomatic CNS disease may be eligible.\n* Requirement for systemic corticosteroid therapy exceeding the protocol-defined limit.\n* Clinically significant cardiovascular disease, including prolonged QT interval, clinically significant arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, uncontrolled hypertension, reduced left ventricular ejection fraction, or use of medications known to prolong the QT interval.\n* History of interstitial lung disease, noninfectious pneumonitis requiring steroid treatment, or current interstitial lung disease or pneumonitis.\n* Inability to swallow oral capsules or gastrointestinal disorders that may interfere with absorption of study treatment.\n* Known allergy or hypersensitivity to VRN110755 or any of its components.\n* Alcohol or drug abuse within the previous 2 years or any medical, psychological, or social condition that, in the opinion of the investigator, would interfere with study participation or interpretation of study results.\n* Use of proton pump inhibitors, histamine-2 receptor antagonists, or locally acting antacids within the protocol-defined washout period or inability to comply with protocol requirements for acid-reducing medications.\n* For Phase 1b and Phase 2 only: Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including MET or HER2 amplification; ALK, ROS1, NTRK, or RET fusion; or BRAF V600E or KRAS G12X mutation.","ALL","18 Years",{"count":20,"type":21},315,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This first-in-human, Phase 1\u002F2, multicenter, open-label, non-randomized study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of VRN110755, a highly selective oral epidermal growth factor receptor (EGFR) inhibitor, in patients with EGFR-mutant non-small cell lung cancer (NSCLC).\n\nThe study includes a Phase 1a dose-escalation portion, a Phase 1b dose-expansion portion, and a Phase 2 evaluation. The study is designed to determine the maximum tolerated dose and recommended Phase 2 dose of VRN110755 and to evaluate preliminary and confirmatory antitumor activity in patients with EGFR-mutant NSCLC, including patients with acquired resistance following EGFR tyrosine kinase inhibitor therapy.",[28],"EGFR-Mutant Non-Small Cell Lung Cancer",[30,31,32,33,34,35,36],"NSCLC","EGFR","Epidermal Growth Factor Receptor","Non-Small Cell Lung Cancer","EGFR Mutation","C797S","EGFR Tyrosine Kinase Inhibitor Resistance","RECRUITING","2026-07-09",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":41},"2024-03-26",{"date":45,"type":21},"2029-01-01",{"name":47,"class":48},"Voronoi, Inc","INDUSTRY",29,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100635304","phase-1-study-to-evaluate-the-effect-of-food-and-a-proton-pump-inhibitor-on-the-pharmacokinetics-of-vrn101099-in-healthy-adult-participants-100635304","NCT07550946","Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN101099 in Healthy Adult Participants","A Phase 1, Open-label, Randomized, 3-Period, 2-Sequence, Crossover Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN101099 in Healthy Adult Participants","Inclusion Criteria:\n\n1. Male or female aged between 18 and 65 years of age (inclusive at the time of informed consent).\n2. In good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and\u002For before the first administration of IP (at the discretion of the PI or designee).\n3. BMI between ≥ 18.0 and ≤ 32.0 kg\u002Fm2 and weight ≥ 50 kg at Screening.\n4. Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee. Note: Repeat testing at Screening is acceptable for out-of-range values at the discretion of the Investigator.\n5. Female participants must be either not of childbearing potential or if they are a woman of childbearing potential and are engaged in heterosexual intercourse, they must agree to use an acceptable, highly effective contraception method in conjunction with a condom for the male partner from Screening until 100 days after the last dose of IP (ie, 90 days plus 5 half-lives of the IP).\n6. Male participants must not be of childbearing potential, or if they are engaged in sexual relations with WOCBP, they must agree to use a condom in conjunction with an acceptable, highly effective contraception method for the female partner from Screening until 100 days after the last dose of the IP.\n7. Males must not donate sperm and females must not donate ova from the first dose of IP until at least 100 days after the last dose of IP (ie, 90 days plus 5 half-lives of the IP).\n8. Able and willing to attend the necessary visits to the CRU.\n9. Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.\n\nExclusion Criteria:\n\n1. Underlying physical or psychological medical condition that, in the opinion of the PI or designee, would make it unlikely for the participant to comply with the protocol or complete the study per protocol. This includes but may not be limited to: medical histories (eg, hepatic\u002Fbiliary, renal, cardiovascular, endocrine, respiratory, digestive, haematologic, oncologic \\[except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to the first administration of IP\\], central nervous system, psychiatric, musculoskeletal) or past medical\u002Fsurgical histories that may affect drug absorption, distribution, metabolism, or excretion (excluding simple appendectomy or herniorrhaphy).\n2. Participants with known or suspected conditions or significant gastrointestinal disorders that may interfere with drug absorption (eg, inflammatory bowel disease, chronic diarhoea, malabsorption syndromes, or prior gastrointestinal surgery affecting absorption).\n3. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents.\n4. History of hypersensitivity and\u002For intolerance to PPIs.\n5. History of infections requiring parenteral antibiotics within 6 months prior to the first administration of IP.\n6. Blood donations of ≥ 400 mL or significant blood loss within 60 days prior to the first administration of investigational product (IP), plasma donation within 7 days prior to the first administration of IP, or platelet donation within 30 days prior to the first administration of IP. Participants must also agree not to donate blood, plasma, or platelets during the study and for at least 30 days after the last dose of IP.\n7. Abnormal findings on 12-lead (triplicate) ECG at Screening that are considered by the PI or designee to be clinically significant; or has a QTcF (Fridericia's formula) interval at Screening of \\> 450 msec for males or \\> 470 msec for females based on the average of the 3 readings. Repeat testing at Screening is acceptable for abnormal values at the discretion of the Investigator (once per parameter).\n8. Abnormal vital sign findings at Screening that are considered clinically significant by the Principal Investigator (PI) or designee, including systolic blood pressure \\>140 mmHg or \\\u003C 90 mmHg, diastolic blood pressure \\> 90 mmHg or \\\u003C 50 mmHg, or a history of symptomatic hypotension. If a screening value falls outside these limits, repeat measurement is permitted at the discretion of the Investigator, with one repeat assessment allowed per parameter. Eligibility should be based on the repeat value.\n9. Active liver disease, or AST and\u002For ALT \\> 1.5 × upper limit of normal at Screening. Note: Repeat testing at Screening is acceptable for out-of-range values at the discretion of the Investigator.\n10. Estimated glomerular filtration rate (eGFR) of ≤ 80 mL\u002Fmin\u002F 1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 formula.\n11. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.\n12. Use of (or anticipated use of) any prescription drugs (other than hormonal contraception; oral contraceptive pills, long-acting implantable hormones, injectable hormones, a vaginal ring, or an intrauterine device), within 14 days prior to the first administration of the IP; or use of any over the counter medication, herbal remedies, supplements, or vitamins within 7 days prior to the first administration of IP and during course of study. Note: Simple analgesia (eg, paracetamol) may be permitted at the discretion of the PI, provided they are used within the recommended maximum daily doses as specified in the package insert.\n13. Use of any drugs, herbal supplements, or foods that are known to be strong or moderate inhibitors\u002Finducers of CYP3A4 (eg, carbamazepine, rifampin, St. John's wort, ketoconazole, ginkgo biloba, grapefruit, grapefruit juice) from within 30 days prior to the first administration of IP until the end of the study.\n14. Use of PPIs, histamine (H)2 blockers, potassium-competitive acid blockers, or locally-acting antacids within 8 weeks before the first dose of IP, or requiring these medications during the study (except for the planned use of rabeprazole specified in the protocol)\n15. Vaccination with a live vaccine within 4 weeks prior to the first administration of IP (and up until 14 days after the last dose of the IP).\n16. Use of any IP or investigational medical device within 30 days prior to the first administration of IP, or 5 half lives of the product (whichever is the longest), and during the course of the study.\n17. Positive toxicology screening panel (urine test including qualitative identification of amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine, tetrahydrocannabinol, and tricyclic antidepressants), or alcohol breath test at Screening. Note: A single repeat test in the event of a false positive is permitted for the drug of abuse urine test at the discretion of the Investigator.\n18. History of regular alcohol consumption defined as \\> 14 standard drinks per week or \\> 3 standard drinks on any single day (where 1 standard drink = 10 g of alcohol) within 3 months prior to Screening.\n19. Unwilling or unable to abstain from the consumption of alcohol and caffeine containing food or drinks beginning 72 hours prior to the first administration of IP and until the end of the study.\n20. Unwilling to abstain from cigarettes or nicotine-containing products (eg, cigars, vapes, nicotine patches) for at least 7 days prior to first IP administration through to the end of the study, or is considered to be dependent on nicotine at the discretion of the PI. Note: Participants that are considered light or social smokers (defined as ≤ 5 cigarettes per week) will be considered eligible for entry into the study but must also adhere to these restrictions.\n21. Unwilling to refrain from strenuous exercise (including weightlifting) from 48 hours prior to each admission (on Day -1, Day 11, and Day 28), during the inpatient stays, and for 48 hours prior to any outpatient visit (including the EOS visit).\n22. Unable or unwilling to consume a high-fat meal.\n23. Pregnant or lactating.\n24. Poor peripheral venous access.\n25. Anything that the PI considers that would jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.",true,"65 Years",{"count":60,"type":21},24,[24],"This Clinical trial is being done to understand how food and a common stomach-acid reducing medicine (called a proton pump inhibitor-PPI) affect how the body absorbs a new drug, VRN101099, in healthy adults.\n\nResearchers will measure how much of the drug gets into the bloodstream and how fast it gets there in each situation.\n\nThis will help identify the most effective way for future patients to use VRN101099 in the treatment of solid tumors and cancers.\n\nThe main questions it aims to answer is:\n\n1. Does food or a PPI change how the body absorbs a single dose of VRN101099?\n2. Is a single dose of VRN101099 safe and well tolerated when taken with or without food or a PPI?\n3. How is VRN101099 removed through urine when taken with or without food or a PPI?",[64],"Healthy Adult","NOT_YET_RECRUITING","2026-04-19",{"date":68,"type":41},"2026-04-24",{"date":70,"type":21},"2026-05-12",{"date":72,"type":21},"2026-09-30",{"name":47,"class":48},1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":74},"100578106","phase-1-a-study-of-vrn101099-in-patients-with-her2-positive-solid-tumors-100578106","NCT06806982","A Study of VRN101099 in Patients With HER2-Positive Solid Tumors","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of VRN101099 in Patients With HER2-Positive Solid Tumors","Inclusion Criteria:\n\n1. Aged ≥ 18 years (patients in Korea must be aged ≥ 19 years).\n2. Able to comprehend and willing to sign an informed consent form and to abide by the study requirements and restrictions.\n3. Has at least 1 evaluable lesion (measurable or non-measurable) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (note: metastatic brain lesions will also be assessed using the Response Assessment in Neuro-Oncology - Brain Metastases \\[RANO-BM\\] as an exploratory objective).\n4. Has confirmed HER2-positive or mutated cancer as determined by immunohistochemistry (IHC) staining (IHC 1+, 2+, 3+) or next-generation sequencing (NGS) of tissue or circulating tumor DNA (i.e., evaluation of HER2 copy numbers or mutations) (note: documentation of HER2 status is required prior to Screening;\n5. In the opinion of the Investigator, is medically confirmed to derive no clinical benefit from other standard therapies.\n6. In the opinion of the Investigator, has a life expectancy \\> 6 months.\n7. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at Screening.\n8. Women of childbearing potential (WOCBP) who engage in heterosexual intercourse must agree to maintain effective contraception during the study and for up to 6 months after EOT; males whose sexual partners are WOCBP must also agree to maintain effective contraceptive method and should refrain from donating sperm during the study and for up to 6 months after EOT.\n\nExclusion Criteria:\n\n1. Has a confirmed HER2 exon 20 mutation (in the documented NGS test result).\n2. Received any IP, cytotoxic chemotherapy, or other anticancer drugs from a previous treatment regimen or clinical study within 3 weeks of the first dose of the study IP (note: Rescreening will be permitted after a washout period of 3 weeks).\n3. Has been previously treated with systemic anticancer treatment of more than 6 regimens for breast cancer or 3 regimens for other solid tumors (note: local administration of rituximab is allowed but intrathecal methotrexate or concurrent chemoradiotherapy is regarded as systemic therapy).\n4. Has any AEs from previous chemotherapy that have not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade ≤ 1 (note: Grade ≤ 2 peripheral neuropathy or hair loss is acceptable).\n5. Is a female who is pregnant, breastfeeding, or (among those of childbearing potential) planning to become pregnant.\n6. Has a history of other active malignancy within 3 years prior to Screening (note: patients with non-melanoma skin cancer, in situ melanoma, or in situ cervical cancer are permitted to be enrolled).\n7. Has any of the following laboratory abnormalities during Screening:\n\n   * Hematology (note: transfusion or hematopoietic growth factor administration within 14 days prior to Screening test is not allowed):\n\n     * -White blood cell (WBC) count \\\u003C 2.5 × 10 power 9\u002FL\n     * -Absolute neutrophil count (ANC) \\\u003C 1500\u002FµL\n     * -Platelets \\\u003C 100000\u002FµL\n     * -Hemoglobin \\\u003C 9.0 g\u002FdL.\n   * Clinical chemistry:\n\n     * -Creatinine clearance \\\u003C 60 mL\u002Fmin according to the Cockroft-Gault equation\n     * -Total bilirubin \\> 1.5 × ULN\n     * -Aspartate aminotransferase\u002Ftransaminase (AST or SGOT) \\> 2.5 × ULN (\\> 5 × ULN with liver metastases)\n     * \\- Alanine aminotransferase\u002Ftransaminase (ALT or SGPT) \\> 2.5 × ULN (\\> 5 × ULN with liver metastases).\n8. Currently has uncontrolled NCI-CTCAE Grade ≥ 2 hypercalcemia.\n9. Has undergone prior treatment with a cumulative dose of doxorubicin of \\> 360 mg\u002Fmeter square or previous treatment with another anthracycline with a cumulative dose equivalent to \\> 360 mg\u002Fmeter square doxorubicin.\n10. Has a current infection (including tuberculosis infection, among others) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to the first dose of the IP (note: antiviral therapy is permitted for patients with hepatocellular carcinoma or chronic hepatitis B virus \\[HBV\\] or hepatitis C virus \\[HCV\\] infection).\n11. Has untreated chronic hepatitis B or is a chronic HBV carrier (undetectable HBV DNA) at Screening (note: patients who are inactive hepatitis B surface antigen \\[HBsAg\\] carriers or have treated and stable hepatitis B (undetectable HBV DNA) can be enrolled; patients with detectable HBsAg or detectable HBV DNA should be managed per treatment guidelines. Patients receiving antivirals at Screening should have been treated for \\> 2 weeks before the first dose of IP).\n12. Has active or chronic hepatitis C (note: patients with a negative HCV antibody test at Screening or positive HCV antibody test followed by a negative HCV RNA test at Screening are eligible; the HCV RNA test will only be performed for patients testing positive for HCV antibody. Patients receiving antivirals at Screening should have been treated for \\> 2 weeks before the first dose of IP).\n13. Has a known history of human immunodeficiency virus infection.\n14. Has received live vaccines within 4 weeks of the first dose of IP (note: the seasonal flu vaccines that does not contain live virus and coronavirus disease 2019 \\[COVID-19\\] vaccines are allowed).\n15. Has had major surgery within 4 weeks prior to the first dose of the IP. Patients should have recovered from the effects of major surgery or significant traumatic injury within 16 days prior to the first dose of the IP (note: major surgery is defined as one that cannot be performed with local anesthesia \\[i.e., general anesthesia, respiratory assistance, or regional anesthesia\\] or an open biopsy).\n16. Has received radiotherapy to a large field or including a vital organ within 14 days prior to the first dose of the IP (or 7 days prior to the first dose of the IP if a vital organ is not included).\n17. Has central nervous system (CNS) metastases or spinal cord compression that are associated with progressive neurological symptoms, or that require treatment with more than 10 mg daily of prednisone or equivalent doses of corticosteroids, or that have not been on stable steroid treatment for at least 2 weeks prior to first drug administration (note: CNS metastases that have been either previously treated and controlled, or are symptomatic, or are untreated and asymptomatic are permitted and, when evaluable, should be captured as target lesion).\n18. Has any other medical condition (with the exclusion of brain metastases as described above) requiring prednisone therapy of more than 10 mg daily or equivalent systemic steroid therapy (steroid replacement therapy for adrenal or pituitary insufficiency is permitted) or has received treatment with steroids for current or past non-infectious pneumonitis\u002Finterstitial lung disease.\n19. Has impaired cardiac function or clinically significant cardiac disease, including:\n\n    * New York Heart Association Grade 2 or higher congestive heart failure.\n    * Left ventricular ejection fraction \\\u003C 50% within the last 6 months.\n    * Coronary artery bypass graft or vascular stent implantation.\n    * Any other uncontrolled cardiac condition such as unstable angina, arrhythmias requiring treatment, atrial fibrillation, or hypertension (systolic blood pressure \\> 160 mmHg, diastolic blood pressure \\> 100 mmHg).\n    * Baseline prolongation of QT interval corrected for heart rate using Fridericia's method (QTcF) of \\> 470 msec for females or \\> 450 msec for males determined (by the average of 3 readings on triplicate 12-lead ECG) or history of long QTc syndrome (congenital or otherwise) or Torsade de Pointes.\n20. Is unable to swallow capsules or has intractable nausea, vomiting, or gastrointestinal diseases that interfere with proper absorption, or has any absorption disorders that may interfere with absorption of the IP.\n21. Has known or suspected allergy or anaphylaxis to any component of the IP.\n22. Has pleural effusion, ascites, or pericardial effusion requiring catheter drainage, peritoneal shunting, or Cell-free and concentrated Ascites Reinfusion Therapy (CART) (note: CART is not allowed within 2 weeks of the Screening visit).\n23. Has retinal vascular disorder, retinopathy, glaucoma, or retinal detachment.\n24. Any other clinically significant comorbidities, such as neurological or psychological disorders, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the subject to safety risks.\n25. For any other reason, as determined by the Investigator, the patient is deemed inappropriate to participate in the study.",{"count":83,"type":21},72,[24],"This FIH open-label study aims to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor effect of VRN101099 in patients with HER2-positive solid tumors for whom no standard therapies are available.",[87],"HER2-positive Solid Tumors",[89],"HER2","2025-08-21",{"date":92,"type":41},"2025-08-28",{"date":94,"type":41},"2025-02-17",{"date":96,"type":21},"2027-07-31",{"name":47,"class":48},""]