[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lung-cancer-locally-advanced-or-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lung-cancer-locally-advanced-or-metastatic":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,77,106,174],{"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":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100637668","phase-1-a-phase-1-first-in-human-study-of-crpa1a2-a-mage-a1hla-a0201-bispecific-t-cell-engager-in-patients-with-solid-tumors-100637668",false,"NCT07583316","A Phase 1 First-in-Human Study of CRPA1A2, a MAGE-A1\u002FHLA-A*02:01 Bispecific T-Cell Engager, in Patients With Solid Tumors","A Phase I First-In-Human Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of CRPA1A2, a Bispecific T Cell Engager, in Patients With HLA-A*02:01 and MAGE-A1 Positive Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients with a histological and\u002For cytological confirmed locally advanced or metastatic unresectable solid tumor (including but not limited to esophageal squamous cell carcinoma, hepatocellular carcinoma, head and neck squamous cell carcinoma and lung squamous cell carcinoma) who have experienced disease progression following available standard therapy and for whom no further standard treatment options are available.\n2. Patients with confirmed positive expression of MAGE-A1 (H-score ≥1, testing by IHC for FFPE) by central lab.\n3. Patients with positive HLA-A\\*02:01 (confirmed by the central lab).\n4. There must be at least one measurable lesion per RECIST v1.1 criteria. (Lesions that have received radiotherapy previously cannot be considered target lesions unless there is evident progression after radiotherapy).\n5. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.\n6. Life expectancy ≥ 3 months, in the opinion of the investigator.\n7. Has adequate organ function, as demonstrated by laboratory values obtained during the screening period.\n8. Participants (both males and females) of childbearing potential must agree to use highly efficient contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational drug.\n\nExclusion Criteria:\n\n1. Patients with history of other malignancies (within 2 years prior to signing the ICF) are excluded, except for those with cured stage IB or earlier stage cervical cancer, non-invasive basal cell or squamous cell skin cancer, malignant melanoma in complete remission (CR) for over 10 years, or other malignancies in complete remission (CR) for over 5 years.\n2. Patients with positive HLA-A\\*02:05 (confirmed by the central lab).\n3. Patients with known sensitivity or immediate hypersensitivity to any components of CRPA1A2 or ingredients of CRPA1A2 injection.\n4. Patients who have been exposed to other MAGE-A1 targeted therapy.\n5. With clinically significant cardiovascular diseases, including but not limited to:\n\n   1. History of heart failure, myocardial ischemia or infarction, unstable angina, arrhythmias, or New York Heart Association (NYHA) Class III-IV within the past 6 months or currently.\n   2. With prolonged QT\u002FQTc intervals on the electrocardiogram during the screening period (QTcF: \\> 480 ms).\n   3. Echocardiogram (ECHO) indicates a left ventricular ejection fraction (LVEF) of ≤50% at screening.\n   4. Poorly controlled hypertension at screening (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg) despite pharmacological treatment.\n   5. History of vascular angioplasty, coronary artery bypass grafting, or other cardiac surgical procedures.\n6. With clinically significant active hepatitis B, HBsAg or HBcAb positive and have an HBV-DNA level above the detection limit at screening (i.e., the upper limit of normal values at each research center's laboratory). With the exception for those that have achieved HBV-DNA negativity after antiviral treatment and have received at least 2 weeks of antiviral therapy before the initial dosing. Additionally, they must be willing to continue antiviral therapy for hepatitis B throughout the study period. For patients with hepatocellular carcinoma, HBV DNA must be \\\u003C1000 IU\u002FmL for study eligibility.\n7. Clinically significant active hepatitis C, indicated by positive HCV antibodies and HCV-RNA levels higher than the detection limit at screening (upper limit of normal values).\n8. Positive Treponema pallidum antibodies (TP-Ab) and positive result for nonspecific syphilis antibodies titer (RPR) at screening.\n9. Prior or concurrent therapies\u002Fprocedures that may confound study evaluation or increase risk, including recent participation in another clinical study; recent anticancer therapy, investigational treatment, or invasive investigational medical device use; major surgery without full recovery; prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation; recent autologous hematopoietic stem cell transplantation; or planned transplantation during the study period.\n10. Active, uncontrolled, or clinically significant medical conditions that may increase the risk of study participation or interfere with study assessments, including severe infection; symptomatic or uncontrolled central nervous system or leptomeningeal metastases; clinically significant pulmonary disease (e.g., interstitial lung disease\u002Fpneumonitis); coagulation or bleeding disorders; autoimmune disease or immunodeficiency (including HIV infection); or significant neurologic or psychiatric disorders.\n11. Unresolved toxicities or other conditions considered by the investigator to make the participant unsuitable for the study, including failure to recover adequately from prior anticancer treatment-related toxicities, prior Grade ≥2 ICANS after T-cell engager or CAR-T therapy, clinically significant abnormal laboratory findings, or other severe\u002Funcontrolled acute or chronic diseases, alcohol abuse, or substance misuse.","ALL","18 Years",{"count":19,"type":20},192,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase I, first-in-human, open-label study of CRPA1A2, a bispecific T-cell engager, in participants with HLA-A\\*02:01-positive and MAGE-A1-positive advanced solid tumors. The study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of CRPA1A2, and to identify recommended dose(s) for further evaluation.\n\nThe study consists of 2 parts: a dose escalation part (Part A) and a dose optimization part (Part B). In Part A, participants will receive escalating doses of CRPA1A2 to determine the recommended dose(s) for optimization, with additional backfill cohorts permitted. In Part B, 2 to 3 selected recommended dose(s) will be further evaluated in participants with selected tumor types to better characterize safety and preliminary anti-tumor activity.\n\nCRPA1A2 will be administered by intravenous infusion in 28-day cycles, starting at 0.0003 mg\u002Fkg. Weekly dosing is planned, although alternative dosing schedules may be explored based on emerging data. Treatment will continue until disease progression, intolerable toxicity, initiation of new anti-tumor therapy, other discontinuation criteria are met, or study termination.",[26,27,28,29],"Lung Cancer (Locally Advanced or Metastatic)","Esophagus Cancer","Head and Neck Cancer","Hepatocellular Carcinoma (HCC)",[31,32,33,34,35],"CRPA1A2","Bispecific T-cell engager","Advanced solid tumors","HLA-A*02:01","MAGE-A1","NOT_YET_RECRUITING","2026-05-06",{"date":39,"type":40},"2026-05-13","ACTUAL",{"date":42,"type":20},"2026-05-29",{"date":44,"type":20},"2030-09-30",{"name":46,"class":47},"Corregene Biotechnology Co., Ltd","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":48},"100628440","evaluation-of-endobronchial-ultrasound-needle-cleaning-techniques-and-their-impact-on-specimen-contamination-100628440","NCT07461662","Evaluation of Endobronchial Ultrasound Needle Cleaning Techniques and Their Impact on Specimen Contamination","EBUS","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Patients undergoing standard-of-care EBUS bronchoscopy for evaluation of suspected lung malignancy\n* Patients undergoing sampling of 2 or more lymph node stations during EBUS bronchoscopy\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Age less than 18\n* Recent (1 month or less) radiation or procedural manipulation of lymph node stations that may significantly change lymph node architecture",{"count":57,"type":20},204,[59],"NA","Endobronchial ultrasound (EBUS) bronchoscopy is commonly used to sample lymph nodes in patients with suspected or known lung cancer to determine the stage of the disease. Accurate staging is essential as it directly impacts treatment decisions and prognosis. During EBUS procedures, needles are often reused across multiple lymph node stations and are typically flushed with saline between samples. This raises the concern that residual tumor cells may contaminate the samples and could potentially incorrectly upstage disease.\n\nThis prospective study will evaluate the current technique used during EBUS procedures to determine if more intensive cleaning leads to reduced cellular contamination without affecting diagnostics. Patients undergoing an EBUS procedure for diagnosis with a large mass and a high probability of malignancy will be selected for the study. Rapid On-Site Examination (ROSE) will be used at the bedside to determine the presence of abnormal cells. Following the final pass, before moving to the next station, the needle will be flushed with saline as normal and then flushed again into another container to evaluate the presence of residual cells. The outcome may help EBUS needle handling practices and improve lung cancer staging accuracy.\n\nNo additional invasive procedures are performed as part of this study; all analyses utilize material obtained during routine EBUS needle flushing, with no added needle sticks or alteration of clinical care.",[26],[63,64,65,66],"Lung Cancer","Endobronchial ultrasound (EBUS) bronchoscopy","Cytologic Contamination","Cancer Staging","2026-03-04",{"date":69,"type":40},"2026-03-10",{"date":71,"type":20},"2026-04-01",{"date":73,"type":20},"2027-08-31",{"name":75,"class":76},"University of Mississippi Medical Center","OTHER",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":48},"100616305","phase-2-golidocitinib-for-refractory-immune-related-hematologic-toxicities-of-advanced-lung-cancer-100616305","NCT07303881","Golidocitinib for Refractory Immune-related Hematologic Toxicities of Advanced Lung Cancer","A Clinical Study Evaluating the Safety and Efficacy of Golidocitinib in Patients With Refractory Immune-related Hematologic Toxicities of Advanced Lung Cancer","JACKPOT22","Inclusion Criteria:\n\n1. Able to provide a signed and dated informed consent form, including compliance with the Informed Consent Form (ICF) and the requirements and limitations listed in this protocol.\n2. The subject is ≥18 years of age at the time of signing the ICF.\n3. Has not experienced disease progression in the past two weeks and has a Eastern Cooperative Oncology Group (ECOG) score of 0-2, with a predicted survival of ≥12 weeks.\n4. Pathologically or cytologically confirmed locally advanced (American Joint Committee on Cancer, AJCC 8th edition IIIB and IIIC stages) or metastatic (stage IV) non-small cell lung cancer, or extensive-stage small cell lung cancer (AJCC 8th edition TNM staging of lung cancer stage IV, or T3-4 disease caused by multiple pulmonary nodules with excessive disease spread, or tumor\u002Fnodule size too large for a tolerable radiation therapy plan).\n5. Patients confirmed by an accredited local laboratory to lack any therapeutically targeted driver gene mutations, i.e., driver gene-negative subjects.\n6. Patients experiencing grade ≥3 refractory hematologic toxicity (white blood cell count \\\u003C2.0 × 10⁹\u002FL or\u002Fand absolute neutrophil count \\\u003C1.0 × 10⁹\u002FL or\u002Fand platelet count \\\u003C50 × 10⁹\u002FL or\u002Fand hemoglobin \\\u003C8.0 g\u002FdL, specific hematologic parameters are detailed in Appendix D), during treatment with immune checkpoint inhibitors (including monotherapy or combination therapy), and the toxicity is considered to be immune-related. Refractory toxicity is defined in two main ways: ① Resistance to conventional treatment: No significant improvement in hematologic toxicity after at least 3 days of supportive care including the use of hormones (e.g., methylprednisolone ≥1 mg\u002Fkg\u002Fd), hematopoietic growth factors (e.g., G-CSF, TPO), and\u002For blood transfusions; ② Positive antinuclear antibody profile indicating anti-SSA antibodies and\u002For Ro52 antibodies, suggesting an immune-mediated mechanism.\n7. Patients with brain metastases must be asymptomatic or have been treated and have stable disease after discontinuation of steroids and anticonvulsants. Patients suspected of having brain metastases at screening should undergo brain CT\u002FMRI before study enrollment.\n8. At least one measurable lesion (as defined in RECIST 1.1): a lesion that has not undergone radiotherapy, has a long diameter ≥10 mm (short diameter ≥15 mm for lymph node lesions), and can be accurately and repeatedly measured from baseline on CT or MRI; and a measurable lesion outside the central nervous system.\n9. Adequate organ system functional reserve, summarized as follows:\n\n   * Total bilirubin ≤1.5×ULN; if Gilbert's syndrome (unconjugated hyperbilirubinemia) is present, total bilirubin should be ≤3×ULN.\n   * ALT and AST ≤2.5×ULN. For patients with documented liver metastases, AST and ALT levels ≤5×ULN.\n   * Creatinine clearance, calculated using the Cockcroft-Gault method, \\>60 ml\u002Fmin for patients treated with cisplatin and \\>45 ml\u002Fmin for patients treated with carboplatin.\n   * Urinalysis shows less than 2+ protein in urine, or 24-hour urine protein quantification \\\u003C1g.\n   * Good coagulation function, defined as International Normalized Ratio (INR) and\u002For Prothrombin Time (PT) ≤1.5 times the ULN and\u002For Activated Partial Thromboplastin Time (APTT) ≤1.5 of the upper limit of normal; if the subject is receiving anticoagulation therapy, PT is acceptable as long as it is within the range intended for use with the anticoagulant.\n   * Serum amylase ≤1.5 times the ULN and\u002For serum lipase ≤1.5 times the ULN.\n   * Echocardiography (ECHO) shows a left ventricular ejection fraction (LVEF) ≥55%.\n10. Women of Childbearing Potential (WOCBP) must undergo a urine and\u002For serum pregnancy test (if the urine test cannot confirm a negative result) within 7 days prior to the first dose of the study drug, and the result must be negative; WOCBP or male subjects and their WOCBP partners should agree to use effective contraception from the signing of the ICF until 6 months after the last dose of the study drug. k. Participants should be able to understand the study protocol and voluntarily comply with the study and follow-up.\n\nExclusion Criteria:\n\na. An active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying medications, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment.\n\nb. Prior to the first dose, any other form of immunosuppressive therapy other than corticosteroids (e.g., TNF-α inhibitors, mycophenolate mofetil, gamma globulin, rituximab, other JAK inhibitors, etc.) was received for hematologic toxicity.\n\nc. Spinal cord compression or meningeal metastases are present. d. Any of the following medical histories:\n\n* Currently participating in an interventional clinical trial, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose; any drug still in development requires a 5-half-life washout (or discussion with the research team);\n* Underwent major surgery (excluding diagnostic or biopsy, excluding vascular access) within 4 weeks prior to the first dose, or is expected to undergo major surgery during the study;\n* Received palliative radiation therapy within 2 weeks prior to the first dose;\n* Have experienced a serious arterial\u002Fvenous thrombotic event within 6 months prior to the first dose, including cerebrovascular accidents (e.g., history of stroke or intracranial hemorrhage), deep vein thrombosis, and pulmonary embolism;\n* Currently receiving (or unable to discontinue at least 1 week prior to the first dose) any known potent inducer or inhibitor of CYP3A, herbal supplements, or foods;\n* Have experienced a grade CTCAE \\> 1 adverse event (excluding any degree of alopecia and hematologic toxicity) due to prior treatment prior to the first dose. e. Has received a solid organ or blood system transplant (e.g., a previous allogeneic bone marrow transplant).\n\n  f. Has a history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring corticosteroid therapy, or currently has active interstitial lung disease (including interstitial lung changes), or immune-mediated pneumonitis caused by immunotherapy.\n\n  g. Has been diagnosed with another malignancy within 5 years prior to the first dose, excluding clinically cured basal cell carcinoma, squamous cell carcinoma, and\u002For radically resected carcinoma in situ.\n\n  h. Has received a live vaccine, including attenuated live vaccines, excluding inactivated vaccines, within 30 days prior to the first dose.\n\n  i. Has known active tuberculosis, such as a positive tuberculin (PPD) test (induration diameter \\> 10 mm), a positive T-SPOT test, tuberculous lesions on chest X-ray\u002FCT, or other positive results found according to routine clinical screening (excluding those cured by investigator assessment after standard anti-tuberculosis treatment).\n\n  j. Subjects with pre-existing, uncontrollable severe infectious diseases must be excluded. If an infectious disease occurred within two months prior to the first dose, its control must be assessed by the research team to determine eligibility for enrollment.\n\n  k. Subjects with active infections, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) (see table below), and active COVID-19 infection (determined by the investigator to be clinically significant, with signs or symptoms). COVID-19 testing will be based on local practice.\n\n  l. Meeting any of the following cardiac criteria:\n* Congestive heart failure (CHF) classified as \\>II by the New York Heart Association (NYHA);\n* Clinically significant valvular heart disease, hypertrophic or constrictive cardiomyopathy;\n* Any clinically significant abnormality on resting ECG, such as complete left bundle branch block, second\u002Fthird-degree atrioventricular block, or PR interval \\>250 msec;\n* Average calibrated QTcF \\>470 msec on three resting ECGs during the screening period;\n* Any factor that could increase the risk of QT interval prolongation or arrhythmic events (e.g., heart failure, hypokalemia, congenital long QT syndrome, or a first-degree relative with long QT syndrome or a family history of unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval);\n* Ventricular arrhythmias requiring treatment;\n* An acute myocardial infarction (AMI), the onset of unstable angina, or a new onset of angina within 6 months prior to administration.\n\n  m. Hypersensitivity to the study drug or any component thereof. n. Intractable nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing medication, intestinal obstruction, or a history of bowel resection that may prevent adequate absorption of the study drug.\n\n  o. Pregnancy or lactation. p. Known bleeding diathesis, i.e., hemophilia or von Willebrand disease. q. Investigator assessment indicating a serious or uncontrolled systemic disease (including poorly controlled hypertension and bleeding disorders) that precludes participation in the clinical study or may lead to poor adherence.",{"count":86,"type":20},16,[88],"PHASE2","This study is a single-arm clinical trial designed to evaluate the safety and efficacy of golidocitinib in patients with refractory, immune-related hematologic toxicity in advanced lung cancer.",[91,92,26],"IrAE","Hematologic Disorder",[94,95,96],"Immune-related hematologic toxicities","irAE","Lung cancer","2025-12-12",{"date":99,"type":40},"2025-12-26",{"date":101,"type":20},"2026-02",{"date":103,"type":20},"2028-12",{"name":105,"class":76},"The First Affiliated Hospital of Guangzhou Medical University",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":142,"overallStatus":163,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100328442","phase-1-vmd-928-monotherapy-and-in-combination-with-pembrolizumab-to-treat-trka-overexpression-driven-solid-tumors-or-lymphoma-100328442","NCT03556228","VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma","A Phase 1\u002F2 Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 as Monotherapy and in Combination With Pembrolizumab in Subjects With Solid Tumors or Lymphoma","Key Inclusion Criteria:\n\n#. Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma:\n\nPhase 1 Dose Escalation only: Subjects with\n\n(A) any advanced solid tumors of\n\n1. Head and Neck Cancers (\"HNC\") (of any types),\n2. Esophageal cancer,\n3. Lung cancers (of any types),\n4. Mesothelioma,\n5. Pancreatic cancers,\n\nOr,\n\n(B) any NTRK1 gene fusion positive (\"NTRK1+\") solid tumors or lymphomas, that is relapsed, refractory or intolerant (R\u002FR\u002FI) to standard of care (SOC) and for which there is no approved or curative therapy. Additionally, patients must not be candidates for or have exhausted regimens known to provide clinical benefit, including hematopoietic stem cell transplantation in lymphoma patients if they are deemed transplant eligible.\n\nPhase 2 Monotherapy and Combination with Pembrolizumab only:\n\nSubjects must have\n\n1. TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or,\n2. any NTRK1+ solid tumors or lymphoma\\*, that is R\u002FR\u002FI to SOC.\n\nKey Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1.\n* Able to swallow and retain oral medication.\n* Subjects must either have available archival tumor tissue samples, or consent to tumor tissue sampling prior to the first dose.\n* Adequate organ system function as defined as follows:\n\n  1. Absolute neutrophil count ≥1.5x10\\^9\u002FL\n  2. Hemoglobin ≥9g\u002FdL\n  3. Platelets ≥100x10\\^9\u002FL\n  4. PT\u002FINR, PTT ≤1.5xULN\n  5. Total bilirubin ≤1.5x ULN\n  6. AST, ALT ≤2.5xULN\n  7. Creatinine ≤1.2xULN for age, weight\n  8. Calculated creatinine clearance or 24h urine creatinine clearance ≥60mL\u002Fmin\n\nKey Exclusion Criteria:\n\n* Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C).\n* Received anticancer therapy with radiation, immunotherapy, and a biologic, surgery and\u002For tumor embolization within the past 2 weeks.\n* Received an investigational anticancer drug within 14 days or 5 half-lives of the investigational agent, whichever is longer, prior to the first dose of VMD-928. Any exceptions to the above must be approved by the Sponsor Medical Monitor.\n* Unresolved toxicity from previous anticancer therapy \\> CTCAE Grade 1 (except alopecia or anemia) unless agreed to by both the Sponsor Medical Monitor and the Investigator.\n* Known active infections including HIV disease.\n* Currently pregnant, nursing, or planning to become pregnant during the course of the study.\n* QTcF interval ≥ 480 msec.\n* Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.\n* Acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks.\n* Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the patient's safety or interfere with assessment of the drug.\n* Psychological, familial, sociological, geographical, or other concurrent conditions that would interfere with safety evaluation, limit the patient's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Patients with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.\n* Patient has had or is currently having other malignant tumors within 3 years.\n* Patients have multiple factors that affect their oral medication.\n* Patients have long-term unhealed wounds or fractures.\n* Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.\n* Patients are taking the following drugs and can't stop them during the study:\n\n  * Tylenol or medicine containing acetaminophen (paracetamol).\n  * Antacids (e.g. TUMS, calcium carbonate, or magnesium hydroxide), proton pump inhibitors (e.g. omeprazole), H2 blockers (e.g. famotidine), or buffered vitamins.\n* Epstein-Barr virus (EBV) negative nasopharyngeal carcinoma.\n\nFor Phase 2 only:\n\n* Negative result on TrkA immunohistochemistry (IHC) assay.\n* Have visceral crisis, defined as severe organ dysfunction and rapid progression of the cancer. (It is not about presence of visceral metastasis.)\n\nFor combination therapy with Pembrolizumab only:\n\n* Serious adverse immune related adverse events (grade 3 or 4) with previous PD-1(L1) inhibitor therapy, that were symptomatic and required prolong immunosuppression (\\>6 weeks).\n* Any grade Pneumonitis and Myocarditis related to prior PD-1(L1) inhibitor therapy.\n* For subjects that received PD-1(L1) inhibitors before, there should be a washout period of at least 21 days between the last day of PD-1(L1) inhibitor and first day of study medications.\n* Subjects who relapsed after prior treatment with PD-1(L1) inhibitors. Relapsed is defined as patients having best overall response of CR or PR after treatment with a PD-1(L1) inhibitor.","80 Years",{"count":115,"type":20},242,[23,88],"This is a multicenter, open-label, Phase 1\u002F2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists",[119,120,63,121,122,123,124,125,126,127,128,129,130,131,132,26,133,134,135,136,137,138,139,140,141],"Head and Neck Carcinoma","Adenoid Cystic Carcinoma","Non-Small Cell Lung Cancer","Pancreatic Cancer","Mesothelioma","Esophageal Cancer","Any Solid Tumors Progressed After a Prior Immunotherapy","Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma HNSCC","Salivary Gland Carcinomas","Head and Neck Cancers - Salivary Gland","Head and Neck Cancers - Nasopharyngeal","Head and Neck Cancers - Throat","Small Cell Lung Cancer ( SCLC )","Head and Neck Cancers - Tonsils","Head and Neck Cancers Hypopharynx","Head and Neck Cancers Larynx","Head and Neck Cancers Lip","Head and Neck Cancers Nasopharynx","Head and Neck Cancers Oral Cavity","Head and Neck Cancers","Head and Neck Cancers Oropharynx","Head and Neck Cancers Trachea",[143,144,119,120,63,121,145,123,146,147,148,149,150,151,152,139,153,154,155,156,157,158,159,160,161,162],"TrkA","NTRK1","NSCLC","Pancreatic","Progression after anti PD-1\u002FPD-L1 immunotherapy","Progressed after an immunotherapy","Esophageal","SCLC","ACC","HNSCC","HNC","Salivary Gland Carcinoma","Nasopharyngeal","Throat","Tonsils","Hypopharynx","Larynx","Oral Cavity","Oropharynx","Trachea","RECRUITING","2025-12-04",{"date":166,"type":40},"2025-12-11",{"date":168,"type":40},"2018-06-08",{"date":170,"type":20},"2028-06",{"name":172,"class":47},"VM Oncology, LLC",15,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":21,"phases":183,"briefSummary":184,"conditions":185,"keywords":190,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":4},"100612936","phase-1-immune-cell-therapy-for-advanced-solid-tumors-100612936","NCT07260058","Immune Cell Therapy for Advanced Solid Tumors","Clinical Study on the Safety and Efficacy of Autologous Immune Cell Therapy for Advanced Solid Tumors","Inclusion Criteria:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. The participant must voluntarily participate in the study and provide written informed consent。\n2. Age ≥ 18 years, male or female.\n3. Histologically and\u002For cytologically confirmed locally advanced or metastatic solid tumor: lung cancer, liver cancer, colorectal cancer, or breast cancer.\n4. ECOG (Eastern Cooperative Oncology Group) performance status score ≤ 2.\n5. Life expectancy ≥ 3 months.\n6. Has not received any other cellular immunotherapy within 3 months prior to enrollment.\n7. Has at least one measurable lesion according to RECIST (Response Evaluation Criteria in Solid Tumors) Version 1.1.\n8. Adequate organ function, defined as follows:\n\nHematology:\n\nWhite Blood Cell (WBC) count \\> 3.5 × 10⁹\u002FL Lymphocyte count \\> 0.9 × 10⁹\u002FL Monocyte count \\> 0.16 × 10⁹\u002FL Absolute Neutrophil Count (ANC) \\> 1.5 × 10⁹\u002FL Platelet (PLT) count \\> 75 × 10⁹\u002FL Hemoglobin (HB) \\> 75 g\u002FL Blood Biochemistry： Total bilirubin ≤ 1.5 × ULN (Upper Limit of Normal) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present)\n\nCoagulation:\n\nProthrombin Time (PT) and International Normalized Ratio (INR) ≤ 1.5 × ULN\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Prior receipt of any salvage chemotherapy, implanted intraperitoneal chemotherapy, targeted therapy, or biological immunotherapy (except: patients whose disease progressed more than 6 months after completing adjuvant, neoadjuvant, or radiosensitizing chemotherapy, or more than 1 month after intraperitoneal chemoperfusion\u002Fwash, are eligible, provided chemotherapy-related toxicities have recovered to Grade 1 or below, excluding alopecia).\n2. Major surgical procedure within 4 weeks prior to enrollment, with incomplete recovery from side effects.\n3. History of any active malignancy within 5 years, except for the specific cancer under investigation in this trial and cured localized tumors such as carcinoma in situ of the cervix, basal cell carcinoma of the skin, and prostate carcinoma in situ.\n4. Presence of more than a small amount of pericardial effusion, or uncontrolled pleural or peritoneal effusion, defined as: detectable by physical examination at screening, or requiring therapeutic paracentesis during the screening period.\n5. Inability to tolerate peripheral blood collection due to various reasons (e.g., severe coronary heart disease, inability to establish peripheral venous access).\n6. Severe cardiovascular disease, including uncontrolled hypertension, unstable angina, history of myocardial infarction within the past 6 months, congestive heart failure \\> NYHA (New York Heart Association) Class III, or severe arrhythmia.\n7. Active infection, unexplained fever ≥ 38.5°C within 7 days prior to medication, or baseline white blood cell count \\> 15×10⁹\u002FL; OR any severe acute or chronic infection requiring systemic antibacterial, antifungal, or antiviral therapy at screening (except for active hepatitis).\n8. Any active autoimmune disease or history of autoimmune diseases (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patients with vitiligo; Patients with childhood asthma that has completely resolved in adulthood without any intervention are eligible; Asthma requiring bronchodilator medical intervention is excluded). Patients are eligible if: they have a history of autoimmune-related hypothyroidism and are on stable thyroid hormone replacement therapy; or have type I diabetes controlled by insulin therapy.\n9. History of drug allergy.\n10. Pregnant or lactating women; OR women of childbearing potential or men with pregnant partners who are unwilling to use adequate contraception during the planned trial period (from the screening visit until 120 days after the last study treatment).\n11. History of organ transplantation.\n12. Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.",{"count":182,"type":20},48,[23,88],"The autologous immune cell induction technology used in this project involves transforming peripheral blood mononuclear cells (PBMC) into autologous DC cells, NK cells, CIK cells and other immune cells through cytokine induction, and then re-administering them to the patients. This therapy utilizes biotechnology to culture the immune cells of cancer patients in vitro and then re-infuse them back into the body, stimulating and enhancing the body's own immune function, killing and inhibiting cancer cells, eliminating small and residual lesions, or achieving the goal of treating cancer by significantly inhibiting the proliferation of residual cancer cells.",[26,186,187,188,189],"Liver Cancer (Locally Advanced or Metastatic)","Colorectal Cancer (Locally Advanced or Metastatic)","Breast Cancer (Locally Advanced or Metastatic)","Advanced Solid Tumors",[189,191,192,193,194,195,196,197,198],"Metastatic Lung Cancer","Metastatic Liver Cancer","Metastatic Colorectal Cancer","Metastatic Breast Cancer","Autologous Immune Cell Therapy","Dendritic Cell Vaccine","CIK Cells","NK Cells","2025-11-20",{"date":201,"type":40},"2025-12-02",{"date":203,"type":20},"2025-12-01",{"date":205,"type":20},"2027-12-31",{"name":207,"class":47},"Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd."]