[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kras-g12d\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kras-g12d":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,56,126,175,208,254,279],{"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":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100532907","phase-1-phase-1-study-to-investigate-tcrts-kras-mutation-in-unresectable-advanced-andor-metastatic-solid-tumors-100532907",false,"NCT06218914","Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Open-label, Phase 1, Multi-Center Master Protocol to Evaluate the Safety and Preliminary Anti-Tumor Activity of TCR-engineered T Cells Recognizing KRAS Mutations in Adult Subjects With Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosed with NSCLC, Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Endometrial Cancer or any other solid tumor\n* Tumors must harbor a KRAS G12D variant mutation and subject must be HLA-C\\*08:02 positive, HLA-A\\*11:01 or HLA-A\\*11:02 positive in at least one allele\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Presence of at least 1 measurable lesion per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment\n\nKey Exclusion Criteria:\n\n* Any other primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of stroke or transient ischemic attack within the 12 months prior to enrollment.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)\n* Female of childbearing potential who is lactating or breast feeding at the time of enrollment\n* Prior treatment with pan-KRAS or KRAS G12D targeting agents unless presence of KRAS G12D mutation is confirmed after the completion of treatment with pan-KRAS or KRAS G12D targeting agents.","ALL","18 Years",{"count":19,"type":20},108,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and\u002For Metastatic Solid Tumors.",[26,27,28,29,30,31],"Non-small Cell Lung Cancer","Colorectal Carcinoma","Pancreatic Ductal Adenocarcinoma","Endometrial Cancer","Solid Tumor, Adult","KRAS G12D",[33,34,31,35,36,37,38,39,28,40,41,42],"TCR-T cell therapy","KRAS","Autologous","PDAC","NSCLC","Colorectal Cancer","Solid tumors","HLA-C*08:02","HLA-A*11:01","HLA-A*11:02","RECRUITING","2026-06-30",{"date":46,"type":47},"2026-07-01","ACTUAL",{"date":49,"type":47},"2024-03-22",{"date":51,"type":20},"2043-11-18",{"name":53,"class":54},"AstraZeneca","INDUSTRY",18,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":21,"phases":65,"briefSummary":67,"conditions":68,"keywords":96,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":125},"100499720","phase-1-phase-12-trial-of-s241656-in-selected-rasmapk-mutation--positive-malignancies-100499720","NCT05786924","Phase 1\u002F2 Trial of S241656 in Selected RAS\u002FMAPK Mutation- Positive Malignancies","A Phase 1\u002F2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With KRAS, BRAF and Other Selected RAS\u002FMAPK Mutation-Positive Malignancies","Key Inclusion Criteria:\n\n* Life expectancy of ≥ 12 weeks in the opinion of the investigator.\n* Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.\n* Adequate bone marrow and organ function.\n* Recovered from toxicity to prior anti-cancer therapy.\n\nPart 1 Dose Escalation cohort ONLY:\n\n* Part 1A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations\n* Part 1B: Advanced\u002Fmetastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1C: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1E: Other advanced\u002Fmetastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations\n\nPart 2 Dose Optimization and Expansion cohorts ONLY:\n\n* Part 2A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations and\u002For BRAF mutations\n* Part 2A1: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations\n* Part 2A2: Advanced\u002Fmetastatic NSCLC with BRAF mutations\n* Part 2A3: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease\n* Part 2A4: Advanced\u002Fmetastatic NSCLC with a KRAS G12C mutation\n* Part 2B1: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B2: Advanced\u002Fmetastatic CRC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B3: Advanced\u002Fmetastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n\nKey Exclusion Criteria:\n\n* Cancer that has a known MEK1\u002F2 mutation.\n* Known allergy\u002Fhypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.\n* Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.\n* Major surgery within 4 weeks of study entry or planned during study.\n* Ongoing anticancer therapy.\n* Ongoing radiation therapy.\n* Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.\n* Clinically significant cardiovascular disease.\n* Symptomatic spinal cord compression.\n* Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.\n* Females who are pregnant or breastfeeding.\n* Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.\n* Prior use of experimental agents that target the KRAS\u002FBRAF\u002FMEK\u002FERK pathway.",{"count":64,"type":20},554,[23,66],"PHASE2","BDTX-4933-101 is a first-in-human, open-label, Phase 1\u002F2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced\u002Fmetastatic NSCLC with KRAS and\u002For BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.",[26,69,70,71,72,73,74,75,76,77,78,79,37,80,81,31,82,83,84,85,86,38,27,87,88,89,90,91,92,93,94,95],"Histiocytic Neoplasm","Histiocytosis","BRAF Gene Mutation","BRAF V600E","BRAF V600 Mutation","BRAF Mutation-Related Tumors","BRAF","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Lung Cancer","Recurrent Lung Cancer","Recurrent Lung Non-Small Cell Carcinoma","Solid Tumor","Solid Carcinoma","KRAS G12V","KRAS Mutation-Related Tumors","NRAS Gene Mutation","Thyroid Cancer","Thyroid Carcinoma","Recurrent Histiocytic and Dendritic Cell Neoplasm","Brain Metastases","Recurrent NSCLC","KRAS G13C","Acquired Resistance to KRAS G12C Inhibitor","KRAS G12A","KRAS G12F","KRAS G12R","KRAS G13D",[97,98,99,34,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114],"BRAF Class I","BRAF Class II","BRAF Class III","Intolerant histiocytic neoplasm","BDTX-4933","Phase 1","dose escalation","dose expansion","MAPK","mitogen-activated protein kinase","RAS","RAF","Upstream oncogenic alterations","RAF inhibitor","intracranial disease","CRAF","NRAS","RAF fusions","2026-06-16",{"date":117,"type":47},"2026-06-17",{"date":119,"type":47},"2023-04-18",{"date":121,"type":20},"2028-06",{"name":123,"class":124},"Institut de Recherches Internationales Servier","OTHER",27,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":147,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100586569","phase-1-bbo-11818-in-adult-subjects-with-kras-mutant-cancer-100586569","NCT06917079","BBO-11818 in Adult Subjects With KRAS Mutant Cancer","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers","Inclusion Criteria:\n\n* Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation\n* Measurable disease by RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Life expectancy \\>24 weeks\n* Adequate organ function\n\nExclusion Criteria:\n\n* Malignancy within the last 2 years as specified in the protocol\n* Untreated brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol.",{"count":134,"type":20},665,[23],"A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.",[138,37,139,140,141,142,92,143,31,144,82,145,146,30],"Non-Small Cell Lung Cancer","PDAC - Pancreatic Ductal Adenocarcinoma","CRC (Colorectal Cancer)","Metastatic Non-Small Lung Cell Cancer","Metastatic Colorectal Cancer (CRC)","KRAS G12C","KRAS G12S","Metastatic Pancreatic Ductal Adenocarcinoma","Advanced Lung Carcinoma",[148,149,150,151,37,152,36,153,154,155,156,157,158,159,160,161,162,163,164],"BBOT","BridgeBio Oncology Therapeutics","Phase1","Phase 1a\u002F1b","CRC","Metastatic Cancer","Advanced Cancer","Pembrolizumab","Cetuximab","Platinum Chemotherapy","Pemetrexed","KONQUER","KONQUER-101","mFOLFOX6","mFOLFIRINOX","Gemcitabine","Nab-paclitaxel","2026-05-29",{"date":167,"type":47},"2026-06-02",{"date":169,"type":47},"2025-03-31",{"date":171,"type":20},"2029-09",{"name":173,"class":54},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)",17,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":183,"phases":4,"briefSummary":184,"conditions":185,"keywords":193,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":206,"locationsCount":4},"100599360","expanded-access-protocol-of-eli-002-102-in-subjects-with-krasnras-mutated-pancreatic-ductal-adenocarcinoma-100599360","NCT07083479","Expanded Access Protocol of ELI-002-102 in Subjects With KRAS\u002FNRAS Mutated Pancreatic Ductal Adenocarcinoma","Expanded Access Protocol for ELI-002 7P Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS)\u002FNeuroblastoma RAS Viral Oncogene Homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC)","AMPLIFY-EAP","Inclusion Criteria:\n\n* Has at least 1 of the 7 KRAS\u002FNRAS mutated alleles (G12D, G12R, G12V, G12A, G12C, G12S, G13D)\n* The following must be met: (1) the patient has no alternative therapy to diagnose, monitor, or treat the disease or condition; (2) enrollment in a clinical trial is not possible; and (3) the potential benefit to the patient justifies the potential risks of treatment.\n* Screening CT scan negative for recurrent disease\n* Eastern Cooperative Oncology Group performance status of 0 or 1\n\nExclusion Criteria:\n\n* Use of immunosuppressive drugs\n* Known brain metastases","EXPANDED_ACCESS","This is an open-label expanded access protocol (EAP) of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide \\[Amph-CpG-7909\\] plus a mixture of lipid-conjugated peptide-based antigens \\[Amph-Peptides 7P\\]) as adjuvant treatment in patients with KRAS\u002FNRAS-mutated pancreatic ductal adenocarcinoma who are at high risk for relapse (ie, presence of isolated tumor cells in a patient whose primary tumor has been removed and is currently without clinical signs of disease). This protocol builds on the experience being obtained with ELI-002 7P (with Amph-Peptides G12D, G12R, G12V, G12A, G12C, G12S, G13D), which is being studied in protocol ELI-002-201.",[28,31,82,144,92,143,94,95,186,187,188,189,190,191,192],"NRAS G12D","NRAS G12V","NRAS G12S","NRAS G12A","NRAS G12C","NRAS G12R","NRAS G13D",[194,195,196,197,198,199,200,201],"Pancreatic ductal adenocarcinoma (PDAC)","Kirsten rat sarcoma (KRAS)","Neuroblastoma ras viral oncogene homolog (NRAS)","Adjuvant therapy","Immunotherapy","Vaccine therapy","Expanded access","Expandd access protocol (EAP)","AVAILABLE","2026-05-18",{"date":205,"type":47},"2026-05-19",{"name":207,"class":54},"Elicio Therapeutics",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":216,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":220,"conditions":221,"keywords":238,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":253},"100514796","phase-2-a-trial-of-targeted-therapies-for-patients-with-slow-flow-or-fast-flow-vascular-malformations-100514796","NCT05983159","A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations","A Modular Open Label, Signal Seeking, Phase II Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations (TARGET-VM)","TARGET-VM","MODULE 1\n\nInclusion Criteria:\n\n1. Adult or paediatric patient, 2 years of age or over\n2. Patient has a clinical diagnosis of a slow-flow vascular malformation\n3. Patient has received standard therapy for the vascular malformation or in which, in the opinion of the investigator, standard therapy is not appropriate\n\n   \\- Note: standard therapy may include treatment with sirolimus. A minimum of 14 days since the last dose of sirolimus is required prior to starting treatment with alpelisib\n4. A documented genetic alteration in the PI3K signalling pathway identified by genetic sequencing prior to enrolment in this study\n5. Adequate performance status (Eastern Cooperative Oncology Group Performance Status Scale (ECOG) 0-2 in patients ≥ 16 years of age; Lansky \\> 50 in patients \\\u003C 16 years of age)\n6. Patient has a life expectancy ≥ 12 weeks\n7. Patient is able to swallow and retain oral medication\n8. Adequate haematologic and end-organ function:\n\n   * Haematology: Haemoglobin ≥ 9.0 g\u002FdL; Absolute neutrophil count ≥ 1.5 x 109\u002FL; Platelets ≥ 90 x 109\u002FL, except where bleeding leading to low haemoglobin level is an indication for treatment, in which case haemoglobin \\\u003C 9.0 g\u002FdL is acceptable.\n   * Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AT) ≤ 3 x ULN; Total bilirubin \\\u003C 2x ULN except for participants with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN\n   * Renal function: Serum creatinine \\\u003C 1.5 x ULN\n   * Biochemistry: Calcium (corrected for serum albumin) and magnesium within normal limits or ≤ Grade 1 according to NCI-CTCAE v5.0 if judged clinically not significant by the investigator; Potassium within normal limits, or corrected with supplements\n   * Fasting blood glucose ≤ 7.0 mmol\u002FL and Glycosylated Haemoglobin (HbA1c) ≤ 6.4% (both criteria must be met)\n9. Patient agrees to abstinence or highly effective contraceptive measures for males and women of childbearing potential (WOCBP)\n\n   * Males who are sexually active must use a condom during intercourse while taking alpelisib and for at least 4 weeks after stopping alpelisib and should not father a child in this period. A condom is required to be used also by vasectomised men in order to prevent delivery of the drug via seminal fluid. In addition, male participants must not donate sperm during the study and for at least 4 weeks after stopping alpelisib\n   * Females who are of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use a highly effective method of contraception during study treatment and for at least 1 week after the last dose of any study treatment. Highly effective contraceptive methods include:\n\n     * Total abstinence (when this is in line with the preferred and usual lifestyle of the subject) Periodic abstinence (eg., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;\n     * Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the women has been confirmed by follow up hormone level assessment;\n     * Male partner sterilisation (at least 6 months prior to screening) of the sole partner of a female participant on the study;\n     * Use of oral (estrogen and progesterone), injected or implanted combined hormonal method of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormonal vaginal ring or transdermal hormone contraception. In the case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n   * Women are considered postmenopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhoea with an appropriate clinical profile (i.e., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least 6 weeks before taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered to be not of child bearing potential.\n10. Patient has signed informed consent and is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations\n\nExclusion Criteria:\n\n1. History of hypersensitivity to any drugs or metabolites of PI3K inhibitors or any of the excipients of alpelisib\n2. Severe infection requiring intravenous antibiotics within 4 weeks prior to enrolment\n3. Patient has had a major surgical procedure within 4 weeks prior to enrolment\n4. Prior use of an alpha-specific PI3K inhibitor\n5. History of pneumonitis or interstitial lung disease\n6. Patient is pregnant or lactating at the time of study registration. A pregnancy test is mandated for women of child-bearing potential in the screening period\n7. Established diagnosis of type I diabetes mellitus, type II diabetes mellitus requiring anti-hyperglycaemic medication or any participant with HbA1c \\> 6.4%\n8. Patient who is currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes\n9. Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to the start of treatment:\n\n   * Strong inducers of CYP3A4\n   * Strong inhibitors of CYP3A4\n   * Inhibitors of BCRP\n10. History of acute pancreatitis within 1 year of screening or past history of chronic pancreatitis\n11. Patient with Child Pugh score B or C\n12. Unresolved osteonecrosis of the jaw\n13. Impairment of GI function or GI disease that may significantly alter the absorption of the study drug based on investigator discretion\n14. Known history of Human Immunodeficiency Virus (HIV) infection (testing for HIV is not mandatory in screening)\n15. Known history of severe cutaneous reactions like Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Erythema Multiforme (EM), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)\n16. Known history of clinically significant, uncontrolled heart disease and\u002For recent cardiac events including:\n\n    * History of angina pectoris, coronary artery bypass graft (CABG), symptomatic pericarditis, or myocardial infarction within 6 months prior to the start of study treatment;\n    * History of documented congestive heart failure (New York Heart Association functional classification III-IV);\n    * History of impaired Left Ventricular Ejection Fraction (LVEF) \\\u003C 50% (an assessment of LVEF is not mandatory in screening)\n    * History of clinically significant cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle branch block, high grade Atrioventricular (AV) block (e.g. bifascicular block, Mobitz type II and third degree AV block without pacemaker in place);\n    * Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mmHg and\u002For Diastolic Blood Pressure (DBP) ≥ 100 mmHg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening;\n    * Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or corrected QT interval \\> 470 msec at screening (using Fridericia correction);\n    * Bradycardia (heart rate \\\u003C 50 beats per minute at rest), by electrocardiogram (ECG) or pulse\n17. Patient has other concurrent severe and\u002For uncontrolled medical conditions that would, in the Treating Physician's judgement, contraindicate administration of alpelisib (eg. active or uncontrolled severe infection, chronic active hepatitis, immune-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure)\n18. Patient is unable to understand and comply with treatment instructions and requirements\n\nMODULE 2\n\nInclusion Criteria:\n\n1. Adult or paediatric patient, 2 years of age or over where Body Surface Area (BSA) is greater than or equal to 0.4m2.\n2. Patient has a clinical diagnosis of a fast-flow vascular malformation\n3. Patient has received standard therapy for the vascular malformation or in which, in the opinion of the investigator, standard therapy is not appropriate\n\n   \\- Note: standard therapy may include treatment with sirolimus. A minimum of 14 days since the last dose of sirolimus is required prior to starting treatment with mirdametinib\n4. A documented genetic alteration in the RAS-MEK-ERK signalling pathway identified by genetic sequencing prior to enrolment in this study\n5. Adequate performance status (Eastern Cooperative Oncology Group Performance Status Scale (ECOG) 0-2 in patients ≥ 16 years of age; Lansky \\> 50 in patients \\\u003C 16 years of age)\n6. Patient has a life expectancy ≥ 12 weeks\n7. Participant has the ability to swallow capsules whole if the capsule dosage form is being utilized. This criterion does not apply if participant is utilizing the dispersible tablet form of study treatment\n8. Adequate haematologic and end-organ function:\n\n   * Haematology: Haemoglobin ≥ 9.0 g\u002FdL; Absolute neutrophil count ≥ 1.5 x 109\u002FL; Platelets ≥ 90 x 109\u002FL, except where bleeding leading to low haemoglobin level is an indication for treatment, in which case haemoglobin \\\u003C 9.0 g\u002FdL is acceptable.\n   * Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AT) ≤ 2 x upper limit of normal (ULN); Total bilirubin \\\u003C 1.5x ULN (isolated bilirubin \\> 1.5x ULN is acceptable if bilirubin is fractioned and direct bilirubin \\\u003C 35%), except where impaired hepatic function is a consequence of the fast-flow malformation and hence is an indication for treatment, in which case impaired hepatic function is acceptable.\n   * Renal function: Serum creatinine \\\u003C 1.5 x ULN\n   * Biochemistry: Calcium (corrected for serum albumin) and magnesium within normal limits or ≤ Grade 1 according to NCI-CTCAE v5.0 if judged clinically not significant by the investigator; Potassium within normal limits or corrected with supplements; Phosphate ≤ 1x ULN.\n9. Patient agrees to abstinence or highly effective contraceptive measures if of childbearing potential (WOCBP)\n\n   * Males who are sexually active must use a condom during intercourse while taking mirdametinib and for at least 90 days after stopping mirdametinib and should not father a child in this period. A condom is required to be used also by vasectomised men in order to prevent delivery of the drug via seminal fluid. In addition, male participants must not donate sperm during the study and for at least 90 days after stopping mirdametinib\n   * Females who are of child-bearing potential, defined as all individuals physiologically capable of becoming pregnant, must use a highly effective method of contraception during study treatment and for at least 180 days after the last dose of any study treatment. Highly effective contraceptive methods include:\n\n     * Total abstinence (when this is in line with the preferred and usual lifestyle of the subject) Periodic abstinence (eg., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;\n     * Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the women has been confirmed by follow up hormone level assessment;\n     * Male partner sterilisation (at least 6 months prior to screening) of the sole partner of a female participant on the study;\n     * Use of oral (estrogen and progesterone), injected or implanted combined hormonal method of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormonal vaginal ring or transdermal hormone contraception. In the case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n   * Women are considered postmenopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhoea with an appropriate clinical profile (i.e., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least 6 weeks before taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered to be not of childbearing potential.\n10. Patient has signed informed consent and is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations\n\nExclusion Criteria:\n\n1. History of hypersensitivity to any drugs or metabolites of MEK inhibitors or any of the excipients of mirdametinib\n2. Severe infection requiring intravenous antibiotics within 4 weeks prior to enrolment\n3. Patient has had a major surgical procedure within 4 weeks prior to enrolment\n4. Prior use of a MEK inhibitor\n5. Patient has abnormal QT interval corrected by Fridericia's formula (\\> 450 msec for male participants, \\> 470 msec for female participants, or \\> 480 msec for participants with bundle branch block) (triplicate ECG readings taken approximately 2 to 3 minutes apart and averaged) at Screening;\n6. Patient is pregnant or lactating at the time of study registration. A pregnancy test is mandated for persons of child-bearing potential in the screening period\n7. Impairment of GI function or GI disease that may significantly alter the absorption of the study drug based on investigator discretion\n8. Any clinically significant active or known history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)\n9. Lymphoma, leukaemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years;\n10. Breast cancer within the past 5 years;\n11. Known history of Human Immunodeficiency Virus (HIV) infection (testing for HIV is not mandatory in screening)\n12. Known history of severe cutaneous reactions like Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Erythema Multiforme (EM), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)\n13. Patient has a history of, or evidence of, retinal pathology on ophthalmologic examination that is considered a risk factor for central serous retinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration. Patients will be excluded from study participation if they have any of the following risk factors for RVO at Screening:\n\n    * Intraocular pressure \\> 21 mmHg;\n    * Serum cholesterol \\> 7.8 mmol\u002FL;\n    * Serum triglycerides \\> 3.4 mmol\u002FL;\n    * Hyperglycaemia (fasting blood glucose \\> 7.0 mol\u002FL );\n    * Age specific hypertension\n\n      * Patients ≥ 13 years of age with a blood pressure ≥ 140\u002F90 mmHg\n      * Patients ≤ 12 years of age with a blood pressure ≥ 95th percentile for age + 12 mmHg\n14. Known history of glaucoma\n15. Known history of clinically significant, uncontrolled heart disease and\u002For recent (within 6 months \\[24 weeks\\] of signing informed consent\u002Fassent) cardiac events including:\n\n    * History of angina pectoris, coronary artery bypass graft (CABG), symptomatic pericarditis, or myocardial infarction within 6 months prior to the start of study treatment;\n    * History of documented congestive heart failure (New York Heart Association functional classification III-IV);\n    * History of clinically significant cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle branch block, high grade Atrioventricular (AV) block (e.g. bifascicular block, Mobitz type II and third degree AV block without pacemaker in place);\n    * Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 140 mmHg and\u002For Diastolic Blood Pressure (DBP) ≥ 90 mmHg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening;\n    * Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or corrected QT interval \\> 470 msec at screening (using Fridericia correction);\n    * Bradycardia (heart rate \\\u003C 50 beats per minute at rest), by electrocardiogram (ECG) or pulse\n16. Patient has recorded a left ventricular ejection fraction (LVEF) \\\u003C 55% at Screening\n17. Patient has experienced a cerebrovascular accident, transient ischaemic attach, or symptomatic pulmonary embolism within 6 months (24 weeks) of signing informed consent\u002Fassent.\n18. Patient has other concurrent severe and\u002For uncontrolled medical conditions that would, in the Treating Physician's judgement, contraindicate administration of mirdametinib (eg. active or uncontrolled severe infection, chronic active hepatitis, immune-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure)\n19. Patient is unable to understand and comply with treatment instructions and requirements","2 Years",{"count":218,"type":20},50,[66],"Recent studies have demonstrated that growth of vascular malformations can be driven by genetic variants in one of 2 signalling pathways. Targeted drugs specific to these pathways have been developed and shown to be effective in treating cancer. This study will describe the effectiveness of (i) 48 weeks of alpelisib therapy for participants with slow-flow vascular malformations and a gene mutation in one of these signalling pathways (module 1) and (ii) 48 weeks of mirdametinib therapy for participants with fast-flow vascular malformations and a gene mutations in the other signalling pathway (module 2).",[222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,143,31],"Slow-Flow Vascular Malformation","Fast-Flow Vascular Malformation","Vascular Malformations","Venous Malformation","Lymphatic Malformation, Low Flow","Lymphatic Malformation","Lymphangioma","Arteriovenous Malformations","Venous Malformation, Low Flow","Cystic Hygroma","Vascular Anomaly","Vascular Anomalies","PI3K Gene Mutation","MAP2K1 Gene Mutation","PIK3CA-related Overgrowth Spectrum","Arteriovenous Malformation (AVM)",[239,240,241,242,243],"Targeted therapy","vascular malformations","skin diseases, vascular","Phosphatidylinositol 3-Kinases","MEK inhibitor 1","2026-04-29",{"date":246,"type":47},"2026-05-05",{"date":248,"type":47},"2024-09-13",{"date":250,"type":20},"2027-05",{"name":252,"class":124},"Murdoch Childrens Research Institute",2,{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":261,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":268,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":278},"100619293","early-phase-1-tcr-t-cell-therapy-for-kras-mutation-in-advanced-solid-tumors-100619293","NCT07342738","TCR-T Cell Therapy for KRAS Mutation in Advanced Solid Tumors","A Cliniacl Study of T Cell Receptor-engineered T-Cell (TCR-T) Injection in Patients With Advanced Solid Tumors Induced by Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutations.","Inclusion Criteria:\n\n1. Voluntary signing of an informed consent form (ICF)；\n2. Males or females, aged 18-70 years (inclusive);\n3. Subjects with advanced solid tumors confirmed by histology\u002Fcytology, have failed with standard treatment, or intolerant to standard treatment, or no standard treatment exists：1）Colorectal cancer：failed or intolerant to at least two lines of standard treatment.2）Non-small cell lung cancer：Absence of the following gene mutations (Epidermal Growth Factor Receptor\\[EGFR\\]、Anaplastic Lymphoma Kinase\\[ALK\\] 、 Proto-oncogene tyrosine-protein kinase 1\\[ROS1\\]) and having failed or intolerant to platinum-based chemotherapy and\u002For immunotherapy and\u002For anti-angiogenic therapy.3）Other advanced solid tumors：failed with standard treatment, or intolerant to standard treatment, or no standard treatment exist.\n4. At least one measurable lesion (according to Response Evaluation Criteria in Solid Tumors\\[RECIST\\], version 1.1);\n5. Patients with tumor tissue or peripheral blood testing positive for KRAS-G12V or G12D mutations and expression of matching HLA-A\\*11:01 or HLA-C\\*01:02 subtypes;\n6. ECOG (Eastern Cooperative Oncology Group)≤2;\n7. Life expectancy ≥3 months;\n8. Adequate functional reserve of organs：1）Hematology (no intensive blood transfusion, platelet transfusion or cell growth factor performed within 14 days before the test)：·Absolute neutrophil count ≥1×10E9\u002FL;·Platelet count ≥50×10E9\u002FL, hemoglobin\\>90g\u002FL;·Absolute lymphocyte count ≥0.5×10E9\u002FL;2）Blood chemistry：·Alanine aminotransferase (ALT) ≤3×Upper Limit of Normal (ULN);·Aspartate aminotransferase (AST) ≤3×ULN（patients with hepatic metastasis, ALT and AST ≤5×ULN）;·Serum creatinine ≤1.5×ULN or Creatinine clearance ≥50 mL\u002Fmin;·Total bilirubin (TB) ≤1.5×ULN；3）Blood chemistry：·APTT≤1.5×ULN，INR≤1.5×ULN4）The subject has left ventricular ejection fraction (LVEF) ≥ 50% and no clinically significant pericardial effusion diagnosed by echocardiography;5）No clinically significant electrocardiographic abnormality;6）Basic oxygen saturation is \\>92% under the indoor natural air environment.\n9. Women of childbearing age must be negative for blood HCG (Human Chorionic Gonadotropin) pregnancy test (by immunofluorescence method) at screening and baseline periods, and agree to use effective contraception for at least 1 year after infusion; and male subjects whose partners are women of childbearing age must agree to use effective barrier contraception methods and avoid sperm donation for at least 1 year after infusion.\n\nExclusion Criteria:\n\n1. Other malignancies (except non-melanoma skin cancer with the disease-free survival of more than 5 years and cervical carcinoma in situ, bladder cancer, or breast cancer);\n2. History of organ transplantation；\n3. A history of mental disorders, which may affect compliance with this protocol or lead to failure in signing the ICF;\n4. A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis and systemic lupus erythematosus) requiring systemic immunosuppressive\u002Fsystemic disease-modulating drugs；\n5. Poorly controlled hypertension with drug (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg) or occurrence of grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stent placement, unstable angina pectoris, or other clinically significant heart diseases within one year prior to signing the ICF; Corrected QT Interval (QTc) interval \\>450 ms for males or QTc interval \\>470 ms for females during screening (QTc interval calculated using the Fridericia formula)；\n6. Patients with intestinal obstruction or obstructive jaundice and are deemed ineligible for enrollment by the investigator；\n7. Symptomatic intracranial metastases, or moderate to severe ascites or pleural effusion requiring drainage to relieve symptoms；\n8. A history of or any central nervous system disorders, such as epileptic seizure, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system within the past 6 months；\n9. A positive result obtained in any of the following virological tests:1）Antibody to human immunodeficiency virus (HIV antibody); 2）Hepatitis C virus antibody (HCV antibody), with a positive result for hepatitis C virus ribonucleic acid (HCV RNA); 3）Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) copies ≥2000 IU\u002FmL; 4）Treponema pallidum antibody (TP antibody) and positive for unheated serum reagin test;\n10. Fungal, bacterial, viral or other infections or suspected fungal, bacterial, viral or other infections that cannot be controlled or require intravenous administration；\n11. Significant tendency for bleeding, such as active gastrointestinal bleeding, coagulation disorders；\n12. Deep vein thrombosis requiring treatment within the past 6 months, unless the risk of thrombosis is acceptable after treatment, as assessed by the investigator；\n13. Interstitial lung disease (such as interstitial pneumonia, pulmonary fibrosis), or a history of clinically significant respiratory system diseases at screening；\n14. Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 2 weeks prior to leukapheresis；\n15. Participation in any other clinical studies within 1 month prior to signing the master informed consent form；\n16. Patients with poor compliance due to physiological, family, social, geographic and other factors, and failure to follow the study protocol and the follow-up plan；\n17. Patients with contraindications to drugs used in the study；\n18. Comorbidities requiring treatment with systemic corticosteroids (dexamethasone at a dose of ≥ 5 mg\u002Fday or other corticosteroids at the equivalent dose) or other immunosuppressive drugs after initiation of the study treatment, as judged by the investigator；\n19. Women who are breastfeeding and are unwilling to stop breastfeeding；\n20. Any other conditions that are, in the opinion of the investigator, not suitable for enrollment.","75 Years",{"count":263,"type":20},25,[265],"EARLY_PHASE1","This is a single-arm, Multicenter, open-label clinical study aimed at evaluating the safety and efficacy of TCR-T injection in patients with advanced solid tumors induced by KRAS mutations.",[82,31,80],"NOT_YET_RECRUITING","2026-01-14",{"date":271,"type":47},"2026-01-15",{"date":273,"type":20},"2026-02-01",{"date":275,"type":20},"2029-02-01",{"name":277,"class":124},"Sun Yat-sen University",1,{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":261,"enrollmentInfo":286,"targetDuration":4,"studyType":21,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":278},"100558056","phase-1-re002-t-cell-injection-for-the-treatment-of-kras-g12d-mutated-solid-tumors-100558056","NCT06546150","RE002 T Cell Injection for the Treatment of KRAS G12D Mutated Solid Tumors","RE002 T Cell Injection for the Treatment of KRAS G12D Mutated Solid Tumors, an Open-label Single-center Phase I Clinical Trial","Inclusion Criteria:\n\n1. Subjects voluntarily participate in the study and sign informed consent;\n2. Age ≥18 years old and ≤75 years old;\n3. Advanced malignant solid tumors with clear pathological diagnosis;\n4. Standard therapies failed or cannot be tolerated or lacks effective treatments;\n5. Have at least one measurable lesion;\n6. During the trial screening period, the following two indicators must be met (the sponsor is responsible):\n\n   HLA-A\\* 11:01 positive; Tumor gene testing carries KRAS G12V mutation;\n7. ECOG score 0-1 and expected survival time greater than 6 months;\n8. Cardiac color ultrasound shows left ventricular ejection fraction ≥50%;\n9. Laboratory examination results should meet the following specified indicators:\n\n   White blood cell count ≧ 3.0×109\u002FL;\n   1. Absolute neutrophil count ≧ 1.5×109\u002FL (without G-CSF and GM-CSF support, enter at least 14 days before group);\n   2. Absolute lymphocyte count ≧ 0.5×109\u002FL;\n   3. Platelets (PLT) ≧ 75×109\u002FL (no blood transfusion treatment in the first 14 days);\n   4. Hemoglobin ≧ 100g\u002FL (no blood transfusion treatment in the first 14 days);\n   5. Prothrombin time international normalized ratio INR ≦ 1.5×upper limit of normal time, unless anticoagulant therapy was received;\n   6. Partial prothrombin time (APTT) ≦ 1.5×upper limit of normal time, unless receiving antibiotics coagulation therapy;\n   7. Serum creatinine ≦ 1.5mg\u002FdL (or 132.6μmol\u002FL);\n   8. Aspartate aminotransferase (AST\u002FSGOT) ≦ 2.5×ULN;\n   9. Alanine aminotransferase (ALT\u002FSGPT) ≦ 2.5×ULN;\n   10. Total bilirubin (TBIL) ≦ 1.5×ULN;\n   11. In patients with liver metastasis, aspartate aminotransferase and alanine aminotransferase need to be ≦ 5×ULN.\n10. Women of childbearing age who have not undergone sterilization before menopause must agree to use effective contraception within at least 12 months from the beginning of the study to T cell infusion, and the serum pregnancy test is negative within 14 days before the first treatment;\n11. Men who have not undergone sterilization must agree to use effective contraception from the beginning of the study to at least 12 months after T cell infusion;\n12. During the entire trial period, you can regularly visit the participating research institutions for relevant testing, evaluation and management.\n\nExclusion Criteria:\n\n1. Those who have received major surgery, conventional chemotherapy, large-area radiotherapy, immunotherapy or biological therapy anti-tumor treatment within 4 weeks before entering the trial;\n2. Previous use of drugs targeting KRAS G12V mutations, including previous participation in cell therapy with similar targets Cellular testing and small molecule inhibitors targeting KRAS G12V mutations, etc.;\n3. Allergic reactions are known to occur to any ingredient (such as dimethyl sulfoxide, cyclophosphamide, fludarabine) or structurally similar compounds treated in this trial;\n4. Failure to recover from adverse reactions related to previous surgery or treatment to \\\u003C Grade 2 CTCAEV5.0;\n5. Hypertension that remains uncontrolled after combined treatment with 2 drugs or clinically significant (such as active) Cardiovascular and cerebrovascular diseases, such as cerebrovascular accident (within 6 months before signing the informed consent form), myocardial infarction (within 6 months before signing the informed consent form), unstable angina, congestive heart failure classified as class II or above by the New York Heart Association, or severe arrhythmia that cannot be controlled with medication or has a potential impact on study treatment; the electrocardiogram showed obvious abnormality or average QTc interval ≧ 450ms for 3 consecutive times (at least 5 minutes interval);\n6. Combined with other serious organic diseases and mental disorders;\n7. Suffering from systemic active infections requiring treatment, including but not limited to active tuberculosis, known HIV positive patients or patients with clinically active hepatitis A, B, or C include virus carriers;\n8. Have a history of inflammatory bowel disease and autoimmune diseases judged by the researcher to be unsuitable for this study (such as systemic lupus erythematosus, vasculitis, etc.);\n9. Those who plan to use the following drugs within 4 weeks before cell therapy and during the study: long-term systemic use steroid hormones, hydroxyurea, immunomodulatory drugs (such as interleukin 2, alpha or gamma interferon, GM-CSF, mTOR inhibitors, cyclosporins, thymosin, etc.);\n10. People with brain metastasis:\n\n    1. Symptomatic brain metastasis should be ruled out. Patients with a previous history of symptomatic brain metastasis and stable symptoms after local treatment were enrolled in the group who did not need antiepileptic drugs and steroids at least 14 days before lymphocyte clearance.\n    2. Subjects with asymptomatic brain metastasis without tumor-related brain edema, displacement, steroids or antiepileptic drugs can be enrolled.\n    3. Subjects with meningitis or meningeal metastasis need to be excluded.\n11. People with bleeding or thromboembolism tendency:\n\n    1. Have clinically significant bleeding symptoms or obvious bleeding tendency within 2 weeks before the study;\n    2. Have inherited or acquired bleeding and thrombosis tendencies;\n    3. A serious arterial\u002Fvenous thromboembolic event within the past 6 months.\n12. Suffering from massive pericardial effusion or symptomatic thoracic or abdominal effusion;\n13. Have received live attenuated vaccines within 4 weeks before cell infusion, or plan to receive this type of vaccine during the study;\n14. History of organ allogeneic transplantation, allogeneic stem cell transplantation and renal replacement therapy;\n15. Uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure;\n16. Known alcohol and\u002For drug abusers;\n17. Pregnant or breastfeeding women;\n18. Have any coexisting medical conditions or diseases that the researcher determines may impair the conduct of this trial subjects;\n19. No legal capacity\u002Frestricted capacity;\n20. Have previously received any gene or cell therapy products.",{"count":287,"type":20},30,[23],"At present, there is an urgent need for new drugs for KRAS mutant tumors in clinic. Preclinical studies support the specificity, safety and anti-tumor activity of RE002. Previous similar studies suggest the feasibility of TCR-T treatment, and measures have been taken to ensure the safe administration of RE002 and the close monitoring and management of adverse events. To sum up, RE002 has controllable safety and anti-tumor activity on KRAS mutant solid tumor, which can be preliminarily studied to provide support for clinical research of patients with advanced solid tumor.",[31,291],"T Cell Therapy","2025-12-08",{"date":294,"type":47},"2025-12-16",{"date":296,"type":47},"2024-03-01",{"date":298,"type":20},"2027-04-01",{"name":300,"class":301},"Henan Cancer Hospital","OTHER_GOV"]