[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-tumors-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-tumors-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,60,91,120,143,172,197,220],{"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":4,"briefSummary":23,"conditions":24,"keywords":40,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":5},"100618120","predicting-response-to-immunotherapy-from-analysis-of-live-tumor-biopsies-elephas-05-100618120",false,"NCT07327489","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies","ELEPHAS-05","Inclusion Criteria:\n\n1. Able and willing to provide informed consent for participation\n2. Age ≥18 years at time of consent.\n3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.\n4. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.\n\nExclusion Criteria:\n\n1. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.\n2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.\n3. Pregnant person(s).","ALL","18 Years",{"count":20,"type":21},2000,"ESTIMATED","OBSERVATIONAL","This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Cancer","Immunotherapy","Advanced Solid Tumors Cancer","Bladder Cancer","TNBC, Triple Negative Breast Cancer","Colorectal Cancer","DMMR Colorectal Cancer","MSI-H Colorectal Cancer","Endometrial Cancer","Head and Neck Cancer","Kidney Cancer","Liver Cancer","NSCLC (Non-small-cell Lung Cancer)","Skin Cancer","Melanoma (Skin Cancer)",[26,41,42,25,43,44,45,46,47,48],"Live Tumor Biopsy","Elephas","Imaging","Tumor Cutting","Treatment Response","Core Needle Biopsy","Forceps Biopsy","Punch Biopsy","RECRUITING","2026-06-25",{"date":52,"type":53},"2026-06-29","ACTUAL",{"date":55,"type":53},"2025-04-14",{"date":57,"type":21},"2038-04",{"name":42,"class":59},"INDUSTRY",{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":70,"briefSummary":64,"conditions":73,"keywords":76,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100645104","phase-1-a-study-of-gfh276-combined-with-cetuximab-or-chemotherapy-in-participants-with-solid-tumors-and-pancreatic-ductal-adenocarcinoma-pdac-harboring-ras-mutation-100645104","NCT07678593","A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation","A Multi-center, Open-label Phase Ib\u002FII Study Exploring the Safety\u002FTolerability, Pharmacokinetics, and Efficacy of GFH276 in Combination With Cetuximab or Chemotherapy in the Treatment of Patients With Advanced Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor and PDAC with RAS mutation or KRAS amplification\n3. At least one measurable lesion according to RECIST v1.1\n4. ECOG performance status 0 or 1\n5. Life expectancy \\> 3 months\n6. Adequate organ function\n7. Willing to provide written informed consent\n8. Fertile participants must use effective contraception\n\nExclusion Criteria:\n\n1. Other active malignancy within 3 years\n2. Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor\n3. History of active clinically significant cardiovascular dysfunction\n4. For participants with known concomitant second oncodriver for PDAC or for solid tumors.\n5. With active infection (HIV, HBV, HCV, syphilis)\n6. The presence of clinical or radiological evidence of intestinal obstruction.\n7. Prior anticancer therapy within 28 days or 5 half-lives\n8. Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months\n9. Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures.\n10. History of central nervous system (CNS)disease\n11. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment.\n12. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.",{"count":68,"type":21},222,"INTERVENTIONAL",[71,72],"PHASE1","PHASE2",[27,74,75],"Pancreatic Ductal Adenocarcinoma","RAS Mutation",[77,78,75,79],"GFH276","PDAC","solid tumors","NOT_YET_RECRUITING","2026-06-24",{"date":83,"type":53},"2026-07-01",{"date":85,"type":21},"2026-09",{"date":87,"type":21},"2028-09",{"name":89,"class":59},"Genfleet Therapeutics (Shanghai) Inc.",3,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":69,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100585137","phase-1-a-study-to-assess-the-safety-tolerability-and-efficacy-of-ndi-219216-in-patients-with-advanced-solid-tumors-100585137","NCT06898450","A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of NDI-219216 in Patients With Advanced Solid Tumors With\u002FWithout Microsatellite Instability and\u002For Deficient Mismatch Repair","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Have unresectable and\u002For metastatic solid tumors (with or without MSI-H\u002FdMMR) refractory to or intolerant to previous SoC therapy or for which no SoC therapy exists\n* Presence of measurable disease according to RECIST version 1.1 except for Part A (Dose Escalation)\n* Adequate bone marrow \u002F hematologic, end-organ, and cardiovascular function\n* Resolution of all acute (or toxic) adverse effects of prior therapies, radiation therapy, or surgical procedures to Grade ≤ 1 (except fatigue, alopecia, and peripheral neuropathy).\n\nExclusion Criteria:\n\n* Clinically significant cardiovascular disease.\n* Patients with known WRN syndrome.\n* Pregnancy, breastfeeding, or intention of becoming pregnant during the study.","99 Years",{"count":100,"type":21},134,[71,72],"The goal of this clinical trial is to learn if NDI-219216 is safe for patients, and if NDI-219216 might be a possible treatment for advanced solid tumors in the later phases of the study.\n\nThe main questions it aims to answer are:\n\nIs NDI-219216 safe and what kinds of side effects might it cause? What kind of effects does NDI-219216 have on the body? Does NDI-219216 have any impact on tumor size?\n\nParticipants will:\n\nTake NDI-219216 every day by mouth. Visit the clinic 6 times during Cycle 1, 2 times during Cycle 2, once a month thereafter for checkups and tests while on the study, then one time for an end of treatment visit. After the End of Study, a follow up will occur but can be done on the phone.\n\nKeep a diary of their tablet consumption and symptoms experienced.",[27,104],"MSI-H Cancer",[106,107,108,109],"Advanced Solid Tumors","Microsatellite Instability","Deficient Mismatch Repair","Werner syndrome helicase","2026-05-04",{"date":112,"type":53},"2026-05-06",{"date":114,"type":53},"2025-03-31",{"date":116,"type":21},"2031-12",{"name":118,"class":59},"Nimbus Wadjet, Inc.",22,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":69,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100632537","phase-1-first-in-human-study-of-khn922-for-injection-100632537","NCT07514975","First-In-Human Study of KHN922 for Injection","A Phase 1\u002F2 Study of KHN922 for Injection to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity in Patients With Advanced Solid Tumors","Inclusion Criteria:1.Signed, written IRB-approved Informed Consent. 2.Male or female. 3.Aged 18 \\~ 75 years. 4.Life expectancy of at least 3 months. 5.Histologically or cytologically confirmed advanced or unresectable solid tumors for wihch failure or difficult to be treated with standard therapies, or not suitable for standard therapies.\n\n6.Measurable disease by CT\u002FMRI as defined in RECIST v1.1. 7.Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n\n\\-\n\nExclusion Criteria:\n\n1.Pregnant or lactating women. 2.Received cancer-directed therapy within the following timeframes:\n\n* Major surgery within 4 weeks or will be expected to require major surgical treatment during the study period.\n* Radical radiotherapy or chest palliative radiotherapy within 4 weeks, or palliative radiotherapy at any other sites except chest within 2 weeks.\n* Antibody-based anti-cancer therapies, macromolecular protein products or cytotherapies within 4 weeks.\n* Hormonal anti-tumor therapy within 2 weeks.\n* Chemotherapy (including non-antibody based immunotherapy therapy) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or 5 times half life of the chemotherapeutic agent (whichever is longer).\n* Any natural medicine with anti-tumor effect within 1 weeks.\n* Tyrosine kinase inhibitor (TKI) treatment within 1 week. 3.Received experimental drug therapy or participated in a clinical study of a medical device within 4 weeks prior to first infusion of KHN922.\n\n  4.Known history of unstable angina, myocardial infarction (MI), or congestive heart failure (CHF) (NYHA Class II-IV) within 6 months or clinically significant arrhythmia (other than stable atrial fibrillation or paroxysmal superventricular tachycardia) requiring anti-arrhythmia therapy 5.Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg) and\u002For diabetes (HbA1c ≥ 8.0%).\n\n  6.serous cavity effusion such as ascites or pleural effusion requiring drainage within 14 days before the first dose of medication. 7.Patients with moderate to severe respiratory dyspnea due to severe primary lung disease or complications of advanced malignancy \\[rated as grade 3\u002F4 by modified Medical Research Council (mMRC) scale\\] (see Appendix 3), or requiring continuous oxygen therapy, or acute exacerbations of chronic obstructive pulmonary disease (AECOPD), or current abnormal and clinically significant of interstitial lung disease (ILD)\u002Fpneumonia, or ILD\u002F pneumonia that could not be ruled out on imaging during screening, or any autoimmune disease\u002Fconnective tissue disease (e.g. Rheumatoid arthritis, Sjogren's syndrome, sarcoidosis) with lungs involvement.\n\n  8.Grade ≥2 anorexia, nausea, vomiting, or diarrhea within 2 weeks prior to first infusion of KHN922.\n\n  9.Active central nervous system (CNS) metastasis (defined as untreated and has symptoms such as consciousness disorder, or need steroid or anticonvulsant therapy to control symptoms) within 1 month prior to first infusion of KHN922.\n\n  10.History of significant active bleeding, intestinal obstruction, gastrointestinal perforation, or other severe gastrointestinal diseases within 6 months prior to first infusion of KHN922.\n\n  11.Newly diagnosed thromboembolic events requiring treatment within 6 months prior to first infusion of KHN922.\n\n  12.Known history of other malignancies diagnosed within 5 years prior to first infusion of KHN922 (patients with basal cell carcinoma, skin squamous cell carcinoma and carcinoma in situ, and with radical resection for more than 3 years could be enrolled).\n\n  13.Known to be allergic to any component of KHN922, or known history of grade ≥3 anaphylaxis to macromolecular protein products\u002Fantibody-based therapy, or known history of grade ≥3 drug-related AEs with the use of topoisomerase I inhibitors such as irinotecan.\n\n  14.Patients who require use of strong inhibitors or inducers of CYP3A4 at least 14 days prior to the first infusion of KHN922 and throughout study. Use of strong inhibitors or inducers of CYP3A4 is not allowed in this study.\n\n  15.Positive for Human Immunodeficiency Virus (HIV) antibody; active Hepatitis B Virus (HBV) \\[subjects with positive HBsAg or HBcAb in this study need to be tested for HBV DNA, and if HBV DNA \\> 500 IU\u002FmL (or 2500 copies\u002Fml), they will be excluded. For subjects with positive HBsAg or HBcAb, it is allowed to receive antiviral treatment until HBV-DNA reaches ≤ 500 IU\u002Fml (or 2500 copies\u002Fml) before enrollment in the study\\]; positive for HCV antibody and HCV-RNA above the lower limit of measurability or 1000 copies\u002FmL (whichever is lower); subjects with untreated or currently treated tuberculosis as diagnosed through inquiry.\n\n  16.Known history of allogeneic cell or solid organ transplantation. 17.Active infection requiring systemic treatment within 2 weeks prior to the first infusion of KHN922.\n\n  18.Confirmed Gilbert's syndrome 19.Live or live attenuated vaccine within 28 days prior to KHN922 administration and live or live attenuated vaccine planned over the course of the study.\n\n  20.Known history of psychotropic substance abuse, alcohol abuse, or drug abuse. 21.Psychological, social, familial, or geographical factors that would prevent regular follow-up. Adults under guardianship, curatorship, safeguard of justice, or family empowerment measure are not eligible.\n\n  22.Otherwise considered inappropriate for the study by the investigator.","75 Years",{"count":129,"type":21},276,[71,72],"A Phase 1\u002F2 Study of KHN922 for Injection to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity in Patients with Advanced Solid Tumors",[27],"2026-04-06",{"date":135,"type":53},"2026-04-09",{"date":137,"type":21},"2026-04",{"date":139,"type":21},"2029-04",{"name":141,"class":59},"Chengdu Kanghong Biotech Co., Ltd.",1,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":69,"phases":152,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100607585","phase-1-pq203-in-advanced-malignant-tumors-including-triple-negative-breast-cancer-100607585","NCT07190469","PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer","A Phase 1, Open-label, Multicenter Clinical Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Anti-Cancer Activity of PQ203 in Patients With Advanced Solid Tumor Malignancies","Inclusion Criteria:\n\n* At least 18 years old\n* Histologically or cytologically documented metastatic or locally advanced solid tumor malignancies having progressed through or being otherwise ineligible to receive approved standard-of-care therapies\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Documented presence of RECIST v1.1 measurable disease\n* Adequate organ function confirmed by the following laboratory values obtained within 14 days of the first dose of PQ203:\n\nBone Marrow Function\n\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10e9\u002FL\n* Platelets \\> 100 × 10e9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL\n\nHepatic Function\n\n* AST, alanine transaminase ALT or ALP ≤ 2.5 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN\n* Bilirubin ≤ 1.5 × ULN (\\\u003C 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome)\n* Serum albumin ≥ 35 g\u002FL (3.5 g\u002FdL)\n\nRenal Function\n\n* Calculated creatinine clearance of ≥ 60 mL\u002Fmin by the Cockcroft-Gault equation\n* Urine protein \\\u003C 2+\n\nCardiac Function\n\n• Left ventricular ejection fraction (LVEF) ≥ 50%\n\nOther\n\n* Understand and voluntarily sign an Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC)\u002FResearch Ethics Board (REB)-approved informed consent form prior to any study-specific evaluation.\n* PT\u002FPTT or INR \\\u003C1.2x upper limit of normal\n* Non-surgically sterile men and women of child bearing potential must agree to use highly effective methods of contraception for at least 4 months beyond the final dose received.\n* Toxicity of previous antitumor therapy has returned to Grade ≤1\n\nExclusion Criteria:\n\n* Patients with primary central nervous system (CNS) malignancies (Patients with stable brain metastases (≥ 4 weeks after a treatment) not requiring steroids or other treatment will be allowed on study).\n* Blood transfusion within 14 days of study treatment\n* Serious comorbid medical conditions such as heart, lung, kidney, liver, and brain disease that, in the opinion of the enrolling investigator, could interfere with study treatment\n* Subjects with history of severe heart disease\n* QTc interval using Fridericia's formula (QTcF) \\> 470 ms\n* Estimated or known weight \\> 115 kg (253 lbs)\n* Known\u002Fsuspected pregnancy and\u002For lactation\n* Diastolic blood pressure \\\u003C 60 mmHg or \\>110 mmHg\n* Uncontrolled intercurrent illness\n* Long term care facility resident or prisoner\n* Any prior receipt of a MMAE-containing drug\n* Any prior receipt of a SORT1-targeting medication\n* Participation in another clinical study investigating a drug or medical device or a neuro-interventional or surgical procedure that is not considered as standard care in the 30 days preceding study enrolment\n* Treatment with any of the following:\n* Chemotherapy or other systemic anti-cancer therapy ≤14 days or 5 half-lives (whichever is shorter) prior to first dose of study drug except for Nitrosoureas or mitomycins ≤42 days\n* Major surgery ≤28 days from first dose of study drug\n* Patients with a history of cerebrovascular accident within 6 months of planned first dose.\n* Patients with clinically symptomatic ocular toxicities\n* Patients with history of (noninfectious) interstitial lung disease (ILD)\u002Fpneumonitis that require steroids, with current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n* Patients with active Grade \\>1 peripheral neuropathy",{"count":151,"type":21},80,[71],"The primary purposes of this study are to determine the safety and tolerability of PQ203 in patients with advanced solid tumors including triple negative breast cancer (TNBC), and to determine a recommended Phase 2 dose level for future studies in TNBC.",[155,27],"Triple Negative Breast Cancer (TNBC)",[157,158,159,160,161],"Triple Negative Breast Cancer","TNBC","PQ203","advanced solid tumors","Phase 1","2026-02-19",{"date":164,"type":53},"2026-02-23",{"date":166,"type":53},"2025-09-16",{"date":168,"type":21},"2029-02",{"name":170,"class":59},"ProteinQure Inc.",4,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":69,"phases":181,"briefSummary":182,"conditions":183,"keywords":184,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100562805","phase-1-orb-021-in-patients-with-advanced-solid-tumors-100562805","NCT06607939","ORB-021 In Patients With Advanced Solid Tumors","OR2-01","Inclusion Criteria:\n\nAll patients must meet the following criteria for inclusion:\n\n1. Age 18 years or older\n2. Patients with evidence of recurrent or refractory solid tumors deemed medically safe to undergo serial biopsies.\n3. Must have received or be ineligible for all standard of care therapies as deemed appropriate by the treating physician.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n5. Adequate organ and marrow function as defined below:\n\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL (\\> 1500 per mm3)\n   * Platelet count ≥ 75 × 109\u002FL (\\> 75,000 per mm\\^3)\n   * Serum bilirubin less than or equal to 1.5 × institutional upper limit of normal (ULN).\n   * AST (SGOT)\u002FALT (SGPT) less than or equal to 2.5 × institutional ULN for patients without known liver metastases and up to 5 x institutional ULN for patients with known liver metastases.\n   * Creatinine clearance (CL) \\> 40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976)\n   * Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 3 days prior to treatment. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause)\n6. Patients and their partners must practice approved forms of contraception. Sexually active WCBP must agree to use a highly effective method of contraception prior to study entry and continuing for 30 days after ORB-021 administration. Highly effective methods of contraception are highly effective birth control methods with a failure rate of \\< 1% per year when used consistently and correctly. Additionally, male patients should refrain from donating sperm for 3 months following the last dose of study drug.\n7. Ability to understand and willingness to sign an Institutional Review Board (IRB)-approved written informed consent document.\n\nExclusion Criteria:\n\n* Patients are to be excluded from the study if they meet any of the following criteria:\n\n  1. Patients who are receiving any other investigational agents\n  2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ORB-021 or its excipients.\n  3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Urinary tract infections (UTIs) are excluded from being an exclusion criterion for treatment unless they are Grade 3 or higher.\n  4. Pregnant women are excluded from this study because the effects of ORB-021 on a pregnant woman or fetus are unknown. Breastfeeding should be discontinued as the potential risk for AEs in nursing infants treated with ORB-021 is unknown.\n  5. Patients with unresolved symptomatic hydronephrosis.\n  6. Any other anticancer therapy (eg, chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, radiation therapy, intravesical therapy, investigational agent) within 28 days or 5 half-lives (whichever is shorter) of the study treatment\n  7. The patient has a diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancer, localized prostate cancer on active surveillance, or localized solid tumors deemed cured by surgery and not treated with systemic anticancer therapy and not expected to require anticancer therapy in the next 2 years\n  8. Patients with primary malignant brain tumors, untreated and\u002For unresolved or symptomatic brain metastasis\n  9. Current or prior use of immunosuppressive medication within 28 days before ORB-021 treatment with the exceptions of ophthalmic, intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid.\n  10. Active or prior documented autoimmune or inflammatory disorders requiring systemic immunosuppressive medications (including inflammatory bowel disease \\[eg. colitis or Crohn s disease\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n\n      * Patients with vitiligo or alopecia\n      * Patients with hypothyroidism stable on hormonal replacement\n      * Patients without active disease in the last 5 years may be included\n      * Patients with celiac disease controlled by diet alone\n  11. History of primary immunodeficiency\n  12. History of allogeneic organ transplant\n  13. History of hypersensitivity to interferon alpha 2b or any excipient\n  14. Active infection with:\n\n      * Tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and PPD testing if indicated),\n      * Hepatitis B (HBV) or hepatitis C Virus (HBC): Patients with active HBV infection or active HCV infection are ineligible. However, patients with a history of HBV infection who have undetectable or low levels of HBV DNA and normal ALT are eligible. Patients with chronic HBV infection who meet the criteria for anti-HBV therapy are eligible if they have initiated anti-HBV therapy prior to treatment with ORB-021. Patients with a history of HCV infection are eligible if they have completed curative antiviral treatment and have a viral load that is below the limit of detection.\n      * HIV: Patients living with HIV infection are ineligible only if they have a CD4 count less than 350 cells\u002FµL and a history of an AIDS-defining infection within the last 12 months. Patients with a CD4 count greater than 350 cells\u002FµL or who have not had an AIDS-defining infection within the last 12 months are eligible. Eligible patients living with HIV should maintain effective anti-retroviral therapy.\n      * SARS-COV2 (PCR positive)\n  15. Receipt of live attenuated vaccination within 28 days prior to the study treatment\n  16. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.\n  17. Patients with uncontrolled seizures\n  18. Any unresolved toxicity National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, endocrinopathies, and the laboratory values defined in the inclusion criteria.\n  19. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with ORB-021 may be included only after consultation with the Principal Investigator\n  20. Patients with QTcF \\> 480 ms\n  21. Patients with prior grade 3 irAE or any irAE that resulted in discontinuation of PD-1 or PD-L1 ICI treatment.",{"count":180,"type":21},36,[71],"The goal of this clinical research study is to determine if an investigational new drug, named ORB-021, developed by Orionis Biosciences is safe and can be tolerated in people diagnosed with an advanced solid tumor.\n\nThe study also aims to find the biologically optimal dose of the study medicine by assessing the safety and potential activity in the treatment of solid tumors.\n\nThere are three phases to this study: screening, treatment and end of treatment.",[27],[185,79,186],"cancer","adults","2026-02-09",{"date":189,"type":53},"2026-02-10",{"date":191,"type":53},"2024-11-21",{"date":193,"type":21},"2027-05",{"name":195,"class":59},"Orionis Biosciences Inc",2,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":69,"phases":206,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":171},"100612900","phase-1-a-study-of-gfh375-combined-with-cetuximab-or-chemotherapy-in-participants-with-solid-tumors-harboring-kras-g12d-mutation-100612900","NCT07259590","A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation","A Multicenter, Open-Label, Phase Ib\u002FII Clinical Study to Explore the Efficacy, Pharmacokinetics and Safety\u002FTolerability of GFH375 in Combination With Cetuximab or Chemotherapy in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutation","Inclusion Criteria:\n\n1. Voluntarily participate in the study and sign the informed consent form.\n2. Participants receiving Regimen A must be ≥ 18 years old when signing the informed consent form, and participants receiving Arm B must be 18 - 75 years old.\n3. Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors, with KRAS G12D mutation.\n4. Failed standard systemic treatment, or intolerant to standard treatment, or unsuitable for standard treatment, or no standard treatment available.\n5. At least one measurable lesions according to RECIST v1.1\n6. Participants receiving Regimen A must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 - 2; participants receiving Regimen B must have an ECOG PS score of 0 - 1.\n7. Have sufficient organ function.\n\nExclusion Criteria:\n\n1. Symptomatic brain metastasis, leptomeningeal metastasis, spinal cord compression, or primary brain tumor.\n2. Presence of known coexisting other cancer driver genes.\n3. Previous or active history of clinically significant cardiovascular dysfunction.\n4. Presence of active infection.\n5. History of central nervous system (CNS) diseases.\n6. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis requiring treatment.\n7. Newly diagnosed deep vein thrombosis or pulmonary embolism within 3 months before the first administration of the study treatment.\n8. Presence of uncontrolled or symptomatic pleural effusion, ascites, or pericardial effusion.\n9. Having received major surgery within 28 days before the start of the study treatment; having experienced major trauma within 14 days before the start of the study treatment; or planning to undergo major surgery during the study period.\n10. Having received radiotherapy within 4 weeks before the start of the study treatment, or having received palliative radiotherapy for bone metastatic lesions within 2 weeks before the start of the study treatment.",{"count":205,"type":21},126,[71,72],"This is a Phase Ib\u002FII clinical study aimed at exploring the safety and efficacy of Regimen A (GFH375 in combination with Cetuximab) and Regimen B (GFH375 in combination with AG) in participants with solid tumors.Phase Ib: To evaluate the safety\u002Ftolerability and pharmacokinetic (PK) characteristics of GFH375 in combination with cetuximab or AG in participants with solid tumors, and to explore the efficacy of the combination therapy. Phase II: To evaluate the efficacy, safety\u002Ftolerability and PK characteristics of the combination therapy, and to explore the correlation between bio-marker and clinical efficacy.",[27,78,209],"CRC (Colorectal Cancer)",[79,211],"KRAS G12D Mutations","2025-11-20",{"date":214,"type":53},"2025-12-02",{"date":216,"type":53},"2025-10-21",{"date":218,"type":21},"2027-07",{"name":89,"class":59},{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":69,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100602069","phase-1-a-study-of-kc1086-in-patients-with-advanced-solid-tumors-100602069","NCT07118709","A Study of KC1086 in Patients With Advanced Solid Tumors","A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Preliminary Efficacy of KC1086 in the Patients With Advanced Recurrent or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed recurrent or metastatic solid tumors;\n2. Patients who have failed standard or conventional treatment or for whom no standard treatment is available( definition of treatment failure: intolerable toxic and side effects, disease progression during treatment recurrence after treatment);\n3. Participants with advanced recurrent, unresectable, and\u002For metastatic tumors must have evaluable or measurable lesions (according to RECIST 1.1)；\n4. Eastern Cooperative Oncology Group performance status score of 0 or 1;\n5. Life expectancy \\> 12 weeks;\n6. Adequate bone marrow, renal, and hepatic function;\n7. Patients should participate in the study voluntarily and sign informed consent.\n\nExclusion Criteria:\n\n1. Any patient who is known to have untreated central nervous system (CNS) metastasis;\n2. Other kinds of malignancies within 5 years;\n3. Gastrointestinal abnormalities;\n4. Cardiovascular and cerebrovascular diseases;\n5. Involved in other clinical trials within 4 weeks before enrollment;\n6. Prior anti-tumor therapies with radiotherapy, immunotherapy, operation within 4 weeks before enrollment;\n7. Prior anti-tumor therapies with small molecule targeting drugs within 2weeks or 5 half-lives (whichever is longer) before enrollment; Prior anti-tumor therapies with chemotherapy within 3 weeks or 5 half-lives (whichever is longer) before enrollment;\n8. Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;\n9. Severe infection within 4 weeks prior to enrollment;\n10. Uncontrolled massive ascites, pleural or pericardial effusion；\n11. Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;\n12. Prior therapies with KAT6 inhibitors\n13. Pregnant or lactating women;\n14. Female subjects of child-bearing potential and male subjects of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study.\n15. Other patients are not eligible for enrollment assessed by investigators.",{"count":228,"type":21},66,[71],"The purpose of this study is to evaluate the safety，tolerability, pharmacokinetics, and preliminary efficacy of KC1086 in participants with advanced recurrent or metastatic solid tumors. The trial will be divided into two parts: dose-escalation phase and dose-expansion phase.",[27],"2025-08-07",{"date":234,"type":53},"2025-08-12",{"date":236,"type":21},"2025-08",{"date":238,"type":21},"2028-12",{"name":240,"class":59},"Beijing Konruns Pharmaceutical Co., Ltd."]