[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumors-phase-1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumors-phase-1":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,71,93,120],{"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":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100620843","phase-1-first-in-human-study-of-adce-b05-in-patients-with-advanced-solid-tumors-100620843",false,"NCT07362888","First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors","A First-in-Human, Phase 1a\u002F1b, Open-Label Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of the Antibody Drug Conjugate ADCE-B05 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of solid tumor\n* Advanced disease (i.e., unresectable locally advanced or metastatic) and refractory to, intolerant of, or ineligible for approved therapies\n* Radiologically or clinically determined progressive disease during or after most recent line of therapy\n* Measurable disease per RECIST 1.1\n* ECOG performance status of 0 or 1\n* Adequate hematological and biochemical parameters\n* A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate\n* A female patient who is not pregnant, not breast feeding, and either not a woman of childbearing potential (WOCBP) or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment\n\nExclusion Criteria\n\n* Treatment with systemic anticancer therapy, including any investigational agent within 3 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration\n* Prior treatment with an ADC containing a topoisomerase I inhibitor payload\n* Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement for which treatment is required\n* Other malignancy\n* Major surgical procedure or significant traumatic injury within 28 days prior to study drug administration\n* Ongoing systemic infection requiring treatment with antibiotics, antivirals, or antimycotics, other than prophylactic treatment\n* Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \\>1\n* Clinically significant cardiovascular disease\n* Acute infection with human immunodeficiency virus (HIV)-1 or HIV-2\n* Current active liver disease due to hepatitis B or hepatitis C\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or pulmonary lymphangitic carcinomatosis","ALL","18 Years",{"count":19,"type":20},180,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the Recommended Expansion Dose and the safety and tolerability of ADCE-B05 when given as a single therapy over a range of different dose levels.",[26],"Solid Tumors (Phase 1)","RECRUITING","2026-07-01",{"date":30,"type":31},"2026-07-02","ACTUAL",{"date":33,"type":31},"2026-03-17",{"date":35,"type":20},"2029-03-14",{"name":37,"class":38},"Adcendo ApS","INDUSTRY",7,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100612353","phase-1-evaluation-of-ras-inhibitor-treatment-in-participants-with-advanced-or-metastatic-solid-tumors-harboring-ras-mutations-100612353","NCT07252479","Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations","A Multi-center, Open-label, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AN9025 in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations","Inclusion Criteria:\n\n1. Aged ≥18 years old at the time of informed consent.\n2. Able to provide informed consent voluntarily before any study-related activities and according to local guidelines.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n4. Have an estimated life expectancy ≥ 12 weeks, in the judgment of the Investigator.\n5. Have histological or cytological evidence of a diagnosis of cancer that is advanced and\u002For metastatic with progression after treatment with available standard therapies.\n6. Documentation of KRAS\u002FNRAS\u002FHRAS mutation determined by validated local testing of tumor tissue or circulating free DNA (cfDNA) in a certified laboratory.\n\n   Note: Participants with melanoma who have documented loss-of-function NF1 mutation and wild type KRAS\u002FNRAS\u002FHRAS\u002FBRAF are also eligible for the backfill of Part 1 cohorts QD, QW.\n7. Have consented to provide archival tumor tissue collected within 5 years or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.\n8. Part 1 Dose-Escalation and Part 2 Food Effect Assessment: cancers including, but not limited to:\n\n   1. Pancreatic ductal adenocarcinoma (PDAC)\n   2. Colorectal cancer (CRC)\n   3. Non-small cell lung cancer (NSCLC)\n   4. Cutaneous melanoma\n   5. Biliary tract cancer (BTC)\n9. Part 3 Dose-Expansion:\n\n   Cohort 3A: RAS-mutated solid tumors (2L\u002F3L)\n   1. Histologically or cytologically confirmed advanced or metastatic disease\n   2. Participants must not have tumors previously tested positive for targetable oncogenic driver mutations including Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), B-Rapidly Accelerated Fibrosarcoma (BRAF), RET, and ROS1\n   3. Participants must have received 1 or 2 prior lines of systemic therapy which include prior immune checkpoint inhibitor and platinum chemotherapy administered either concurrently or sequentially, and have not received docetaxel previously\n   4. Participants must be refractory to anti-PD-1\u002FPD-L1 therapy.\n   5. Adjuvant therapy or multimodal therapy with curative intent is considered prior therapy if disease progression occurred or treatment completion was within 6 months of first dose of AN9025.\n   6. Participants must not have tumors previously tested positive for Class I BRAF mutations i.e. V600X.\n10. Have adequate organ functions prior to enrollment:\n\n    1. ANC: \\>= 1.5 x 10\\^9\u002FL\n    2. Platelets: \\>= 100x 10\\^9\u002FL\n    3. Hemoglobin: \\>= 9.0 g\u002FdL\n    4. AST and ALT: \\\u003C= 2.5 x Upper Limit of Normal (ULN) or ,+ x ULN if liver metastases are present\n    5. Total bilirubin: \\\u003C= 1.5 x ULN\n    6. Creatinine clearance (CrCl): CrCl \\>= 50 ml\u002Fmin as determined by Cockcroft-Gaulat formula\n    7. International Normalized Ratio (INR) or prothrombin (PT) time or activated partial thromboplastin time (aPTT): PT or aPTT \\\u003C= 1.5 x ULN or INR \\\u003C 1.5\n11. Have discontinued all previous treatments for cancer with resolution of any adverse events (AEs) to ≤ Grade 1 (except for alopecia, and endocrinopathies that are managed with replacement therapy), and all clinically significant toxicities from prior locoregional therapy, surgery, radiotherapy, or systemic anticancer therapy to ≤ Grade 1 prior to enrollment.\n12. Corrected QT interval (QTc) ≤ 470 msec for females and ≤ 450 msec for males per the Fridericia's Formula (QTcF).\n13. Able to swallow oral medication and comply with study requirements.\n14. Left ventricular ejection fraction (LVEF) greater than 50% on echocardiography or multiple gated acquisition (MUGA) scan.\n15. Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study treatment administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ≤ 14 days prior to the first dose of the study treatment.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will not be eligible for participation in the study.\n\n1. Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.\n2. Have tumors previously tested positive for Class I BRAF mutations i.e. V600X.\n3. Prior treatment with a pan-RAS(ON) inhibitor, ) except for participants enrolled in the backfill cohorts who have experienced radiological or clinical disease progression on prior pan-RAS(ON) inhibitor therapy.\n4. Gastrointestinal conditions that may interfere with drug absorption (e.g., malabsorption syndrome, chronic nausea\u002Fvomiting, active inflammatory bowel disease).\n5. Have a serious concomitant systemic disorder that, in the judgment of the Investigator, would compromise the participant's ability to adhere to the protocol, such as the following:\n\n   1. Known human immunodeficiency virus (HIV) infection per HIV 1 and\u002For 2 antibodies.\n   2. Participants with evidence of active Hepatitis B or Hepatitis C infections (positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody)\n   3. Active tuberculosis, fungal infection\n   4. Active infection requiring intravenous antibiotic therapy. Use of oral antibiotics for minor infections (e.g., uncomplicated UTI or URI) is permitted if clinically stable, at the Investigator's discretion\n6. The participant has a serious pre-existing medical condition(s) that, in the judgment of the Investigator, would preclude participation in this study, including interstitial lung disease (ILD), severe dyspnea at rest, or requiring oxygen therapy.\n7. Prior or second concurrent primary malignancies that, in the judgment of the Investigator, may affect the interpretation of results. Participants with carcinoma in situ of any origin and participants with prior malignancies who are in remission and whose likelihood of recurrence is very low (such as basal cell carcinoma), as judged by the Investigator, or malignancies that don't need treatment (i.e., small renal cell carcinoma \\[RCC\\] and localized prostate cancer) are eligible for this study.\n8. Moderate or severe cardiovascular disease, such as the following:\n\n   1. congestive heart failure\n   2. New York Heart Association Class III\u002FIV heart disease\n   3. unstable angina pectoris\n   4. myocardial infarction or cardiovascular event within the last 6 months before enrollment\n   5. valvulopathy that is severe, moderate, or deemed clinically significant\n   6. arrhythmias that are symptomatic or require treatment (not including Participants with rate-controlled supraventricular tachycardia)\n   7. a history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT syndrome)\n   8. require the use of concomitant medications that prolong the QT\u002FQTc interval\n9. Have symptomatic central nervous system (CNS) malignancy or metastasis.\n10. Are pregnant or planning to become pregnant during the study or within 6 months following the last dose of AN9025. Plan to be breastfeeding from the initial dose of study treatment or within 6 months following the last dose of AN9025.\n11. Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.\n12. Use of other herbal supplements, traditional medicines, or prescription medications that are known or suspected to interact with the investigational product or effect disease treatment\u002Fside effect management, as determined by the study Investigator.\n13. Known allergic reaction against any of the components of the study treatments.\n14. Current use of drugs known to be strong or moderate inhibitors or inducers of isoenzyme cytochrome P450 3A4 (CYP3A4) including herbal medications.\n15. Current use of drugs known to be of P-glycoprotein (P-gp) inhibitors.\n16. Participants who are unable to discontinue proton pump inhibitors (PPIs) for at least 5 days prior to the first dose of AN9025, or unable to abstain from PPI use throughout the study treatment period.\n17. Participant likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures to the best of the participant and Investigator's knowledge.",{"count":48,"type":20},118,[23],"The goal of this clinical trial is to learn determine if AN9025 is safe and tolerable to treat solid cancer tumors with specific genetic mutations. It will help identify doses for use in future testing and establish the safety profile of the drug. The main questions it aims to answer are:\n\nWhich dose(s) of AN9025 are safe and tolerable for use in evaluating anti-tumor activity in participants with Rat Sarcoma oncogene (RAS) mutated solid tumors?\n\nWhat medical problems do participants have when taking AN9025?\n\nParticipants will:\n\nTake AN9025 by mouth every day or once a week until their disease progresses, they experience severe ill side effects from taking the drug, or withdraw from the study due to their own choice or as recommended by their physician.\n\nVisit the clinic 3-4 times during the first 21 days of treatment for study testing, blood draws and tumor tissue sample collection (if needed). The blood draws will be used to check drug levels in the participants blood for research purposes.\n\nVisit the clinic every 21 days for checkups and tests and monitoring of participant progress.\n\nReturn to the clinic at 14 and 30 days after AN9025 treatment is stopped. Participants will be contacted every 3 months to check on the participants disease status and general well being.\n\nParticipants may also partake in a food effect study, where the effect of eating is studied to see if there is any effect on AN9025 in the body.",[26,52],"RAS Mutation",[54,55,56,57,58,59,60],"RAS","RAS (ON)","RAS Solid Tumor","KRAS G12X(C\u002FD\u002FV)","KRAS G13D","NRAS Q61X(L\u002FK)","Oral Pan RAS medication","2026-06-05",{"date":63,"type":31},"2026-06-08",{"date":65,"type":31},"2026-01-28",{"date":67,"type":20},"2028-06-01",{"name":69,"class":38},"Adlai Nortye Biopharma Co., Ltd.",3,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100636120","phase-1-phase-i-study-of-hsk42360-na-in-solid-tumors-with-braf-v600-mutation-100636120","NCT07561554","Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation","A Phase I, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of HSK42360-Na in Patients With BRAF V600 Mutation Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years#Male and female patients, at time of signing informed consent form (ICF).\n2. ECOG performance status 0-1, or KPS (Karnofsky Performance Status) Score≥70.\n3. Life expectancy ≥ 3 months.\n4. Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology, who have failed standard treatment (disease progression after treatment or intolerable treatment); patients who have previously received BRAF and\u002For MEK inhibitor therapy are allowed to be included in this study.\n5. Positive BRAF V600 mutation result confirmed prior to the administration of HSK42360-Na.\n6. Patients will provide blood or tumor sample according to their own willingness.\n7. Measurable or non-measurable disease by RECIST 1.1 or RANO criteria.\n8. Brain metastasis patients with inactive CNS lesions; Original intracranial tumor patient with inactive CNS lesions, or patients treated with ≤4mg\u002Fday corticosteroid and without convulsion for ≥2 weeks.\n9. Adequate hematologic, hepatic, and renal function.\n10. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose.\n\nExclusion Criteria:\n\n1. malignant tumor within 2 years, with the exception of cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, or other tumors with low malignancy.\n2. Uncontrollable pleural effusion, ascites, or pericardial effusion per protocol.\n3. Treatment with any of the following:\n\n   Prior treatment with anti-tumor drug within 4 weeks or approximately 5 × t1\u002F2 prior to the first dose of HSK42360-Na, whichever is shorter; Prior treatment with nitrosourea or mitomycin C within 6 weeks prior to the first dose of HSK42360-Na; Prior treatment with palliative radiotherapy or anti-tumor herbs within 2 weeks prior to the first dose of HSK42360-Na; Prior treatment with radiotherapy, electric field therapy, or other anti-tumor therapies within 4 weeks prior to the first dose of HSK42360-Na.\n4. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia, dermal toxicity, and other toxicity considering no safety risks by investigator.\n5. Any disease which would preclude drug absorption, metabolism or pharmacokinetics, e.g. active peptic ulcer or chronic gastroesophageal reflux disease.\n6. Patients who have clinically significant or uncontrolled cardiac disease, include: QTc interval ≥ 450(male)\u002F470(female) msec; any clinically significant arrhythmia; left ventricular ejection fraction \\\u003C 50%; myocardial infarction, unstable angina, or class III\u002FIV cardiac failure by the NYHA that occurred within 6 months prior to the first dose of HSK42360-Na.\n7. Any thromboembolic events within 6 months prior to the first dose of HSK42360-Na; any familial or acquired thrombophilia.\n8. Uncontrolled hypertension (systolic pressure≥160mmHg, or diastolic pressure≥100mmHg), diabetes (fasting blood-glucose≥10mmol\u002FL), seizures, chronic obstructive pulmonary disease (COPD), interstitial pneumonia, pulmonary interstitial fibrosis, Parkinson's disease, active bleeding, or systemic active infection.\n9. Any unstable systemic disease, e.g. severe metabolic disease: liver cirrhosis, renal failure, or uremia.\n10. Treatment with inhibitors\u002Finducers for CYP3A4, or substrates of CYP3A4, CYP2C9, CYP2C8, OATP1B1, OATP1B3, OAT1, OAT3, P-gp or BCRP within 14 days or approximately 5 × t1\u002F2 prior to the first dose of HSK42360-Na, whichever is shorter.\n11. Patient with cognitive dysfunction, or history of mental illness, other uncontrolled comorbidities, alcohol dependence, hormone dependence or drug abuse.\n12. Autologous transplantation surgery within 3 months prior to the first dose of HSK42360-Na; Allogeneic transplantation, or stem-cell Transplant surgery within 6 months prior to the first dose of HSK42360-Na; Major surgery or significant traumatic injury occurring within 4 weeks prior to the first dose of HSK42360-Na.\n13. Patient with a history of immunodeficiency, including HIV positive, or other acquired\u002Fcongenital immunodeficiency diseases.\n14. Any disease of the eyes \\> CTCAE v5.0 Grade 1.\n15. Patient with active hepatitis B or hepatitis C.\n16. Patient with active syphilis infection.\n17. Allergic to any HSK42360-Na active constituent or ingredients.\n18. Participate in other clinical trials within 4 weeks prior to the first dose of HSK42360-Na.\n19. Positive pregnancy test, or breastfeeding.\n20. Any other circumstances that would, in the investigator's judgment, prevent the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.",{"count":79,"type":20},159,[23],"This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK42360-Na when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid Tumors.",[26],"2026-04-27",{"date":85,"type":31},"2026-05-01",{"date":87,"type":31},"2026-03-06",{"date":89,"type":20},"2028-12-02",{"name":91,"class":38},"Haisco Pharmaceutical Group Co., Ltd.",2,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100615157","phase-1-a-early-study-of-absk131-in-patients-with-advancedmetastatic-solid-tumors-100615157","NCT07288957","A Early Study of ABSK131 in Patients With Advanced\u002FMetastatic Solid Tumors","A Phase 1, First-in-Human, Multicenter, Open-Label Study of ABSK131 to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Patients With MTAP-Deficient Advanced\u002FMetastatic Solid Tumors","ABSK131-101","Inclusion Criteria:\n\n* 1\\. Patients should understand, sign, and date the written informed consent form before screening.\n* 2\\. Male or female aged 18 years or older.\n* 3\\. Patients with histologically or cytologically confirmed metastatic or locally advanced solid tumor; have received and progressed, are refractory or are intolerant to standard therapy or lack of standard therapy for the particular tumor type.\n* 4\\. Patients with homozygous deletion of MTAP gene based on central testing or sponsor-accepted local report (depending on the availability of regional genetic testing), or with MTAP expression loss in the tumor based on the central testing.\n* 5\\. Patients should provide archival tumor sample or undergo tumor biopsy at baseline if archival sample is not available or inadequate.\n* 6\\. Backfill cohorts and expansion cohorts: Patients with 1 of the following cancers and have received no more than 3 prior lines of therapy。1)NSCLC；2) Pancreatic cancer；3)Esophageal cancer；4)Gastric cancer；5)Mesotheliomas.\n\nFood effect: a. Be able to eat a standardized high-fat meal within 30 minutes. b. Without primary GI tumors or metastasis.\n\n* 7\\. Patients must have at least one measurable target lesion according to RECIST v1.1.\n* 8\\. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* 9\\. Life expectancy ≥3 months.\n* 10.Adequate organ function and bone marrow function as indicated by the screening assessments performed within 14 days prior to the first dose of study drug.\n* 11.Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150\u002F90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the first dose.\n* 12.Non-surgically sterilized male or female patients of childbearing potential must agree to use highly effective methods of birth control from signing the informed consent to approximately 6 months after the last dose of study drug. A condom is also required to be used by vasectomized men to prevent delivery of the drug via seminal fluid.\n\nExclusion Criteria:\n\n* 1\\. Known allergy or hypersensitivity to any component of ABSK131.\n* 2\\. Prior treatment with a PRMT5 or MAT2A inhibitor therapy.\n* 3\\. Another active primary malignancy.\n* 4\\. Unable to swallow capsules or malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction, or current evidence of GI disease that present with diarrhea. If any of these conditions exist, the sites' staff should discuss with the sponsor to determine patient eligibility.\n* 5\\. Any of the situation within the specified time frame prior to the first administration of study drug.\n* 6\\. Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤ 1 severity (CTCAE v5.0) with the exception of which eligibility criteria allows, or alopecia, vitiligo, hypothyroidism stable on hormone replacement, or Grade 2 peripheral neurotoxicity.\n* 7\\. Potent strong inhibitors or inducers of CYP3A family within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort); consumption of grapefruit juice, grapefruit hybrids, pomegranates, starfruits, pomelos, seville oranges or juice products within 3 days prior to the first dose of study treatment.\n* 8\\. Proton pump inhibitors, such as omeprazole, lansoprazole, dexlansoprazole, or pantoprazole within 7 days before the first dose of study treatment.\n* 9\\. Imaging (CT or MRI) showed tumor invasion of large blood vessels (such as aorta, pulmonary artery, pulmonary vein, vena cava, etc.) or risk of bleeding (such as esophageal and gastric varices).\n* 10.Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic) or symptomatic unstable brain metastases. Patients with a history of brain metastases have been treated and are stable ≥ 28 days may be enrolled. Patients with no steroid use for at least 2 weeks prior to the time of enrollment are permitted.\n* 11.Impaired cardiac function or clinically significant cardiac disease.\n* 12.Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test for HIV 1\u002F2 antibody.\n* 13.Exclusion of hepatitis infection.\n* 14.Patients with ascites or pleural effusion, or pericardial effusion which is refractory\u002Funcontrolled, or requiring the intervention within 2 weeks prior to the first dose.\n* 15.Confirmed or suspected ILD\u002Fpneumonitis or history of (non-infectious) ILD\u002Fpneumonitis that required oral or IV steroids or supplemental oxygen.\n* 16.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test within 7 days prior to the start of study drug.\n* 17.Vaccination with a live, attenuated vaccine within 4 weeks prior to the first dose of study treatment except for administration of inactivate vaccines .\n* 18.Has had an allogenic tissue\u002Fsolid organ transplant.\n* 19.Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.\n* 20.Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of investigators, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.",{"count":102,"type":20},266,[23],"This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK131 in patients with MTAP-Deficient Advanced\u002FMetastatic Solid Tumors to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.",[26],[107,108,109],"ABSK131","MTAP","PRMT5","2025-12-04",{"date":112,"type":31},"2025-12-17",{"date":114,"type":31},"2025-07-22",{"date":116,"type":20},"2029-07-30",{"name":118,"class":38},"Abbisko Therapeutics Co, Ltd",1,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":130,"briefSummary":131,"conditions":132,"keywords":137,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":4},"100566234","phase-1-phase-1-dose-escalation-and-expansion-to-evaluate-arog4-01-in-patients-with-advanced-solid-tumors-100566234","NCT06652529","Phase 1 Dose Escalation and Expansion to Evaluate AROG4-01 in Patients With Advanced Solid Tumors","First in Human Phase 1 Dose Escalation and Expansion Clinical Trial to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of Intravenous AROG4-01 in Patients With Advanced Solid Tumors","AROG4-01-01","Inclusion Criteria:\n\n1. Male or female patients, 18 years or older, with a diagnosis (histology or citology) of advanced (unresectable or metastatic) solid tumor for which there is no curative therapy, has progressed on SOC treatment or for whom SOC is no longer an option. In part B patients will be included in different cohorts according to the histology (mesothelioma vs. non-mesothelioma).\n2. Evaluable (part A) or measurable disease (part B) as per RECIST v1.1 (part A) or mRECIST v1.1. (part B). Progressive disease to the on or following the last line of antitumor treatment.\n3. ECOG performance status ≤ 2.\n4. Life expectancy ≥12 weeks.\n5. Hematology and clinical chemistry laboratory parameters within acceptable ranges.\n6. Adequate organ function as defined below:\n\n   * Hemoglobin ≥9 g\u002FdL\n   * Neutrophil count ≥1.000x10\u002FmcL\n   * Platelets ≥100.000\u002FmcL\n   * Total bilirubin ≤1,5 x Upper Limit of Normal (ULN) (unless Gilbert's Disease)\n   * AST (SGOT)\u002FALT (SGPT) ≤ 2,5 x institutional ULN (or ≤ 5X ULN in the presence of liver metastases)\n   * Creatinine ≤1.5 mg\u002FdL and creatinine CL ≥40 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n7. Adequate coagulation profile as defined below:\n\n   * INR≤ 1,5\n   * aPTT ≤ 1,5 x ULN\n   * Serum or urine negative pregnancy test for women with childbearing potential.\n8. No previous antitumor treatment (radiation therapy, systemic treatment, or surgery) in the previous 28 days and current adverse events from them ≤ grade 1.\n\nExclusion Criteria:\n\n1. Systemic anti-cancer therapy within 4 weeks prior to study admission.\n2. Radiation therapy within 4 weeks prior to study entry.\n3. Any major surgery within 4 weeks before first dose of study treatment No major surgery must be planned during the trial expected treatment. receiving study treatment. Participants with recent surgery with only local anesthesia may be included.\n4. Non-malignant systemic disease including cerebrovascular accident, myocardial infarction in the last 6 months, unstable angina pectoris, unstable cardiac arrhythmia, New York Heart Association (NYHA) Class III or IV heart failure, coagulation abnormalities and clinically significant pulmonary compromise, .\n5. Left ventricular ejection fraction below institutional normal limits.\n6. Patients with symptomatic central nervous system (CNS) primary tumor or metastases (including leptomeningeal carcinomatosis). Patients with documented treated CNS metastases stable for at least 4 weeks may be enrolled at the discretion of the investigator.\n7. Breast feeding, pregnancy or not willing to adopt safe contraceptive measures by the patient or the patient's partner, to become pregnant during treatment or within 6 months after the end of treatment.\n8. Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except HbsAc after vaccination) or hepatitis C infection.\n9. Any other diseases or medical condition that may interfere with the planned treatment, compliance, or place the patient at risk if participating in the study, at investigator criteria.",{"count":129,"type":20},35,[23],"The goal of this clinical trial is to learn if drug AROG4-01 is safe in patients with solid tumors who have no available treatment alternative. Different doses will be tested in order to identify the most suitable one. Once it is identiffied, up to 20 patients will be treated with that dose, to check if thye get clinical benefit.\n\nParticipants will: receive intravenous administrations of ARG4-01 twice weekly, and visit the clinic twice every week for checkups and tests.",[26,133,134,135,136],"Mesothelioma","Colorectal Carcinoma","Ovarian Cancer","NSCLC (Advanced Non-small Cell Lung Cancer)",[138,139,140,141,142,143,144,145],"Phase I","AROG4-01","mesothelioma","solid tumors","NSCLC","ovarian cancer","colorectal cancer","dose escalation","NOT_YET_RECRUITING","2024-11-05",{"date":149,"type":31},"2024-11-07",{"date":151,"type":20},"2025-01",{"date":153,"type":20},"2026-12",{"name":155,"class":38},"Aromics Therapeutics"]