[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Adlai Nortye Biopharma Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,73],{"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":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100643536","phase-1-an-initial-evaluation-of-an8025-in-solid-tumors-100643536",false,"NCT07639047","An Initial Evaluation of AN8025 in Solid Tumors","Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of AN8025 in Participants With Unresectable Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Aged ≥18 years old.\n2. Able to provide informed consent obtained 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 or are intolerant to or refuse standard therapies that are known to provide clinical benefit.\n6. Part A Dose Escalation only: Participants have unresectable advanced or metastatic solid tumors, with no preference of cancer type.\n7. Part B Dose Expansion only: Participants enrolled into tumor-specific cohorts have unresectable advanced metastatic disease. Participants must also have progressed after treatment with the appropriate targeted therapy. Participants must be primary refractory or non-responding to anti-PD-1 monotherapy as defined by:\n\n   1. The participant has received at least 2 doses of an approved anti-PD-1\u002FPD-L1 monoclonal antibody\n   2. The participant has demonstrated progressive disease (PD) after anti-PD-1\u002FPD-L1 therapy as defined by RECIST Version 1.1, which was subsequently confirmed by a second assessment no less than 4 weeks from the date of the first documented PD to rule out pseudo-progression.\n   3. Participants who have received anti-PD-1\u002FPD-L1 therapy as part of their adjuvant therapy but experienced recurrence with locally advanced or metastatic disease within 6 months after completing adjuvant therapy may be eligible for Part B.\n8. Part B Dose Expansion only: Participants enrolled into the expansion cohort must have documented PD-L1 tumor expression on ≥1% tumor cells (i.e. TPS or TC ≥1%) as assessed by validated immunohistochemistry (IHC) assay on archival or fresh tumor tissue.\n9. Participants have consented to provide archival tumor tissue collected within 5 years or a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Archival tumor tissue can be formalin-fixed, paraffin embedded (FFPE) tissue blocks or at least 15 freshly-sectioned slides. Tissue should be obtained from surgical resection or core needle biopsy. Fine-needle aspiration (FNA), pleural effusion, or ascitic fluid samples are not acceptable. FFPE blocks are preferred to slides and newly obtained biopsies are preferred to archival tissue. For participants who have consented to provide newly obtained fresh biopsy of baseline tumor tissue, the biopsy is required to be collected during the screening period. Tissue requirements may be waived on a case-by-case basis after discussion with the sponsor if tissue or biopsy is not available or feasible.\n10. Have at least one measurable lesion as defined per RECIST v1.1. Bone metastases are not considered measurable. Participants who only have non-measurable lesion(s) may be eligible for Part A, except for \"back-filled\" cohorts.\n11. Have adequate hematologic function and major organ function, defined by laboratory assessment documented within 7 days prior to first dose of study treatment:\n\n    1. Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL.\n    2. Hemoglobin ≥ 9 g\u002FdL (which may be reached by transfusion).\n    3. Platelets ≥ 100 x 109\u002FL (which may be reached by transfusion).\n    4. International normalized ratio (INR) ≤ 1.5.\n    5. Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if liver metastases are present.\n    6. Total bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN if Gilbert's syndrome is present.\n    7. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCL) \\> 50 mL\u002Fmin.\n    8. Thyroid stimulating hormone (TSH) within normal limits. If TSH is not within normal limits at baseline, the participant will still be eligible if total T3 or free T3 (FT3) and free T4 (FT4) are within the normal limits.\n12. Have discontinued previous cancer treatment and recovered from the acute toxicity of therapy. Participants must have discontinued from previous treatment with length of time prior to first dose of study treatment.\n13. 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 ≤ 7 days prior to the first dose of the study treatment.\n\nExclusion Criteria:\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 a serious concomitant systemic disorder that, in the judgment of the investigator, would compromise the participant's ability to adhere to the protocol.\n3. Known human immunodeficiency virus (HIV) infection per HIV 1 and\u002For 2 antibodies.\n4. Participants with evidence of Hepatitis B or Hepatitis C infections (positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody) must fulfill the following criteria in order to be eligible for the study:\n\n   1. Hepatitis B virus (HBV) viral load ≤2500 copies or ≤500 IU\u002FmL before study enrollment, and participants with active HBV need to be on anti-HBV suppression ≥3 months, throughout treatment and for 6 months after; and\n   2. Hepatitis C virus (HCV) viral load ≤lower limits of detection, participants with curable or controllable HCV infection are eligible. Participants with detectable HCV RNA can remain on continuous, effective antiviral therapy during the study.\n\n   Note: The necessity of conducting HBV DNA\u002FHCV RNA quantitative testing is based on the local epidemiology and local clinical practice.\n5. Active tuberculosis.\n6. Active infection requiring intravenous 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, are eligible for this study.\n8. Have an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. This criterion does not apply to participants with:\n\n   1. Resolved childhood asthma\u002Fatopy or who require intermittent use of bronchodilators or corticosteroid;\n   2. Raynaud's syndrome; or\n   3. Sjogren's syndrome. Use of topical, ophthalmic, inhaled, and intranasal corticosteroids are permitted.\n9. Evidence of (a) interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity (for example, interstitial lung disease); (b) active, noninfectious pneumonitis; or (c) history of noninfectious pneumonitis that required corticosteroid therapy or immune related pneumonitis.\n10. Moderate or severe cardiovascular disease, including:\n\n    1. A myocardial infarction or any other arterial thrombotic event including cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment;\n    2. Unstable angina pectoris;\n    3. New York Heart Association Class III\u002FIV congestive heart failure;\n    4. Aneurysm of major vessels or heart;\n    5. Left ventricular ejection fraction \\\u003C50% (evaluation based on institutional lower limit of normal);\n    6. Uncontrolled hypertension;\n    7. Severe, moderate, or clinically significant valvulopathy;\n    8. Documented major ECG abnormalities that, in the judgment of the investigator, are clinically significant (for example, arrhythmia requiring treatment)\n    9. Mean QTc ≥470 ms calculated using Fridericia's correction and confirmed by triplicate ECG.\n11. History of Grade ≥ 3 immune related Adverse Events (irAE) related to prior immune checkpoint inhibitor therapy or any active or unresolved AE from prior anti-cancer therapy that has not resolved to ≤ Grade 1 or baseline (except controlled endocrinopathies). Participants with a history of Grade ≥3 irAEs attributed to prior anti-CTLA4 (e.g. ipilimumab) combined with anti-PD(L)1 (e.g. pembrolizumab, nivolumab, atezolizumab) are eligible for enrollment if the irAE occurred during combination therapy, and they subsequently tolerated anti-PD(L)1 monotherapy without recurrence of Grade ≥3 irAEs.\n12. Participants permanently discontinued due to any immune-related toxicity requiring prolonged (≥10 weeks) high-dose corticosteroids (≥20 mg\u002Fday prednisone equivalent) or other immunosuppressants (e.g., infliximab, mycophenolate, cyclophosphamide) will be excluded.\n13. Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Participants with treated CNS metastases are eligible for this study if they are not requiring concurrent treatment, including but not limited to surgery, radiation, corticosteroids and\u002For anticonvulsants to treat CNS metastases, and their disease is asymptomatic and radiographically stable for at least 30 days.\n14. Have received a live vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (for example, FluMist®) are live attenuated vaccines and are not allowed.\n15. Are pregnant or planning to become pregnant during the study or within 6 months following the last dose of AN8025. Plan to be breastfeeding from C1D1 of study or within 6 months following the last dose of AN8025.\n16. 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.\n17. 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","ALL","18 Years",{"count":19,"type":20},91,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this clinical trial is to determine the appropriate dose of AN8025 for use in the treatment of advanced solid tumors. This study will be conducted in in adults \\>18 years of age. The main questions to answer:\n\n1. Determine which dose level of AN8025 is safe and tolerability in participants with advanced solid tumors\n2. To determine the maximum tolerated of AN8025 for future testing.\n\nParticipants will visit their study site in 3 week cycles, during which they will be under go treatment with AN8025 and visit their clinical site during each cycle for check ups and testing.",[26],"Advanced Solid Tumor (Phase 1)",[28,29,30],"Advance Solid tumors","Tri-specific","PD-L1","RECRUITING","2026-06-05",{"date":34,"type":35},"2026-06-10","ACTUAL",{"date":37,"type":35},"2025-11-01",{"date":39,"type":20},"2028-01",{"name":41,"class":42},"Adlai Nortye Biopharma Co., Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":5},"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":52,"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.",[56,57],"Solid Tumors (Phase 1)","RAS Mutation",[59,60,61,62,63,64,65],"RAS","RAS (ON)","RAS Solid Tumor","KRAS G12X(C\u002FD\u002FV)","KRAS G13D","NRAS Q61X(L\u002FK)","Oral Pan RAS medication",{"date":67,"type":35},"2026-06-08",{"date":69,"type":35},"2026-01-28",{"date":71,"type":20},"2028-06-01",{"name":41,"class":42},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100439214","phase-1-first-in-human-dose-escalation-study-of-an4005-100439214","NCT04999384","First in Human, Dose Escalation Study of AN4005","Clinical Study Protocol AN4005X0101 An Open-Label, Multicenter, Phase 1 Study of AN4005 in Patients With Advanced Tumors","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years at the time of informed consent and have provided signed informed consent for the trial.\n\n  2\\. Willing and able to comply with all aspects of the protocol.\n\n  3\\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\n  4\\. Life expectancy ≥ 3 months.\n\n  5\\. Subjects with histologically or cytologically confirmed advanced solid tumors that are metastatic or unresectable, or relapsed or refractory (r\u002Fr) lymphoma, and for whom standard life-prolonging measures are not available. Types of lymphoma may include, but are not limited to, natural killer (NK)\u002FT-cell lymphoma, classic Hodgkin lymphoma (cHL), peripheral T-cell lymphoma (PTCL), and diffuse large B-cell lymphoma (DLBCL).\n\n  6\\. No standard therapy available or standard therapy is considered unsuitable or intolerable according to the Investigator.\n\n  7\\. Patients with or without measurable disease are considered eligible. Patients who have measurable disease as assessed by the local site investigator and\u002For radiologist. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\n  8\\. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. If previously treated with anti-PD-1\u002FPD-L1 therapy, tumor tissue sample obtained following the most recent anti-PD-1\u002FPD-L1 therapy is required. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. For patients with specific types of lymphomas, bone marrow biopsy will be required as appropriate.\n\n  9\\. Left ventricular ejection fraction (LVEF) greater than 50% on echocardiography or multiple gated acquisition (MUGA) scan.\n\n  10\\. Patient has organ function as shown by the following:\n  1. Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL.\n  2. Hemoglobin ≥8 g\u002FdL (which may be reached by transfusion).\n  3. Platelets ≥100 x 109\u002FL (which may be reached by transfusion).\n  4. International normalized ratio (INR) ≤1.5.\n  5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x upper limit of normal (ULN) or \\\u003C5.0 x ULN if liver metastases are present.\n  6. Total serum bilirubin ≤ ULN or ≤1.5 x ULN if liver metastases are present; or total bilirubin ≤3.0 x ULN with direct bilirubin below or within normal range in patients with well documented Gilbert's Syndrome. Gilbert's syndrome is defined as presence of episodes of unconjugated hyperbilirubinemia with normal results from cells blood count (including normal reticulocyte count and blood smear), normal liver function test results, and absence of other contributing disease processes at the time of diagnosis.\n  7. Creatinine clearance (CrCL) \\>60 mL\u002Fmin calculated by the Cockcroft-Gault Equation.\n\n     11\\. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  \u003C!-- -->\n\n  1. Not a woman of childbearing potential Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks prior to Screening. 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 not of child-bearing potential.\n  2. Woman of childbearing potential who agrees to follow contraceptive guidance during the treatment period and for at least 90 days after the last dose of study treatment.\n\nHighly effective contraception is defined as either:\n\n* Total abstinence: When this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n* Female sterilization: When the female study patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.\n* Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female study patients, the vasectomized male partner should be the sole partner for that patient.\n* Using a combination of any two of the following:\n\n  * Placement of an intrauterine device (IUD) or intrauterine system (IUS), and\n  * Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository.\n  * Hormonal contraception methods (e.g., oral, injected, implanted).\n\n    12\\. A male participant must agree to use contraception during the treatment period and for at least 90 days after the last dose of the study treatment.\n\nExclusion Criteria:\n\n1. Have been discontinued treatment due to a Grade 3 or higher immune-related AE (irAE) from prior anti-PD-1or anti-PD-L1 therapy, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).\n2. Have received prior systemic anti-cancer therapy including investigational oncology agents within 4 weeks or 5 half-lives, whichever is shorter.\n\n   Note: Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or returned to baseline. Participants with ≤ Grade 2 neuropathy or alopecia may be eligible.\n3. At least 6 weeks must have elapsed since CAR-T infusion and subjects must have experienced disease progression, and not have residual circulating CAR-T cells in peripheral blood (based on local assessment). Any encountered treatment-related toxicities must have resolved to Grade ≤1.\n4. Have received prior palliative radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-central nervous system (CNS) disease.\n5. Uncontrolled tumor-related pain.\n6. Have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Non live COVID vaccinations or boosters should not occur within 30 days prior to the first dose of study drug and during Cycle 1.\n7. Are currently participating in a study of an investigational agent or investigational device within 4 weeks or less than 5 half-lives, prior to the first dose of study treatment.\n\n   Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been at least 4 weeks after the last dose of the previous investigational agent (see Number 2 above).\n8. Have had an allogenic tissue (e.g., bone marrow or stem cells)\u002Fsolid organ transplant within the past 5 years.\n9. Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.\n10. With a history of another primary malignancy within the past 2 years, with the following exceptions: basal or squamous cell skin cancer, or carcinoma in situ of the cervix or breast that has undergone potentially curative therapy; or patients with a prior history of or clinically stable concurrent malignancy provided the malignancy is clinically insignificant, no treatment is required, and the patient is clinically stable.\n11. Have known severe hypersensitivity to study treatment components.\n12. Have an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n13. Have a history of (non-infectious) pneumonitis that has required steroids or have current pneumonitis.\n14. Have an active infection requiring systemic therapy within 2 weeks prior to the first dose of the study drug.\n15. Significant cardiovascular (CV) impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of the study drug; or cardiac arrhythmia requiring medical treatment (including oral anticoagulation). Patients who meet the following criteria should be excluded: a) A marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\>470 milliseconds (ms) using Fredericia's QT correction formula). b) A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). c) The use of concomitant medications that prolong the QT\u002FQTc interval.\n16. Major surgery within 4 weeks before the first dose of the study drug. Note: If participant received major surgery, they must have recovered adequately from surgery and the toxicity and\u002For complications requiring the intervention prior to starting study treatment.\n17. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the oral bioavailability of the investigational drugs.\n18. 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.\n19. Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study, e.g. history of or active major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, or history of suicidal attempt or ideation, homicidal ideation (e.g., risk of doing harm to self or others), or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders \\[DSM V\\]) are not eligible. Note: For patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous six weeks prior to start of study drug.\n20. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study treatment.\n21. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures \\>\u002F=1 time per month.\n22. Leptomeningeal disease.\n23. Spinal cord compression not definitively treated with surgery and\u002For radiation, or previously diagnosed and treated but without evidence that disease has been clinically stable for \\>\u002F=2 weeks prior to the first dose of the study drug.\n24. Oral or IV antibiotics within 2 weeks prior to the first dose of the study drug (except for prophylactic dose).\n25. Active tuberculosis.\n26. Patient is currently being treated with drugs known to be strong cytochromes P450 (CYP)3A4, inhibitors or inducers; UGT inducers or inhibitors; inhibitors of P-gP; sensitive substrates for CPY3A4, CYP2C9, CPY2C19 or P-gP (Appendix 4: List of Concomitant Drugs to Avoid Two Weeks Prior to and During Patient Enrollment) and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.\n27. Patient has a history of non-compliance to any medical regimen or inability to grant consent.",{"count":81,"type":20},31,[23],"Open-label, multicenter, phase 1 study to investigate the safety, tolerability, and PK of AN4005 in patients with advanced tumors. This study is a first-in-human, dose escalation study with the objective to establish the MTD and\u002For RP2D of AN4005.\n\nExcept for Dose Level 0 (50 mg), a traditional \"3 + 3 design\" will be utilized for dose finding with dose escalation and\u002For de-escalation as appropriate.",[85,86],"Advanced Solid Tumor","Advanced Lymphoma","2025-11-17",{"date":89,"type":35},"2025-11-18",{"date":91,"type":35},"2021-09-27",{"date":93,"type":20},"2026-12",{"name":41,"class":42},7,""]