[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nanjing Immunophage Biotech Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":154},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,66,88,110,132],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100645233","phase-1-ipg1094-phase-i-study-for-china-healthy-participants-100645233",false,"NCT07679113","IPG1094 Phase I Study for China Healthy Participants","A Phase I Clinical Trial Evaluating Pharmacokinetic Characteristics of IPG 1094 in Chinese Healthy Adults","Inclusion Criteria:\n\n1. Male and female healthy Chinese participants aged 18 to 50 years (inclusive).\n2. Comprehensive assessments including physical examination, vital signs, 12-lead ECG, chest X-ray and laboratory tests are normal or with abnormalities judged not clinically significant by the investigator.\n3. Body weight: Male ≥50.0 kg, Female ≥45.0 kg; Body Mass Index (BMI) ranges from 19.0 to 26.0 (inclusive). BMI = Weight(kg) \u002F Height(m)².\n4. Female participants are non-pregnant and non-lactating.\n5. Participants have no pregnancy plan and no sperm\u002Fegg donation plan from 2 weeks before screening to 6 months after the end of the study, and agree to use effective contraception during this period.\n6. Voluntarily sign the written informed consent form, and fully understand the trial content and potential adverse reactions.\n\nExclusion Criteria:\n\n1. History of severe cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological, psychiatric or other systemic diseases with clinical significance.\n2. QTcF interval \\>450 ms (male) or \\>470 ms (female).\n3. History of recurrent headache, nausea or vomiting.\n4. Blood loss ≥400 mL within 3 months before screening, or plan to donate blood during the study.\n5. History of orthostatic hypotension or dysphagia.\n6. History of gastrointestinal diseases affecting drug absorption.\n7. Lactose intolerance, special dietary restrictions, or unable to follow unified diet requirements during the trial.\n8. History of drug\u002Ffood allergy, drug abuse or alcohol abuse.\n9. Heavy smoking, excessive intake of tea, coffee or caffeinated beverages within 3 months before screening.\n10. Use of any prescription drugs, over-the-counter drugs, health products or Chinese herbal medicines within 14 days before screening.\n11. Use of drugs affecting liver metabolism or gastrointestinal environment within 30 days before screening.\n12. Intake of citrus fruits\u002Fjuices within 5 days before screening or during the trial.\n13. Participated in other clinical trials within 3 months before screening.\n14. Positive result of urine drug screen or breath alcohol test at admission.\n15. Difficulty in venous blood collection, history of syncope during blood collection.\n16. Acute illness before screening, or other conditions judged inappropriate for participation by the investigator.",true,"ALL","18 Years","50 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This Phase 1 open-label study enrolls 24 healthy Chinese adults to investigate the pharmacokinetics, safety and tolerability of oral IPG1094 tablets. The trial includes two parts. Part A (12 participants) uses a crossover design to explore the impact of food on a single 200 mg dose of IPG1094; participants will receive the drug under fasting and post-meal conditions on separate days, with intensive blood sampling for PK analysis. Part B (12 participants) evaluates multiple-dose PK, where participants take 200 mg IPG1094 twice daily for 10 days to observe drug exposure and accumulation. All participants will undergo comprehensive safety checks such as lab tests, ECG and adverse event monitoring during screening, treatment and post-dosing follow-up. No placebo or blinding is applied in this study.",[28],"Healthy Volunteers",[30],"Healthy Volunteers，Phase 1, IPG1094, Pharmacokinetics, Safety,","NOT_YET_RECRUITING","2026-06-25",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":22},"2026-07-29",{"date":39,"type":22},"2027-01-30",{"name":41,"class":42},"Nanjing Immunophage Biotech Co., Ltd","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":43},"100632059","phase-1-ipg7236-combined-with-toripalimab-in-participants-with-advanced-solid-tumors-100632059","NCT07508761","IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors","A Phase I\u002FII Multicenter, Non-randomized, Open-label, Dose Escalation and Expansion Study of IPG7236 Combined With Toripalimab Treatment of Advanced Solid Tumors in Adult Patients to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity","Inclusion Criteria:\n\n1. Written informed consent must be obtained before any study procedure is performed.\n2. Men or women 18 years of age or older.\n3. Histologically or cytologically confirmed advanced or recurrent malignant solid tumors that are metastatic or unresectable. (Subjects must submit tumor tissue sections from within the past 5 years for CCR8 expression testing. For subjects without paraffin-embedded tissues, a fine-needle aspiration biopsy may be performed. Subjects who cannot provide tumor tissue sections or undergo biopsy are only eligible for inclusion during the dose escalation phase. During the dose expansion phase, CCR8 positivity must be known or tumor tissue sections must be provided with confirmed CCR8 expression.)\n4. Subjects must have failed or been intolerant to standard antitumor therapy, or lack a standard treatment regimen, or be deemed by the investigator as currently unsuitable for standard therapy.\n5. According to the RECIST 1.1 criteria, there is at least one measurable lesion.\n6. Life expectancy ≥ 3 months.\n7. Subjects must be able to swallow the oral investigational drug.\n8. The ECOG performance status score is 0 or 1.\n9. Sufficient hematologic and organ function, with the following laboratory test values:\n\n   1. Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹\u002FL; platelet count ≥ 75×10⁹\u002FL; Hemoglobin ≥ 9 g\u002FdL; lymphocytes ≥ 0.8×10⁹\u002FL;\n   2. Renal: Creatinine clearance calculated by the Cockcroft-Gault method ≥ 50 mL\u002Fmin or serum creatinine ≤ 1.5× upper limit of normal (ULN);\n   3. Hepatic: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3×ULN, or ≤ 5×ULN for subjects with liver metastases; total bilirubin ≤ 1.5×ULN, or ≤ 3×ULN for subjects with Gilbert syndrome or genetically equivalent conditions;\n   4. Coagulation: Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5× upper limit of normal (ULN).\n10. Patients must be willing and able to comply with all scheduled visits, treatments, laboratory tests, and other study requirements.\n11. Male and female participants of reproductive potential who engage in heterosexual sexual behavior must agree to use reliable contraceptive methods (hormonal, barrier, or abstinence,etc.) for at least 4 months during the trial period and after the last study drug administration (refer to Appendix 13.1 of the protocol)\n\nExclusion Criteria:\n\n1. Primary malignant tumors of the central nervous system or malignant tumors associated with human immunodeficiency virus (HIV) .\n2. Previous use of CCR8-targeted therapy.\n3. Received the following treatment within the specified time frame:\n\n   1. Planned major surgery within 4 weeks prior to the first dose administration (excluding minor procedures such as vascular access placement, gastrointestinal\u002Fbiliary stent placement, or biopsy);\n   2. Immunotherapy or biological therapy administered within 28 days prior to the initial administration;\n   3. Chemotherapy \\\u003C21 days prior to the first dose, or mitomycin or nitrosoureas \\\u003C 42 days prior, or oral fluoropyrimidines \\\u003C 14 days prior;\n   4. Targeted small-molecule therapy or traditional Chinese medicine with antitumor indications administered within 14 days prior to the initial dose;\n   5. Hormone therapy or other adjuvant therapies are not permitted if initiated within 14 days prior to the first dose. Exceptions: anti-estrogen therapy, bisphosphonates, RANKL monoclonal antibodies, somatostatin analogs, and leuprorelin are permitted if initiated ≥ 14 days prior to the first dose.\n   6. Radiotherapy administered within 28 days prior to the first dose, or palliative radiotherapy within 14 days prior. Exception: Palliative radiotherapy (e.g., for analgesia) may be performed during the study drug administration period, provided that it is not permitted during the DLT observation period, any previously induced adverse events from radiotherapy have been resolved to grade \\\u003C2, and the radiotherapy was not directed at the target lesion.\n   7. Other investigational or treatments administered within 28 days prior to the first dose;\n   8. Any previous allogeneic tissue\u002Fsolid organ transplantation, including allogeneic stem cell transplantation;\n4. Previous treatment-related toxicity has not yet resolved to a level of ≤ 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0 or to the specified levels in the inclusion\u002Fexclusion criteria (except for safety risks deemed by the investigator as not significant, such as alopecia, grade 2 peripheral neuropathy, hypothyroidism or hyperthyroidism, or other endocrine disorders well-controlled by hormone replacement therapy).\n5. In combination with other active malignancies (excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or superficial bladder cancer with no evidence of disease after potentially curative treatment; For other patients with previous malignant tumors who have survived without disease for more than 3 years, they are also (acceptable).\n6. Immune-related adverse events (irAEs) of grade ≥ 3 or those leading to treatment discontinuation during prior immunotherapy, or grade ≥ 2 immune-mediated myocarditis, or treatment discontinuation due to allergic or infusion-related reactions.\n7. Diagnosis of primary or acquired immunodeficiency, or receipt of systemic glucocorticoids or any other form of immunosuppressive therapy within 7 days prior to the first dose. Exceptions: intraocular, intranasal, intra-articular, inhaled, or systemic glucocorticoids (prednisone dose ≤ 10 mg\u002Fday or equivalent, or doses used for adrenal replacement therapy), as well as a single dose of immunosuppressive medication for contrast agent allergy prophylaxis (if no active autoimmune disease is present).\n8. History of autoimmune disease requiring systemic therapy or active autoimmune diseases (i.e., requiring glucocorticoids or immunosuppressive agents for disease control) within 2 years prior to study initiation are eligible, provided they do not require immunosuppressive therapy for conditions such as type 1 diabetes mellitus, vitiligo, psoriasis,hypothyroidism, or hyperthyroidism.\n9. Known severe or life-threatening allergic reactions to humanized monoclonal antibodies (mAbs) or intravenous immunoglobulin (Ig) preparations; known hypersensitivity to any investigational drug, its analogues, or excipients.\n10. Untreated brain metastases, meningeal metastases, or spinal cord compression not definitively treated with surgery or radiotherapy. (Patients with brain metastases who have stabilized without symptoms after prior treatment and have not received high-dose steroid therapy are eligible for enrollment.)\n11. Uncontrolled or requiring intravenous anti-infective therapy for active bacterial, fungal, or viral infections.\n12. Active hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV) and\u002For HIV:\n\n    1. Participants must be negative for hepatitis B surface antigen (HBsAg).\n    2. For HCV antibody-positive subjects, the HCV RNA quantification must be below the research center's detection limit.\n    3. HIV test must be negative at screening;\n13. Administration of live or live-attenuated vaccines within 4 weeks prior to the first dose (inactivated vaccines, viral vector vaccines, and mRNA vaccines are permitted; seasonal vaccines should be completed prior to the first dose).\n14. The serum pregnancy test is positive within 3 days before the first dose.\n15. Lactating female subjects.\n16. Pneumonitis, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis) requiring glucocorticoid therapy.\n17. Patients with clinically uncontrollable ascites or pleural effusion are deemed unsuitable for enrollment by the investigator.\n18. Symptomatic cardiovascular or cerebrovascular disease; accident\u002Fstroke or myocardial infarction (MI), unstable angina, congestive heart failure (NYHA class III or higher), or severe arrhythmias uncontrolled by pharmacotherapy within 6 months prior to enrollment; mean QT interval corrected for heart rate using the Fridericia formula (QTcF) ≥ 470 ms.\n19. Any medical or social condition that may expose subjects to higher risks, affect compliance, or obscure the interpretation of safety or other clinical study data",{"count":52,"type":22},52,[25,54],"PHASE2","Phase 1\u002F2 Study for IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors",[57],"Advanced Solid Tumor","RECRUITING",{"date":60,"type":35},"2026-06-29",{"date":62,"type":35},"2026-06-16",{"date":64,"type":22},"2029-07-30",{"name":41,"class":42},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":43},"100634115","phase-2-efficacy-and-safety-of-ipg11406-in-moderately-to-severely-active-ulcerative-colitis-phase-2-100634115","NCT07535489","Efficacy and Safety of IPG11406 in Moderately to Severely Active Ulcerative Colitis (Phase 2)","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of IPG11406 Tablets in Adult Patients With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:1.Males and females aged ≥18 and ≤70 years at randomization 2.Diagnosis of moderately to severely active UC with mMS 5-9, mMES 2-3, SF ≥1, RB ≥1 3.Documented UC diagnosis for ≥3 months prior to screening 4.Inadequate response, loss of response, or intolerance to conventional or advanced therapies 5.Stable background UC therapy for specified intervals before baseline 6.Willingness to use effective contraception throughout the study and for 1 month after last dose 7.Ability to comply with study visits and procedures 8.Signed informed consent\n\nExclusion Criteria:\n\n1. Diagnosis of indeterminate colitis or Crohn's disease\n2. History of bowel surgery for UC or likely requiring surgery during study\n3. Ulcerative proctitis only (distal ≤15 cm)\n4. History of colonic dysplasia or adenomatous polyps not completely removed\n5. Active intestinal infection (including C. difficile) within 30 days\n6. HBV, HCV, HIV, or untreated latent\u002Factive TB\n7. Significant cardiovascular disease or uncontrolled hypertension\n8. Clinically significant abnormal ECG or QTcF prolongation\n9. Treatment with prohibited medications within specified windows\n10. Abnormal laboratory values at screening\n11. History of malignancy (except non-melanoma skin cancer or in situ cervical cancer)\n12. Pregnancy, breastfeeding, or plan to become pregnant\n13. Alcohol or drug abuse within 6 months\n14. Prior participation in an IPG11406 study\n15. Other conditions deemed inappropriate by the investigator","70 Years",{"count":75,"type":22},144,[54],"This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and pharmacokinetics of IPG11406, an investigational oral drug, in adult patients with moderately to severely active ulcerative colitis (UC).\n\nUC is a chronic inflammatory bowel disease that causes long-term inflammation and ulcers in the colon, leading to symptoms like frequent diarrhea, rectal bleeding, abdominal pain, and urgent bowel movements. IPG11406 works by targeting the GPR183 receptor, which helps reduce immune cell migration to the inflamed colon, potentially easing UC symptoms and promoting mucosal healing.\n\nIn this study, 144 eligible adult patients will be randomly assigned (1:1:1:1) to receive one of three doses of IPG11406 (10 mg, 20 mg, or 40 mg, taken twice daily by mouth) or a matching placebo for 12 weeks. Neither the patients nor their study doctors will know who is receiving the active drug or placebo to ensure unbiased results.\n\nThe main goal of the study is to see how well IPG11406 works to achieve clinical remission (reduced or no UC symptoms) at 12 weeks, measured by the modified Mayo Score. Additional goals include evaluating other efficacy measures (such as clinical response, endoscopic remission, and histological improvement), long-term safety, how the drug is absorbed and processed in the body (pharmacokinetics), and changes in inflammatory biomarkers like fecal calprotectin and hsCRP.\n\nAll participants will undergo regular study visits for safety assessments, including physical exams, laboratory tests, colonoscopies, and monitoring for any side effects throughout the 12-week treatment period and a 2-week follow-up. This study will help determine the optimal dose of IPG11406 for future larger clinical trials in UC patients.",[79],"Moderately to Severely Active Ulcerative Colitis (UC)","2026-04-10",{"date":82,"type":35},"2026-04-17",{"date":84,"type":22},"2026-07-07",{"date":86,"type":22},"2029-12-01",{"name":41,"class":42},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":73,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100571251","phase-1-phase-iia-study-for-ipg11406-in-patients-with-lupus-nephritis-100571251","NCT06717815","Phase IIa Study for IPG11406 in Patients With Lupus Nephritis","A Multi-center, Multi-dose Phase Ib\u002FIIa Clinical Study Evaluating the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Impact on Biomarkers of IPG11406 in Patients With Lupus Nephritis","Criteria for Inclusion and Exclusion \\\u003CInclusion Criteria\\>\n\n1. The age range is between 18 and 70 years old (including 18 and 70), with no gender restrictions.\n2. Weight ≥ 45kg.\n3. Adult subjects who meet the revised classification criteria of the American College of Rheumatology (ACR) 1997 and were diagnosed with systemic lupus erythematosus before screening.\n4. During the screening period, the disease activity was confirmed as follows: SLEDAI-2K score ≥ 6 points. Accompanied by lupus nephritis (according to the 2003 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) classification criteria, there is active, biopsy-confirmed type III or type IV proliferative lupus nephritis, with coexistence of type V allowed; the biopsy must be performed within 1 year before the screening visit or during the screening period, and the biopsy report is used to confirm patient eligibility.)\n5. During the screening period, the patient's 24-hour urinary protein to creatinine ratio (UPCR) is greater than 1.0g\u002Fg, and the estimated glomerular filtration rate (eGFR) calculated using the MDRD formula is ≥60 mL\u002Fmin\u002F1.73 m\\^2; and the 24-hour urinary protein is ≥1g.\n6. The patient's baseline serum IFN-γ exceeded the upper limit of normal values.\n7. The Th1\u002FTh2 ratio in peripheral blood of the patient during the baseline period is ≥14.\n8. Subjects who have not undergone induction therapy are allowed to be enrolled, but during the study and follow-up period, they must not receive any other treatment for systemic lupus erythematosus and lupus nephritis. Subjects are allowed to be enrolled while receiving any of the following standard treatment regimens: 1) Oral prednisone (or equivalent) monotherapy: a. Treatment duration: medication use ≥2 weeks before screening and maintaining a stable dose ≥2 weeks before enrollment; b. Dose requirements: maximum daily dose: 1mg\u002Fkg\u002Fday; 2) Immunosuppressants: a. Permissible drugs include: antimalarials, azathioprine, cyclophosphamide, mycophenolate mofetil\u002Fmycophenolic acid, methotrexate, cyclosporine A, tacrolimus; b. Treatment duration: medication use ≥12 weeks before screening and maintaining a stable dose ≥8 weeks before enrollment; c. Dose requirements: hydroxychloroquine ≤400mg\u002Fday, azathioprine ≤100mg\u002Fday, cyclophosphamide ≤800mg\u002F4 weeks, mycophenolate mofetil\u002Fmycophenolic acid ≤2g\u002Fday, oral, subcutaneous (SC), or intramuscular methotrexate ≤15mg\u002Fweek, Cyclosporine A ≤ 3 mg\u002Fkg\u002Fd, tacrolimus ≤ 3 mg\u002Fd; 3) Oral prednisone (or equivalent medication) monotherapy ± hydroxychloroquine sulfate ± an immunosuppressant: a. The treatment duration and dose stability requirements for Oral glucocorticoids (OCS) and immunosuppressants mentioned above must be met; b. The maximum daily\u002Fweekly dose of each drug in 1) and 2) must not be exceeded.\n9. Female subjects must be in a non-pregnant and non-breastfeeding period during the trial.\n10. The subjects have no plans to become pregnant within 6 months after the screening and the end of the trial, voluntarily adopt effective contraceptive measures, and have no plans to donate sperm or eggs;\n11. The subjects voluntarily participate in the study, are able to sign the informed consent form, and comply with the requirements stated on the informed consent form.\n\n\\\u003CExclusion Criteria\\>\n\n1. Pregnant and lactating women.\n2. Screening for participation in other clinical trials within the previous 3 months and\u002For currently (excluding those who have not used the trial medication).\n3. Active severe lupus nephritis, with estimated glomerular filtration rate (eGFR) calculated using the MDRD formula \\\u003C60ml\u002Fmin\u002F1.73m\\^2.\n4. Severe neuropsychiatric SLE includes but is not limited to the following: seizures, new or worsening impaired level of consciousness, psychosis, delirium or confusion state, aseptic meningitis, ascending or transverse myelitis, chorea, cerebellar ataxia, multiple mononeuropathy, demyelinating syndrome, or situations that make the subject unable to fully understand the ICF.\n5. History or current diagnosis of clinically significant non-SLE-related vasculitis syndrome or overlap with other connective tissue diseases.\n6. Any active skin diseases that may interfere with the research evaluation of SLE, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE skin lupus manifestations (such as skin vascular disease, perifollicular telangiectasia, fingertip sclerosis, rheumatoid nodules, erythema multiforme, leg ulcers) or drug-induced lupus, except for SLE.\n7. Those with a history of lymphoproliferative diseases, or those who have had or currently have malignant tumors within the past 5 years (except for squamous cell carcinoma in situ, basal cell carcinoma, and cervical carcinoma in situ, which have been thoroughly treated and show no evidence of recurrence).\n8. Patients with uncontrolled antiphospholipid syndrome (APS).\n9. History of significant organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002Fbone marrow transplantation.\n10. Major surgical procedures (craniotomy, thoracotomy, or abdominal surgery) or unhealed wounds, ulcers, or fractures within 4 weeks before screening.\n11. Individuals who have received live\u002Fattenuated vaccine within the 8 weeks before screening or plan to receive live\u002Fattenuated vaccine during the trial period.\n12. Allergic to the trial medication (including excipients) or suffering from severe allergic diseases or belonging to an allergic constitution (such as being allergic to two or more drugs, foods, or pollen), which, in the judgment of the researcher, may compromise the safety of the subject.\n13. During screening, any of the following cardiac impairments is present: a. New York Heart Association (NYHA) functional class III to IV; b. Uncontrolled angina, congestive heart failure, or myocardial infarction within 6 months prior to the first dose of medication; c. Prolonged QTcF interval calculated using the Fridericia formula (male \\> 450 msec; female \\> 470 msec); d. Second-degree type II atrioventricular (AV) block, third-degree AV block, or PR interval \\>250 msec; e. Various factors that may increase the risk of QTcF prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, or a family history of sudden unexplained death of a first-degree relative before the age of 40; f. Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n14. Active or latent tuberculosis infection during screening.\n15. There is a serious herpes virus infection during screening, such as herpes encephalitis, disseminated herpes, and ocular herpes.\n16. Needs to take oral anti-infective drugs (including antiviral drugs) or intravenous antibiotics due to infection within 2 weeks before screening.\n17. Hospitalization due to opportunistic infections within 3 months before screening.\n18. Treatment with traditional Chinese patent medicines and simple preparations such as Tripterygium Wilfordii within 4 weeks before screening.\n19. Hepatitis B test shows HBsAg positive (if HBsAg is negative but HBcAb is positive, then HBV-DNA quantitative test is required, and patients with HBV-DNA test results ≥ the upper limit of the reference value of each center or requiring antiviral treatment do not meet the conditions to participate in the study), hepatitis C antibody positive (HCV-RNA test can be added, if negative, the patient can be included), Treponema pallidum antibody positive (if Treponema pallidum antibody is positive, further Treponema pallidum serological tests will be conducted. Patients who have been judged by the investigator to have been infected with syphilis in the past but have been cured meet the inclusion criteria), HIV antibody test positive.\n20. During screening, subjects with significant abnormalities in liver and kidney function tests and blood routine examination, including: alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) exceeding twice the upper limit of normal values, total serum bilirubin exceeding 1.5 times the upper limit of normal values; serum creatinine greater than 1.5 times the upper limit of normal values; hemoglobin \\\u003C90g\u002FL; white blood cell count \\\u003C3.0×10\\^9\u002FL, platelet count (PLT) \\\u003C75×10\\^9\u002FL; neutrophil count \\\u003C1.0×10\\^9\u002FL; other laboratory test results that may affect the subject's ability to complete the trial or interfere with the trial results as judged by the investigator.\n21. Those who have difficulty swallowing.\n22. History of drug addiction or drug abuse;\n23. Those who have acute diseases before using the clinical trial drugs;\n24. Other conditions that the investigator deem unsuitable for enrollment.",{"count":96,"type":22},36,[25,54],"A multi-center, multi-dose phase Ib\u002FIIa clinical study evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics, and impact on biomarkers of IPG11406 in patients with Lupus Nephritis",[100],"Lupus Nephritis","2026-01-12",{"date":103,"type":35},"2026-01-13",{"date":105,"type":35},"2025-02-25",{"date":107,"type":22},"2026-04-22",{"name":41,"class":42},17,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100532382","phase-1-phase-iii-study-of-ipg1094-in-advanced-solid-tumors-patients-100532382","NCT06212076","Phase I\u002FII Study of IPG1094 in Advanced Solid Tumors Patients","A Phase I\u002FII, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic Characteristics and Initial Anti-tumor Activity of IPG1094 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be included in the study:\n\n1. Male or female aged ≥ 18 years.\n2. In Part A:\n\n   Subjects must have a histological diagnosis of locally advanced or metastatic malignant solid tumors, and that is not amenable to curative surgical and\u002For locoregional therapies;\n\n   In Part B:\n\n   Subjects must have a histological diagnosis of locally advanced or metastatic malignant solid tumors, and that is not amenable to curative surgical and\u002For locoregional therapies (tumor types in Part B will include but not limited to small cell lung cancer, triple-negative breast cancer, head and neck cancer, and melanoma).\n3. Subjects must have failed or have been intolerant to established standard therapies, or standard therapies did not exist or were no longer effective for a given tumor type, or in the opinion of the investigator have been considered ineligible for a particular form of standard therapy on medical grounds.\n4. Subjects must have at least one evaluable lesion according to RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n6. Life expectancy ≥ 12 weeks.\n7. Subjects must have adequate organ and bone marrow function (no hematopoietic growth factor, blood transfusion, or platelet therapy within 2 weeks before the screening and during the screening):\n\n   * Complete blood count (CBC): neutrophils ≥ 1.5 × 109\u002FL, platelets ≥ 100 × 109\u002FL, hemoglobin ≥ 9.0 g\u002FdL.\n   * Liver function: total bilirubin ≤ 1.5 × ULN; ALT\u002FAST ≤ 2.5 × ULN without liver metastasis; ALT\u002FAST ≤ 5 × ULN with liver metastasis;\n   * Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients undergoing anticoagulant therapy. The investigator will judge that the INR and APTT are within a safe treatment range);\n   * Renal function: creatinine clearance \\> 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula) in the condition of creatinine level \\> ULN; urine protein qualitative ≤ 1 + (if ≥ 2+, 24 hours of urine protein test is required, if 24 hours urine protein \\\u003C1 g, then allowed to enroll);\n   * Adequate cardiac function left ventricular ejection fraction (LVEF) \\> 50% for 2 dimensional cardiac ultrasound.\n8. Women of childbearing potential (WOCBP) and fertile males with WOCBP partners must use highly effective contraception throughout the study (from first dose and through 28 days after final dose of study drug).\n9. Subjects must have signed and dated an Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC) approved written informed consent form that under regulatory and institutional guidelines, and this must be obtained before the performance of any protocol-related procedures.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded from the study:\n\n1. Subjects who received anti-tumor therapy (except for mitomycin, nitrosourea, and fluorouracil oral drugs) within 4 weeks before the first dose, including but not limited to chemotherapy, radiotherapy (palliative radiotherapy is completed at least 2 weeks before the first dose can be enrolled), targeted therapy or immunotherapy.\n\n   Note: Mitomycin and nitrosourea have been treated within 6 weeks after the last dose; oral fluorouracil such as tegafur and capecitabine has been treated within 2 weeks after the last dose.\n2. Subjects who have previous toxicity of anti-tumor therapy that has not been returned to level 0 or 1. (Alopecia, chemotherapy-induced peripheral neurotoxicity and ototoxicity ≤ Grade 2 can be enrolled).\n3. Subjects who received CYP3A4 strong inhibitors or CYP3A4 strong inducers (see https:\u002F\u002Fdrug-interactions.medicine.iu.edu\u002FMainTable.aspx) within 14 days prior to the first dose and the subjects who need to continue using these drugs throughout the study.\n4. Subjects who received clinical intervention for biliary obstruction 14 days prior to the first dose or the investigator judges that the symptoms had not resolved or required anti-infective treatment.\n5. Subjects who had clinically uncontrollable pleural effusion, ascites, or pericardial effusion within 2 weeks prior to the first dose.\n6. Subjects who have symptomatic brain metastases or spinal cord compression. Subjects who have previously treated for brain metastases, if the clinical condition is stable and imaging evidence does not show disease progression within 4 weeks prior to the first dose and do not need corticosteroid treatment within 2 weeks prior to the first dose, can be enrolled.\n7. Subjects who have active bacterial or fungal infections (≥ Grade 2) that required systemic treatment within 14 days prior to the first dose.\n8. Subjects who participated in any other study in which receipt of an investigational new drug, or investigational device occurred within 28 days or 5 half-lives (whichever is shorter) of the first dose of the study drug.\n9. Receiving systemic steroid therapy (\\> 10 mg\u002Fday of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study drug.\n10. Subjects who have a chronic or active infection requiring systemic therapy.\n11. Subjects who have gastrointestinal disorders that will affect oral administration or the investigator judges that the absorption of IPG1094 will be interfered.\n12. Known or suspected allergy or hypersensitivity to any component of IPG1094.\n13. Subjects who received a diagnosis of, and\u002For tested positive at screening for human immunodeficiency virus (HIV).\n14. Subjects with positive Hepatitis B surface antigen \\[HBsAg\\] test, except for subjects who have negative HBsAg test and positive Hepatitis B core antibody \\[HBcAb\\] test combined with negative HBV DNA test at screening.\n15. Co-infection of hepatitis B virus (HBV) and hepatitis C virus (HCV), subjects with a history of HCV infection but who are negative for HCV RNA by PCR will be considered non-infected with HCV.\n16. Active other malignancy requiring treatment with the exception of any of the following:\n\n    * Adequately treated basal cell carcinoma;\n    * Squamous cell carcinoma of the skin, or in situ cervical cancer;\n    * Low-risk prostate cancer (i.e. Gleason score \\\u003C 7 and prostate specific antigen \\\u003C 10 ng\u002FmL); or\n    * Any other cancer from which the individual has been disease-free for ≥ 5 years.\n17. Subjects who have clinically significant cardiovascular diseases that occurred 6 months prior to enrollment. Cardiovascular diseases include, but not limited to follows:\n\n    * Acute myocardial infarction;\n    * Severe\u002Funstable angina;\n    * Cerebrovascular accident or transient ischemic attack;\n    * Congestive heart failure (New York Heart Association \\> Class II);\n    * Arrhythmias that require antiarrhythmic treatment except for beta blockers or digoxin;\n    * Repeated ECG with QTc interval ≥ 470 msec regardless of sex (corrected according to Fridericia's formula);\n    * High blood pressure that cannot be controlled by antihypertensive drugs (systolic blood pressure \\> 150 mm Hg, diastolic blood pressure \\> 100 mmHg).\n18. Subjects who are receiving warfarin (low-dose warfarin as 2 mg\u002Fday is acceptable); or receiving antiplatelet anticoagulant therapy (aspirin at dose ≥300 mg\u002Fday, clopidogrel at dose ≥75 mg\u002Fday).\n19. Major surgery or significant traumatic injury occurring within 28 days prior to the first dose of the study drug. If major surgery occurred \\> 28 days prior to the first dose of the study drug, the individual must have recovered adequately from the toxicity and\u002For complications from the intervention prior to the first dose of the study drug.\n20. Female subjects in pregnancy or lactation.\n21. Having difficulty in venous blood collection. Any other circumstances, in the opinion of the investigator, that may affect the subject's informed consent or adherence to the protocol, or that the subject's participation in the study may affect the outcome of the study or their own safety.",{"count":118,"type":22},60,[25,54],"This is a phase 1, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) characteristics and initial anti-tumor activity of IPG1094 in patients with advanced solid tumors. The study will be conducted in two parts: dose escalation phase (Part A) and expansion phase (Part B).",[122],"Solid Tumor","2025-09-22",{"date":125,"type":35},"2025-09-24",{"date":127,"type":35},"2024-07-11",{"date":129,"type":22},"2027-07-09",{"name":41,"class":42},2,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100450215","phase-1-phase12a-study-for-ipg7236-in-patients-with-advanced-solid-tumors-100450215","NCT05142592","Phase1\u002F2a Study for IPG7236 in Patients With Advanced Solid Tumors","A Phase 1\u002F2a, Multi-center, Non-randomized, Open-label, Dose-escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of IPG7236 Administered Orally as a Single Agent in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. A written informed consent must be signed prior to performing any study procedures.\n2. Male or females 18 years or older.\n3. Diagnosis of advanced or recurrent, histologically or cytologically confirmed, a solid malignancy that is either metastatic or unresectable.\n\n   * Part 1 Dose Escalation: all solid tumor types.\n   * Part 2 Dose Expansion: the following tumor types are tentatively planned for expansion. It may be modified based on the results from the dose escalation phase.\n\n     * Renal cancer\n     * Triple-negative breast cancer\n     * Head and neck cancer\n     * Melanoma\n4. Subjects must have failed established standard medical anti-cancer therapies for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for standard therapies on medical grounds.\n5. Subjects must demonstrate measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n6. Subjects must have a life expectancy of ≥ 3 months.\n7. Subjects must have an Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 1.\n8. Subjects must have adequate hematologic and organ function as indicated by the following laboratory values\n\n   1. Hematologic\n\n      * Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL.\n      * Platelet count ≥ 100×109\u002FL\n      * Hemoglobin ≥ 9 g\u002FdL (subjects that required transfusion or growth factor need to demonstrate stable hemoglobin for 7 days of 9 g\u002FdL)\n   2. Renal\n\n      • Estimated glomerular filtration rate（eGFR ）≥ 50 mL\u002Fmin OR serum creatinine ≤ 1.5 × upper limit of normal (ULN).\n   3. Hepatic\n\n      * Aspartate aminotransferase levels ≤ 3 ×ULN (if liver metastases are present, ≤ 5× ULN)\n      * Alanine aminotransferase levels ≤ 2.5 × ULN (if liver metastases are present, ≤ 5×ULN).\n      * Bilirubin ≤ 1.5 × ULN\n   4. Coagulation • Prothrombin time and activated partial thromboplastin time ≤ 1.5 × ULN\n9. Subjects must be able to swallow and retain orally administered medication.\n10. Patients must be willing and able to comply with all scheduled visits, treatment, laboratory tests, be able to take oral medication, and other requirements of the study\n11. Female patients of child-bearing potential must have a negative pregnancy test.\n12. Female patient who is of child-bearing potential is eligible to participate but must use an acceptable form of birth control method, including abstinence, hormonal contraception for at least 3 months in combination with a barrier method, intrauterine device (placement at least 3 months prior to screening), diaphragm with spermicide, cervical cap, condoms with contraceptive gel\u002Ffoam \u002Fcream, or surgical sterilization (tubal ligation at least 6 months prior to screening) or partner who had a vasectomy at least 6 months prior to screening\n13. Male patient with a female partner of child-bearing potential is eligible to participate but must be either documented to be surgically sterile (vasectomy), practicing complete abstinence for 90 days after study drug administration, or using two adequate forms of highly effective contraception (together with the female partner), one of which should be a physical barrier method, for 90 days after the study drug administration.\n\nExclusion Criteria:\n\n1. Subjects with primary malignancy of the central nervous system or malignancies related to human immunodeficiency virus (HIV) or solid organ transplant.\n2. Subjects who have not recovered from all toxic effects from prior antitumor therapy or surgical procedures, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 according to NCI CTCAE v5.0.\n3. Subjects with recent prior therapy defined as\n\n   1. Any investigational or Food and Drug Administration (FDA)-approved anti-cancer drug within 14 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.\n   2. Any radiotherapy, chemotherapy, targeted therapy or immunotherapy within 14 days or major surgery within 28 days or anti-neoplastic antibody or nitrosoureas\u002Fmitomycin C within 42 days prior to the first dose of study drug\n4. Subjects with any uncontrollable diseases (e.g., severe mental, neurological, cardiovascular, respiratory, and other systemic diseases) or obvious active infections that may affect the clinical study.\n5. Subjects with positive Coronavirus disease（COVID）-19 PCR tests (patients who recovered from COVID-19 but have positive COVID-19 PCR tests may be included at the judgment of the Investigator)\n6. Subjects who have received the live or attenuated vaccine within 4 weeks prior to study treatment or intend to receive a live or attenuated vaccine during the study\n7. Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of study treatment. History of known HIV infection.\n\n   Note:\n   1. Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative Hepatitis C RNA polymerase chain reaction (PCR) is obtained.\n   2. Subjects with well-controlled HIV may be enrolled if all the following criteria are met:\n\n      * must be stable on their anti-retroviral regimen, and participants must be healthy from an HIV perspective\n      * Participants must have a cluster of differentiation 4（CD4） count of greater than 250 cells\u002Fmicro litre（mcL ）over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count \\\u003C 200 cells\u002FmcL over the past 2 years unless it was deemed related to THE CANCER AND\u002FOR CHEMOTHERAPY-induced bone marrow suppression\n\n        \\- For patients who have received chemotherapy in the past 6 months, a CD4 count \\\u003C 250 cells\u002FmcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy\n      * Participants must have an undetectable viral load and a CD4 count \\>= 250 cells\u002FmcL within 7 days of enrollment\n      * Participants must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months. HIV-infected patients should be monitored every 12 weeks for viral load and CD4 counts\n8. Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent may be included at the judgment of the Investigator.\n9. Subjects with symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. Note: Subjects previously treated for these conditions that have had stable central nervous system (CNS) disease (verified with consecutive imaging studies) for \\>1 month, are asymptomatic and off corticosteroids, or are on a stable dose of corticosteroids for at least 1 month prior to study Day 1 are permitted. The stability of brain metastases must be confirmed with imaging. The subject treated with gamma knife therapy can be enrolled 2 weeks post-procedure as long as there are no post procedure complications or the subject is stable.\n10. Subjects with active upper digestive tract ulcer or other disorders that can affect drug absorption, distribution, metabolism or clearance.\n11. Subjects with a marked baseline prolongation of QT\u002Fcorrected QT interval（QTc） interval (e.g., repeated demonstration of a QTc interval \\>480 milliseconds (CTCAE grade 1) using Fridericia QT correction formula.\n12. Subjects using concomitant medications known to prolong the QT\u002FQTc interval.\n13. Pregnancy or breastfeeding female; Female patients must be surgically sterile or be postmenopausal, or must agree to the use of effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.\n14. Subjects who are unable to comply with study and follow-up procedures",{"count":140,"type":22},196,[25,54],"This is a Phase 1\u002F2a first-in-human, multi-center, non-randomized, open-label study to assess the safety, tolerability, pharmacokinetics profile, and preliminary anti-tumor activity of IPG7236 administered orally as a single agent to patients with advanced solid tumors.\n\nThe study will include a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2a).\n\nEach part will consist of a screening period of up to 28 days, a treatment period, an end of treatment visit and a safety follow-up of approximately 30 days after the last dose. IPG7236 will be given on an empty stomach (either one hour before or two hours after a meal) twice daily (approximately every 12±1 hours) in continuous 28-day cycles.",[144,145,146],"Safety Issues","Tolerability","Pharmacokinetics",{"date":125,"type":35},{"date":149,"type":35},"2021-11-15",{"date":151,"type":22},"2025-12-21",{"name":41,"class":42},7,""]