[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Suzhou Genhouse Bio Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":165},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,62,85,107,127,146],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100627291","phase-1-a-study-to-evaluate-safety-pk-and-efficacy-of-gh55-in-combination-with-gh21-in-patients-with-solid-tumors-100627291",false,"NCT07446725","A Study to Evaluate Safety, PK and Efficacy of GH55 in Combination With GH21 in Patients With Solid Tumors","Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Efficacy of GH55 Capsule in Combination With GH21 Capsule in Subjects With Locally Advanced or Metastatic Solid Tumors Harboring Aberrantly Activated MAPK Signaling Pathway.","Inclusion Criteria:\n\n* 1\\. Aged 18-80 years (inclusive), regardless of gender.\n* 2\\. Histologically or cytologically confirmed locally advanced or metastatic solid tumor with aberrantly activated MAPK signaling pathway (RAS\u002FRAF\u002FMEK\u002FERK).\n* 3\\. Failed standard treatment, has no standard treatment options, refuses standard treatment, or is not eligible for standard treatment at the current stage.\n* 4\\. Has at least one measurable tumor lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* 5\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* 6\\. Estimated survival time ≥ 3 months.\n* 7\\. Essential organ function is basically normal, with screening laboratory results meeting the following criteria:\n\n  * Hematological system (no blood transfusion or hematopoietic stimulants within 14 days)\n  * Absolute Neutrophil Count (ANC) ≥1.5×109\u002FL\n  * Platelet (PLT) ≥75×109\u002FL\n  * Hemoglobin (Hb) ≥90g\u002FL\n  * Liver function\n  * Albumin (ALB) ≥3.0g\u002FdL\n  * Total Bilirubin (TBIL) ≤1.5×Upper Limit of Normal (ULN); \\\u003Cbr\u002F\\>For patients with --Gilbert syndrome: ≤3×ULN\n  * Alanine Aminotransferase (ALT) ≤2.5×ULN; \\\u003Cbr\u002F\\>For patients with liver metastasis or liver cancer: ≤5×ULN\n  * Aspartate Aminotransferase (AST) ≤2.5×ULN; \\\u003Cbr\u002F\\>For patients with liver metastasis or liver cancer: ≤5×ULN\n  * Renal function\n  * Creatinine (Cr) ≤1.5×ULN\n  * Creatinine Clearance (Ccr) ≥50ml\u002Fmin (calculated by Cockcroft-Gault formula)\n  * Coagulation function\n  * Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN\n  * International Normalized Ratio (INR) ≤1.5×ULN\n  * Cardiac function\n  * Left Ventricular Ejection Fraction (LVEF) ≥50%\n  * Fridericia-corrected QT interval (QTcF) Male\\\u003C450ms; Female\\\u003C470ms\n* 8\\. Eligible patients of childbearing potential (male and female) must agree to use reliable contraceptive methods (hormonal, barrier, or abstinence) with their partners during the trial and for at least 3 months after the last dose; female patients of childbearing potential must have a negative serum pregnancy test within 1 week before the first dose.\n* 9\\. Must understand the study requirements, voluntarily sign a written informed consent form before the trial.\n\nExclusion Criteria:\n\n* 1\\. Received chemotherapy within 3 weeks, or radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before the first dose, except:\n* \\- Nitrosourea or mitomycin C: within 6 weeks before the first dose;\n* \\- Oral fluoropyrimidines, small-molecule targeted drugs, or traditional Chinese medicine with anti-tumor indications: within 2 weeks before the first dose;\n* \\- Local palliative radiotherapy: within 2 weeks before the first dose.\n* 2\\. Received other unmarketed clinical research drugs or treatments within 4 weeks before the first dose.\n* 3\\. Underwent major organ surgery (excluding needle biopsy) or suffered significant trauma within 4 weeks before the first dose.\n* 4\\. Used strong inhibitors or inducers of CYP3A4 or P-gp within 1 week before the first dose.\n* 5\\. Previously received other selective ERK inhibitors and\u002For SHP2 inhibitors.\n* 6\\. Previously received hematopoietic stem cell transplantation or organ transplantation.\n* 7\\. Adverse reactions from previous anti-tumor treatment have not recovered to NCI CTCAE v5.0 Grade ≤ 1 (except for toxicities judged by investigators to be safe, such as alopecia, Grade 2 peripheral neuropathy, or hypothyroidism stabilized with hormone replacement therapy).\n* 8\\. Symptomatic parenchymal brain metastasis or meningeal metastasis, deemed unsuitable for enrollment by investigators.\n* 9\\. Has an active infection requiring intravenous anti-infective treatment.\n* 10\\. Has a history of immunodeficiency, including positive HIV antibody test.\n* 11\\. Active hepatitis B (HBsAg positive and HBV-DNA \\> 500 IU\u002Fml, 1000 cps\u002Fml, or the study center's lower limit of detection \\[if higher\\]); antiviral therapy (excluding interferon) is allowed. Active hepatitis C (patients with positive HCV antibody but HCV-RNA \\\u003C the study center's lower limit of detection are eligible).\n* 12\\. Has a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n* \\- Severe cardiac arrhythmia or conduction abnormalities requiring clinical intervention (e.g., ventricular arrhythmia, third-degree atrioventricular block);\n* \\- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥ 3 cardiovascular and cerebrovascular events within 6 months before the first dose;\n* \\- New York Heart Association (NYHA) cardiac function class ≥ III;\n* \\- Clinically uncontrolled hypertension;\n* \\- Any factors increasing the risk of QTc prolongation or arrhythmia (e.g., heart failure, intractable hypokalemia, congenital long QT syndrome, family history of long QT syndrome, use of any known drugs that prolong the QT interval \\[see Appendix 8\\]).\n* 13\\. Has a history of other malignant tumors (except cured in situ cancers with no recurrence for 5 years, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, as deemed eligible by investigators; eligible in the dose escalation phase at the discretion of investigators).\n* 14\\. Has a history of retinal vein occlusion or central serous chorioretinopathy.\n* 15\\. Unable to swallow oral medications, or has conditions severely affecting gastrointestinal absorption (e.g., chronic diarrhea, intestinal obstruction) as judged by investigators.\n* 16\\. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently).\n* 17\\. Has a history of interstitial pneumonia within 6 months before the first dose, or any evidence of clinically active interstitial lung disease.\n* 18\\. Has aberrantly activated PI3K-mTOR pathway (including PI3K activating mutations, AKT activating mutations, and PTEN deletion or inactivation).\n* 19\\. Has known alcohol or drug dependence.\n* 20\\. Has a mental disorder or poor compliance.\n* 21\\. Has a history of severe allergies or allergies to multiple drugs.\n* 22\\. Is pregnant or lactating.\n* 23\\. Deemed unsuitable for the study by investigators for other reasons.","ALL","18 Years","80 Years",{"count":20,"type":21},152,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","GH55 Capsule is a novel, highly selective small molecule dual mechanism ERK1\u002F2 inhibitor. GH21 Capsule is a potent, orally active human SHP2 allosteric inhibitor. The combination of an ERK1\u002F2 inhibitor and an SHP2 inhibitor achieves a dual effect: synergistic upstream and downstream blockade of the aberrantly activated RTK MAPK signaling pathway, as well as complementation of resistance mechanisms.\n\nThis study will evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of GH55 Capsule in combination with GH21 Capsule in patients with advanced solid tumors with aberrantly activated MAPK signaling pathway, and investigate the efficacy of this combination regimen in the same patient population.",[28],"Advanced Solid Tumor Cancer","NOT_YET_RECRUITING","2026-02-25",{"date":32,"type":33},"2026-03-03","ACTUAL",{"date":35,"type":21},"2026-02-24",{"date":37,"type":21},"2029-12-31",{"name":39,"class":40},"Suzhou Genhouse Bio Co., Ltd.","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":41},"100617440","phase-2-phase-2-clinical-study-to-evaluate-the-efficacy-safety-tolerability-and-pharmacokinetics-of-gh21-capsules-combined-with-d-1553-tablets-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-with-the-krasg12c-mutation-100617440","NCT07318649","Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GH21 Capsules Combined With D-1553 Tablets in Subjects With Locally Advanced or Metastatic Solid Tumors With the KRASG12C Mutation","Inclusion Criteria:\n\n* 1)Patients or their legal representatives can understand and voluntarily sign a written informed consent form (before starting this study and any study procedures); 2)Age ≥ 18 years, male or female; 3)Cohort 1: Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer with KRASG12C mutation who have failed standard therapy or no standard therapy and have been treated with KRASG12C inhibitors; Cohort 2: Histologically or cytologically confirmed locally advanced or metastatic solid tumors (except non-small cell lung cancer) with KRASG12C mutation who have failed standard therapy or have no standard therapy and have been treated with KRASG12C inhibitors.\n\n  4)Patients must have at least one measurable lesion that meets the definition of RECISTv1.1 (tumor lesions located in previously irradiated areas or other locoregional treatment sites are generally not considered measurable unless there is definite progression of the lesion); 5)Expected survival ≥ 3 months; 6)ECOG performance score: 0-1; 7)Patients must have adequate organ function, defined as follows: Blood\n  * Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL without granulocyte colony-stimulating factor support within 14 days;\n  * Platelets≥100×109\u002FL without thrombopoietin (TPO) and interleukin-11 (IL-11) transfusion within 14 days;\n  * Hemoglobin ≥ 90 g\u002FL without transfusion within 14 days and without erythropoietin (EPO); Renal\n  * Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 ml\u002Fmin calculated using the modified Cockcroft-Gault equation or eGFR ≥ 60 ml\u002Fmin estimated by the MDRD equation; Liver\n  * Albumin ≥ 3.0 g\u002FdL;\n  * Total bilirubin ≤ 1.5 × ULN; in case of liver metastasis, total bilirubin ≤ 2.5 × ULN;\n  * AST\u002FALT ≤ 2.5 × ULN; in case of liver metastasis, AST\u002FALT ≤ 5 × ULN; Coagulation\n  * International normalized ratio (INR) and prothrombin time (PT) ≤ 1.5 × ULN unless the patient is receiving anticoagulant therapy (INR \\\u003C 2.5 × ULN) and PT or PTT is within the therapeutic range of the intended use of anticoagulants;\n  * Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN unless the patient is receiving anticoagulant therapy (APTT \\\u003C 2.5 × ULN) and PT or PTT is within the therapeutic range of the intended use of anticoagulants.\n\n    8)Men of childbearing potential and women of childbearing potential must agree to practice reliable contraception (hormonal or barrier methods or abstinence) from signing of informed consent until 6 months after the last dose of study drug. Females of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of study drug.\n\nExclusion Criteria:\n\n* 1)Patients who have received chemotherapy, biological agents for anti-tumor therapy within 3 weeks before the first dose, radiotherapy, endocrine therapy and other anti-tumor drugs within 4 weeks before the first dose, except for the following:\n\n  * nitrosourea or mitomycin C within 6 weeks before the first use of study drugs;\n  * oral fluorouracil, small molecule targeted drugs and Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 5 half-lives or 2 weeks before the first use of study drugs (whichever is shorter);\n  * Local palliative radiotherapy within 2 weeks before the first use of study drugs; 2)Receiving other unmarketed investigational drugs or treatments within 5 half-lives or 4 weeks (whichever is shorter) before the first dose; 3)Patients who underwent major organ surgery (excluding needle biopsy) or had significant trauma within 4 weeks before the first dose, or required elective surgery during the trial; 4)Use of strong inhibitors or strong inducers of CYP3A4 or P-gp within 2 weeks or 5 half-lives before the first dose; 5)Previous treatment with other SHP2 inhibitors. 6)Evidence of the following cardiac diseases: acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose;\n  * Grade III-IV heart failure according to New York Heart Association functional classification at screening;\n  * left ventricular ejection fraction (LVEF)≤50% by echocardiography (ECHO) at screening;\n  * Fridericia-corrected QT interval (QTcF)≥450 ms (male) and≥470 ms (female) at screening;\n  * poorly controlled hypertension (systolic blood pressure≥160 mmHg and\u002For diastolic blood pressure≥100 mmHg) after drug therapy at screening; 7)Dysphagia or gastrointestinal diseases or other malabsorption conditions affecting drug absorption, such as intestinal obstruction, Crohn 's disease, ulcerative colitis, short bowel syndrome, gastric emptying disorder or severe gastrointestinal related toxicity before the first dose and not recovered to less than grade 2; or confirmed to have clinically significant or acute gastrointestinal diseases; 8)Uncontrolled pleural effusion, pericardial effusion or pleural effusion requiring repeated drainage (once a month or more frequently); 9)Patients with active brain metastases or with symptoms of active central nervous system metastases including headache, vomiting and vertigo are eligible only if all of the following criteria are met, and asymptomatic patients with CNS lesions treated or untreated are eligible: • Measurable lesions located outside the CNS as determined by RECISTv1.1;\n  * Stable brain metastases after treatment are defined as no evidence of disease progression or bleeding within 28 days before the start of treatment, and steroid hormones and other therapeutic agents are discontinued for at least 14 days before enrollment; 10)patients with interstitial pneumonia within 6 months before the first dose, or any evidence of clinically active interstitial lung disease; 11)Hyperarterial\u002Fvenous thrombotic events within 6 months before the first dose, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism; 12)Patients with a history of other malignant tumors (cured skin squamous cell carcinoma in situ, basal cell carcinoma and cervical carcinoma in situ that have not recurred for 5 years, unless the investigator believes that they can be enrolled; in the dose escalation stage, unless the investigator believes that they can be enrolled); 13)Patients who have a history of severe allergy, or have a history of allergy to test drugs\u002Fany excipients\u002Fcombination therapy drugs, or have a history of allergy to multiple drugs; 14)Hepatitis B virus infection (HBsAg positive and DNA copy number \\> 1000 IU\u002Fml); or hepatitis C virus infection (HCV antibody positive, HCV RNA \\> upper limit of normal); or human immunodeficiency virus infection (HIV antibody positive); 15)Active infection (≥ Grade 2) requiring anti-infective treatment or fever of unknown origin exceeding 38℃ within 28 days before the first dose; 16)autoimmune diseases in the active stage as judged by the investigator within 28 days prior to the first dose; 17)Any toxicity caused by previous anti-tumor treatment before the first dose has not recovered CTCAE 5.0 grade evaluation ≤ 1 (unless alopecia, grade 2 peripheral neuropathy and\u002For other adverse events ≤ grade 2 that do not pose a safety risk); 18)Pregnant or lactating women; 19)The investigator considers that there are any clinical or laboratory abnormalities or other reasons that make the subject unsuitable to participate in this clinical study.",{"count":49,"type":21},120,[25],"The study is divided into 2 cohorts, Cohort 1 is patients with KRASG12C mutated non-small cell lung cancer who have failed standard therapy or no standard therapy and have been treated with KRASG12C inhibitor; Cohort 2 is patients with KRASG12C mutated solid tumors (except non-small cell lung cancer) who have failed standard therapy or have no standard therapy and have been treated with KRASG12C inhibitor. Each cohort consists of two stages, and 10 subjects are planned to be enrolled in the first stage of each cohort. According to the preliminary efficacy and safety data, each party will discuss and decide whether to continue the second stage. Twenty to fifty subjects were planned to be enrolled in Stage II of each cohort. A total of 20-120 subjects were enrolled.\n\nScreened eligible subjects received GH21 in combination with D-1553 in 21-day cycles until the investigator considered the subject no longer benefiting, or the subject developed intolerable toxicity, or the subject withdrew consent, or the subject died, or was lost to follow-up, or received a new anticancer treatment, whichever came first.",[53],"Locally Advanced or Metastatic Solid Tumors","2026-01-04",{"date":56,"type":33},"2026-01-06",{"date":58,"type":21},"2025-12-30",{"date":60,"type":21},"2027-06-30",{"name":39,"class":40},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100577315","phase-1-a-phase-iaib-clinical-study-of-gh56-capsules-in-subjects-with-mtap-deleted-advanced-solid-tumors-100577315","NCT06796699","A Phase Ia\u002FIb Clinical Study of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors","A Multi-center, Single-Arm, Open-Label Phase Ia\u002FIb Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Willing to participate in the clinical trial, understand and sign the informed consent, and comply with the study visits and procedures.\n* 2\\. Men or women ≥18 years old.\n* 3\\. Men or women with MTAP-Deleted Advanced Solid Tumors.\n* 4\\. Subjects with solid tumors must have at least one evaluable lesion which should be measurable by RECIST v1.1.\n* 5\\. Eastern Cooperative Oncology Group (ECOG) performance status (Table 12) 0 to 1.\n* 6\\. Survival expectations ≥ 12 weeks.\n* 7\\. Subjects with adequate organ function and the laboratory test critera.\n* 8\\. Serum pregnancy test (for female of childbearing potential) negative within 7 days prior to first dosing of study treatment. Male and female subjects of childbearing potential must agree to use effective methods of contraception from the time of ICF signed, throughout the study and for 6 months after the last dose of the investigational product. A patient is of childbearing potential if, in the opinion of the Investigator, he\u002Fshe is biologically capable of having children and is sexually active.\n\nExclusion Criteria:\n\n* 1\\. Subject has not recovered from a prior surgical procedure or has undergone any major surgery within 4 weeks prior to the first dose.\n* 2\\. Known (including suspected) allergic to GH56 or its components.\n* 3\\. Has received any anti-tumor agents within 28 days without delayed toxicity for the treatment of advanced tumors prior to the first administration of GH56 Capsule or has received radiation therapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor drug treatments within 28 days prior to the first administration of GH56 Capsule, or other anti-tumor drugs or treatments within the following interval before the first administration of GH56 Capsule.\n* 4\\. Has symptomatic or active progressive central nervous system (CNS) metastases such as molluscum contagiosum metastases.\n* 5\\. Subjects who have difficulty in swallowing and have a history of gastrointestinal surgery or other relevant medical disorders that may interfere with the absorption of GH56.\n* 6\\. Subjects had a malignant tumor other than the current tumor within 5 years prior to the first administration of GH56 Capsule, except for localized cancers that have been apparently cured or without disease progression or recurrence for at least 5 consecutive years.\n* 7\\. Uncontrolled or significant cardiovascular disease\n* 8\\. Subjects with documented positive virology status of hepatitis, as confirmed by Screening hepatitis B virus (HBV) and hepatitis C virus (HCV) tests, Human Immunodeficiency Virus (HIV).\n* 9\\. Conditions that the investigator considers inappropriate for participation in this clinical trial.",{"count":70,"type":21},90,[24],"This is a multicenter, single-arm, open-label, dose-escalation, dose-expansion study to evaluate the safety, tolerability, PK\u002FPD, and preliminary anti-tumor activity of GH56 Capsule in subjects with advanced solid tumors who have failed or are intolerant in standard treatment, or have no standard therapy. The clinical trial will be carried out in two parts: phase Ia study (dose escalation study) and phase Ib (dose expansion study).",[74],"Advanced Solid Tumors With MTAP Gene Deletion","RECRUITING","2025-03-25",{"date":78,"type":33},"2025-03-28",{"date":80,"type":33},"2025-03-07",{"date":82,"type":21},"2028-02-29",{"name":39,"class":40},4,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100539639","phase-1-a-phase-ibii-clinical-study-of-gh21-capsules-combined-with-osimertinib-mesylate-tablets-in-patients-with-nsclc-100539639","NCT06306456","A Phase Ib\u002FII Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC","A Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Oral Administration of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With Advanced NSCLC With EGFR Mutations","Inclusion Criteria:\n\n1. Subjects or their legal representatives can understand and voluntarily sign the written ICF (before the start of screening and any study procedures);\n2. Male or female subjects aged ≥18 years;\n3. Advanced NSCLC patients with EGFR mutations confirmed by cytological or histological assessments, and meet the following requirement:\n\n   * Phase Ib： patients with disease progression previously at least treated with third-generation EGFR-TKIs and platinum-containing chemotherapy;\n   * Phase IIa and IIb：patients with disease progression previously at least treated with a third-generation EGFR-TKIs (Osimertinib, Furmonertinib Almonertinib etc.).\n4. Patients have at least one measurable lesion as defined by RECIST v1.1 (a tumor lesion in the area that has undergone radiotherapy or other loco-regional therapies, is generally not considered as measurable unless there is a disease progression in the lesion);\n5. Consent to provide samples for genetic testing;\n6. Life expectancy of ≥ 3 months;\n7. ECOG PS score of 0-1;\n8. The subjects must have adequate organ functions;\n9. Male and female of reproductive potential must agree to take reliable contraceptive measures (hormone or barrier methods or abstinence) from signing the ICF until 30 days after the last dose. Pregnancy test results must be negative for female of reproductive potential within 7 days prior to the first dose of the investigational product.\n\nExclusion Criteria:\n\n1. Subjects who receive any chemotherapy or antitumor biologics within 3 weeks, or antitumor therapies such as radiotherapy and endocrine therapy within 4 weeks prior to the first dose of the investigational product, except for the following:\n\n   * Use of nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational product;\n   * Oral administration of fluorouracils, small molecule targeted drugs, and Chinese herbal medicines or Chinese patent medicines with antitumor indications within 5 half-lives or 2 weeks before the first dose of the investigational product (whichever is shorter);\n   * Small molecule TKI inhibitors within 5 half-lives or 2 weeks prior to the first dose of the investigational product (whichever is shorter);\n   * Local palliative radiotherapy within 2 weeks prior to the first dose of the investigational product;\n2. Subjects who have had another investigational new drug or therapy within 4 weeks prior to the first dose of the investigational product;\n3. Subjects who have had a major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose of the investigational product, or require an elective surgery during the study;\n4. Subjects who have received strong CYP3A4 inhibitors or inducers and strong P-gp inhibitors or inducers within 2 weeks or within 5 half-lives (whichever is longer) prior to the first dose of the investigational product;\n5. Subjects with evidence of the following heart conditions:\n\n   * Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months prior to the first dose of the investigational product;\n   * Grade III-IV heart failure diagnosed according to the cardiac function classification of the New York Heart Association at screening;\n   * Echocardiography (ECHO) shows the left ventricular ejection fraction (LVEF) ≤ 50% at screening;\n   * QT interval corrected by Fridericia method (QTcF) is ≥ 450 ms (male) or ≥ 470 ms (female) at screening;\n   * Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg) despite of medication treatment at screening;\n6. Subjects with dysphagia, gastrointestinal disorders that affect drug absorption, or other malabsorption conditions, such as intestinal obstruction, Crohn's disease, ulcerative colitis, short bowel syndrome, delayed gastric emptying, or severe gastrointestinal toxicities that have not resolved to Grade 2 or lower prior to the first dose of the investigational product; or subjects are diagnosed with a clinically significant or acute gastrointestinal disease;\n7. Subjects with poorly controlled clinical pleural ascites assessed by the investigator;\n8. Subjects with active central nervous system metastasis and\u002For carcinomatous meningitis (e.g., brain metastases accompanied by central nervous system symptoms, including headache, vomiting and dizziness, etc.);\n9. Subjects with interstitial pneumonia, or any evidence of clinically active interstitial lung disease within 6 months before the first dose of the investigational product;\n10. Subjects with a history of other malignancies (excluding those deemed eligible by the investigator, such as skin squamous cell carcinoma in situ, basal cell carcinoma, and cervical cancer in situ that have been cured and have not relapsed for 5 years; or subjects deemed eligible by the investigator in Phase Ib);\n11. Subjects with a history of severe allergies, a history of allergies to Osimertinib, or to multiple drugs;\n12. Subjects with hepatitis B virus infection (HBsAg positivity and DNA copies \\\u003C 100 IU\u002FmL); or hepatitis C virus infection (HCV antibody positivity, and HCV RNA \\> ULN); or human immunodeficiency virus infection (HIV antibody positivity);\n13. Subjects with active infections requiring anti-infective treatment (Grade ≥ 2) or fever \\> 38°C of unknown etiology within 28 days prior to the first dose of the investigational product;\n14. Subjects with any toxicity caused by a previous antitumor therapy that has not resolved to Grade ≤ 1 according to CTCAE 5.0 (except for alopecia, Grade 2 peripheral neuropathy, and\u002For other Grade ≤ 2 AEs of insignificant safety risks) before the first dose of the investigational product;\n15. Female subjects who are pregnant or breastfeeding;\n16. Subjects who are not suitable for this study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.",{"count":93,"type":21},94,[24,25],"This study, including phase Ib , phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations.",[97],"Non-Small Cell Lung Cancer With EGFR Mutation","2024-07-04",{"date":100,"type":33},"2024-07-08",{"date":102,"type":33},"2024-03-05",{"date":104,"type":21},"2026-12-31",{"name":39,"class":40},6,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":4},"100549548","phase-1-gh21-combined-with-d-1553-in-kras-g12c-mutant-advanced-solid-tumors-100549548","NCT06435455","GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors","A Phase Ib\u002FII Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GH21 Capsule Combined With D-1553 Tablets in Patients With Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation","Inclusion Criteria:\n\n* The patient or his legal representative is able to understand and voluntarily sign a written informed consent (before commencing this study and any research procedure);\n* Age ≥18 years old, male or female;\n* KRAS G12C mutant advanced solid tumor;\n* ECOG Performance Status of 0 or 1\n* At least one measurable lesion as defined by RECIST 1.1\n\nExclusion Criteria:\n\n* acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months before first administration; Grade III-IV heart failure based on the New York Heart Association Cardiac Function Scale at screening; During screening, echocardiography (ECHO) showed left ventricular ejection fraction (LVEF) ≤50%;\n* Patients who have a history of severe allergy, or have a history of allergy to the experimental drug\u002Fany excipient\u002Fcombination drug, or have a history of allergy to multiple drugs;\n* There is an active infection (≥ grade 2) requiring anti-infective treatment or an unexplained fever exceeding 38 ° C within 28 days before the first dose;\n* Any toxicity from previous antitumor therapy prior to initial administration has not returned to CTCAE 5.0 rating ≤ Class 1 (unless hair loss, grade 2 peripheral neuropathy, and\u002For other grade ≤2 adverse events that do not pose a safety risk);\n* Pregnant and lactating women;\n* The investigator considers that there are any clinical or laboratory abnormalities or other reasons to be unsuitable for participating in this clinical study.",{"count":115,"type":21},126,[24,25],"This s a multi-center, open-label phase Ib\u002FII study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GH21 combined with D-1553 in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation.",[119],"Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation","2024-07-03",{"date":100,"type":33},{"date":123,"type":21},"2024-07-01",{"date":125,"type":21},"2027-12-31",{"name":39,"class":40},{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":41},"100541388","phase-1-a-phase-iaib-study-of-gh2616-tablet-in-subjects-with-advanced-solid-tumors-100541388","NCT06329206","A Phase Ia\u002FIb Study of GH2616 Tablet in Subjects With Advanced Solid Tumors","A Phase Ia\u002FIb Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of GH2616 Tablet in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n* Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:\n\n  1. Men or women ≥18 years old.\n  2. The following two points are evaluated by the Investigator and are deemed suitable to participate in the study: a. The subject fully understands the requirements of the study and voluntarily signs the written informed consent; b. Be able to comply with the medication requirements of the study and all study related procedures and evaluations.\n  3. Meeting the requirements of tumor types shown below:\n\n     Phase Ia Study:\n\n     Subjects with a histological or cytological diagnosis of recurrent or metastatic advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy. The specific tumor types include but not limited to high-grade serous ovarian cancer (HGSOC), uterine carcinosarcoma (UCS), lung adenocarcinoma (LUAD), lung squamous cell carcinoma (LUSC), triple-negative breast cancer (TNBC), bladder urothelial carcinoma (BLCA), colorectal cancer (CRC), etc.\n\n     Phase Ib study:\n\n     Dose expansion study (Phase Ib): Subjects with a histological or cytological diagnosis of recurrent or metastatic advanced solid tumors harboring TP53 mutation and WGD+ who have failed or are intolerant to standard treatment, or have no standard therapy.\n\n     The specific tumor types include but not limited to high-grade serous ovarian cancer (HGSOC), uterine carcinosarcoma (UCS), lung adenocarcinoma (LUAD), lung squamous cell carcinoma (LUSC), triple-negative breast cancer (TNBC), bladder urothelial carcinoma (BLCA), colorectal cancer (CRC), etc.. Note: The specific tumor types\u002Fbasket design with specific gene(s) will be determined by the principal Investigator and the Sponsor based on the Phase Ia study results.\n  4. Survival expectations are ≥ 12 weeks.\n  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (Appendix 1).\n  6. Subjects with advanced solid tumors have at least one evaluable lesion according to RECIST 1.1 (Appendix 2).\n  7. Subjects with adequate organ function at the time of screening (requiring no blood transfusion, no use of hematopoietic stimulating factor or human albumin within 14 days prior to screening), specifically defined as:\n\n     1. Blood routine: Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; Platelet count (PLT) ≥100×109\u002FL; Hemoglobin (HGB) ≥ 90 g\u002FL (9 g\u002FdL);\n     2. Liver function: Serum Total bilirubin (TBIL) ≤ 1.5 Upper limit of normal value (ULN), and serum TBIL≤ 3×ULN in patients with liver metastasis or confirmed Gilbert syndrome. Alanine aminotransferase (ALT) and Aspartate transferase (AST) ≤ 2.5×ULN in subjects without liver metastasis; ALT or AST≤ 5×ULN in subjects with liver metastasis;\n     3. Renal function: estimated creatinine clearance (CLcr) ≥ 60 mL\u002Fmin as calculated using Cockcroft-Gault formula (Appendix 3);\n     4. Coagulation function: Activated Partial thromboplastin Time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN (or within target range if on anticoagulation therapy);\n     5. Cardiac function: Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) \\> 50%.\n  8. Serum pregnancy test (for female of childbearing potential) negative within 7 days prior to first dosing of study treatment. Male and female subjects of childbearing potential must agree to use effective methods of contraception throughout the study and for 3 months (male) or 6 months (female) after the last dose of the investigational product. A subject is of childbearing potential if, in the opinion of the Investigator, he\u002Fshe is biologically capable of having children and is sexually active.\n\nExclusion Criteria:\n\n* In Phase Ia and Ib studies, subjects will be excluded if they meet any of the following criteria:\n\n  1. Has received chemotherapy within 21 days prior to the first administration of GH2616 Tablet or has received radiation therapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor drug treatments within 28 days prior to the first administration of GH2616 Tablet, or other anti-tumor drugs or treatments within the following interval before the first administration of GH2616 Tablet: Nitrosoureas or mitomycin C within 6 weeks prior to the first administration of the investigational drug. Oral fluoropyrimidines, small molecule targeted therapies, and Chinese herbal medicines with indications for anti-tumor within 14 days prior to the first administration of the investigational drug. Local palliative radiation therapy within 14 days prior to the first administration of the investigational drug.\n  2. Has received other investigational drugs or treatments not yet approved for marketing within 28 days prior to the first administration.\n  3. Acute toxic effects of prior anti-tumor therapy have not recovered to clinically significant NCI-CTCAE V5.0 grade ≤ 1 toxicity or baseline specified in the inclusion criteria within 28 days prior to the first administration of GH2616 Tablet (excluding toxicities such as alopecia and fatigue that the Investigator deems to have no safety risk).\n  4. At rest, the average Corrected QT interval (QTc, Fridericia's correction formula used) obtained by 12-lead Electrocardiograph (ECG) examination is \\> 450 ms for males or 470 ms for females (confirmed by repeated examinations). A variety of clinically significant arrhythmia, conduction, and resting ECG abnormalities, such as complete left bundle branch block, degree III, degree II, PR interval \\>250 ms. Various factors that may increase the risk of prolonged QTc or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, a family history of long QT syndrome in a direct family member or sudden unexplained death before age 40, and use of any medications known to prolong QT intervals.\n  5. Has evidence of infectious diseases:\n\n     1. Active hepatitis B (hepatitis B surface antigen (HbsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV-DNA) \\> 500 IU\u002Fml or 1000 cps\u002Fml or lower limit of detection at the study site \\[only if lower limit of detection at the study site is higher than 500 IU\u002Fml or 1000 cps\u002Fml\\]), antiviral therapy other than interferon is allowed; active hepatitis C (subjects with hepatitis C virus (HCV) antibody positive but hepatitis C virus ribonucleic acid (HCVRNA) \\\u003C lower limit of detection at the study site are allowed to be enrolled);\n     2. HIV infected patients (HIV 1\u002F2 antibody positive detected by antigen\u002Fantibody test); Considering that HIV infections can be chronically managed, expanding cancer clinical trial eligibility to be more inclusive of patients with HIV infections is justified in many cases, and may accelerate the development of effective therapies in cancer patients with these chronic infections. Therefore, well-controlled HIV patients who have been on established antiretroviral therapy (ART) for at least four weeks and have an HIV viral load less than 400 copies\u002FmL prior to enrollment should be included. Note: patients who are using ART drugs that are prohibited or cautious concomitant medications specified in the protocol (e.g. strong inhibitors or strong inducers of P-gp) could be switched to an alternate effective ART regimen (with minimal drug-drug interaction potential) before study participation or should be excluded from the study if their regimen cannot be altered.\n     3. Known active syphilis infection.\n  6. Has symptomatic or active central nervous system (CNS) metastases. Treated or untreated asymptomatic patients with CNS lesions are eligible only if all of the following criteria are met:\n\n     1. Presence of measurable lesions outside the CNS as determined by RECIST 1.1.\n     2. No history of intracranial or spinal hemorrhage.\n     3. No stereotactic radiation therapy or whole brain radiation therapy or neurosurgical resection within 28 days prior to initiation of study treatment.\n     4. No continuous use of corticosteroids during CNS disease treatment period.\n     5. Metastases limited to the cerebellum or supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).\n     6. No evidence of intermediate progression between completion of CNSdirected therapy (if given) and initiation of study treatment.\n  7. Concurrent diseases that have not been controlled, such as:\n\n     1. Severe infection, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications, occurs within 28 days prior to initiation of study treatment; Or patients who received therapeutic oral or intravenous antibiotics within 14 days prior to starting study treatment; Subjects receiving prophylactic antibiotics for needle biopsy can be included.\n     2. Heart failure consistent with New York Heart Association Grades ≥ II within 6 months prior to initiation of study treatment.\n     3. Other malignancies (other than in situ cancers such as non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, breast\u002Fcervical carcinoma in situ, superficial bladder carcinoma that have received radical treatment and no evidence of disease recurrence, etc.) within 5 years prior to initiation of treatment.\n     4. Current subjects with cancerous meningitis, spinal cord compression, etc..\n     5. Has a history of poorly controlled hypertension within 28 days prior to initiation of study treatment, defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg, despite treatment with multiple antihypertensive medications.\n     6. Any arterial thromboembolic event, including myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months prior to initiation of study treatment.\n     7. Significant malnutrition, such as the need for intravenous nutrient supplementation. Those who were stable for more than 28 days after correction of malnutrition before treatment of first dose of investigational product could be included.\n     8. Tumor invasion of surrounding important organs or blood vessels (such as mediastinal great vessels, superior vena cava, trachea, esophagus, etc.), or at risk of esophagotracheal fistula or esophagopleural fistula.\n     9. After endoesophageal or tracheal stent implantation.\n     10. Has a history of gastrointestinal perforation and\u002For fistula 6 months prior to initiation of study treatment.\n     11. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (monthly or more frequent).\n     12. Uncontrolled tumor-related pain, or no stable pain regimen.\n  8. Allergic to GH2616 Tablet or its components.\n  9. Significant impairment of oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction, etc..\n  10. Has severe lung disease or history, such as moderate to severe chronic obstructive pulmonary disease (COPD), evidence of interstitial lung disease (ILD)\u002Fpneumonitis on baseline imaging, history of ILD, drug-induced ILD, acute or chronic infectious pneumonia, lung transplantation, etc..\n  11. Use of strong inhibitors or inducers of P-glycoprotein (P-gp) within 14 days or 5 halflives (whichever is longer) before the first administration (refer to Appendix 5).\n  12. Use of sensitive narrow therapeutic index CYP3A4 substrate within 14 days or 5 halflives (whichever is longer) before the first administration (refer to Appendix 4).\n  13. Pregnant or lactating women.\n  14. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n  15. Has a major surgical procedure (craniotomy, thoracotomy, laparotomy, vascular intervention) within 28 days prior to the first administration, or had an unhealed wound, ulcer, or fracture. Note: For palliative care purposes, local surgical treatment of isolated lesions is acceptable.\n  16. Has a clear history of mental disorder with ongoing treatment.\n  17. Has a treatment history of KIF18A inhibitor.\n  18. Subjects with POLE gene hotspot mutated, or hypermutator phenotype.\n  19. In the opinion of the Investigator, there are other factors that the subject is unsuitable for participation in this clinical study.",{"count":135,"type":21},156,[24],"This is a Phase Ia\u002FIb, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics (PD) and preliminary efficacy of GH2616 Tablet in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib).",[139],"Advanced Solid Tumors",{"date":100,"type":33},{"date":142,"type":33},"2024-03-20",{"date":144,"type":21},"2026-09-01",{"name":39,"class":40},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":41},"100539941","phase-1-gh55-for-advanced-cancers-with-mapk-mutations-a-study-on-safety-and-early-results-100539941","NCT06310382","GH55 for Advanced Cancers With MAPK Mutations: A Study on Safety and Early Results","A Phase I\u002FII Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of GH55 in Patients Harboring MAPK Pathway Mutations in Advanced Solid Tumors","Inclusion Criteria:\n\nSubjects must meet all the following inclusion criteria to be qualified for study enrollment:\n\n1. Male or female subjects aged 18-80 years (inclusive).\n2. Patients with histologically or cytologically confirmed MAPK mutant (presence of RAS\u002FRAF\u002FMEK\u002FERK mutations) locally advanced or metastatic solid tumors.\n3. Patients who have failed standard treatment or have no standard treatment regimen or are not suitable for standard treatment currently.\n4. Dose escalation: At least one assessable tumor lesion according to RECIST version 1.1; Dose expansion: At least one measurable tumor lesion according to RECIST version 1.1 (tumor lesion located in the region of previous radiotherapy or other locoregional treatment sites is usually not considered a measurable lesion, unless this lesion shows clear progression or persists for 3 months after radiotherapy).\n5. Eastern Cooperative Oncology Group (ECOG) performance status score: Phase I dose escalation: 0-1. Phase II dose expansion: 0-2.\n6. 3 months or longer expected survival.\n7. Major organs are functioning normally, and laboratory tests meet the following criteria during the screening period.\n\nHematological system (has not received any blood transfusion or hematopoietic stimulating factor therapy within the past 14 days) Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL Platelet Count (PLT) ≥ 75 × 109\u002FL Hemoglobin (Hb) ≥ 90 g\u002FL Liver function Albumin (ALB) ≥ 3.0 g\u002FdL Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) Liver metastasis or liver cancer patients: ≤ 2.5 × ULN Alanine Aminotransferase (ALT) ≤ 2.5 × ULN; Liver metastasis or liver cancer patients: ≤ 5 × ULN Aspartate aminotransferase (AST) ≤ 2.5 × ULN; Liver metastasis or liver cancer patients: ≤ 5 × ULN Renal function Creatinine clearance rate (Ccr) ≥ 60 mL\u002Fmin (calculated based on the Cockcroft-Gault formula) Coagulation function Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 × ULN Cardiac function Left ventricular ejection fraction (LVEF) ≥ 50% QT interval corrected by the Fridericia formula (QTcF) Males \\\u003C 450 ms, Females \\\u003C 470 ms 7. Qualified patients (male and female) with childbearing potential must agree to use reliable contraceptives (hormone or barrier or abstinence) with their partners during the study and until at least 3 months after the last dose; female patients with childbearing potential must be negative for the blood pregnancy test within 1 week before the first dose.\n\n8\\. Subjects must give informed consent to the study and voluntarily signed the informed consent form prior to study initiation.\n\nExclusion Criteria:\n\nSubjects who meet any one of the following exclusion criteria are not eligible for study enrollment:\n\n1. Received antitumor therapy such as chemotherapy within 3 weeks before the first dose, radiotherapy, biotherapy, endocrine therapy, targeted therapy, and immunotherapy within 4 weeks before the first dose, except for the following:\n\n   * Use of nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug;\n   * Use of oral fluorouracil(s), small molecule targeted drugs, and antitumor traditional Chinese medicine within 2 weeks prior to the first dose of the investigational drug;\n   * Local palliative radiotherapy within 2 weeks prior to the first dose of the investigational drug.\n2. Received other unmarketed clinical investigational drug or therapy within 4 weeks prior to the first dose.\n3. Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 4 weeks prior to the first dose or requires selective surgery during the study period.\n4. Use of strong CYP3A4 inhibitors or inducers within 1 week prior to the first dose of the investigational drug.\n5. Previously received other selective ERK inhibitors.\n6. Previously received allogeneic HSCT or organ transplantation.\n7. Adverse drug reactions of previous antitumor treatment have not recovered to grade ≤ 1 as per CTCAE version 5.0 (except for toxicity without safety risk judged by the investigator, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism that is stable after hormone replacement therapy).\n8. Brain parenchymal metastasis or meningeal metastasis with clinical symptoms unsuitable for study participation as judged by the investigator.\n9. Patient with active infection and currently requires intravenous anti-infective therapy.\n10. History of immunodeficiency, including being positive for HIV antibody test.\n11. Active hepatitis B \\[HBsAg positive and HBV-DNA \\> 500 IU\u002FmL or LLQ of the study site (when the LLQ is \\> 500 IU\u002FmL)\\], for which antiviral therapies other than interferon are permitted; Active hepatitis C (patients who are positive for HCV antibody but whose HCV-RNA is \\\u003C study site LLQ can be included).\n12. History of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n    * Severe abnormalities in cardiac rhythm or conduction, such as ventricular arrhythmia or second- or third-degree atrioventricular block requiring clinical intervention;\n    * Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or greater cardiovascular and cerebrovascular events within 6 months prior to the first dose;\n    * New York Heart Disease Association (NYHA) class ≥ III cardiac function or left ventricular ejection fraction (LVEF) \\\u003C 50%;\n    * Clinically uncontrolled hypertension;\n    * Any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia that is difficult to correct, congenital long QT syndrome, family history of long QT syndrome, and use of concomitant medication known to prolong QT interval.\n13. History of other malignant tumors (except for the cured squamous cell carcinoma in situ of the skin, basal cell carcinoma, and cervical carcinoma in situ that have not recurred within 5 years and are considered acceptable for study enrollment by the investigator; except for patients who are considered acceptable for enrollment by the investigator in the dose escalation study).\n14. History of retinal vein occlusion or central serous retinopathy, or patients with clinically significant abnormalities in the ophthalmological examination during the screening period and judged by the investigator to be unsuitable for enrollment.\n15. Unable to swallow medication or has conditions that severely impact gastrointestinal absorption (e.g. Chronic diarrhea or intestinal obstruction) as judged by the investigator.\n16. Clinically uncontrolled third space effusion judged by the investigator to be unsuitable for enrollment.\n17. Patients with current interstitial lung disease (except radiation-induced pulmonary fibrosis that does not required hormone therapy).\n18. Known alcohol or drug dependence.\n19. Mental disorder or poor compliance.\n20. Previous history of severe allergy, or allergy to any active or non-active ingredients of the investigational drug.\n21. Pregnant or lactating women.\n22. Other conditions judged by the investigator that render the subject unsuitable for participation.",{"count":154,"type":21},110,[24,25],"This is a multi-center, open-label, dose escalation phase I and dose expansion phase II study aimed to evaluate the safety, tolerability, PK and PD profiles as well as to observe the efficacy of GH55 in patients with MAPK mutant advanced solid tumors.\n\nThis study is divided into two parts, namely the dose escalation phase I study and the dose expansion phase II study.",[158],"Advanced Solid Tumors With MAPK Signal Pathway Mutations",{"date":100,"type":33},{"date":161,"type":33},"2022-12-07",{"date":163,"type":21},"2025-08-04",{"name":39,"class":40},""]