[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"InxMed (Shanghai) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":197},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,66,90,114,137,156,178],{"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":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100640222","phase-1-fak-inhibitor-in-patients-with-advanced-solid-tumors-100640222",false,"NCT07596381","FAK Inhibitor in Patients With Advanced Solid Tumors","A Phase I\u002FIb Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Efficacy of Focal Adhesion Kinase Inhibitor IN10028 as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Able to understand and voluntarily sign the written Informed Consent Form (ICF), which must be signed prior to conducting the study-specific procedures required by the trial.\n* At the time of signing the ICF, subjects are aged 18 to 75 years, inclusive, male and female.\n* Subjects must have a histologically or cytologically confirmed diagnosis of advanced or metastatic malignant solid tumor.Monotherapy dose-escalation and dose expansion: Patients with solid tumors who failed prior standard systemic therapy, have no standard treatment options, or are intolerant to standard regimens.\n* Prior systemic antitumor therapy must be completed at least 3 weeks before the first study drug treatment; prior small molecule TKIs or oral fluoropyrimidines require a minimum 2-week washout period.\n* Subjects must have at least one measurable tumor lesion per RECIST v1.1. Previously irradiated lesions should not be selected as target lesions, unless such irradiated lesion is the only measurable lesion and has documented radiological disease progression, and may then be selected as a target lesion.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Subjects have an estimated expected survival time of at least 3 months.\n* Has adequate organ function.\n* Urine protein negative or trace (±); or urine protein 1+, but urine protein to creatinine ratio (UPCR) of random morning urine \\\u003C 0.5, or 24-hour urine protein quantitation \\\u003C 0.5 g\u002F24 h.\n* Female subjects of childbearing potential must have a negative serum pregnancy test and agree to use effective contraception during the study drug treatment period and for 120 days after the last dose of study drug administration. Male subjects with female partners of childbearing potential must agree to use effective contraception during the study drug treatment period and for 120 days after the last dose of study drug administration. In this protocol, a woman of childbearing potential is defined as a sexually mature female.\n\nExclusion Criteria:\n\n* Subjects unable to receive oral administration or with conditions that severely affect drug digestion and absorption (e.g., subtotal gastrectomy or duodenectomy, severe sinus tract affecting digestion and absorption, and other related diseases.\n* Subjects with known central nervous system (CNS) metastases, excluding those with asymptomatic CNS metastases or asymptomatic brain metastases following prior treatment, provided that the lesions have been confirmed to be stable for more than 3 months by computed tomography (CT) or magnetic resonance imaging (MRI), and no steroid therapy has been required for at least 4 weeks.\n* Subjects with known hypersensitivity to any components of the study drug or its analogues.\n* Subjects with prior treatment of focal adhesion kinase inhibitors (FAKi).\n* Subjects with a history of any other malignancy within 5 years prior to screening, excluding cured cervical carcinoma in situ and completely resected basal cell carcinoma of the skin.\n* Subjects with uncontrolled cardiac clinical symptoms or diseases, including:(1) Heart failure classified as New York Heart Association (NYHA) Class Ⅱ or above; (2) unstableangina; (3) Myocardial infarction within the past 1 year;(4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) Corrected QT interval (QTc) \\> 450 ms in males and QTc \\> 470 ms in females. The QTc interval is calculated using Fridericia's correction formula: QTcF = QT\u002F(RR\\^0.33); (6) Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n* Subjects with known hereditary or acquired bleeding and thrombotic predispositions (e.g., hemophilia, coagulation disorders, thrombocytopenia, etc.)\n* Subjects with an active infection within 4 weeks prior to enrollment, or those with other chronic medical conditions deemed unsuitable for study participation by the Investigator.\n* Subjects with congenital or acquired immunodeficiency disorders (e.g., human immunodeficiency virus \\[HIV\\] infection), or those with a history of organ transplantation.\n* Hepatitis B surface antigen (HBsAg) positive with hepatitis B virus DNA (HBV DNA) ≥ 2500 copies\u002FmL (or 500 IU\u002FmL); or positive for hepatitis C virus RNA (HCV RNA).\n* Have received a live vaccine within 30 days prior to the first dose of administration.\n* Women of childbearing potential who are pregnant-planning or lactating.\n* Subjects who are inability to comply with protocol requirements or who is otherwise considered unsuitable for study participation by the investigator's judgment.\n* Subjects receiving concomitant intravenous or oral medications that affect CYP isoenzymes (strong inducers or strong inhibitors of CYP3A4), or who have used such medications within at least 1 week prior to the first dose of administration.","ALL","18 Years","75 Years",{"count":20,"type":21},75,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is A Phase I\u002FIb Study，aimed to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Efficacy of Focal Adhesion Kinase Inhibitor IN10028 as Monotherapy and Combination Therapy in Patients with Advanced Solid Tumors.",[27],"Advanced Solid Tumors","NOT_YET_RECRUITING","2026-05-12",{"date":31,"type":32},"2026-05-19","ACTUAL",{"date":34,"type":21},"2026-05-30",{"date":36,"type":21},"2028-02-28",{"name":38,"class":39},"InxMed (Shanghai) Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100481630","phase-1-in10018-in-combination-with-standard-chemotherapy-in-high-grade-serous-epithelial-ovarian-cancer-100481630","NCT05551507","IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer","A Phase Ib\u002FII, Open-label Clinical Study to Evaluate the Safety, Tolerability and Antitumor Activities of IN10018 in Combination With Standard Chemotherapy in Subjects With High-grade Serous Epithelial Ovarian Cancer","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign informed consent(s). Signed informed consent must be obtained before any study specific procedures, except those procedures used as institutional standard of care falling into the protocol specified window and fulfilling study specific requirements such as tumor imaging.\n2. Female subjects ≥ 18 years at the time of signing informed consent.\n3. Histologically confirmed epithelia ovarian cancer, fallopian tube cancer or primary peritoneum cancer with the subtype limited to high-grade serous carcinoma (HGSC) only.\n4. Subjects with platinum-resistant disease, defined as having relapsed or progressed between 1- 6 months after completion of prior platinum-based therapy (at least 4 cycles).\n5. Have maximum total of 5 prior lines of systemic therapy and maximum 2 prior lines of systemic therapy following diagnosis of platinum-resistance.\n6. At least one measurable lesion can be accurately measured per RECIST 1.1 as assessed by investigator.\n7. ECOG performance status of 0 or 1.\n8. Life expectancy of at least 3 months as assessed by investigator.\n9. Availability of archival or fresh (newly obtained) tumor tissue sample during Screening Phase: Fresh tumor tissue sample obtained after most recent relapse or progression is preferred; if no sample or not sufficient number of slides can be provided or collected, a joint decision between Sponsor and investigator is needed for the enrollment of this subject.\n10. Must have recovered from all AEs due to previous therapies to ≤ Grade 1 (CTCAE 5.0) or stable status as assessed by investigator.\n11. Adequate bone marrow, liver, renal, and coagulation function within 5 days prior to first dose of study treatment.\n12. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n    * Not a woman of childbearing potential (WOCBP) . OR\n    * A WOCBP who agrees to follow the contraceptive guidance during the treatment period and through 3 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Has had major surgery or significant traumatic injury within 28 days prior to first dose of study treatment, or diagnostic biopsies within 14 days prior to first dose of study treatment.\n2. Has received prior systemic anticancer therapy including investigational agents, such as within 14 days or less than 5 half-lives (whichever is shorter) of chemotherapy or targeted therapy, or within 28 days of immunotherapy, prior to first dose of study treatment.\n3. Has received prior radiotherapy within 14 days prior to first dose of study treatment.\n4. Has received prior treatment of any FAK inhibitor or prior treatment of PLD.\n5. Has a known previous or concurrent cancer that is distinct in primary site or histology from current ovarian cancer within 3 years prior to first dose of study treatment, except for curatively treated cancers such as cervical carcinoma in situ.\n6. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n7. Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases (e.g., congestive heart failure, acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep vein thrombosis or pulmonary embolism) within 6 months before first dose of study treatment, or has any of the following abnormality:\n\n   * QTc interval \\> 480 msec;\n   * Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n   * New York Heart Association (NYHA) functional classification ≥ Grade 2；\n   * Clinically significant arrhythmia;\n   * Uncontrolled hypertension;\n   * Other clinically significant heart diseases.\n8. Has known uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. Note: A small amount of ascites that can only be detected by imaging examination is allowed.\n9. Has malabsorption syndrome or inability to take oral drugs.\n10. Has clinically significant gastrointestinal abnormalities including uncontrolled gastrointestinal inflammatory lesions (Crohn's disease, or ulcerative colitis in active) or uncontrolled gastrointestinal bleeding.\n11. Has an active infection requiring systemic therapy within 14 days prior to the first dose of study treatment.\n12. Has known human immunodeficiency virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority and\u002For site.\n13. Has known active Hepatitis B or Hepatitis C virus infection. Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority and\u002For site.\n14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n15. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.\n16. Known allergy or hypersensitivity to IN10018 or PLD, or their ingredients.\n17. Has received prior cumulative anthracycline dose of 550 mg\u002Fm2 or more.\n18. Has received systemic treatment of CYP3A4, CYP2D6 or P-gp strong inhibitors\u002Finducers within 14 days prior to the first dose of study treatment, or anticipation of the systemic treatment of these drugs during Treatment Phase.","FEMALE",{"count":50,"type":21},150,[24,52],"PHASE2","This is a phase Ib\u002FII, open label clinical study to evaluate the safety, tolerability and antitumor activities of IN10018 in combination with standard chemotherapy in subjects with high-grade serous ovarian cancer (including fallopian tube cancer and primary peritoneum cancer, collectively defined as ovarian cancer).",[55],"Platinum-resistant Ovarian Cancer","RECRUITING","2026-05-01",{"date":59,"type":32},"2026-05-04",{"date":61,"type":32},"2020-07-27",{"date":63,"type":21},"2026-09-30",{"name":38,"class":39},7,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100606388","phase-3-a-phase-3-study-of-in10018-in-combination-with-d-1553-versus-standard-therapy-for-first-line-non-squamous-non-small-cell-lung-cancer-with-kras-g12c-mutation-100606388","NCT07174908","A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation","A Phase 3 Multicenter, Randomized, Controlled, and Open-Label Study of IN10018 in Combination With D-1553 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Able and willing to provide informed consent and comply with study requirements\n* Has histologically confirmed locally advanced (Stage IIIB\u002FC) or metastatic (Stage IV) non-squamous NSCLC\n* Aged 18-80 years at the time of consent\n* Has KRAS G12C mutation confirmed by central laboratory\n* Has not received prior systemic therapy for advanced or metastatic NSCLC\n* Has at least one measurable lesion per RECIST v1.1\n* ECOG performance status of 0-1\n* Has adequate organ function\n* Life expectancy ≥3 months in the opinion of the Investigator\n* Male and female subjects of reproductive potential must agree to use effective contraception during and for 6 months after treatment\n\nExclusion Criteria:\n\n* Has other histological subtypes of NSCLC (e.g., small cell or neuroendocrine)\n* Has active or untreated CNS metastases or carcinomatous meningitis\n* Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or immune checkpoint inhibitors\n* Has another known driver mutation with approved targeted therapy (e.g., EGFR, ALK, ROS1)\n* Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease requiring systemic therapy\n* Has history of another malignancy within 5 years, except those curatively treated and considered low risk (e.g., basal cell carcinoma, cervical carcinoma in situ)\n* Has gastrointestinal conditions that may interfere with absorption of oral drugs (if applicable)\n* Has known active hepatitis B, hepatitis C, or HIV infection\n* Has received a live vaccine within 30 days before first dose of study drug\n* Pregnant or breastfeeding women\n* Has psychiatric or substance abuse disorders that would interfere with study compliance\n* Is participating in another interventional clinical study\n* Any condition that, in the opinion of the Investigator, would interfere with participation or study results","80 Years",{"count":75,"type":21},400,[77],"PHASE3","This is a multicenter, randomized, open-label, phase III clinical study, to evaluate the efficacy and safety of IN10018 in combination with D-1553 as compared to anti-PD-1 monoclonal antibody (mAb) in combination with platinum and pemetrexed as the first-line treatment for the locally advanced or metastatic KRASG12C mutation-positive non-squamous non-small cell lung cancer (NSCLC).",[80],"Non-Small Cell Lung Cancer","2026-02-27",{"date":83,"type":32},"2026-03-03",{"date":85,"type":32},"2025-09-10",{"date":87,"type":21},"2030-09",{"name":38,"class":39},11,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100626864","phase-1-in10018-in-combination-with-rnk08954-for-the-treatment-of-krasg12d-mutation-positive-locally-advanced-or-metastatic-solid-tumors-100626864","NCT07441174","IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors","A Multicenter, Open-Label, Phase Ib\u002FII Clinical Trial of IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* 1\\. Voluntarily participate in the study after being fully informed, sign the written ICF, and agree to comply with the procedures specified in the protocol.\n* 2\\. Male or female aged ≥18 years at the time of signing the ICF.\n* 3\\. Subjects with pathologically confirmed locally advanced or metastatic solid tumors.\n* 4\\. Subjects confirmed to be KRASG12D mutation-positive in tumor tissue samples. Subjects may use historical results from local laboratories (within 2 years before signing the ICF).\n\nNote: Test results must be provided by a laboratory certified by the Clinical Laboratory Improvement Amendments (CLIA) or an equivalent certification, a third-party laboratory recognized by the investigator, or the pathology department of grade A tertiary hospital.\n\n* 5\\. Requirements for tumor type are as follows:\n\n  1. Phase Ib: Subjects with locally advanced or metastatic solid tumors who have documented radiologically disease progression, and are intolerant to standard treatment, or have no standard treatment, or have failed to standard treatment.\n  2. Phase II Cohort 1: Subjects with locally advanced or metastatic PDAC who have previously received gemcitabine- or nab-paclitaxel-based chemotherapy regimens or FOLFIRINOX\u002FmFOLFIRINOX standard treatment and failed to standard treatment (have received at least first-line standard therapy and failed to standard treatment);\n  3. Phase II Cohort 2: Subjects with locally advanced or metastatic solid tumors who have documented radiologically disease progression and are intolerant to standard treatment, or have no standard treatment, or have failed to standard treatment (Selected tumor types will be determined based on prior study results).\n* 6\\. Presence of at least 1 measurable lesion assessable by computed - tomography (CT) or magnetic resonance imaging (MRI) according to RECIST Version 1.1. For lesions previously treated with radiotherapy or other local treatments, radiological confirmation of disease progression is required before they can be considered measurable lesions.\n* 7\\. ECOG performance status score of 0 or 1.\n* 8\\. Life expectancy of at least 3 months (assessed by the investigator).\n* 9\\. Laboratory tests within 7 days before the first dose confirm adequate bone marrow, liver, kidney, and coagulation function reserves, and no blood transfusion or blood products have been received within 14 days before the relevant tests:\n\n  1. Platelets ≥100×10⁹\u002FL, and no platelet transfusion or thrombopoietin (TPO) treatment has been received within 14 days before the screening blood routine test.\n  2. Hemoglobin ≥90 g\u002FL, and no blood transfusion, red blood cell transfusion, or erythropoietin (EPO) treatment has been received within 14 days before the screening blood routine test.\n  3. Neutrophil count ≥1.5×10⁹\u002FL, and no colony-stimulating factor (CSF) has been used within 14 days before the screening blood routine test.\n  4. Creatinine clearance (Clcr) estimated by the Cockcroft-Gault (C-G) formula ≥60 mL\u002Fmin, or estimated glomerular filtration rate (eGFR) estimated by the Modification of Diet in Renal Disease (MDRD) equation ≥60 mL\u002Fmin.\n  5. Urine protein negative or weakly positive (±); or urine protein 1+, but urine protein-to-creatinine ratio (UPCR) in random morning urine \\\u003C0.5 or 24-hour urine protein quantification \\\u003C0.5 g\u002F24 h.\n  6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×Upper Limit of Normal (ULN) (≤5×ULN if liver metastasis exists). g) Total bilirubin ≤1.5×ULN (≤3×ULN is allowed for subjects with Gilbert's syndrome).\n  7. Prothrombin time and activated partial thromboplastin time ≤1.5×ULN, International Normalized Ratio (INR) ≤1.5. For subjects receiving anticoagulant therapy, INR \\\u003C3.0 or within the target range of anticoagulant therapy (if applicable).\n* 10\\. Female subjects of childbearing potential must agree to abstain from sexual intercourse or use effective contraceptive methods from the time of signing the ICF until 6 months after the last dose of study drug. Acceptable contraceptive methods include: oral, injectable, or implantable hormonal contraception; intrauterine device or intrauterine system; male condom with spermicide or occlusive cap (diaphragm or cervical\u002Fvaginal cap).\n* 11\\. Male subjects must agree to abstain from sexual intercourse, undergo sterilization surgery, or use effective contraceptive methods from the time of signing the ICF until 6 months after the last dose of study drug.\n\nNote: Effective contraceptive methods include: use of a male condom, with the female partner also using hormonal contraception or an intrauterine device (used for at least 4 weeks before administration); use of a male condom, with the female partner also using a diaphragm with spermicide or a cervical\u002Fvaginal cap.\n\nExclusion Criteria:\n\n* 1\\. Previous treatment with KRASG12D inhibitors. Note: Except for subjects in Phase Ib, who may have received previous treatment with KRASG12D inhibitors.\n* 2\\. Previous treatment with focal adhesion kinase (FAK) inhibitors.\n* 3\\. Received any anti-cancer drug treatment (including cytotoxic therapy, targeted therapy, biological therapy, or hormonal therapy other than alternative therapy) or other investigational drug treatment and radiotherapy within 14 days before the first dose.\n* 4\\. Have other KRAS mutations (excluding KRASG12D mutation), and have other positive mutation sites with available marketed targeted drugs.\n* 5\\. Subjects with known spinal cord compression symptoms, unstable or symptomatic\u002Fprogressive central nervous system (CNS) metastasis, or meningeal metastasis. Subjects with a history of brain metastasis who are clinically and radiologically stable (i.e., no progression of CNS disease confirmed by two consecutive brain MRI or CT scans (if MRI is not suitable) with an interval of at least 4 weeks) may be enrolled (if the subject has previously received radiotherapy for brain metastasis, the MRI or CT scan must be performed at least 4 weeks after the last brain radiotherapy). For subjects who have received corticosteroid treatment, corticosteroids must have been discontinued for at least 2 weeks before the first dose of study drug. For subjects receiving anti-epileptic treatment, their medication dose must have been stable for at least 2 weeks.\n* 6\\. Any of the following cardiovascular conditions:\n\n  1. Congestive heart failure with New York Heart Association (NYHA) functional class II or higher.\n  2. Severe arrhythmia and left bundle branch block requiring drug treatment.\n  3. Acute myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass surgery within 6 months before the first dose.\n  4. Left ventricular ejection fraction (LVEF) \\\u003C50%.\n  5. Prolonged corrected QT interval (QTcF) by Fridericia's formula at rest, with an average QTc interval \\>480 ms measured by three consecutive ECGs, or risk factors for torsades de pointes, such as clinically significant hypokalemia, family history of long QT syndrome, or familial arrhythmia (e.g., Pre-excitation Syndrome) as judged by the investigator.\n  6. Uncontrolled hypertension (defined as systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥100 mmHg after standardized antihypertensive drug treatment).\n  7. Deep vein thrombosis (other than implantable venous access port or catheter-related thrombosis) or pulmonary embolism within 6 months prior to the first dose of study treatment.\n* 7\\. Subjects with stroke or other severe cerebrovascular diseases (e.g., acute cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage) within 12 months prior to the first dose of study treatment.\n* 8\\. Subjects with interstitial lung disease or any active infection requiring systemic treatment within 14 days prior to the first dose of study treatment, including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.\n* 9\\. Subjects with active autoimmune diseases (e.g., autoimmune thyroid disease, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease) requiring systemic treatment (including disease-modifying drugs, corticosteroids, or immunosuppressants) within the past 2 years. Hashimoto's thyroiditis, vitiligo, and psoriasis that do not require systemic treatment are excluded. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n* 10.The investigator judges that the subject has a history or evidence of substance abuse, or has medical, psychological, or social conditions that may interfere with study participation or evaluation of study results.\n\nNote: The following conditions are not recommended for enrollment, including but not limited to: 1) Presence of pleural effusion, pericardial effusion, or ascites that is poorly controlled and requires clinical management; 2) Active bleeding such as hemoptysis or gastrointestinal bleeding during the screening period, subjects with only a small amount of blood in sputum are allowed to enroll; 3) Received live vaccines or attenuated live vaccines within 28 days prior to the first dose of study treatment.\n\n* 11.Subjects with gastrointestinal (GI) disorders that may significantly impair the oral administration, absorption, or metabolism of the study drug, including dysphagia, refractory nausea and vomiting, malabsorption syndrome, gastrectomy or small bowel resection that impairs the oral absorption or metabolism of the study drug, symptomatic inflammatory bowel disease, and partial or complete intestinal obstruction.\n\nNote: Subjects with clinical or radiological evidence of intestinal obstruction, or those who developed intestinal obstruction within the previous 3 months with unresolved underlying cause are not recommended for enrollment.\n\n* 12.The subject has not recovered from the toxicity of previous anti-tumor treatment (except for alopecia and pigmentation), defined as not recovered to NCI CTCAE v5.0 ≤Grade 1 (≤Grade 2 for peripheral neuropathy).\n* 13.The subject has undergone major surgery within 4 weeks prior to the first dose of study drug or has not fully recovered from previous surgical treatment. For percutaneous liver biopsy and other needle biopsies, a 14-day washout period is required before the first dose of study treatment.\n\nNote: Subjects expected to undergo major surgery or those who need to interrupt study medication for scheduled surgery during the study treatment, should also be excluded.\n\n* 14.The subject has received or plans to receive within 2 weeks before the first dose of study drug treatment:\n\n  1. Drugs that are known to be narrow therapeutic window substrates of CYP3A.\n  2. Drugs that are known to be strong inducers or inhibitors of CYP3A4.\n  3. Drugs that are known to be strong inhibitors of P-glycoprotein.\n  4. Drugs known\u002Fpotentially causing QTc interval prolongation or torsades de pointes (e.g., antiarrhythmic drugs).\n\nNote: For details, refer to Appendix 9 in Section 10.9.\n\n* 15.Pregnant or lactating women.\n* 16.Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥2500 copies\u002FmL or 500 IU\u002FmL, positive for hepatitis C virus (HCV) antibody with HCV ribonucleic acid (HCV RNA) above the lower limit of detection, or positive for human immunodeficiency virus (HIV) antibody.\n* 17.A history of other malignant tumors within 5 years before the first dose, except for cured basal cell carcinoma of the skin, carcinoma in situ (e.g., carcinoma in situ of the breast, squamous cell carcinoma in situ of the skin, cervical carcinoma in situ).\n* 18.Known allergy (such as life-threatening hypersensitivity reaction) or other intolerances to IN10018, RNK08954 or their pharmaceutical excipients; or subjects with severe allergic diathesis.",{"count":98,"type":21},92,[24,52],"This is a multicenter, open-label, Phase Ib\u002FII clinical study. The study includes Phase Ib-Dose Exploration Stage and Phase II - Efficacy Exploration and Determination Stage.",[102,103],"Solid Tumor Cancer","PDAC",[105],"KRASG12D mutation-positive","2026-02-25",{"date":81,"type":32},{"date":109,"type":21},"2026-02-28",{"date":111,"type":21},"2031-02-28",{"name":38,"class":39},14,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":40},"100515640","phase-1-in10018-combination-therapy-in-advanced-egfr-mutation-positive-nsclc-100515640","NCT05994131","IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC","A Multicenter, Open-label, Phase Ib\u002FII Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Anti-tumor Efficacy of IN10018 Combined With Third-generation EGFR-TKI in Patients With Advanced EGFR Mutation-positive NSCLC","Inclusion Criteria\n\n1. Be able to understand and be willing to sign informed consent.\n2. Male or female aged ≥ 18 years old at the time of signing informed consent.\n3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC, who is not suitable for radical surgery or radiotherapy.\n4. Documented EGFR mutations known to be associated with EGFR-TKI sensitivity, including Ex19del or L858R. Except for EGFR-TKI sensitive mutation, coexisting with other EGFR mutation types such as T790M can be allowed.\n5. Prior systemic antitumor therapy allowed are listed as follows:\n\n   * Cohort 1: Subjects who are on the treatment of Furmonertinib as the first-line treatment setting.\n   * Cohort 2: Subjects failed in third-generation EGFR-TKI treatment and also failed in or were intolerant to 1-2 lines of chemotherapy.\n   * Cohort 3: subjects who haven't accepted any systemic therapy before. Prior adjuvant or neoadjuvant chemotherapy is permitted if an interval from the lost dose of adjuvant or neoadjuvant chemotherapy to the first documented PD is \\>6 months.\n6. Measurable lesions at baseline according to RECIST 1.1 criteria.\n7. Has an ECOG performance status of 0 or 1.\n8. Estimated life expectancy is more than 3 months.\n9. Adequate bone marrow, liver, renal, and coagulation function within 7 days prior to the first dose of study treatment\u002Frandomization.\n\nExclusion Criteria\n\n1. Have experienced major surgical procedures or major trauma within 28 days prior to the first dose of study treatment\u002Frandomization.\n2. Have received the following prior systemic antitumor therapy:\n\n   * Cohort 1: Have received chemotherapy, target therapy besides Furmonertinib, immunotherapy, biological therapy, and other antitumor drugs.\n   * Cohort 2: Have received chemotherapy, targeted therapy, immunotherapy, biological therapy, and other antitumor drugs within 28 days prior to the first dose of study treatment.\n   * Cohort 3: Have received systemic antitumor therapy for locally-advanced or metastatic NSCLC including chemotherapy, target therapy, immunotherapy, biotherapy, etc.\n3. Cohort 2 only： Presence of other gene mutations, including ALK mutation, MET amplification, HER2 amplification, RAS mutation, etc. after progression on prior third-generation EGFR-TKI treatment.\n4. Cohort 3 only：Has received the treatment of EGFR-TKI。\n5. Prior FAK inhibitors treatment.\n6. Have received systemic administration of potent inhibitors\u002Finducers of CYP3A4, or P-gp inhibitors within 14 days prior to the first dose of treatment\u002Frandomization or are expected to receive systemic administration of these drugs during study treatment.\n7. Has received radiotherapy for study disease or radiotherapeutic area covered for more than 30% of the bone marrow within 28 days prior to the first dose of study treatment\u002Frandomization.\n8. Has had interstitial lung disease (ILD), drug-induced ILD, radiation pneumonia requiring steroid therapy; or diagnosis of clinically active ILD during the screening period.\n9. Has a prior history of other malignancy within 3 years prior to signing informed consent.\n10. Has known symptoms of spinal cord compression, active central nervous system (CNS) metastases, and\u002For carcinomatous meningitis.\n11. Has a history of severe cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment\u002Frandomization.\n12. Has known uncontrollable pleural effusion, pericardial effusion, and ascites.\n13. Has hemoptysis within 1 month prior to the first dose of study treatment\u002Frandomization with a blood volume of ≥2.5 mL every time or expected to require continuous hemostasis therapy during the study treatment.\n14. Has active infections that are poorly controlled by systemic treatment.\n15. Has active tuberculosis.\n16. Known allergy, hypersensitivity or intolerance to IN10018 and\u002For third-generation EGFR-TKI, or their ingredients.\n17. Pregnant or lactating women.",{"count":122,"type":21},110,[24,52],"This is a multicenter, open-label, phase Ib\u002FII clinical study to evaluate the safety, tolerability, pharmacokinetics and antitumor efficacy of IN10018 in combination with third-generation EGFR-TKI (Furmonertinib is the proposed) in previously-treated or naïve advanced EGFR-mutation positive NSCLC.",[126],"NSCLC",[128],"EGFR mutation-positve","2025-04-28",{"date":131,"type":32},"2025-04-30",{"date":133,"type":32},"2023-07-13",{"date":135,"type":21},"2026-07-31",{"name":38,"class":39},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":40},"100517206","phase-2-in10018-in-combination-with-pegylated-liposomal-doxorubicin-pld-vs-placebo-in-combination-with-pld-for-the-treatment-of-platinum-resistant-recurrent-ovarian-cancer-100517206","NCT06014528","IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer","A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign informed consent(s). Signed informed consent must be obtained before any study specific procedures, except those procedures used as institutional standard of care falling into the protocol specified window and fulfilling study specific requirements such as tumor imaging.\n2. Female subjects ≥ 18 years at the time of signing informed consent.\n3. Histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneum cancer and its subtype is high-grade serous carcinoma (HGSC).\n4. Have received platinum containing therapy and have radiological relapse or progression during platinum containing treatment or \\\u003C 6 months (184 calendar days) after completion of prior platinum-based therapy (at least 4 cycles).\n\n   Note: Disease progression or recurrence requires evidence of radiographic or clinical progression (e.g., new ascites or cytological reports of pleural fluid), and elevated CA125 alone is not a criterion for progression or recurrence. Primary platinum-refractory ovarian cancers (defined as progression during or within 4 weeks after first line platinum-based therapy) is excluded, while secondary platinum-refractory disease is allowed and does not require at least 4 cycles of platinum-based therapy.\n5. Maximum total of 3 prior lines of systemic therapy are allowed. Note: Hormonal therapies (e.g., tamoxifen), PARP inhibitors and bevacizumab given in the maintenance setting post response to platinum-based therapy will not count as a treatment line. Other maintenance regimens may also not count as a treatment line by discussion between the investigator and sponsor.\n6. At least one measurable lesion can be accurately measured per RECIST 1.1 as assessed by investigator.\n\n   Note: Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n7. ECOG performance status of 0 or 1.\n8. Life expectancy of at least 3 months as assessed by investigator.\n9. Availability of archival or fresh (newly obtained) tumor tissue sample during screening phase: fresh tumor tissue sample obtained after most recent relapse or progression is preferred; if no sample or not sufficient number of slides (refer to Laboratory Manual which will be provided separately) can be provided or collected, a joint decision between sponsor and investigator is needed for the enrollment of this subject.\n10. Must have recovered from all AEs due to previous therapies to ≤ Grade 1 (CTCAE 5.0) or stable status as assessed by investigator.\n\n    Note: subjects with minor toxicities with no safety concern like alopecia and Grade 2 neuropathy could be enrolled per evaluation of investigator.\n11. Adequate bone marrow, liver, renal, and coagulation function within 7 days prior to randomization.\n\n    1. Hemoglobin (Hb) ≥ 100 g\u002FL (10 g\u002FdL), independent of blood infusion, red blood cell transfusion and erythropoietin (EPO) use within 14 days prior to the screening period examination.\n    2. Platelet count ≥ 100 × 109\u002FL, independent of platelet infusion within 14 days prior to the screening period examination.\n    3. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, independent of colony stimulating factor (CSF) use within 14 days prior to the screening period examination.\n    4. Total bilirubin ≤ upper limit of normal (ULN).\n    5. Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for subjects with documented liver involvement of their disease).\n    6. Serum creatinine ≤ 1.5 × ULN, Estimated Creatinine clearance rate (Clcr) by the Cockcroft-Gault (C-G) equation ≥ 60 mL\u002Fmin or estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) equation ≥ 60 mL\u002Fmin.\n    7. Urinary protein negative or trace (±); or urinary protein ≥ 1+ but with a urine protein to creatinine ratio (UPCR) in a morning spot urine sample \\\u003C 0.5 or a 24-hour urine protein \\\u003C 0.5 g\u002F24 h.\n    8. International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Subjects with stable anticoagulation treatment is allowed.\n12. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n    1. Not a woman of childbearing potential (WOCBP) as defined in section 10.4 Appendix 4 of the full protocol.\n\n       OR\n    2. A WOCBP who agrees to follow the contraceptive guidance in section 10.4 Appendix 4 of the full protocol during the treatment period and through 3 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Has had major surgery or significant traumatic injury within 28 days prior to randomization, or diagnostic biopsies within 14 days prior to randomization.\n\n   Note: Subjects with anticipation of the need for major surgery during study treatment should be excluded. Subjects who underwent diagnostic biopsy within 14 days prior to randomization may also be enrolled if the investigator and sponsor determine that the diagnostic biopsy will not affect the efficacy evaluation.\n2. Has received prior systemic anticancer therapy including investigational agents, such as within 14 days or less than 5 half-lives (whichever is shorter) of chemotherapy or targeted therapy, or within 28 days of immunotherapy, macromolecular drugs (eg., bevacizumab) or investigational drugs prior to randomization.\n3. Has received prior radiotherapy within 14 days prior to randomization. Note: A 7-day washout is permitted for palliative radiation (≤ 14 days of radiotherapy) to non-central nervous system (CNS) disease.\n4. Has received prior treatment of any FAK inhibitor or prior treatment of PLD.\n5. Has a known previous or concurrent cancer that is distinct in primary site or histology from current ovarian cancer within 3 years prior to randomization, except for curatively treated cancers such as cervical\u002Fbreast\u002Fprostate carcinoma in situ and basal cell carcinoma.\n6. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n\n   Note: Subjects with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks apart by repeat imaging (note that the repeat imaging should be performed during screening phase) for at least 28 days prior to randomization.\n7. Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases (e.g., congestive heart failure, acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep vein thrombosis or pulmonary embolism) within 6 months before randomization, or has any of the following abnormality:\n\n   1. QTc interval corrected using Fridericia's formula \\> 470 ms (based on QTcF).\n   2. Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n   3. New York Heart Association (NYHA) functional classification ≥ Grade 2.\n   4. Clinically significant arrhythmia.\n   5. Uncontrolled hypertension or diabetes.\n   6. Other clinically significant heart diseases.\n8. Has known pleural effusion, pericardial effusion or ascites accompanied by clinical symptoms or requiring puncture or drainage. Subjects who received drainage within the first 3 months of randomization should be excluded. A small amount of ascites that can only be detected by imaging examination and without clinical symptom is allowed.\n9. Has malabsorption syndrome or inability to take oral drugs.\n10. Has clinically significant gastrointestinal abnormalities including uncontrolled gastrointestinal inflammatory lesions (Crohn's disease, or ulcerative colitis in active) or uncontrolled gastrointestinal bleeding.\n11. Clinical or radiographic evidence of intestinal obstruction, or aetiology of previous recurrent ileus not excluded.\n12. Currently have interstitial pneumonia (except for radiation pulmonary fibrosis that does not require hormonal therapy).\n13. Has not well controlled active infection after systemic therapy.\n14. Has known human immunodeficiency virus (HIV) infection or known active Hepatitis B or Hepatitis C virus infection.\n\n    Note: No HIV, Hepatitis B and Hepatitis C testing is required unless mandated by local health authority and\u002For site.\n15. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n16. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.\n17. Known allergy or hypersensitivity to IN10018 or PLD, or their ingredients.\n18. Has received prior cumulative anthracycline dose of 550 mg\u002Fm2 or more.\n19. Has received systemic treatment of CYP3A4, CYP2D6 or P-gp strong inhibitors\u002Finducers within 14 days prior to randomization, or anticipation of the systemic treatment of these drugs during Treatment Phase.",{"count":145,"type":21},168,[52],"This is a multicenter, randomized, double-blind, phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers).",[149],"Ovarian Cancer Recurrent",{"date":131,"type":32},{"date":152,"type":32},"2022-09-06",{"date":154,"type":21},"2026-12-24",{"name":38,"class":39},{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},"100518416","phase-1-in10018-combination-therapy-in-treatment-nave-es-sclc-100518416","NCT06030258","IN10018 Combination Therapy in Treatment-naïve ES-SCLC","A Phase Ib\u002FII Clinical Trial to Evaluate the Anti-tumor Efficacy, Safety, Tolerability, and Pharmacokinetics of IN10018 Combined With Anti-PD-1\u002FL1 Antibody and Chemotherapy as First-line Treatment in Extensive-stage Small Cell Lung Cancer","Inclusion Criteria\n\n1. Male or female aged 18-75 years old at the time of signing informed consent.\n2. Be able to understand and be willing to sign informed consent.\n3. Histologically confirmed ES-SCLC (according to the Veterans Administration Lung Study Group (VALG) staging system), which is not suitable for locally radical therapy.\n4. Has not received any systemic antitumor therapy for ES-SCLC.\n5. Has at least one measurable tumor lesion per RECIST 1.1.\n6. Has an ECOG performance status of 0 or 1.\n7. Estimated life expectancy is more than 3 months.\n8. Has adequate organ function of bone marrow, liver, kidney, and coagulation. Relative laboratory tests must be performed within 7 days prior to first dose of study treatment\u002Frandomization.\n9. AEs due to prior antitumor therapy must be recovered to ≤ Grade 1 (CTCAE v5.0) or a steady state as assessed by investigators\n10. Subjects (male and female) with childbearing potential must agree to use contraception during the treatment phase and through 3 months after the last dose of study treatment.\n\nExclusion Criteria\n\n1. Has known active or untreated central nervous system (CNS) metastases, and\u002For carcinomatous meningitis.\n2. Spinal cord compression without surgery and\u002For radiation therapy, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 7 days prior to the first dose of study treatment\u002Frandomization.\n3. Pleural, pericardial or abdominal effusion that are clinically symptomatic and require puncture or drainage.\n4. Symptomatic hypercalcemia.\n5. Malignancies other than the study disease within 3 years prior to the first dose of study treatment\u002Frandomization.\n6. Have received palliative radiotherapy for bone metastasis within 14 days prior to the first dose of study treatment\u002Frandomization.\n7. Have had allogeneic haematopoietic stem cell transplantation or organ transplantation.\n8. History of active autoimmune disease required systemic treatment (including but not limited to drugs for disease control, corticosteroids, or immunosuppressive drugs) within the past 2 years.\n9. Have an immunodeficiency disorder or have received systemic steroid therapy (prednisone or equivalent corticosteroid \\> 10 mg\u002Fday) or other immunosuppressants within 7 days prior to the first dose of study treatment\u002Frandomization.\n10. History of idiopathic pulmonary fibrosis, idiopathic pneumonia and organizing pneumonia, and interstitial pneumonitis or active pneumonia diagnosed per imaging examination at baseline.\n11. Have had FAK inhibitors treatment.\n12. Has a history of major cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment\u002Frandomization.\n13. Have malabsorption syndrome or cannot take study drugs orally.\n14. Any active infection requiring systemic therapy within 14 days prior to the first dose of study treatment.\n15. Active pulmonary tuberculosis\n16. Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.\n17. Known hypersensitivity or allergy to IN10018, anti-PD-1\u002FL1 monoclonal antibodies, carboplatin or etoposide or to their drug components.\n18. Pregnant or lactating women or are expected to be pregnant or lactating during study treatment.",{"count":164,"type":21},120,[24,52],"This is a multicenter, open-label, Randomized, phase Ib\u002FII clinical study to evaluate the anti-tumor efficacy, safety, tolerability, and PK of IN10018 in combination with anti-PD-1\u002FL1 monoclonal antibody (Tislelizumab is proposed as the combination drug) and chemotherapy (platinum and etoposide) as the first-line treatment in Extensive-stage small cell lung cancer (ES-SCLC).",[168],"Small Cell Lung Cancer Extensive Stage",[170],"First-line",{"date":131,"type":32},{"date":173,"type":32},"2023-10-30",{"date":175,"type":21},"2025-12-24",{"name":38,"class":39},3,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":40},"100502864","phase-1-in10018-standard-chemotherapy-kn046-in-subjects-with-advanced-pancreatic-cancer-100502864","NCT05827796","IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer","A Phase Ib\u002FII, Open-label Clinical Study to Evaluate the Safety, Tolerability and Antitumor Activities of IN10018+Standard Chemotherapy and IN10018+Standard Chemotherapy+KN046 in Subjects With Advanced Pancreatic Cancer","Inclusion Criteria:\n\n1. With a full understanding of the study, each subject voluntarily agreed to participate in this study and sign the informed consent form.\n2. Female or male subjects ≥ 18 years at the time of signing informed consent.\n3. Histological or cytology-confirmed pancreatic ductal adenocarcinoma (including adenosquamous carcinoma).\n4. No previous systemic treatment for unresectable, locally advanced, or metastatic pancreatic cancer.\n5. At least one measurable lesion per RECIST 1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Life expectancy of at least 3 months as assessed by the investigator.\n8. Must have recovered from all AEs due to previous anticancer therapies to ≤ Grade 1 (CTCAE 5.0) or stable status as assessed by the investigator. Subjects with any grade of alopecia and grade 2 peripheral neuropathy could be enrolled.\n9. Adequate bone marrow, liver, renal, and coagulation function .\n10. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n    * Not a woman of childbearing potential (WOCBP) . or\n    * A WOCBP who agrees to follow the contraceptive guidance.\n\nExclusion Criteria:\n\n1. Has had major surgery or major trauma within 28 days prior to the first dose of study treatment.\n2. Has known BRCA1\u002F2 mutations.\n3. Has received prior systemic anticancer therapy including chemotherapy, targeted therapy, immunotherapy, unmarketed investigational drugs or therapy within 28 days prior to the first dose of study treatment.\n4. Previous anti-programmed death 1(PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody therapy, or any other antibody or drug that specifically targets T-cell co-stimulation or checkpoint pathways, or prior treatment with focal adhesion kinase (FAK) inhibitors.\n5. Has received radical radiotherapy within 3 months prior to the first dose of study treatment. Subjects who have received palliative radiotherapy with a local standardized dose within 2 weeks prior to the first dose of study treatment.\n6. Has received previous allogeneic hematopoietic stem cell transplantation or organ transplantation.\n7. Has received live vaccines and live attenuated vaccines within 28 days prior to the first dose of study treatment.\n8. Has interstitial pneumonia or lung disease.\n9. History or current active autoimmune diseases.\n10. Has a prior history of other malignancy, other than cured cutaneous squamous cell carcinoma, basal cell cancer, non-basal invasive bladder cancer, and prostate\u002Fcervical\u002Fbreast cancer in situ within 5 years prior to the first dose of study treatment.\n11. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n12. Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases within 6 months before the first dose of study treatment.\n13. Active infection with poor systemic treatment control.\n14. Has known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or hepatitis C (HCV) infection, or active syphilis and tuberculosis.\n15. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.",{"count":186,"type":21},70,[24,52],"This study is a multicenter, open-label, single-arm, phase Ib\u002FII clinical study comprising two phases: dose confirmation phase and dose expansion phase. The objective of the dose confirmation phase is to determine the recommended Phase II dose (RP2D) of IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine) and IN10018 + KN046 + standard chemotherapy in subjects with advanced pancreatic cancer. The dose expansion phase will further explore the antitumor activities and safety of combination therapy in subjects with advanced pancreatic cancer.",[190],"Pancreatic Cancer",{"date":131,"type":32},{"date":193,"type":32},"2022-12-08",{"date":195,"type":21},"2026-03-31",{"name":38,"class":39},""]