[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-or-metastatic-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-or-metastatic-solid-tumors":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100594150","phase-1-a-study-of-subcutaneous-trastuzumab-deruxtecan-in-participants-with-metastatic-solid-tumors-100594150",false,"NCT07015697","A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors","A Phase 1, Multicenter Trial of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors","Key Inclusion Criteria:\n\n1. Sign and date the ICF, prior to the start of any trial- specific qualification procedures.\n2. Adults ≥18 years or the minimum legal adult age (whichever is greater).\n3. a) Disease State: If HER2 status is required for eligibility (for all populations, except \"Pan-tumor, heavily pretreated, with no SoC\"), a documented HER2 test result must be available. A participant population would only be considered in regions where T-DXd is approved for that indication and an approved or validated test is available, if required per country regulations. Note: for all indications, all local HR testing and HER2 testing shall be per ASCO\u002FCAP guidelines, as applicable, in the advanced setting, using a validated or approved test as required per local regulations. The most recent available samples should be used to confirm eligibility, if applicable. For full description of each population, see below. Breast Cancer: adults with pathologically documented unresectable or metastatic breast cancer HER2-positive BC: have received a prior anti-HER2-based regimen. For HER2-positive BC participants in Part 2 only, prior anti-HER2 based therapy should have been received in either:\n\n   * the metastatic setting, or\n   * the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy. HR-, HER2-low BC: have received a prior systemic cytotoxic therapy in the metastatic setting; or developed disease recurrence during or within 6 months of completing (neo)adjuvant chemotherapy. HR+, HER2-low\u002Fultralow BC: have received previous ET AND an additional line of ET must not be the next line of treatment considered in the participant's best interest.\n   * For participants in Part 2 with HR+ HER-2low\u002Fultralow BC, the following criteria also apply:\n   * had disease progression while receiving 1 previous line of ET with a CDK4\u002F6i and is not expected to benefit from immediate use of a second line of ET, OR\n   * had disease progression on at least 2 previous lines of ET with or without a target therapy such as CDK4\u002F6, mTOR or PI3-K inhibitors) administered for the treatment of metastatic disease\n   * of note:\n   * If the 1 line was given while in the adjuvant setting, if disease recurrence occurred while on the first 24 months of adjuvant ET, that will be considered a line of therapy and only 1 additional line of ET will be required in the metastatic setting, with or without targeted therapy (such as CDK4\u002F6, mTOR or PI3-K inhibitors)\n   * Any progression after discontinuing or completing a course of adjuvant ET will not be considered a line of therapy\n   * Single agent PARP inhibitor therapy does not count as ET or as cytotoxic is not considered a line of ET\n   * Changes in dosing schedules, or discontinuations\u002Frestarting of the same drugs or the addition of a targeted therapy to an ET without progression (eg, adding a CDK4\u002F6 inhibitor to a current aromatase inhibitor regimen) will not be considered separate lines of therapy.\n   * participants may not have received more than 2 prior lines of cytotoxic therapy in the recurrent or metastatic setting. NSCLC, HER2 mut: adults with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy.\n\n   Gastric Cancer, HER2-positive: adults with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+\u002FISH+) gastric or gastroesophageal junction adenocarcinoma who have received a prior anti-HER2-based regimen Pan-tumor, HER2-positive: adults with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior treatment or have no satisfactory alternative treatment options Heavily pretreated tumors: adults with unresectable or metastatic solid tumors (other than described above), who have received prior systemic treatment and have no satisfactory treatment alternative b) Part 2 only: At least 1 RECIST 1.1 measurable lesion on CT or MRI.\n4. Radiologic or objective evidence of disease progression on or after the last systemic therapy prior to starting trial intervention.\n5. Part 2 only: confirmation of availability of the most recent available adequate FFPE archival tumor tissue sample obtained in the advanced setting, or provision of newly obtained tumor tissue if clinically feasible and at an acceptable risk as determined by the Investigator.\n6. ECOG PS of 0 to 1.\n\nKey Exclusion Criteria:\n\n1. Prior treatment with ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor; NOTE exception for SDC 1 and 2, where prior exposure to such agents is permitted provided the following are met:\n\n   1. At least 1 year has elapsed since last dose of exatecan derivative ADC.\n   2. The participant did not discontinue nor reduce the dose due to toxicity.\n   3. The participant did not experience any drug-related Grade 3\u002F4 toxicity.\n   4. The participant did not experience ILD of any grade while on or after the exatecan derivative ADC treatment.\n2. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products.\n3. Has a history of severe hypersensitivity reactions to other monoclonal antibodies.\n4. Medical history of MI within 6 months before enrollment or symptomatic CHF (New York Heart Association class II to IV). Participants with troponin levels above ULN at screening (as defined by the manufacturer), and without any MI-related symptoms should have a cardiologic consultation during the Screening Period to rule out MI.\n5. Has a corrected QT interval (QTcF) prolongation to \\> 480 ms (regardless of participant's sex) based on average of the screening triplicate 12-lead ECG.\n6. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.","ALL","18 Years",{"count":19,"type":20},76,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a dose escalation, and dose expansion study of T-DXd plus hyaluronidase administered subcutaneously, to assess the safety, tolerability, PK and efficacy of SC T-DXd plus hyaluronidase in participants with metastatic solid tumors.",[26],"Recurrent or Metastatic Solid Tumors",[28,29,30],"T-DXd","solid tumor","subcutaneous","RECRUITING","2026-03-18",{"date":34,"type":35},"2026-03-20","ACTUAL",{"date":37,"type":35},"2025-07-17",{"date":39,"type":20},"2028-12-31",{"name":41,"class":42},"Daiichi Sankyo","INDUSTRY",26,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100541453","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-ifinatamab-deruxtecan-i-dxd-in-subjects-with-recurrent-or-metastatic-solid-tumors-ideate-pantumor02-100541453","NCT06330064","A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)","A Phase 1B\u002F2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)","Participants must meet all of the following criteria to be included in the study:\n\nCommon Inclusion Criteria for All Participants\n\n1. Participant must have at least 1 lesion, not previously irradiated, amenable to core biopsy and must consent to provide a pretreatment biopsy tissue sample. An archival tumor tissue sample obtained within 6 months of consent and after progression during\u002Fafter treatment with the participant's most recent cancer therapy regimen is also acceptable.\n2. Participants ages ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years).\n3. At least 1 measurable lesion on computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as assessed by the investigator.\n4. Documentation of radiological disease progression on or after the previous standard-of-care regimen in the advanced\u002Fmetastatic setting.\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nAdditional Inclusion Criteria for EC Participants\n\n1. Pathologically or cytologically documented EC of any histological carcinoma subtype or endometrial carcinosarcoma, irrespective of microsatellite instability or mismatch repair status.\n2. Relapse or progression after a platinum-containing systemic treatment and an immune checkpoint inhibitor (ICI)-containing regimen (combined or sequential). Subjects with actionable target tumor mutation should have been previously treated with targeted therapy, with a maximum of 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma. Neoadjuvant\u002Fadjuvant therapy may count as 1 line of therapy if the subject progressed within 6 months after completion of therapy.\n\nAdditional Inclusion Criteria for HNSCC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx, excluding nasopharynx, nasal cavity and paranasal sinuses, and unknown primary.\n2. Has disease progression after platinum-based and ICI treatment, whether administered in combination or separately. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy, with a maximum of 2 prior therapy lines for unresectable or metastatic HNSCC.\n3. Participants without radiographic evidence of major blood vessel invasion\u002Finfiltration or tumor demonstrating a \\>90-degree abutment or encasement of a major blood vessel.\n4. Participants with no prior history of Grade ≥3 bleeding as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 within 28 days prior to the start of study drug related to the current head and neck cancer may be included in the study.\n5. Documented p16 status for oropharyngeal cancer (historical results are acceptable if available).\n\nAdditional Inclusion Criterion for PDAC Participants\n\n1\\. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma that has relapsed or progressed after 1 prior line of gemcitabine-based systemic therapy in the locally advanced\u002Fmetastatic setting or after 2 lines of therapy if the subject has actionable target tumor mutation and has been previously treated with targeted therapy. No prior treatment with topoisomerase I inhibitors, such as irinotecan or topotecan.\n\nAdditional Inclusion Criteria for CRC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic CRC with microsatellite stable status.\n2. Relapse or progression after 1 prior line of systemic therapy including a fluoropyrimidine plus oxaliplatin with or without anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb) or anti-epidermal growth factor receptor mAb therapy, as clinically indicated, or relapse or progression after 2 lines of therapy if the subject has received targeted therapy.\n\n   Note: Prior adjuvant\u002Fneoadjuvant systemic cytotoxic chemotherapy will count as 1 line of prior systemic therapy if there is documented disease progression during therapy or within 6 months of chemotherapy completion.\n3. No prior treatment with topoisomerase I inhibitors, such as irinotecan or topotecan.\n\nAdditional Inclusion Criteria for HCC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic HCC (fibrolamellar and mixed hepatocellular\u002Fcholangiocarcinoma subtypes are not eligible) or noninvasive diagnosis of HCC as per the American Association for the Study of Liver Diseases (AASLD) criteria in subjects with a confirmed diagnosis of cirrhosis.\n2. Relapse or progression after 1 prior line of an ICI-containing regimen (combination or monotherapy) in the locally advanced\u002Fmetastatic setting, with a maximum of 2 prior lines. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.\n3. Barcelona Clinic Liver Cancer (BCLC) Stage B or C.\n4. Liver function status should be Child-Pugh (CP) Class A.\n5. Albumin-Bilirubin (ALBI) Grade 1 within 7 days prior to the first dose of study drug.\n6. Participants with large esophageal varices at risk of bleeding must be treated with conventional medical intervention: beta blockers or endoscopic treatment.\n\nAdditional Inclusion Criteria for Ad-eso\u002FGEJ\u002FGastric Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic Ad-eso\u002FGEJ\u002FGastric that has relapsed or progressed after 1 prior line of systemic therapy in the locally advanced\u002Fmetastatic setting. Subjects with PD-(L)1+ or MSI-H\u002FdMMR should receive ICI treatment if ICIs are standard of care in the country, unless the subject is ineligible for ICI treatment.\n2. If the participant has known history of HER2 positivity (defined by IHC 3+ or IHC 2+ and in situ hybridization \\[ISH\\] positive, as classified by American Society of Clinical Oncology - College of American Pathologists \\[ASCO CAP\\]) or actionable target, the subject must have been previously treated with a targeted therapy.\n\nAdditional Inclusion Criteria for UC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic UC of the bladder, renal pelvis, ureter, or urethra. Participants with histological variants are allowed if urothelial histology is predominant. Small cell\u002Fneuroendocrine tumors are not allowed even if mixed histology.\n2. Relapse or progression after at least 1 prior line of ICI-containing systemic therapy, and 1 prior line of systemic chemotherapy, given in combination with other anticancer therapy or separately, with a maximum of 3 prior therapy lines.\n\n   1. At least 1 line of therapy should include enfortumab vedotin in countries where enfortumab vedotin is approved and available.\n   2. Perioperative systemic therapies will be counted as 1 line of therapy.\n   3. To meet inclusion criteria requirement of prior ICI-containing therapy, use in the perioperative or metastatic setting will suffice.\n   4. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.\n   5. The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy.\n\nAdditional Inclusion Criteria for CC Participants\n\n1. Histologically confirmed unresectable or metastatic CC that was previously treated with ≥1 prior line of systemic therapy in the locally advanced or metastatic setting. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.\n2. Participants should receive prior anti-programmed death 1\u002Fprogrammed death-ligand 1 treatment and\u002For tisotumab vedotin if those are standard of care in the country, unless the subject is ineligible for these treatments.\n\nAdditional Inclusion Criteria for OVC Participants\n\n1. Histologically confirmed high-grade serous OVC, high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer that was previously treated with at least 1 line of platinum-based therapy and bevacizumab unless the subject is ineligible for treatment with bevacizumab.\n2. Participant is no longer considered eligible for platinum-based therapy per the investigator's opinion or has progressed less than 180 days after the last dose of platinum therapy.\n3. Participant is not considered primary platinum refractory and has not progressed during platinum treatment or within 4 weeks after the completion of platinum treatment.\n4. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.\n\nAdditional Inclusion Criteria for BTC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic BTC (intra- or extrahepatic cholangiocarcinoma or gallbladder carcinoma).\n2. Relapse or progression after at least 1 prior line of systemic therapy, or 2 prior lines of systemic therapy if the participant has an actionable target and has received targeted therapy.\n3. Histological subtypes other than ampullary cancer, small cell cancer, lymphoma, sarcoma, neuroendocrine tumors, mixed tumor histology, and\u002For mucinous cystic neoplasms (Please note that the histological subtypes listed here are not allowed.)\n\nAdditional Inclusion Criteria for HER2-Low BC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic BC.\n2. Low HER2 expression, defined as IHC 2+\u002FISH- or IHC 1+ (ISH- or untested), according to ASCO-CAP 2018 HER2 testing guidelines, based on most recent testing, regardless of hormonal status.\n3. Progression on or after treatment with trastuzumab deruxtecan (T-DXd).\n4. Relapse or progression after at least 2 and a maximum of 3 prior lines of systemic therapy. Subjects with metastatic hormone receptor (HR)+ BC who have received endocrine-based therapy and have received at least 2 and a maximum of 3 prior lines of additional systemic therapy in the metastatic setting. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.\n\nAdditional Inclusion Criteria for HER2 IHC 0 BC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic BC.\n2. Negative for HER2 expression, defined as IHC 0 (ISH- or untested) according to ASCO-CAP 2018 HER2 testing guidelines, based on the most recent testing, regardless of hormonal status.\n3. Relapse or progression after at least 2 and a maximum of 3 prior lines of systemic therapy. Participants with metastatic HR+ BC who have received endocrine-based therapy and have received at least 2 and a maximum of 3 prior lines of additional systemic therapy in the metastatic setting. Subjects with actionable target tumor mutation should have been previously treated with targeted therapy.\n\nAdditional Inclusion Criteria for Cutaneous (Acral and Non-acral) Melanoma Subjects\n\n1. Histologically or cytologically confirmed cutaneous (acral and non-acral) melanoma.\n2. Disease progression while on or after having received treatment with ≥1 prior line of ICI based therapy. Prior anti-PD-(L)1 therapy in the adjuvant setting may be counted as 1 line if there is recurrence within 12 weeks of the last dose. If the subject had BRAF mutated melanoma or other actionable target tumor mutation, they must have had disease progression on targeted therapy as well.\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd.\n2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, T-DXd) due to treatment-related toxicities.\n3. Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.\n4. Inadequate treatment washout period before enrollment as specified in the protocol.",{"count":52,"type":20},520,[54],"PHASE2","This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso\u002FGEJ\u002Fgastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; and cutaneous melanoma.",[26],[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73],"Recurrent or metastatic solid tumors","Endometrial cancer","Head and neck squamous cell carcinoma","Colorectal cancer","Hepatocellular carcinoma","Adenocarcinoma of esophagus, gastroesophageal junction, and stomach","Urothelial carcinoma","Ovarian cancer","Cervical cancer","Biliary tract cancer","Human epidermal growth factor 2 (HER2)-low breast cancer","HER2 immunohistochemistry 0 breast cancer","Cutaneous melanoma","Pancreatic ductal adenocarcinoma","Ifinatamab deruxtecan (I-DXD)","DS7300a","2026-02-10",{"date":76,"type":35},"2026-02-12",{"date":78,"type":35},"2024-04-10",{"date":80,"type":20},"2028-07-25",{"name":41,"class":42},119,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100523285","phase-1-an-exploratory-study-of-a-337-in-the-management-of-malignant-solid-dose-escalation-and-expansion-phases-100523285","NCT06093698","An Exploratory Study of A-337 in the Management of Malignant Solid Dose Escalation and Expansion Phases","An Exploratory Study of A-337 in the Management of Malignant Solid Dose","A-337","Inclusion Criteria:\n\n* 18-75 years, all genders\n* Patients with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard treatment, have no standard treatment options, or are not suitable for standard treatment at this stage.\n* The interval between the first dose of investigational drug and previous major surgery, medical device treatment, or local radiotherapy was at least 28 days. At least 21 days between the first dose of investigational drug and previous cytotoxic chemotherapy, immunotherapy, or biological agents; At least 14 days between he first dose of investigational drug and previous tumor-related endocrinotherapy and minor surgery; The interval between he first dose of investigational drug and small molecule targeted drugs was at least 21 days or 5 half-lives, whichever is longer; At least 14 days interval between the first dose of investigational drug and antineoplastic chinese traditional medicines.\n* Patients with at least one measurable lesion on the basis of RECIST v1.1.\n* ECOG ≤ 1\n* Patients are willing to provide archival tumor tissue or undergo fresh tissue biopsy.\n* Life expectancy is at least 3 months.\n* Having adequate organ and bone marrow functional reserve, defined as follows:\n\n  1. Blood routine (corrected with no growth factor support, blood transfusion, or other medication within 2 weeks before screening) ANC ≥ 1.5 ×109 \u002FL,PLT≥ 75×109\u002FL,HGB≥ 90 g\u002FL\n  2. hepatic parameters :TBIL ≤ 1.5 × ULN For patients with liver metastases or a history of Gilbert's syndrome\u002Fsuspected disease,TBIL ≤ 3 ×ULN For patients without liver metastases,ALT≤ 2.5 ×ULN,AST≤ 2.5 ×ULN For patients with liver metastases,ALT or AST ≤ 5 ×ULN\n  3. renal function:Cr≤ 1.5×ULN or CrCl≥ 45 mL\u002Fmin (using The Cockcroft-Gault formula )\n  4. coagulation function:APTT≤ 1.5 × ULN,INR≤ 1.5 × ULN. Patients who were in the therapeutic window for long-term use of anticoagulants who did not meet these criteria could be enrolled at the investigator's discretion.\n* Participants are capable of providing written informed consent and adhering to the protocol.\n\nExclusion Criteria:\n\n* Past or present malignant tumor diagnosed in the past 3 years and\u002For required treatment.Except for the completely resected basal and squamous cell skin cancers and any type in situ.\n* Patients with CNS metastases, unless the metastases were treated and stable for at least 4 weeks and without taking systemic steroids ≥ 10 mg prednisone\u002Fday or equivalent.\n* Patients suspected or confirmed immunocompromised:\n\n  1. Patients with HIV\n  2. Patients requiring systemic or local treatment with systemic steroids or any immunomodulatory drug (at a level that results in a systemic dose effect).E.g. High-dose oral or intravenous steroids \\> 10 mg\u002F day prednisone or its equivalent, or methotrexate \\> 15 mg once weekly).Allow topical, inhaled or topical use of steroids (at levels not thought to cause systemic dose effects);\n  3. Patients with active autoimmune disease or a history of autoimmune disease with potential recurrence(e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autohemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis).Exceptions are patients with type I diabetes, hypothyroidism that is manageable with hormone-replacement therapy, skin conditions (e.g., vitiligo, psoriasis, or alopecia) that require no systemic treatment, or childhood asthma\u002Fallergies that have resolved without any intervention in adulthood.\n  4. Patients with allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation)\n  5. Any other condition that was considered by the investigator to place the patient at unacceptable risk as a result of receiving immunomodulatory therapy.\n* Anticancer therapy, including hormonal therapy, biological therapy, cellular therapy, or radiation therapy, was administered within 4 weeks prior to the initiation of study treatment, except in the following cases:\n\n  1. Hormonal therapy for prostate cancer using gonadotropin-releasing hormone (GnRH) agonists.\n  2. Hormone replacement therapy or oral contraceptives\n* Participants with any disease, medical condition, or social factor that was judged by the investigator to be likely to affect the study results or adherence were excluded from the study according to the protocol:\n\n  1. Uncontrolled acute infection or confirmed bacteremia.\n  2. Patients with HIV or HBV,and HBV copy number \\> 1000\u002FmL or HBV DNA titer \\> 200 IU\u002FmL.And patients with HCV.\n  3. Severe dyspnea, pulmonary insufficiency, or continuous oxygen therapy.\n  4. The patients were classified as New York Heart Association (NYHA) class 3 or 4 or left ventricular ejection fraction (LVEF) \\\u003C 50%.\n  5. Myocardial infarction, unstable angina, stroke, or transient ischemic attack, or other cardiovascular events of grade III or higher, occurred within 6 months before dose administration.\n  6. Severe arrhythmia or uncontrolled hypertension (systolic blood pressure \\> 180 mmHg and diastolic blood pressure \\> 100 mmHg) or diabetes mellitus.\n* Patients with uncontrolled systemic infection.\n* Patients with positive treponema pallidum antibody.\n* Patients who had undergone major surgical procedures (craniotomy, thoracotomy, or laparotomy) or who had nonhealed wounds, ulcers, or fractures within 4 weeks before the administration of the first dose of investigational drug, with the exception of needle biopsy procedures.\n* Patients with alcohol or drug dependence.\n* Patients with mental disorders, including epilepsy or dementia, or poor adherence.\n* Patients with tumor types of nonepithelial origin.\n* Patients with received an EpCAM antibody class, CD3 dual antibody class, or CAR-T therapy.\n* Patients who did not recover to grade 1 or less toxicity (CTCAE 5.0) from previous antineoplastic therapy(except alopecia) .Patients who did not recover to grade 1 or below (CTCAE 5.0) after radiotherapy (except no effect).\n* Pregnant (positive pregnancy test), lactating women.Women of childbearing age who did not agree to use contraception for at least 3 months after signing the informed consent form until the end of the study.Women of childbearing age had a positive HCG test within 7 days before the first day of treatment.\n* Male subjects who did not agree to use contraception for at least 3 months after signing the informed consent form until the end of the study (except surgical sterilization)\n* Patients with a allergy to the study drug or its excipients.\n* Patients who were deemed by the investigator to be ineligible for this study.","75 Years",{"count":93,"type":20},94,[23],"Title: An Exploratory Study of A-337 in the Management of Malignant Solid Dose Escalation and Expansion Phases",[26],"NOT_YET_RECRUITING","2023-10-17",{"date":100,"type":35},"2023-10-23",{"date":102,"type":20},"2023-12-01",{"date":104,"type":20},"2026-12-31",{"name":106,"class":42},"ITabMed Co., Ltd."]