[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroesophageal-junction-gej-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroesophageal-junction-gej-cancer":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,57,97,123,211],{"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":25,"conditions":26,"keywords":41,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":4},"100633678","phase-1-phase-12-study-of-bhb810-in-advanced-gastric-and-gej-adenocarcinoma-100633678",false,"NCT07529808","Phase 1\u002F2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma","Phase 1\u002F2, Open-Label, Multicenter, Dose Escalation and Expansion Study of BHB810 in Participants With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.\n* Histologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on, was nonresponsive to, or for which no standard or available curative therapy exists.\n\n  * Participants in Phase 1 Backfill Cohorts \\& Phase 2 must be CDH17-positive by central testing.\n  * Other gastrointestinal (GI) tumor types may be enrolled in Backfill Cohorts and Phase 2.\n* At least 1 measurable target lesion at baseline per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)\n* Provision of FFPE archival tumor tissue. Additional fresh biopsies at screening are required in Phase 1 Backfill Cohorts and Phase 2.\n* Adequate organ and marrow function as defined in the protocol\n\nExclusion Criteria:\n\n* Prior cancer treatment as follows, relative to the first planned dose of trial intervention:\n\n  * Chemotherapy or targeted therapy withing 4 weeks or 5-halflives (whichever is shorter)\n  * Monoclonal antibody-based therapy (including ADCs) within 4 weeks\n  * Immune checkpoint inhibitors within 4 weeks\n  * Wide-field radiation therapy (\\>30% marrow-bearing bones) within 4 weeks or \\\u003C 2 weeks of focal palliative radiation to nontarget lesions\n* Prior treatment with a CDH17-directed therapy or an ADC with an auristatin (MMAE or MMAF)\n* Known hypersensitivity or allergic reaction to BHB810 or it's excipients\n* Left ventricular ejection fraction \\\u003C50% or history of congestive heart failure Class III\u002FIV\n* QTc interval \\> 470 msec, history of risk factors for Torsade de Pointes, or taking a medication known to prolong QT\u002FQTc\n* Pregnant or breastfeeding females, or if you or your partner are planning to become pregnant\n* Known or suspected brain metastases, leptomeningeal disease, or spinal cord compression. Participants with stable, treated brain metastases may be enrolled.\n* Current treatment with a strong CYP3A4 inhibitor or inducer, Pgp inhibitor, or CYP3A4 sensitive substrate within 2 weeks of first dose of trial intervention\n* Any condition that may compromise participant safety, compliance, or interfere with the evaluation of the study drug.","ALL","18 Years",{"count":19,"type":20},164,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This study is looking at how safe BHB810 is in adults with gastric and gastroesophageal adenocarcinoma (GEJ). The purpose of this study is also to look at: how well the study drug works, how the study drug moves into, through, and out of the body, and how your body reacts to the study drug. Participants will get an IV infusion of BHB810 every 2 weeks while on study treatment.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Gastric Cancer","Gastric Adenocarcinoma","Gastric (Stomach) Cancer","Gastroesophageal Adenocarcinoma","Gastroesophageal Cancer (GC)","Gastroesophageal Junction (GEJ) Adenocarcinoma","Gastroesophageal Junction (GEJ) Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Adenocarcinoma","Gastrointestinal Cancers","Colorectal (Colon or Rectal) Cancer","Pancreatic Cancer","CDH17-positive Advanced Solid Tumors","Advanced Gastric Cancer",[42,43,44],"Antibody Drug Conjugate (ADC)","Monomethyl Auristatin E (MMAE)","CDH17 protein","NOT_YET_RECRUITING","2026-05-05",{"date":48,"type":49},"2026-05-08","ACTUAL",{"date":51,"type":20},"2026-06",{"date":53,"type":20},"2028-12",{"name":55,"class":56},"BigHat Biosciences, Inc.","INDUSTRY",{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":67,"conditions":68,"keywords":82,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100447533","phase-1-a-study-of-nx-1607-in-adults-with-advanced-malignancies-100447533","NCT05107674","A Study of NX-1607 in Adults With Advanced Malignancies","A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types","Key Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Measurable disease per disease-specific response criteria.\n* Patients must have disease that is metastatic or unresectable and have received standard treatment options, are not candidates for standard treatment options, or will otherwise be prevented from receiving any standard treatment options.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Minimum of 3 weeks or 5 half-lives (whichever is shorter) since last dose of systemic cancer therapy (unless otherwise specified) or minimum of 2 weeks since last radiotherapy, or minimum of 6 weeks since last systemic therapy with nitrosoureas, antibody-drug conjugate, or radio immuno-conjugate therapy.\n* Adequate organ and bone marrow function, in the absence of growth factors (with limited exception for DLBCL), as defined by laboratory parameters.\n* Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol.\n* Patient must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.\n* Each patient must sign an informed consent form (ICF).\n* Histological or cytological diagnosis of platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma; gastric\u002FGEJ cancer; HNSCC; recurrent and either metastatic or unresectable melanoma; NSCLC; mCRPC; MPM; TNBC; locally advanced or metastatic urothelial cancer; cervical cancer; MSS CRC; or DLBCL (including DLBCL-RT)\n* Accessible tumor (for all cohorts) or lymph node (DLBCL only) for biopsy (Phase 1b only).\n\nKey Exclusion Criteria:\n\n* Active untreated brain metastases.\n* Patient has any of the following:\n* Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension or diabetes, or ongoing active infection requiring systemic therapy.\n* Patients with primary refractory EOC defined as patients who do not respond to their first platinum-containing regimen or who relapse less than 6 months after completion of that first platinum-containing regimen\n* Psychiatric illness that would limit compliance with study requirements.\n* Treatment with any of the following prior to the first dose of NX-1607: CPI (anti-PD-1, PD-L1, cytotoxic T-lymphocyte-associated protein 4, etc) within 3 weeks; autologous or allogeneic stem cell transplant within 100 days; prior systemic cancer therapy within 3 weeks or 5 half-lives (whichever is shorter) (unless otherwise specified) (including hormonal therapy except for hormonal prophylaxis for a prior malignancy); prior radiotherapy within 2 weeks; prior systemic therapy with nitrosoureas, antibody-drug conjugate, or radio-immuno-conjugate therapy within 6 weeks; use of strong or moderate CYP3A4 inducers or inhibitors within 14 days or 7 days, respectively, or 5 half-lives (whichever is longer)\n* History of CAR-T therapy within 30 days prior to the first dose of NX-1607.\n* Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to Grade 1 or less except for Grade 2 alopecia and Grade 2 peripheral neuropathy or patients receiving endocrine replacement therapy\n* Patients who experienced Grade 3 or higher irAEs with prior immunotherapy.\n* History of uveitis, or an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Unable to swallow capsules or has malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction likely to interfere with the delivery, absorption, or metabolism of NX-1607.\n* Known allergies, hypersensitivity, or intolerance to components of NX-1607.\n* Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of NX-1607.\n* Patient is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of NX-1607 and, as applicable, within 6 months after the last dose of paclitaxel.\n* Patient has had major surgery (e.g., requiring general anesthesia) within 4 weeks before the planned first dose of NX-1607, or will not have fully recovered from surgery, or has surgery planned during the time the patient is expected to participate in the study or within 4 weeks after the last dose of NX-1607. Note: Patients with minor planned surgical procedures to be conducted under local anesthesia may participate.\n* Vaccinated with a live vaccine within 28 days (with the exception of the annual inactivated influenza vaccine) or COVID-19 vaccination within 14 days prior to the first dose of NX-1607.\n* Active known second malignancy with the exception of any of the following:\n\n  * Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer.\n  * Adequately treated Stage I cancer from which the patient is currently in remission and has been in remission for ≥ 2 years.\n  * Low-risk prostate cancer with Gleason score \\\u003C 7 and PSA \\\u003C 10 ng\u002FmL.\n  * Any other cancer from which the patient has been disease-free for ≥ 2 years.\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Patients with well controlled HIV (e.g., CD4 \\> 350\u002Fmm3 and undetectable viral load) are eligible.\n* Current active hepatitis, including hepatitis A (hepatitis A virus immunoglobulin M \\[IgM\\] positive), hepatitis B (hepatitis B virus \\[HBV\\] surface antigen positive), or hepatitis C (hepatitis C virus \\[HCV\\] antibody positive, confirmed by HCV RNA). Patients with HCV with undetectable virus after treatment are eligible. Patients with prior exposure to HBV may be entered if quantitative PCR is negative.\n* Use of systemic corticosteroids (\\> 20 mg prednisone or equivalent) within 15 days (except for prophylaxis for radio diagnostic contrast reactions and\u002For prophylaxis for patients receiving paclitaxel), or other immunosuppressive drugs within 30 days, prior to the first dose of NX-1607.\n* Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg \\[NIH 2020\\] (Note: Patients who switch from a high dose to a dose of 30 µg\u002Fday or less at least 1 day prior to Screening assessments are eligible for study entry).\n* Receipt of an IP or has been treated with an investigational device within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NX-1607.\n* Any of the following within 6 months prior to the first dose of NX-1607 or ongoing:\n\n  * Myocardial infarction\n  * Unstable angina\n  * Unstable symptomatic ischemic heart disease\n  * New York Heart Association Class III or IV heart failure\n  * Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events)\n  * Any other significant cardiac condition (e.g., pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, or severe congenital heart disease)\n  * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator in consultation with the Medical Monitor.",{"count":65,"type":20},345,[23],"This is a first-in-human Phase 1a\u002F1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-1607 in patients with advanced malignancies.",[69,27,70,71,72,73,74,75,76,77,78,79,80,81],"Ovarian Cancer, Epithelial","GastroEsophageal Junction (GEJ) Cancer","Head and Neck Squamous Cell Carcinoma","Metastatic or Unresectable Melanoma","Non-small Cell Lung Cancer (NSCLC)","Metastatic Castration-resistant Prostate Cancer (mCRPC)","Malignant Pleural Mesothelioma (MPM)","Triple Negative Breast Cancer (TNBC)","Metastatic Urothelial Carcinoma","Cervical Cancer","Diffuse Large B Cell Lymphoma (DLBCL)","Richter Transformation","Microsatellite Stable Colorectal Carcinoma",[83,84,85],"Ubiquitin Ligase Inhibitor","Advanced Malignancies","T-cell Activation","RECRUITING","2025-09-05",{"date":89,"type":49},"2025-09-09",{"date":91,"type":49},"2021-09-29",{"date":93,"type":20},"2028-02-28",{"name":95,"class":56},"Nurix Therapeutics, Inc.",17,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":122},"100508009","phase-1-t-dxd-in-combination-with-ramucirumab-as-her2-low-gastric-or-gastroesophageal-junction-gej-adenocarcinoma-100508009","NCT05894824","T-Dxd in Combination With Ramucirumab as HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma","An Open Label, Single-arm, Multicenter Phase Ib\u002FII Study to Evaluate the Safety and Efficacy of T-Dxd in Combination With Ramucirumab as a 2nd Line in Patients With HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma","Inclusion Criteria:\n\n1. Able and willing to give written informed consent and has signed the appropriate weitten informed consent form(ICF) prior to performance of any trial activityes.\n2. Eligible male and female subjects aged ≥19 years.\n3. Histologically or cytologically proven metastatic or locally advanced HER2 low gastric or GEJ adenocarcinoma: The definition of HER2 low is 1+ by immunohistochemistry (IHC) or 2+ by IHC and without HER2 gene amplification (negative by in situ hybridization\\[ISH\\]).\n4. Progressed after 1st line palliative treatment. Adjuvant chemotherapy will be counted as 1st line treatment if the cancer has recurred within 6 months of completion of adjuvant chemotherapy.\n5. Has measurable or evaluable disease as determined by RECIST ver 1.1.\n6. ECOG performance status of 0 -1 at trial entry.\n7. Life expectancy ≥12 weeks as judged by the Investigator.\n8. Has LVEF ≥ 50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before enrollment.\n9. Adequate baseline organ function defined as:\n\n   * Absolute neutrophil count ≥1500\u002Fmm3\n   * Platelets ≥100,000\u002Fmm3\n   * Hemoglobin ≥9.0 g\u002FdL\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN) of the study site (or ≤5.0 × ULN in patients with liver metastases)\n   * Total bilirubin ≤1.5 × ULN - Serum albumin ≥2.5 g\u002FdL\n   * Creatinine ≤1.5 × ULN or creatinine clearance (either measured value or estimated value using the Cockcroft-Gault equation) \\>40ml\u002Fmin - Urinary protein ≤1+ on dipsick or routine urinalysis - INR and PTT\u002FaPTT ≤1.5 × ULN 10. Adequate treatment washout period before randomization\u002Fenrollment. - Major Surgery ≥ 4 weeks - Radiation Therapy including palliative stereotactic radiation therapy to chest ≥ 4 weeks\n   * Anti-Cancer chemotherapy \\[Immunotherapy (non-antibody based therapy)\\] ≥ 3 weeks\n\n11\\. Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.\n\n12\\. Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for 7 months after the last dose of IMP.\n\n13\\. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to 4 months after the final dose of IMP. 14. Female subjects must not donate, or retrieve for their own use, ova from the time of enrollment and throughout the study treatment period, and for at least 7 months after the final study drug administration\n\nExclusion Criteria:\n\n1. Anticancer treatment within 14 days before the start of trial treatment.\n2. Major surgery within 28 days before the start of trial treatment.\n3. Have received more than 2 prior lines of chemotherapy.\n4. Grade ≥ 2 peripheral neuropathy.\n5. Multiple primary malignancies within 3 years.\n6. Participants with a medical history of myocardial infarction within 6 months before treatment, symptomatic CHF (New York Heart Association Class II to IV), unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (\\\u003C 6 months) cardiovascular event, including myocardial infarction, unstable angina pectoris, and stroke.\n7. Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\>450 msec (males) based on an average of the screening triplicate 12-lead ECG.\n8. Gastrointestinal perforation or fistula or any Grade 3-4 bleeding within 3 months of first dose of protocol therapy; or any arterial thromboembolic event, significant gastro-intestinal bleeding or any significant venous thromboembolism within 3 months before treatment\n9. History of (non-infectious) ILD \u002F pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n10. Lung criteria: A. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder. B. Any autoimmune, connective tissue or inflammatory disorders C. Prior pneumonectomy\n11. Has known active CNS metastases and\u002For carcinomatous meningitis.\n12. Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.\n13. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n14. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.\n15. Active primary immunodeficiency, known uncontrolled active HIV infection or active hepatitis B or C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1. 16. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 17. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IMP. 18. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. 19. Known allergy or hypersensitivity to study treatment or any of the study drug excipients.\n\n20\\. History of severe hypersensitivity reactions to other monoclonal antibodies.\n\n21\\. Pregnant or breastfeeding female patients, or patients who are planning to become pregnant.\n\n22\\. Otherwise inappropriate for this study in the investigator's or sub-investigator's opinion.\n\n23\\. Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.\n\n24\\. Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy.\n\n25\\. The patient is receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg\u002Fday) is permitted.\n\n26\\. The patient has uncontrolled or poorly-controlled hypertension (\\>160 mmHg systolic or \\> 100 mmHg diastolic for \\>4 weeks) despite standard medical management.","19 Years",{"count":106,"type":20},58,[23,24],"This is a Phase Ib\u002FII study to identify the RP2D of T-DXd combination with Ram and to assess the safety and clinical efficacy of this combined treatment in advanced gastric cancer. The study will be conducted in two parts: Phase Ib dose escalation study to determine the MTD and RP2D of T-DXd combination and Ram, and Phase II to further evaluate the safety and tolerability of T-DXd combinations with Ram at the RP2D and determine anti-tumor activity.",[27,33],[111],"HER2 gastric cancer, T-Dxd, Ramucirumab","2025-07-09",{"date":114,"type":49},"2025-07-11",{"date":116,"type":49},"2024-02-05",{"date":118,"type":20},"2026-01-01",{"name":120,"class":121},"Yonsei University","OTHER",1,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":134,"conditions":135,"keywords":170,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":210},"100445919","phase-1-a-beta-only-il-2-immunotherapy-study-100445919","NCT05086692","A Beta-only IL-2 ImmunoTherapY Study","A Phase 1\u002F2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors","ABILITY-1","Key Inclusion Criteria:\n\n1. Aged at least 18 years (inclusive at the time of informed consent).\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)\n5. Demonstrated adequate organ function\n6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and\u002For MRI.\n7. Life expectancy of ≥ 12 weeks.\n8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.\n9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.\n\nKey Exclusion Criteria:\n\n1. Last administration of prior antitumor therapy:\n\n   * Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.\n   * Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\\\u003C2 weeks of radiotherapy) to non-CNS disease.\n   * Radiation therapy to the lung that is \\> 30Gy within 6 months prior to start of treatment.\n   * Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.\n2. Has known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.\n3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.\n4. Condition requiring long-term systemic treatment with either corticosteroids \\> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.\n5. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.\n6. Severe pulmonary, cardiac or other systemic disease.\n7. Known hepatitis B or C virus infection.\n8. Females who are pregnant or lactating or planning to become pregnant during the study.\n9. Has had an allogeneic tissue\u002Fsolid organ transplant.\n10. Active infection requiring systemic therapy.\n11. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol\n12. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.\n13. Known severe hypersensitivity to any component of study drug(s).\n14. Inability to comply with study and follow up procedures as judged by the Investigator.",{"count":132,"type":20},115,[23,24],"This is a Phase 1\u002F2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.",[136,137,138,139,140,141,142,27,78,143,144,145,146,147,148,149,150,151,152,153,154,155,156,33,157,158,159,160,161,162,163,164,165,166,167,168,169],"Advanced Solid Tumor","Unresectable Solid Tumor","Clear Cell Renal Cell Carcinoma","Triple Negative Breast Cancer","Non-Small Cell Lung Cancer Squamous","Non-Small Cell Lung Cancer Non-squamous","Colorectal Cancer (MSI-H)","Basal Cell Carcinoma","Bladder Cancer","Merkel Cell Carcinoma","Squamous Cell Carcinoma of Head and Neck","Cutaneous Squamous Cell Carcinoma","Pleural Mesothelioma","Esophageal Cancer","Endometrial Carcinoma","Solid Tumor","Solid Tumor, Adult","MSI-H Solid Malignant Tumor","Cancer With A High Tumor Mutational Burden","Epithelial Ovarian Carcinoma","Primary Peritoneal Cancer","Acral Melanoma","Mucosal Melanoma","Cutaneous Melanoma","DMMR Solid Malignant Tumor","Fallopian Tube Cancer","Ovarian Cancer","MSI-H Cancer","DMMR Cancer","Pancreas Adenocarcinoma (MSI-H)","Skin Cancer","Viral Cancer","Cervical Cancers","Endometrial Cancer",[171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201],"IL-2","IL2","Interleukin-2","cancer","metastatic","ccRCC","TNBC","NSCLC","CRC","GEJ","intrahepatic","extrahepatic","MCC","SCCHN","CSCC","Gastroesophageal Junction","advanced","unresectable","MSI-H","dMMR","Microsatellite Instability-High","Mismatch Repair Deficient","PD-1","immunotherapy","anti-PD-1","BCC","RCC","HCC","Tumor Mutation Burden High","TMB-H","PDAC","2025-07-03",{"date":112,"type":49},{"date":205,"type":49},"2021-08-27",{"date":207,"type":20},"2026-12-30",{"name":209,"class":56},"Medicenna Therapeutics, Inc.",27,{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":219,"enrollmentInfo":220,"targetDuration":222,"studyType":223,"phases":4,"briefSummary":224,"conditions":225,"keywords":226,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":122},"100587558","the-effect-of-different-digestive-tract-reconstruction-methods-on-postoperative-quality-of-life-after-proximal-gastrectomy-100587558","NCT06929949","The Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy","A Single-center, Prospective, Observational Cohort Study on the Effect of Different Digestive Tract Reconstruction Methods on Postoperative Quality of Life After Proximal Gastrectomy","STARS-GC10","Inclusion Criteria:\n\n* Age from over 18 to under 75 years.\n* Preoperative gastroscopic pathological biopsy was performed, and histologically confirmed as carcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma, mixed adenocarcinoma, etc.) or adenoma.\n* Diagnosed with upper gastric cancer (T1N0M0, T1N1M0, or T2N0M0) or esophagogastric junction cancer with a diameter ≤4 cm based on the 8th edition of the AJCC staging system, as confirmed by CT, MRI, endoscopic ultrasound, and pathology.\n* Undergoing proximal gastrectomy with D2 lymphadenectomy is expected to achieve curative resection, with the remaining gastric volume required to be at least half of the pre-resection volume.\n* Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale.\n* ASA (American Society of Anesthesiology) class I to III.\n* The patient has adequate organ function and is capable of tolerating surgery.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Patients who have received preoperative radiotherapy, chemotherapy, targeted therapy, or immunotherapy.\n* Presence of multiple malignant tumors in the stomach.\n* History of upper abdominal surgery, except for laparoscopic cholecystectomy.\n* History of gastric surgery, except for endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) for gastric cancer.\n* Evidence of distant metastasis diagnosed by thoracoabdominal CT\u002FMRI or PET-CT.\n* Pregnant or lactating women.\n* History of uncontrolled epilepsy, central nervous system disorders, or psychiatric illness.\n* Patients with limb disabilities or motor function impairment.\n* History of other malignant diseases within the past five years, except for cured skin cancer and cervical carcinoma in situ.\n* Clinically severe (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or higher congestive heart failure, severe arrhythmia requiring medical intervention, or myocardial infarction within the past six months.\n* History of stroke or cerebral hemorrhage within the past six months.\n* Severe, uncontrolled recurrent infections or other serious uncontrolled comorbidities.\n* Pulmonary function test showing FEV1 \\\u003C 50% of the predicted value.\n* Patients requiring emergency surgery due to tumor-related complications (e.g., bleeding, perforation, or obstruction).","75 Years",{"count":221,"type":20},90,"3 Years","OBSERVATIONAL","Gastric cancer ranks as the fifth most common malignancy worldwide and the fourth leading cause of cancer-related deaths. In China, its incidence and mortality rank third among all cancers. While the global incidence of gastric cancer is declining, proximal gastric cancer and adenocarcinoma of the esophagogastric junction (AEG) are on the rise. Due to the unique characteristics of AEG, there is no standardized treatment consensus, making the selection of an optimal surgical approach and reconstruction method crucial for improving patient outcomes.\n\nFor early-stage proximal gastric cancer and AEG, total gastrectomy (TG) and proximal gastrectomy (PG) are common surgical options. PG, increasingly favored for its function-preserving benefits, has been shown to be a safe and effective alternative to TG. While TG effectively removes lymph nodes and reduces reflux risk, it leads to permanent loss of gastric function and nutritional deficiencies. PG better preserves gastrointestinal function but is limited by the risk of reflux esophagitis, highlighting the need for improved reconstruction techniques.\n\nSeveral reconstruction methods exist after PG, including esophagogastric anastomosis, jejunal interposition, double-tract reconstruction (DTR), double-flap technique (DFT), and tubular gastric anastomosis, each with varying efficacy in preventing reflux. Studies suggest that DTR reduces reflux and improves quality of life compared to esophagogastric anastomosis, while DFT, first introduced in 1998, has gained popularity for its advantages in maintaining nutrition and minimizing reflux. Additionally, tubular gastric anastomosis, which constructs a narrow gastric tube to facilitate tension-free anastomosis, has shown potential benefits for AEG patients.\n\nMost existing studies on laparoscopic or robot-assisted reconstruction techniques for proximal gastric cancer are retrospective, lacking high-quality prospective evidence. Furthermore, comparative data on their anti-reflux efficacy and postoperative quality of life remains l",[33,27],[227,228,229,230],"Robot-assisted surgery","Laparoscopic-assisted surgery","Proximal gastrectomy","Digestive tract reconstruction","2025-04-08",{"date":233,"type":49},"2025-04-16",{"date":235,"type":49},"2024-11-25",{"date":237,"type":20},"2030-11-25",{"name":239,"class":121},"The First Hospital of Jilin University"]