[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-negative\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-negative":57},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,71],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100634986","phase-2-study-of-denikitug-gs-1811-given-alone-or-with-nivolumab-or-chemotherapy-in-adults-with-metastatic-gastric-gastroesophageal-junction-gej-and-esophageal-adenocarcinomas-100634986",false,"NCT07546812","Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas","A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate Denikitug as Monotherapy or in Combination With Nivolumab or Chemotherapy in Participants With HER2-Negative, Unresectable, Recurrent, and\u002For Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas","Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of locally advanced, unresectable, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC).\n* Human epidermal growth factor receptor 2 (HER2)-negative status, as determined by local assessment using a validated immunohistochemistry assay, in situ hybridization or other amplification testing.\n* Has had disease progression during or after first line of systemic therapy for advanced or metastatic gastric, GEJ, or EACs, which must have included at least one of the following:\n\n  1. Platinum- and fluoropyrimidine-based chemotherapy.\n  2. Therapy with an anti-programmed cell death protein 1 (PD1) or anti-programmed cell death ligand 1 (anti-PD-L1) monoclonal antibody (patients with PD-L1-positive tumors must have received prior PD-1\u002FPD-L1-based therapy).\n  3. Zolbetuximab or other Claudin-18 (CLDN18).2-targeted therapy, if indicated based on biomarker status.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Have adequate organ function.\n* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception.\n\nKey Exclusion Criteria:\n\n* Active or history of autoimmune disease requiring systemic treatment within 2 years, inflammatory bowel disease (IBD) (Crohn's\u002Fulcerative colitis), celiac disease, or noninfectious enteritis\u002Fcolitis. (Physiologic hormone replacement not considered systemic treatment).\n* History or current noninfectious pneumonitis\u002Finterstitial lung disease, including radiation-induced pneumonitis requiring steroids or active\u002Frecurrent pneumonitis of any etiology.\n* Documented microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) disease by local polymerase chain reaction (PCR) (microsatellite status) and\u002For informed consent form (ICH) (mismatch repair (MMR)) assay\n* (For Part 2 only) Has known history of peripheral neuropathy ≥ Grade 2 (per National Cancer Institute(NCI)-Common Tenninology Criteria for Adverse Events (CTCAE) Version 5.0).\n* (For Part 2 only) Known coagulopathy that increases the risk of bleeding, bleeding diatheses. Any other Grade 3 or higher hemorrhage\u002Fbleeding event within 28 days prior to enrollment.\n\nPrior\u002FConcurrent Therapy or Clinical Study Experience\n\n* Prior treatment with DEN or other C-C chemokine receptor 8 (CCR8)-targeted agents.\n* Prior Lonsurf (trifluridine-tipiracil) or paclitaxel (PAC)-based regimens in the first-line setting for advanced\u002Fmetastatic gastroesophageal adenocarcinoma.\n* Any systemic therapy (including investigational) targeting vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR) signaling pathways.\n* Anticancer biologic within 4 weeks, orchemotherapy, targeted small molecule, or radiation therapy within 2 weeks prior to enrollment with unresolved adverse events (AE)s (Grade \\>2). (Observational study participants are eligible).\n* Prior allogenic tissue\u002Fsolid organ or stem cell transplantation. (Exception: corneal transplant not requiring systemic immunosuppression is allowed).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based combinations in in participants with human epidermal growth factor receptor 2 (HER2)-Negative, unresectable, recurrent, and\u002For metastatic, gastroesophageal junction (GEJ), and esophageal adenocarcinomas.\n\nThe primary objective of this study is to assess the effect of DEN as a monotherapy or in combination with nivolumab (NIVO) or ramucirumab (RAM) and paclitaxel (PAC) on objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST Version1.1).",[26,27,28,29],"HER2-negative","Gastroesophageal Junction","Esophageal Adenocarcinoma","Gastric Adenocarcinoma","RECRUITING","2026-05-14",{"date":33,"type":34},"2026-05-18","ACTUAL",{"date":36,"type":20},"2026-05",{"date":38,"type":20},"2030-01",{"name":40,"class":41},"Gilead Sciences","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100587721","phase-2-phase-ii-trial-of-iparomlimabtuvonralimab-ql1706--xelox-in-her2-negative-low-pd-l1-ggej-adenocarcinoma-100587721","NCT06932068","Phase II Trial of Iparomlimab\u002FTuvonralimab (QL1706) + XELOX in HER2-Negative, Low PD-L1 G\u002FGEJ Adenocarcinoma","Safety and Efficacy of Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy for the Treatment of HER2-Negative, Low PD-L1 Expressing, Unresectable or Metastatic Gastric\u002FGastroesophageal Junction Adenocarcinoma: A Phase II Single-Arm Trial","SEARCH","Inclusion Criteria:\n\n1. Aged 18-75 years, gender is not limited;\n2. Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;\n3. HER2-negative by immunohistochemistry (IHC);\n4. low PD-L1 expression status (CPS \\\u003C 5);\n5. Has at least 1 measurable lesion as determined by RECIST 1.1;\n6. No systematic treatment in the past, or the patient has received neoadjuvant\u002Fadjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment;\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n8. Adequate organ function;\n9. The life expectancy is at least 3 months;\n10. Willing to join the study and signed an informed consent form (ICF) with good compliance and cooperation in follow-up.\n\nExclusion Criteria:\n\n1. Allergic to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;\n2. Cardiovascular and cerebrovascular events that are not well controlled;\n3. Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks;\n4. Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);\n5. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases;\n6. Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment;\n7. Brain metastasis or leptomeningeal metastasis;\n8. Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug;\n9. Has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ);\n10. Any major surgery was performed ≤ 28 days before the first trial drug administration;\n11. History of allogeneic stem cell transplantation or organ transplantation;\n12. Duodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases at present; or other conditions that may cause gastrointestinal bleeding or perforation judged by the researchers; or history of intestinal perforation or fistula, but has not recovered after surgical treatment;\n13. Live vaccine was inoculated within 4 weeks (inclusive) before the first administration of the trial drug, not including seasonal influenza vaccines but intranasal vaccine.\n14. Has other factors that may lead to the forced termination of this trial according to the judgment of the investigator, such as other serious diseases (including psychological and mental diseases) requiring combined treatment, serious laboratory examination abnormalities, and family or social factors, which may affect the safety of the subject, or the collection of data and samples;\n15. Participating in other therapeutic clinical studies or using research instruments within 4 weeks before the first administration;\n16. Others conditions do not meet the inclusion according to the judgment of the investigator.","75 Years",{"count":53,"type":20},77,[23],"This is single - arm study to explore the safety and efficacy of iparomlimab and tuvonralimab (QL1706) combined with chemotherapy for treating her2-negative, low PD-L1 expressing, unresectable or metastatic gastric\u002Fgastroesophageal junction adenocarcinoma",[57,58,59],"HER2 Negative","Low PD-L1 Expressing","Unresectable or Metastatic Gastric\u002FGastroesophageal Junction Adenocarcinoma","2026-05-02",{"date":62,"type":34},"2026-05-07",{"date":64,"type":34},"2025-03-26",{"date":66,"type":20},"2027-10-31",{"name":68,"class":69},"Qilu Hospital of Shandong University","OTHER",29,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":42},"100575218","phase-1-hs-10502-combination-treatment-in-patients-with-advanced-solid-tumors-100575218","NCT06769425","HS-10502 Combination Treatment in Patients With Advanced Solid Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10502 Combination Treatment in Subjects With Advanced Solid Tumors","HS-10502","Inclusion Criteria:\n\n* Males or females aged 18 years or older (≥18 years).\n* Patients diagnosed with pathologically confirmed advanced solid tumors.\n* Subjects have at least one target lesion as assessed per the RECIST 1.1.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose.\n* Have a life expectancy of at least 12 weeks.\n* Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent until 6 months after the last dose; male subjects must agree to use barrier contraception (i.e. condoms) from signing the informed consent to 6 months after the last dose.\n* Female subjects must have a negative pregnancy test within 7 days prior to the first dose (for subjects with tumor related abnormal elevation of human chorionic gonadotropin \\[HCG\\], an ultrasound of uterus and appendages should be performed within 7 days prior to the first dose to rule out pregnancy), or demonstrate no risk for pregnancy.\n* Subject must be voluntarily enrolled in this clinical trial, be able to understand the study procedures and to sign written informed consent.\n\nExclusion Criteria:\n\n* Have received or is currently receiving the following treatment: PARPi\u002FB7-H4\u002FB7-H3-targeted therapies;\n* Have received or is currently receiving the following treatment: PARPi\u002FB7-H4\u002FB7-H3-targeted therapies;\n* Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 14 days prior to the first dose of study drug; or need to continue these drugs during the study.\n* Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events due to prior anti-tumor therapy.\n* Presence of pleural\u002Fabdominal effusion requiring clinical intervention.\n* Known history of other primary malignancy.\n* Evidence of brain metastasis and\u002For cancerous meningitis\n* Inadequate bone marrow reserve or hepatic\u002Frenal functions.\n* Cardiological examination abnormality.\n* Severe, uncontrolled or active cardiovascular disorders.\n* Serious or poorly controlled diabetes.\n* Serious or poorly controlled hypertension.\n* Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose of study treatment.\n* Serious infections within 4 weeks prior to the first dose.\n* Have received systemic glucocorticoid therapy for more than 7 days within 28 days prior to the first dose study treatment, or require chronic (≥ 7 days) use of systemic glucocorticoids during the study, or have other acquired, congenital immunodeficiency disorders, or a history of organ transplantation.\n* Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus infection, etc.\n* Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis.\n* Any moderate or severe lung diseases that may interfere with the detection and treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.\n* History of severe neurological or psychiatric disorder.\n* Pregnant or breast-feeding women or women who intend to become pregnant during the study.\n* Attenuated live vaccination within 4 weeks prior to the first dose.\n* Subjects with autoimmune disease that is active or is likely to recur.\n* Subjects with gastrointestinal fistula, visceral fistula, gastrointestinal perforation, or abdominal abscess, or with symptoms\u002Fsigns of intestinal obstruction within 6 months prior to the first dose of study drug.\n* Subjects unlikely to comply with study procedures, restrictions and requirement as determined by the investigator.\n* Subjects with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.",{"count":80,"type":20},157,[82],"PHASE1","HS-10502 is a PARP1-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 Combination Treatment in subjects with advanced solid tumors.",[85,26,86,87,88,89],"Recurrent Ovarian Cancer","Advanced Breast Cancer","TNBC","Advanced Prostate Cancer","Advanced Gastric Cancer",[91,77,92,93,87,94,95],"Poly(ADP-ribose) polymerase-1 inhibitor","ovarian cancer","breast cancer","prostate cancer","gastric cancer","2025-06-18",{"date":98,"type":34},"2025-06-24",{"date":100,"type":34},"2025-05-07",{"date":102,"type":20},"2026-08-31",{"name":104,"class":41},"Jiangsu Hansoh Pharmaceutical Co., Ltd."]