[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Arvinas Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,64],{"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":28,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100650606","phase-1-a-study-to-evaluate-arv-6723-alone-and-with-pembrolizumab-in-participants-with-advanced-solid-tumors-100650606",false,"NCT07749586","A Study to Evaluate ARV-6723 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ARV-6723 Administered as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\nPart A1 dose escalation and A2 dose optimization: Participants must meet all of the following criteria:\n\n* Have a histologic or cytologic diagnosis of unresectable or metastatic solid tumor malignancy.\n* Have previously received at least one prior therapy targeting programmed cell death protein 1 (PD-1), programmed death-ligand 1 (PD-L1), cytotoxic T-lymphocyte antigen 4 (CTLA-4), lymphocyte-activation gene 3 (LAG-3), and\u002For another T-cell co-stimulatory or immune checkpoint pathway, in any treatment setting (including neoadjuvant or adjuvant).\n* Have received prior SOC therapy appropriate for their disease type and stage and have no remaining available treatment options with established clinical benefit; or, in the opinion of the investigator, are unlikely to tolerate or derive clinically meaningful benefit from appropriate SOC therapy; or have declined SOC therapy.\n* Participants must have demonstrated radiographic progression and have at least 1 measurable lesion per RECIST v1.1 that has not been previously irradiated or has demonstrated progression of disease since radiation therapy.\n* ECOG PS 0 or 1 or equivalent. Participants with ECOG PS 2 may be considered upon discussion with the Sponsor Medical Monitor.\n* Participants with adequate organ function.\n\nExclusion Criteria:\n\nExclusion Criteria (Part A)\n\n* Active brain metastases (new lesions identified on imaging, existing lesions showing progression per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)\u002Fimaging characteristics or by clinical criteria, lesions requiring active interventions for symptom control).\n* Carcinomatous meningitis.\n* Known or suspected hypersensitivity to ARV-6723 or pembrolizumab or any of its excipients.\n* Active autoimmune disease or history of autoimmune diseases that may relapse.\n* History of severe immune-related adverse events (irAE) attributed to prior anti-PD-1\u002Fanti-CTLA-4\u002Fanti-LAG-3 therapy.\n* Prior treatment with any HPK1-targeting agent\n* Systemic anti-cancer therapy or radiation therapy within 14 days prior to study treatment start.\n* Current use of any prohibited concomitant medication(s) or herbal supplements which cannot be discontinued, prior to start of study intervention and for the duration of the study.\n* Baseline (screening) standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.","ALL","18 Years",{"count":19,"type":20},499,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a study to evaluate the safety and potential anti-tumor activity of an investigational drug called ARV-6723, in participants with advanced solid tumors.\n\nThis is an open-label study which means that participants and study staff will know that all participants will receive ARV-6723. The investigational drug ARV-6723 will be given as an oral tablet on its own and also in combination with other drugs.\n\nResearchers think that ARV-6723 can help the body's immune system to better recognize, attack, and destroy cancer cells in adults with advanced solid tumors. ARV-6723 is an investigational drug, and this is the first time ARV-6723 will be used in humans.\n\nDepending on the treatment assignment, the investigational drug, ARV-6723, will be given as an oral tablet either on its own (monotherapy) or in combination with pembrolizumab, either through a vein (intravenously or IV) or through an injection beneath the skin (subcutaneously or SQ).\n\nThis study will include multiple parts:\n\nIn Part A1 (Phase 1a), different small groups of participants will receive lower to higher doses of ARV-6723 as monotherapy or in combination with standard-dose of pembrolizumab.\n\nIn Part A2 (Phase 1b), two groups of participants with specific tumor indication(s) (TBD) will receive one of two doses selected based on information from Part A1.\n\nDetails of Part B will be determined based on information generated from Part A.",[27],"Advanced Solid Tumor",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50],"Advanced solid tumors","PROTAC","HPK1","MAP4K1","Immune checkpoint inhibitor","Non-small cell lung cancer (NSCLC)","Renal cell carcinoma (RCC)","Melanoma","Gastric cancer","Gastroesophageal cancer","Esophageal cancer","Head and Neck Squamous cell carcinoma (HSNCC)","Urothelial carcinoma (UC)","Colorectal Cancer (CRC)","Triple-negative breast cancer (TNBC)","Ovarian cancer","Cervical cancer","Merkel cell carcinoma","Skin squamous cell carcinoma (SCC)","Nasopharyngeal carcinoma","Small cell lung cancer (SCLC)","Hepatocellular carcinoma (HCC)","RECRUITING","2026-08-04",{"date":54,"type":55},"2026-08-06","ACTUAL",{"date":57,"type":55},"2026-07-29",{"date":59,"type":20},"2032-03-31",{"name":61,"class":62},"Arvinas Inc.","INDUSTRY",3,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100546346","phase-1-a-study-of-arv-393-in-relapsedrefractory-non-hodgkin-lymphoma-100546346","NCT06393738","A Study of ARV-393 in Relapsed\u002FRefractory Non-Hodgkin Lymphoma.","A Phase 1 First in Human Study of ARV-393 in Adult Participants With Advanced Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* For Part A and B: Have relapsed\u002Frefractory NHL and \\>=2 prior systemic therapies, (including rituximab), and be ineligible for known therapies with demonstrated clinical benefit per investigator assessment or, histologically confirmed AITL that has recurred or progressed following institutional standard of care therapy.\n* For Part C and D: Have R\u002FR DLBCL, not otherwise specified \\[NOS (DLBCL, NOS)\\] or large B-cell lymphoma (LBCL) arising from follicular lymphoma and have received two or more lines of systemic therapy.\n* Have at least one bi dimensionally measurable lesion \\>1.5-centimeter (cm) in largest dimension for nodal or \\>1.0 cm for extranodal lesion.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (NOTE: For Part A only - ECOG PS of 2 is allowed for participants with secondary CNS lymphoma).\n* Adequate bone marrow function\n* Adequate kidney function\n* Adequate Liver Function\n\nExclusion Criteria:\n\n* Current or past history of peripheral eosinophilia, hypereosinophilic syndrome (HES), organ-specific eosinophilic disorder, or drug reaction with eosinophilia and systemic symptoms (DRESS).\n* Prior allogeneic stem cell transplant (SCT) or solid organ transplantation.\n* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, melanoma in situ or carcinoma in situ of the breast or cervix, and prostate cancer with active surveillance.\n* Any of the following in the previous 6 months:\n\n  * Myocardial infarction, long QT syndrome or family history of long QT syndrome, or Torsade de Pointes;\n  * Clinically important atrial or ventricular arrhythmias;\n  * Serious conduction system abnormalities, 3rd degree atrioventricular (AV block), unstable angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure (CHF), New York Heart Association Class III or IV;\n  * Cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and\u002For other clinically significant episode of thromboembolic disease;\n* Active inflammatory gastrointestinal (GI) disease, chronic diarrhea, previous gastric resection, or lap band surgery.\n* Uncontrolled hypertension despite optimal medical treatment\n* History of myocarditis.\n* In ability to comply with listed prohibited treatments.\n* Standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.\n* Cardiac ejection fraction \\\u003C45%.",{"count":72,"type":20},255,[23],"This clinical trial is studying the safety and potential anti-tumor activity of an investigational drug called ARV-393 in patients diagnosed with advanced Relapsed\u002FRefractory non-Hodgkin's lymphoma (R\u002FR NHL) to determine if ARV-393 may be a possible treatment option.\n\nARV-393 is thought to work by breaking down a protein present in many types of non-Hodgkins lymphomas, which may prevent, slow or stop tumor growth. This is the first time ARV-393 will be used by people. The investigational drug will be given as an oral tablet.",[76,77],"Relapsed\u002FRefractory (R\u002FR) Mature B Cell Non Hodgkin Lymphoma (NHL)","Relapsed\u002FRefractory (R\u002FR) Angioimmunoblastic T-cell Lymphoma (AITL)",[79,80,81,82,83,84,85],"Relapsed\u002FRefractory B cell Non Hodgkin Lymphoma (NHL)","Relapsed\u002FRefractory Angioimmunoblastic T-cell lymphoma (AITL)","Advanced non-Hodgkin Lymphoma","advanced NHL","relapsed non-Hodgkin Lymphoma","refractory non-Hodgkin Lymphoma","B Cell Advanced Non-Hodgkin Lymphoma","2026-02-06",{"date":88,"type":55},"2026-02-10",{"date":90,"type":55},"2024-09-05",{"date":92,"type":20},"2028-03",{"name":61,"class":62},17,""]