[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NextCure, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100576996","phase-1-a-phase-i-study-of-sim0505-in-participants-with-advanced-solid-tumors-100576996",false,"NCT06792552","A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors","A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Written informed consent is obtained prior to any procedures that are not considered standard of care\n2. ≥18 years of age.\n3. In Part 1:\n\n   1. Participants with histologically or cytologically confirmed advanced solid tumors, who have failed or are ineligible for standard of care therapies.\n   2. Have progressed on at least one prior systematic anti-tumor regimen, and presence of at least one evaluable lesion according to RECIST Version 1.1. Measurable lesions are required in the backfill period.\n   3. In the backfill period, eligible tumor types are limited to high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, USC, clear cell RCC, papillary RCC and adenocarcinoma of NSCLC without actionable mutation of epidermal growth factor receptor (EGFR). For participants with NSCLC, presence of CDH6 expression through immunohistochemical examination of tumor tissue by central laboratory is required.\n4. In Part 2: Participants must have a diagnosis of specific type of metastatic or locally advanced solid tumors and have progressed on or cannot benefit from the most recent systematic anti-tumor regimen (unless otherwise specified), with presence of at least one measurable lesion according to RECIST Version 1.1.\n\nPlatinum-resistant ovarian cancer cohort:\n\na. Participants with histologically or cytologically confirmed high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n\nRenal cell carcinoma cohort:\n\na. Participants with histologically- or cytologically-confirmed clear cell RCC or papillary RCC.\n\nUterine serous carcinoma cohort:\n\na. Participants with histologically- or cytologically-confirmed USC.\n\nNon-Small Cell Lung Cancer cohort:\n\n1. Participants with histologically- or cytologically-confirmed adenocarcinoma of NSCLC without actionable mutation of EGFR.\n2. Presence of CDH6 expression through immunohistochemical examination of tumor tissue.\n\n   5\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n\n   6\\. Life expectancy of ≥12 weeks. 7. Have adequate organ function as indicated by the laboratory values listed within the protocol.\n\n   8\\. Women of childbearing potential (WOCBP)must have a negative serum pregnancy test within 72 hours prior to the start of study treatment. WOCBP or male participants are required to use highly effective contraceptive methods , and agree to refrain from donating sperm\u002Fegg from signing of informed consent through 180 days after the last dose of study treatment.\n\n   9\\. Able to provide tumor tissue sample (archival or newly obtained core or excisional biopsy) at biomarker-screening (for NSCLC in both Part 1 and 2) or screening (for non-NSCLC in Part 1) visit of a tumor lesion not previously irradiated for CDH6 testing.\n\n   Exclusion Criteria:\n   1. For Part 2: has clear cell, mucinous or sarcomatous histology, mixed tumors containing any histology, or low-grade\u002Fborderline ovarian cancer; mixed nonsmall cell and small cell carcinoma, or adenosquamous cell lung cancer with an adenocarcinoma component \\\u003C50% (the participant is eligible if the adenocarcinoma component is ≥50%).\n   2. Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.\n   3. Participant has symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 2 weeks of first dose of study treatment.\n   4. History of bowel obstruction within 3 months prior to the first dose of study treatment.\n   5. Known psychiatric disorder or drug abuse that would interfere the study requirements.\n   6. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment.\n   7. Any active infection requires systemic treatment via intravenous infusion within 2 weeks prior to the first dose of study treatment.\n   8. History of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease (ILD) or severe obstructive pulmonary disease.\n   9. Prior exposure to other CDH6-targeted agents or an ADC with a topoisomerase I inhibitor payload (e.g., raludotatug deruxtecan\u002FDS-6000).\n\n   12\\. Major surgery within 2 weeks of receiving the first dose of study treatment.\n\n   13\\. Has received prior anti-cancer therapies within the following time frames prior to the first dose of study treatment; Previous cytotoxic therapy, anticancer targeted small molecules (e.g., tyrosine kinase inhibitors), hormonal agents within 2 weeks, Anti-cancer antibody or ADC within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study treatment, Chinese medicines\u002Fherbal preparations with anticancer indication taken within 2 weeks and\u002For Radiation therapy \\\u003C4 weeks.\n\n   14\\. Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment.\n\n   15\\. Administration of below medications≤14 days prior to the first dose of SIM0505; Strong and moderate CYP3A4 inhibitors and Drugs with known risk of Torsades de Pointes (TdP).\n\n   16\\. Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).\n\n   17\\. Active hepatitis B or hepatitis C infection 18. Participants with clinically significant cardiovascular diseases. 19. History of allogeneic organ transplantation or graft-versus-host disease. 20. Known hypersensitivity to study drug or any of the excipients. 21. Participant is pregnant or breastfeeding. 22. Other conditions that researchers consider inappropriate for inclusion.","ALL","18 Years",{"count":19,"type":20},414,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid Tumors",[26],"Advanced Solid Tumors","RECRUITING","2026-01-28",{"date":30,"type":31},"2026-01-29","ACTUAL",{"date":33,"type":31},"2025-02-26",{"date":35,"type":20},"2028-08",{"name":37,"class":38},"NextCure, Inc.","INDUSTRY",17,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100575644","phase-1-a-phase-1-study-of-lncb74-in-advanced-solid-tumors-100575644","NCT06774963","A Phase 1 Study of LNCB74 in Advanced Solid Tumors","A Phase 1, Open-label, Dose Escalation and Dose Expansion Study for LNCB74, a B7-H4 Targeted Antibody Drug Conjugate, as Monotherapy in Participants With Advanced Solid Tumors","LNCB74-01","Inclusion Criteria:\n\n1. The participant provides written informed consent\n2. ≥ 18 years of age on day of signing informed consent.\n3. Participant with histologically or cytologically confirmed diagnosis of advanced unresectable and\u002For metastatic solid tumors\n4. A male participant must agree to use contraception and refrain from sperm donation or expecting to father a child\n5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential\n6. Have measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology\n7. Able to provide tumor tissue sample.\n8. Willing to undergo fresh tumor biopsy at Screening and On-treatment if archival tissue not available\n9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n10. Life expectancy greater than or equal to 12 weeks as judged by the Investigator.\n11. Have adequate organ function\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive serum pregnancy test (within 72 hours) prior to treatment.\n2. Has received prior investigational agents within 4 weeks prior to treatment.\n3. Has received anti-cancer chemotherapy (Immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy within 2 weeks prior to treatment.\n4. Has received antibody-based anti-cancer therapy within 4 weeks prior to treatment.\n5. Has received targeted agents and small molecules within 2 weeks or 5 half-lives, whichever is longer.\n6. Has received prior platinum-based chemotherapy and progressed within 4 weeks of initiating therapy (platinum-refractory disease)\n7. Has received an ADC with MMAE payload.\n8. Has received prior radiotherapy within 2 weeks of start of study treatment for focal radiation or within 4 weeks for wide-field radiotherapy\n9. Has received G-CSF or GM-CSF within 7 days prior to start of study treatment.\n10. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.\n11. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n12. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n13. Has known active CNS metastases and\u002For carcinomatous meningitis\n14. Has severe hypersensitivity (≥ Grade 3), known allergy or reaction LNCB74 or any of its excipients.\n15. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease.\n16. Has active ≥Grade 2 sensory or motor neuropathy.\n17. Has active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy or any clinically significant corneal disease.\n18. Has an active infection requiring systemic therapy.\n19. Any major surgery within 4 weeks of study drug administration.\n20. Toxicity (except for alopecia) related to prior anti-cancer therapy and\u002For surgery, unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible.\n21. Prior organ or tissue allograft.\n22. Uncontrolled or significant cardiovascular disease\n23. Participants with serious or uncontrolled medical disorders.\n24. Participants who are on total parenteral nutrition (TPN)\n25. Participants with history of bowel obstruction within one month of screening\n26. Participants with history of significant ascites requiring paracentesis within 2 weeks of screening\n27. Has a known history of human immunodeficiency virus (HIV) infection with an acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within the last year, or a current CD4 count \\\u003C350 cells\u002Fµl\n28. Has known active Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection\n29. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study\n30. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study",{"count":49,"type":20},145,[23],"This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and \u002F or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors.",[53,54,55,56,57,58],"Ovarian Cancer","Breast Cancer","Endometrial Cancer","Biliary Tract Cancer","Non-Small Cell Lung Cancer","Advanced or Metastatic Solid Tumors","2025-12-08",{"date":61,"type":31},"2025-12-16",{"date":63,"type":31},"2025-01-07",{"date":65,"type":20},"2026-12",{"name":37,"class":38},14,""]