[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644002":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":19,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":19,"enrollmentInfo":37,"targetDuration":19,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":19,"overallStatus":46,"whyStopped":19,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":19},{"fullName":5,"class":6},"D3 Bio (Wuxi) Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"D3L-002","EXPERIMENTAL","Dose Escalation\n\n* Cohort 1 (starting dose)\n* Cohort 2\n* Cohort 3\n* Cohort 4",[13],"Drug: D3L-002",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","D3L-002 is an investigational anti-TIGIT\u002Fanti-PVRIG bispecific antibody administered as an intravenous infusion every 3 weeks (Q3W).",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Medical Director","CONTACT","+86 21 61635900","D3bio_CT@d3bio.com",{"type":27,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100644002","phase-1-study-of-d3l-002-in-subjects-with-advanced-solid-tumors-100644002",false,"NCT07667842","Study of D3L-002 in Subjects With Advanced Solid Tumors","A Phase 1, Open-label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-002 (an Anti-TIGIT\u002FAnti-PVRIG Bispecific Antibody) Monotherapy in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Ability to provide written informed consent and comply with study procedures\n2. Age ≥18 years\n3. Histologically confirmed metastatic or locally advanced incurable solid tumor that has progressed after ≥1 line of therapy or has no available standard treatment\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n5. Adequate organ function (hematologic, hepatic, renal)\n6. Life expectancy ≥12 weeks\n7. Willingness to provide tumor tissue (if available) and blood samples\n8. Agreement to use effective contraception\n9. Negative pregnancy test for participants of childbearing potential\n\nExclusion Criteria:\n\n1. Prior anti-TIGIT or anti-PVRIG therapy\n2. Recent anticancer therapy without adequate washout\n3. Active or uncontrolled illness\n4. Interstitial lung disease\u002Fpneumonitis\n5. Active Central Nervous System (CNS) disease\n6. Uncontrolled effusions\n7. Unresolved ≥Grade 2 toxicities\n8. Severe prior immunotherapy-related toxicity\n9. Active autoimmune disease\n10. Active infection\n11. Active hepatitis B\u002FC or HIV\n12. Recent malignancy (exceptions apply)\n13. Significant cardiovascular disease\n14. Immunosuppressive therapy within 14 days\n15. Live vaccine within 30 days\n16. Pregnancy or breastfeeding\n17. Hypersensitivity to study drug\n18. Investigator-determined unsuitability","ALL","18 Years",{"count":38,"type":39},24,"ESTIMATED","INTERVENTIONAL",[42],"PHASE1","This is a first-in-human, multicenter, open-label, single-arm, dose-escalation Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of D3L-002 monotherapy in subjects with advanced solid tumors. D3L-002 will be administered as an intravenous infusion every 3 weeks (Q3W) in 21-day cycles. Approximately 24 subjects will be enrolled. Dose escalation will follow a Bayesian Optimal Interval (BOIN) design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).",[45],"Advanced Solid Tumor","NOT_YET_RECRUITING","2026-06-21",{"date":49,"type":50},"2026-06-25","ACTUAL",{"date":52,"type":39},"2026-07-18",{"date":54,"type":39},"2028-02-12",{"name":5,"class":6}]