[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"D3 Bio (Wuxi) Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":140},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,39,67,89,114],{"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":4},"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":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"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).",[26],"Advanced Solid Tumor","NOT_YET_RECRUITING","2026-06-21",{"date":30,"type":31},"2026-06-25","ACTUAL",{"date":33,"type":20},"2026-07-18",{"date":35,"type":20},"2028-02-12",{"name":37,"class":38},"D3 Bio (Wuxi) Co., Ltd","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100507402","phase-1-a-phase-12-study-of-d3s-002-as-monotherapy-or-combination-therapy-in-adult-subjects-with-advanced-solid-tumors-with-mapk-pathway-mutations-100507402","NCT05886920","A Phase 1\u002F2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations","A Phase 1\u002F2, Open Label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose of D3S-002 Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations","Inclusion Criteria:\n\n* Part 1: Subjects must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor with evidence of progressive disease.\n* Part 2: Subjects must have a histologically or cytologically confirmed metastatic or locally advanced non-small cell lung cancer with evidence of PD.\n\n  * Subjects with non-small cell lung cancer (NSCLC) should have no known epidermal growth factor receptor (EGFR) mutations, ALK\u002FROS1\u002FRET rearrangements, NTRK1\u002F2\u002F3 gene fusions, v-Raf murine sarcoma viral oncogene homolog B (BRAF) V600E mutations, or MET exon 14 skipping mutations.\n\nNote: EGFR mutations include but are not limited to EGFR Exon19 Deletions, Exon21 p.L858R, Exon21 p.L861Q, Exon18 p.G719X, Exon20 p.S768I, Exon20 Insertions, Exon20 p.T790M. If other EGFR mutations are present, the Investigator should have a consultation with the sponsor's Medical Monitor before making the enrollment decision.\n\n* Part1: Subjects must have documented mitogen-activated protein kinase (MAPK) pathway mutation(s) within the last 5 years identified by a local test on tumor tissue or blood (eg, rat sarcoma (RAS), rapidly accelerated fibrosarcoma (RAF), and MAPK kinase (MAPKK) mutations).\n* Part 2: Subject must have documented Kirsten rat sarcoma viral oncogene (KRAS) p. glycine 12 to cysteine (p.G12C) mutation identified within the last 5 years by a local test on tumor tissue or blood.\n\nNote:\n\n• All the local tests should clearly distinguish KRAS p.G12C from all other KRAS p.G12x variants. If not specified, subjects should have no known second KRAS mutations (including G12A, G12V, G12R, G13C, G12D, G12S, H95, Y96, Q61, and R68).\n\n* Part 1: Subjects must be refractory to or intolerable with standard treatment, or have no available standard of care (SOC).\n* Part 2: Subject must have received at least 1 line of prior standard of care systemic therapy for locally advanced and unresectable or metastatic disease, including KRAS p.G12C inhibitor.\n\nNote:\n\n* Subjects should only have received 1 type of prior KRAS p.G12Ci treatment (including all types of KRAS p.G12C inhibitor which are either under investigation or in market, except D3S-001).\n* During the prior KRAS p.G12C treatment, subject has achieved best response of partial or complete response regardless of KRAS p.G12Ci treatment duration, or stable disease for at least 6 months. However, subjects, who have stopped KRAS p.G12Ci therapy earlier than 6 months due to safety\u002Ftolerability reasons only, would be allowed. In such a situation, the Investigator should have a consultation with the Sponsor Medical Monitor before making the enrollment decision.\n\n  * Part 2: Subjects must have measurable disease per RECIST v1.1.\n  * Part 2: Subjects must agree to provide archival tumor tissue, if available, for genetic analysis. If archival tumor tissue is not available, or of insufficient quantity, an optional fresh biopsy is highly recommended.\n  * Part 2: Subjects must agree to provide blood samples for genetic analysis (Table 2 schedule of activities for Part 2).\n  * Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n  * Subject must have adequate organ and marrow function within the screening period.\n  * Subjects must comply with all reproductive and contraceptive requirements outlined in the protocol.\n\nExclusion Criteria:\n\n* Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.\n* Part 2: subjects with mixed small-cell lung cancer, or large cell neuroendocrine histology, or sarcomatoid carcinoma.\n* Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.\n* Part 1: Uncontrolled or untreated brain metastasis.\n* Part 2: Asymptomatic and stable brain metastases subjects will be eligible for enrollment per the following criteria.\n\n  * Treated or untreated brain metastases\n  * Neurologically asymptomatic\n  * Stable and not requiring steroids more than 10 mg\u002Fday of prednisone or equivalent for at least 4 weeks prior to the first dose of study medication.\n* Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).\n* Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.\n* Any concurrent chemotherapy, immunotherapy, targeted therapy, cell therapy, biologic or hormonal therapy and any medical devices for cancer treatment.\n\nNOTE: Other protocol inclusion\u002Fexclusion criteria may apply",{"count":47,"type":20},67,[23,49],"PHASE2","This first-in-human (FIH) study aims to assess the safety, tolerability, pharmacokinetics, and recommended phase 2 dose (RP2D) of D3S-002 given orally daily for 21-day cycles in adult subjects with advanced solid tumors with mitogen-activated protein kinase (MAPK) pathway mutations.",[52],"Advanced Solid Tumors With MAPK Pathway Mutations",[54,55,56],"Advanced solid tumors","mitogen-activated protein kinase","mutation","RECRUITING","2026-06-04",{"date":60,"type":31},"2026-06-08",{"date":62,"type":31},"2023-07-10",{"date":64,"type":20},"2028-08",{"name":37,"class":38},14,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":5},"100628008","phase-1-a-phase-1-study-of-d3s-003-as-monotherapy-in-participants-with-advanced-solid-tumors-with-a-kras-pg12d-mutation-100628008","NCT07456046","A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.","A Phase 1, Open-label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-003 Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation","Inclusion Criteria:\n\n* Subjects must have histologically confirmed locally advanced, recurrent, or metastatic malignancy that has progressed following at least one line of standard therapy or where standard therapy has proven to be ineffective or intolerable or is considered inappropriate or when participation in a clinical trial of an investigational agent is considered a standard therapeutic option.\n* Subjects must have documented presence of KRAS p.G12D mutation by a local test identified through tumor tissue or blood collected within the last 5 years.\n* Subjects must have measurable disease per RECIST v1.1.\n* Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Subject must have adequate organ and marrow function within the screening period.\n\nExclusion Criteria:\n\n* Participant has any prior treatment with a specific KRAS G12D inhibitor\u002Fdegrader or pan RAS inhibitor\u002Fdegrader.\n* Subject has uncontrolled intercurrent illness, including but not limited to serious chronic gastrointestinal conditions associated with diarrhea, ongoing or active infections, uncontrolled or significant cardiovascular disease, autoimmune or inflammatory disorders or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events (AEs), or compromise the ability of the subject to give written consent.\n* Uncontrolled or untreated brain metastases\n* Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy\n\nNOTE: Other protocol inclusion\u002Fexclusion criteria may apply.",{"count":75,"type":20},42,[23],"This is a first-in-human (FIH) multicenter, open-label, dose-escalation Phase 1 clinical trial to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of D3S-003 in participants with advanced KRAS p.G12D mutant solid tumors.",[79],"KRAS P.G12D",[81],"KRAS P.G12D Mutation, Advanced solid tumors","2026-06-03",{"date":58,"type":31},{"date":85,"type":31},"2026-05-29",{"date":87,"type":20},"2028-01-11",{"name":37,"class":38},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100512829","phase-1-a-study-of-d3l-001-as-monotherapy-in-subjects-with-her2-positive-advanced-solid-tumors-100512829","NCT05957536","A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors","A Phase 1, Open-label Dose Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-001 Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors.","Inclusion Criteria:\n\n* Subject must have documented HER2 positivity (determined by immunohistochemistry \\[IHC\\], in situ hybridization \\[ISH\\], Next Generation Sequencing \\[NGS\\] or other analysis techniques as appropriate).\n* Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Subject must have left ventricular ejection fraction (LVEF) ≥50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within the screening period.\n* Subject must have adequate organ and marrow function within the screening period.\n\nExclusion Criteria:\n\n* Subject has any prior treatment with anti-CD47 or SIRPα agent.\n* Subject has any prior treatment without adequate washout periods as defined in the protocol.\n* Subject has immunosuppressive medication that is not completed 14 days before the first dose of study medication.\n* Subject has uncontrolled intercurrent illness that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.\n* Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).\n* Judgment by the Investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions, and requirements.",{"count":97,"type":20},128,[23],"This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of D3L-001 in subjects with HER2-positive advanced solid tumors.",[101],"HER-2 Positive Advanced Solid Tumors",[103,104],"HER-2 Positive","Advanced Solid Tumors","2026-03-11",{"date":107,"type":31},"2026-03-13",{"date":109,"type":31},"2023-09-19",{"date":111,"type":20},"2028-12-19",{"name":37,"class":38},9,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},"100470767","phase-1-a-study-of-d3s-001-monotherapy-or-combination-therapy-in-subjects-with-advanced-solid-tumors-with-a-kras-pg12c-mutation-100470767","NCT05410145","A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation","A Phase 1\u002F2, Open Label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation","Inclusion:\n\n* Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.\n* Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.\n* Subject must have measurable disease per RECIST v1.1.\n* Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Subject must have adequate organ and marrow function within the screening period.\n\nExclusion:\n\n* Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.\n* Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.\n* Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).\n* Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.\n* Concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the nontreatment phases of these studies (e.g., follow-up phase).\n\nOther protocol inclusion\u002Fexclusion criteria may apply",{"count":122,"type":20},442,[23,49],"This is a first-in-human (FIH), multicenter, open-label, dose-escalation, and dose-expansion Phase 1\u002F2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of D3S-001 or combination therapy in subjects with advanced KRAS p.G12C mutant solid tumors. D3S-001 will be taken daily by oral administration in 21-day treatment cycles.",[126],"KRAS P.G12C",[128,129,130],"KRAS p.G12C","Mutation","advanced solid tumors","2026-03-10",{"date":133,"type":31},"2026-03-12",{"date":135,"type":31},"2022-08-03",{"date":137,"type":20},"2027-04",{"name":37,"class":38},52,""]