[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"DualityBio Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":263},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,65,97,120,146,180,231],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100558720","phase-1-first-in-human-study-of-db-1419-for-advancedmetastatic-solid-tumors-100558720",false,"NCT06554795","First-in-human Study of DB-1419 for Advanced\u002FMetastatic Solid Tumors","A Phase 1\u002F2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in Participants With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Adults aged ≥ 18 years at the time of voluntarily signing informed consent.\n2. Histologically or cytologically confirmed unresectable advanced\u002Fmetastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available.\n3. At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria (Only applicable to backfill participants in phase 1a and participants in phase 1b\u002F2a). CRPC participants with bone-only disease may be eligible on a case-by-case basis after discussion with the Medical Monitor.\n4. Has a life expectancy of ≥ 3 months.\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.\n6. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.\n7. Has adequate organ function within 7 days prior to the first dose of study treatment.\n8. Has adequate treatment washout period prior to the first dose of study treatment.\n9. Is willing to provide pre-existing resected tumor samples when available or undergo fresh tumor biopsy if feasible for the measurement of B7-H3 level and other biomarkers if no contraindication.\n\n   Note: there is no minimum B7-H3 expression level mandatory for entry into the study.\n10. Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.\n11. Male and female participants of reproductive\u002Fchildbearing potential must agree to avoid pregnancy during the study and for at least 4 months and 7 months after the last dose of study treatment, respectively.\n12. Male participants must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study treatment administration. Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study treatment administration.\n\nExclusion Criteria:\n\n1. Prior treatment with B7-H3 targeted therapy or prior treatment with ADC containing a topoisomerase I inhibitor payload.\n2. Has a medical history of symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] classes II-IV or serious cardiac arrhythmia requiring treatment.\n3. Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.\n4. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \\> 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.\n5. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis which needs glucocorticoids and antibiotics) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.\n6. Has a history of underlying pulmonary disorder including, but not limited to, pulmonary emboli within 3 months of the start of study treatment, severe asthma, severe COPD, restrictive lung disease, and other clinically significant pulmonary compromise or requirement for supplemental oxygen.\n7. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.\n8. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals within 2 weeks before first dose of study treatment.\n9. Know human immunodeficiency virus (HIV) infection.\n10. Has active viral hepatitis.\n11. Is a lactating mother, or pregnant as confirmed by pregnancy tests performed within 7 days prior to enrollment.\n12. Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with asymptomatic CNS metastases who are radiologically and neurologically stable for at least 4 weeks following CNS-directed therapy, and are on stable or decreasing doses of corticosteroids equivalent to ≤10 mg\u002Fday prednisone are eligible for study entry.\n13. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v 5.0, Grade ≤ 1 or baseline.\n14. Has a prior history of immune-related adverse event that required permanent immune checkpoint inhibitor discontinuation per NCCN guidelines.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},360,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","A Phase 1\u002F2a First-in-Human Study of DB-1419 in Advanced\u002FMetastatic Solid Tumors",[27],"Solid Tumor, Adult","RECRUITING","2026-06-04",{"date":31,"type":32},"2026-06-05","ACTUAL",{"date":34,"type":32},"2024-09-03",{"date":36,"type":20},"2027-02",{"name":38,"class":39},"DualityBio Inc.","INDUSTRY",36,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100564168","phase-1-a-phase-12a-study-of-db-2304-in-healthy-adults-and-slecle-participants-100564168","NCT06625671","A Phase 1\u002F2a Study of DB-2304 in Healthy Adults and SLE\u002FCLE Participants","A Randomized, Double-Blind, Phase 1\u002F2a Study to Evaluate the Safety, Tolerability, PK and PD of DB-2304 for Injection in Healthy Adult Participants and Participants With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus","Inclusion Criteria (Part A):\n\n1. Participants who fully understand the purpose, nature, method, and potential adverse reactions of the study and voluntarily sign the informed consent form (ICF) and agree to participate.\n2. Healthy male or female participants; 18 to 55 years of age (both inclusive) on the day of signing ICF; meet the body mass index (BMI) criteria.\n3. Based on the investigator assessment, there are no abnormal findings or findings with clinical significance from the medical history consultation, physical examination, vital signs assessment, clinical laboratory tests, and 12-lead ECG.\n4. Female participants of childbearing potential or male participants agree to use highly effective contraception during the study.\n5. Participants who are willing and able to comply with the prescribed protocol treatment and evaluations\n\nInclusion Criteria (Part B):\n\n1. Participants who fully understand the purpose, nature, method, and potential adverse reactions of the study and voluntarily sign the informed consent form (ICF) and agree to participate.\n2. Participants who are willing and able to comply with the prescribed protocol treatment and evaluations.\n3. Male or female participants, 18 to 70 years of age (both inclusive) on the day of signing ICF.\n4. Currently receiving a stable SLE\u002FCLE treatment regimen of any medication for a period of at least 1 month prior to randomization.\n\nFor SLE： 4. Meet the European Alliance of Associations for Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) 2019 classification criteria for SLE.\n\n5\\. History or presence at Screening of positive antinuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies.\n\n6\\. At screening have active lupus skin disease defined by the SELENA-SLEDAI at screening and randomization.\n\nFor CLE： 8. Must have diagnosis of CLE that has been histologically confirmed, with or without systemic LE manifestations.\n\n9.Must have active CLE despite an adequate trial of conventional therapies.\n\nExclusion Criteria (Part A):\n\n1. Evidence or history of clinically significant diseases.\n2. History of herpes zoster (shingles) or recurrent herpes simplex (e.g., oral cold sores or gen-ital sores).\n3. Any active or suspected bacterial, viral, fungal, or parasitic infection within 30 days prior to dosing.\n4. History of sensitivity to any ingredients of DB-2304.\n5. Participants who have undergone surgery within the past 3 months or have plans for sur-gery during the study.\n\nExclusion Criteria (Part B):\n\n1. Have active lupus nephritis or moderate-to-severe or chronic kidney disease\n2. Have active neuropsychiatric SLE within 8 weeks prior to screening\n3. Any active skin conditions or active arthritis other than SLE that may interfere with skin or arthritis assessments (e.g., psoriasis, non-LE skin lesions, non-LE alopecia areata, drug-induced lupus, rheumatoid arthritis) at screening.\n4. History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies with the exception of basal cell carcinomas and squamous cell carcinomas and carcinoma in situ of the cervix that have been completely excised and considered cured \\>2 years prior to Screening.\n5. Known history of a primary immunodeficiency (e.g., common variable immunodeficiency syndrome), splenectomy, or any underlying condition that predisposes the participant to infection.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",true,"70 Years",{"count":51,"type":20},148,[23,24],"A Phase 1\u002F2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus",[55],"Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus","2026-05-29",{"date":58,"type":32},"2026-06-02",{"date":60,"type":32},"2024-10-04",{"date":62,"type":20},"2027-12-30",{"name":38,"class":39},7,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100589336","phase-2-db-1311-in-combination-with-bnt327-or-db-1305-in-advancedmetastatic-solid-tumors-100589336","NCT06953089","DB-1311 in Combination With BNT327 or DB-1305 in Advanced\u002FMetastatic Solid Tumors","A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n* Adults aged ≥ 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent.\n* At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria.\n* Has a life expectancy of ≥ 3 months.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1\n* Has adequate organ function within 7 days prior to enrollment\u002Frandomization,\n* Has adequate treatment washout period prior to the first dose of trial treatment.\n\n  * For HCC patients: Histological\u002Fcytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC; Has a Child-Pugh class A liver score.\n  * For CC patients: Has persistent, recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology\n  * For Melanoma patients: Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma.\n  * For PROC patients (Cohort A): Participants must have a confirmed diagnosis of OC, primary peritoneal cancer, or fallopian tube cancer, all of which with high-grade serous histology. Patients must have platinum-resistant disease.\n  * For HNSCC patients: Histologically or cytologically confirmed recurrent (recurrent disease that is not amendable to curative treatment with local\u002F or systemic therapies)\u002F (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies.\n  * For NSCLC patients: Pathologically documented Stage IIIB or IIIC NSCLC not amenable for radical surgery or definitive chemoradiation or Stage IV NSQ NSCLC. Not harboring an EGFR-sensitizing mutation or ALK gene rearrangements or other onco-driver gene mutations\n  * For PSOC: Must have PSOC, defined as radiographically documented disease recurrence or progression occurring \\>6 months after completion of the last dose of platinum-based chemotherapy.\n  * For PDAC: Participants must have histologically or cytologically confirmed metastatic PDAC., who have progressed after at least one prior line of standard systemic treatment ((≥2L PDAC).)\n  * For breast cancer:\n\n    * HR+\u002FHER2-low or HR+\u002FHER2-ultralow or HR+\u002FHER2-negative BC participants: Pathologically or cytologically documented HR-positive unresectable or metastatic BC with HER2-low, HER2-ultralow or HER2-negative expression.\n    * Triple negative breast cancer (TNBC): Pathologically or cytologically documented unresectable or metastatic TNBC\n  * For mCRC: Participants who have metastatic CRC and have relapsed or progressed after 1 prior line of systemic treatment including a fluoropyrimidine plus oxaliplatin with or without anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb) or anti-epidermal growth factor receptor mAb therapy, as clinically indicated, or have relapsed or progressed after 2 lines of therapy if the participant has received targeted therapy\n  * For mCRPC: Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate and mCRPC\n\nExclusion Criteria:\n\n* 1\\. Prior treatment with B7H3 targeted therapy.\n* Prior treatment with antibody-drug conjugate with topoisomerase inhibitor.\n* Is a candidate to locoregional treatment with potential to induce complete or near complete response and prolonged tumor control, per investigator's assessment.\n* Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs.\n* Has uncontrolled or significant cardiovascular disease. Has clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy.\n* Has a history of (non-infectious) ILD\u002Fpneumonitis.\n* Any autoimmune, connective tissue or inflammatory disorders.\n* Has spinal cord compression or clinically active central nervous system (CNS) metastases.\n* Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.",{"count":73,"type":20},450,[24],"A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced\u002FMetastatic Solid Tumors",[77],"Solid Tumors",[79,80,81,82,83,84,85,86,87],"B7-H3","PD-L1\u002FVEGF-A","TROP2 (Trophoblast cell surface antigen 2)","ADC (antibody-drug conjugate)","HNSCC (head and neck squamous cell carcinoma)","HCC (hepatocellular carcinoma)","Melanoma","NSCLC(non-small cell lung cancer)","OC (ovarian cancer)","2026-05-20",{"date":90,"type":32},"2026-05-22",{"date":92,"type":32},"2025-07-18",{"date":94,"type":20},"2030-06-30",{"name":38,"class":39},37,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100613208","phase-1-a-study-of-db-1324-in-advancedmetastatic-gastrointestinal-tumors-100613208","NCT07263594","A Study of DB-1324 in Advanced\u002FMetastatic Gastrointestinal Tumors","A Phase 1\u002F2, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1324 in Participants With Advanced\u002FMetastatic Gastrointestinal Tumors","Inclusion Criteria:\n\n1. Pathologically documented advanced\u002Funresectable, or metastatic GI tumor.\n2. Have relapsed or progressed on or after standard systemic treatments, or are intolerant to standard treatment, or for which no standard treatment is available.\n3. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in RECIST v1.1.\n4. Has a life expectancy of ≥ 3 months.\n5. Has an ECOG PS of 0-1.\n6. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.\n7. Has adequate organ functions within 7 days prior to Day 1 of Cycle 1.\n8. Has an adequate treatment washout period before Day 1 of Cycle 1.\n9. Participants are willing to provide archived tumor tissue or undergo a tumor biopsy for the measurement of CDH17 levels and other biomarkers.\n10. Other protocol-defined Inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Prior treatment with CDH17 targeted therapy.\n2. Prior treatment with ADC with topoisomerase I inhibitor.\n3. Has chronic enteritis or inflammatory bowel disease. Or has clinically significant bleeding of GI tract or adjacent organs within 1 month prior to the first dose of study treatment. Or has clinically significant obstruction and\u002For perforation and\u002For fistulae (including prior GI fistula operation) of GI tract or adjacent tissues within 6 months prior to the first dose of study treatment.\n4. Uncontrolled or significant cardiovascular disease.\n5. Has a medical history of cerebrovascular accident including transient ischemic attack within 6 months before enrollment.\n6. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, or has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n7. Have a lung-specific intercurrent clinically significant illness.\n8. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.\n9. Has clinically active brain metastases.\n10. Has unresolved toxicities from previous anticancer therapy.\n11. Other protocol-defined Exclusion criteria apply.",{"count":105,"type":20},127,[23,24],"This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.",[109],"Gastrointestinal Cancer",[111],"Gastrointestinal Tumors, DB-1324","2026-05-19",{"date":90,"type":32},{"date":115,"type":32},"2026-01-20",{"date":117,"type":20},"2028-12",{"name":38,"class":39},9,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":21,"phases":129,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100603837","phase-1-a-study-of-db-1317-in-selected-advancedmetastatic-solid-tumors-100603837","NCT07141706","A Study of DB-1317 in Selected Advanced\u002FMetastatic Solid Tumors","A Phase 1a\u002F1b, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1317 in Participants With Selected Advanced\u002FMetastatic Solid Tumors","Key Inclusion Criteria:\n\n1. Male or female adults\n2. Unresectable advanced or metastatic selected solid tumors that have relapsed or progressed on or after standard systemic treatments.\n3. Only applicable to backfilling participants in Phase 1a and participants in Phase 1b: At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria. Participants with non-measurable disease are allowed for CRPC participants.\n4. Has a life expectancy of ≥ 3 months.\n5. Has an ECOG PS of 0-1.\n6. Has LVEF ≥ 50% within 28 days before enrollment.\n7. Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of ADAM9 expression level and other biomarkers if no contra-indication.\n8. Male and female participants of reproductive\u002Fchildbearing potential must agree to use adequate contraceptive methods\n\nKey Exclusion Criteria:\n\n1. Prior treatment with ADAM9 targeted therapy.\n2. Prior treatment with antibody-drug conjugate with topoisomerase I inhibitor.\n3. Has a medical history of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment.\n4. Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.\n5. Has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG\n6. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \\> 470 ms in males and females\n7. Has a history of (non-infectious) ILD\u002Fpneumonitis\n8. Has a lung-specific intercurrent clinically significant illness\n9. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.\n10. Known human immunodeficiency virus (HIV) infection;Chronic, active, or uncontrolled hepatitis B;\n11. Known chronic, active, or uncontrolled hepatitis C\n12. Has clinically significant corneal disease.\n13. Has clinically active brain metastases\n14. Has unresolved toxicities from previous anticancer therapy Concurrent malignancy \\\u003C 3 years.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":128,"type":20},233,[23],"This is a multicenter, open-label, multiple-dose, FIH Phase 1a\u002F1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes up to 3 randomized dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.",[132],"Advanced\u002FMetastatic Solid Tumors",[134,135,136],"ADAM9","Solid tumor","DB-1317","2026-04-07",{"date":139,"type":32},"2026-04-09",{"date":141,"type":32},"2025-09-23",{"date":143,"type":20},"2028-06",{"name":38,"class":39},6,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":155,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},"100499629","phase-1-a-study-of-db-1310-in-advancedmetastatic-solid-tumors-100499629","NCT05785741","A Study of DB-1310 in Advanced\u002FMetastatic Solid Tumors","A Phase 1\u002F2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1310 in Subjects With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria\n\n1. Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).\n2. Have relapsed or progressed on or after standard systemic treatments, or intolerable with standard treatment, or for which no standard treatment is available. Documented radiological disease progression during\u002Fafter most recent treatment regimen for advanced\u002Funresectable, or metastatic disease.\n3. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.\n4. Has a life expectancy of ≥ 3 months.\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.\n6. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.\n7. Is willing to provide archived tumor tissue or undergo fresh tumor biopsy for the retrospective measurement of human epidermal growth factor receptor 3 (HER3) level and other biomarkers if no contraindication. For HER2 IHC 0 breast cancer subjects, it is highly recommended to collect additional tumor sample (Refer to Lab Manual).\n8. Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.\n9. Male and female subjects of reproductive\u002Fchildbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) during the study and for at least 4 months and 7 months after the last dose of study drug, respectively.\n\n   Females must be using highly effective contraceptive measures during the study and for at least 7 months after the last dosing of study drug, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:\n   * Post-menopausal defined as aged 50 years or more and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments\n   * Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution\n   * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation\n10. Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration.\n11. Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.\n12. Phase 1 monotherapy subjects (Phase 1 monotherapy ONLY):\n\n    * Pathologically documented advanced\u002Funresectable, or metastatic solid tumors that is refractory to or intolerable with standard treatment, or for which standard treatment is not available.\n\nExclusion Criteria\n\n1. Prior treatment with HER3 targeted therapy.\n2. Prior treatment with antibody drug conjugate with topoisomerase I inhibitor (except topoisomerase I inhibitor HER2 ADC for backfilled subjects in Combo A of Phase 1 and subjects in Cohort 2e of Phase 2a, and not applicable for subjects enrolled for DLT observation in Phase 1).\n3. Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] classes II-IV) or serious cardiac arrhythmia requiring treatment.\n4. Has a medical history of myocardial infarction or unstable angina or cerebrovascular accident including transient ischemic attack (TIA) within 6 months before first dose. Or has uncontrolled hypertension (defined as systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg).\n5. Has any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG), e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval \\> 250 milliseconds (ms).\n6. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \\> 470 millisecond (ms) based on a 12-lead electrocardiogram (ECG) in triplicate.\n7. Unable or unwilling to discontinue concomitant drugs that are known to prolong the QT interval.\n\n   For Combo B of Phase 1 and Cohort 2g, 2k of Phase 2a, patients currently receiving (or unable to stop use prior to receiving the first dose of Osimertinib) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3-week prior) (refer to Section 6.9.1) are ineligible, and all patients must try to avoid concomitant use of any medications, herbal supplements and\u002For ingestion of foods with known inducer effects on CYP3A4.\n8. Has a history of (non-infectious) ILD\u002Fpneumonitis and\u002For radiation pneumonitis that required glucocorticoids, or has current ILD\u002Fpneumonitis and\u002For radiation pneumonitis, or where suspected ILD\u002Fpneumonitis and\u002For radiation pneumonitis cannot be ruled out by imaging at screening.\n9. Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months prior to Cycle 1 Day 1, severe asthma, severe chronic obstructive pulmonary disorder, restrictive lung disease, significant pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and\u002For prior pneumonectomy (complete).\n10. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.\n11. Know human immunodeficiency virus (HIV) infection. Subjects should be tested for HIV prior to enrollment if required by local regulations or by the IRB\u002F EC.\n12. Subjects have active viral (any etiology) hepatitis are excluded.\n13. Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by serum pregnancy tests performed within 7 days prior to Cycle 1 Day 1.\n14. Has clinically active central nervous system (CNS) metastases, defined as untreated, or symptomatic, or requiring therapy with glucocorticoids or anticonvulsants to control associated symptoms. However, subjects with asymptomatic CNS metastases who are radiologically and neurologically stable for at least 4 weeks following CNS-directed radiotherapy or surgery, and who are on stable or decreasing doses of glucocorticoids equivalent to ≤10 mg\u002Fday prednisone are eligible for study entry.\n15. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE version 5.0, grade ≤ 1 or baseline.\n16. Has multiple primary malignancies within 5 years before enrollment, except adequately resected non-melanoma skin cancer (e.g., resected basal or squamous cell skin cancer), curatively treated in-situ disease (e.g., carcinoma in situ of the cervix or breast), other solid tumors curatively treated (e.g., \\\u003C T1 urothelial carcinoma), or contralateral breast cancer.\n17. Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation or evaluation of the clinical study in the opinion of the investigator.\n18. Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product.\n19. Patients with other reasons that, in the opinion of the Investigator, make them unsuitable to participate in this study.\n20. For Combo B of Phase 1 and Cohort 2g, 2k, 2m of Phase 2a, patients with refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of Osimertinib or capecitabine are ineligible.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":154,"type":20},1000,[23,24],"This is a dose-escalation and dose-expansion Phase 1\u002F2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.",[158],"Advanced Solid Tumor",[160,161,162,163,164,165,166,167,168,169,170],"HER3","NSCLC","CRPC","HNSCC","BC","non-small cell lung cancer","castration-resistant prostate cancer","head and neck squamous cell carcinoma","breast cancer","ESCC","BTC","2026-03-31",{"date":173,"type":32},"2026-04-06",{"date":175,"type":32},"2023-08-17",{"date":177,"type":20},"2028-04-30",{"name":38,"class":39},24,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":21,"phases":189,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100450837","phase-1-a-phase-12a-study-of-db-1303bnt323-in-advancedmetastatic-solid-tumors-100450837","NCT05150691","A Phase 1\u002F2a Study of DB-1303\u002FBNT323 in Advanced\u002FMetastatic Solid Tumors","A Phase 1\u002F2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303\u002FBNT323 in Patients With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n* Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced\u002Funresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.\n* At least 1 measurable lesion (per RECIST 1.1)\n* Provide signed informed consent\n* ECOG performance status (PS) of 0-1.\n* LVEF ≥ 50% by ECHO or MUGA\n* Adequate organ functions\n* Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing.\n* Life expectancy of ≥ 3 months.\n\nAdditional Inclusion Criteria for Part 2 Expansion Group 9:\n\n1\\. Has pathologically documented advanced\u002Funresectable, recurrent, or metastatic EC (including UCS and USPC) and has progressed on or after at least 1 line of systemic treatment including platinum-based therapy and exposure to ICI but no more than prior 3 lines of therapy for advanced\u002Funresectable, or metastatic disease. Note: endocrine therapy will not qualify as a systemic therapy line.\n\nExclusion Criteria:\n\n* History of symptomatic CHF (New York Heart Association \\[NYHA\\] classes II-IV) or serious cardiac arrhythmia requiring treatment.\n* History of myocardial infarction or unstable angina within 6 months before Day 1.\n* Average QTcF \\> 450 ms in males and \\> 470 ms in females\n* History of clinically significant lung diseases\n* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.\n* HIV infection with AIDS defining illness or active viral hepatitis.\n* Clinically active brain metastases\n* Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline.\n* A known hypersensitivity to either the drug substances or inactive ingredients in the drug product.\n* Part 2 (expansion) Only:Multiple primary malignancies within 3 years, except adequately resected non- melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.",{"count":188,"type":20},796,[23,24],"This is a dose-escalation and dose-expansion Phase 1\u002F2a trial to evaluate the safety and tolerability of DB-1303\u002FBNT323 in subjects with advanced solid tumors that express HER2.",[192],"HER2-positive Advanced Solid Tumor",[194,195,196,197,198,199,192,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,161,219,220,221],"HER2","HER2-positive","HER2-positive Breast Cancer","HER2-positive Gastric Cancer","HER2-positive Endometrial Cancer","HER2-positive Biliary Tract Cancer","HER2 low","HER2 high","metastatic cancer","HER2-positive GEJ","Uterine serous papillary carcinoma","USPC","recurrent cancer","carcinoma","neoplasms","breast neoplasms","gastrointestinal neoplasms","endometrial neoplasms","biliary tract neoplasms","Antineoplastic Agents, Biological","stomach cancer","bile duct cancer","Cholangiocarcinoma","liver cancer","liver neoplasms","Non-Small Cell Lung Cancer","NSCLC HER2 mutation","HER2 Low Breast Cancer","2026-01-27",{"date":224,"type":32},"2026-01-28",{"date":226,"type":32},"2022-01-31",{"date":228,"type":20},"2027-10",{"name":38,"class":39},102,{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":240,"briefSummary":241,"conditions":242,"keywords":244,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":259,"leadSponsor":261,"locationsCount":262},"100509491","phase-1-a-phase-12a-study-of-db-1311bnt324-in-advancedmetastatic-solid-tumors-100509491","NCT05914116","A Phase 1\u002F2a Study of DB-1311\u002FBNT324 in Advanced\u002FMetastatic Solid Tumors","A Phase 1\u002F2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).\n2. Histologically or cytologically confirmed unresectable advanced\u002Fmetastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment; or for which no standard treatment is available.\n3. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria (measurable disease as defined by RANO 2.0 criteria for GBM subjects). Castrate-resistant prostate cancer (CRPC) subjects with bone only disease may be eligible on a case-by- case basis after discussion with the Medical Monitor.\n4. Has a life expectancy of ≥ 3 months.\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.\n6. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.\n7. Has adequate organ function within 7 days prior to Day 1 of Cycle 1\n8. Has adequate treatment washout period prior to Day 1 of Cycle 1\n9. Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of B7-H3 level and other biomarkers if no contraindication.\n\n   Note: there is no minimum B7-H3 expression level mandatory for entry into the study.\n10. Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.\n11. Male and female subjects of reproductive\u002Fchildbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) during the study and for at least 4 months and 7 months after the last dose of study drug, respectively.\n12. Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration.\n13. Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.\n14. SCLC subjects (Phase 2a Cohort 1 ONLY):\n\n    * Pathologically documented locally advanced, or metastatic SCLC not amenable to curative surgery or radiation.\n    * Prior therapy with at least one platinum-based line as systemic therapy for extensive stage disease with at least two cycles of therapy (except in the case of early objective PD).\n    * Prior treatment regimens with irinotecan, topotecan or any other TOP I inhibitor including investigational TOP I inhibitors are not allowed.\n15. NSCLC subjects (Phase 2a Cohort 2 ONLY):\n\n    * Pathologically documented locally advanced, or metastatic NSCLC and is not amenable to curative surgery or radiation.\n    * Has received prior treatment with platinum-based chemotherapy regimen and\u002For anti-PD-1\u002FPD-L1 antibody-based regimen in the advanced\u002Funresectable, or metastatic setting unless unable or unwilling. Subjects with NSCLC known to harbor a genomic alteration(s) other than EGFR mutation(s) (e.g., ALK rearrangement, ROS1 rearrangement, KRAS G12C mutation, BRAF V600E mutation, NTRK1\u002F2\u002F3 Gene fusion, MET Exon 14 skipping, RET rearrangement etc.) for which treatment is available must have also received prior treatment with at least 1 genotype-directed therapy.\n16. ESCC subjects (Phase 2a Cohort 3 ONLY):\n\n    * Pathologically documented locally advanced, or metastatic ESCC and is not amenable to curative surgery or radiation.\n    * Having received at least one prior therapy for unresectable disease. Patients with recurrence within 6 months of completion of neoadjuvant or adjuvant therapy will be considered as having received one prior therapy for unresectable disease.\n17. CRPC subjects (Phase 2a Cohort 4 ONLY):\n\n    • Pathologically documented metastatic adenocarcinoma of the prostate cancer.\n    * Progressive metastatic CRPC as defined: 1) castrate levels of serum testosterone \\\u003C 50 ng\u002FdL AND 2) progressive disease as defined by PCWG3 criteria.\n    * Having received prior docetaxel (before or after an AR-targeted therapy). Docetaxel rechallenge was allowed.\n    * Having received prior novel hormone therapy.\n18. Melanoma subjects (Phase 2a Cohort 5 ONLY) • Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma not amenable to local therapy, must have had either:\n\n    \\> Previously treated with a PD-1 or PD-L1 inhibitor.\n\n    \\> If subjects with BRAF gene mutant melanoma, must have had a prior treatment regimen that included vemurafenib, dabrafenib, or another BRAF gene and\u002For mitogen-activated protein kinase (MEK) protein inhibitor.\n19. HCC subjects (Phase 2a Cohort 6 ONLY)\n\n    * Histological\u002Fcytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria (fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC are not eligible), and:\n    * Has received 1 or 2 prior systemic therapy regimens for recurrent or metastatic disease;\n    * Has experienced disease progression during or after treatment with an anti-PD-1\u002FL1 agent administered either as monotherapy or in combination.\n\n    Note: Subjects basically should receive prior standard therapy.\n\n    • However, if the investigator judges the therapy is not appropriate for the subject, the prior standard therapy is not necessarily mandated for the eligibility.\n\n    • Has a Child-Pugh class A liver score within 7 days of first dose of study drug.\n20. Cervical cancer subjects (Phase 2a Cohort 7 ONLY) • Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and:\n\n    • Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defined as either: d. paclitaxel + cisplatin + bevacizumab + anti-PD-(L)1 agent, or e. paclitaxel + carboplatin + bevacizumab + anti-PD-(L)1 agent, or f. paclitaxel + topotecan + bevacizumab + anti-PD-(L)1 agent Note: In cases where bevacizumab and\u002For anti-PD-(L)1 agent is not a standard of care therapy or the subject was ineligible for such treatment according to local standards, prior treatment with bevacizumab and\u002For anti-PD-(L)1 agent is not required.\n\n    • Has received 1 or 2 prior systemic therapy regimens for recurrent or metastatic cervical cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as a systemic therapy regimen. Single agent therapy with an anti-PD(L)1 agent for recurrent or metastatic cervical cancer should be counted.\n21. Subjects with other solid tumors (Phase 2a Cohort 8 ONLY) • Histologically or cytologically confirmed solid tumors. • Progressed or relapsed after at least one prior standard therapeutic regimen (Patients who have not received all approved or standard treatments for their cancer must be informed that these alternatives to receiving DB-1311\u002FBNT324 are available prior to consenting to participate in this trial).\n22. HNSCC subjects (Phase 2a Cohort 9 and Cohort 13)\n\n    • Histologically or cytologically confirmed refractory\u002Fmetastatic (R\u002FM) HNSCC (not including NPC) that is considered incurable by local therapies.\n\n    • Progressed on or after prior standard therapeutic regimen.\n23. Subjects with rare tumors (Phase 2a Cohort 10 ONLY) Histologically or cytologically confirmed rare tumor types. Progressed or relapsed after at least one prior standard therapeutic regimen (Patients who have not received all approved or standard treatments for their cancer must be informed that these alternatives to receiving DB-1311\u002FBNT324 are available prior to consenting to participate in this trial).\n24. Post lutetium-177 CRPC subjects (Phase 2a Cohort 11 ONLY):\n\n    Pathologically documented metastatic adenocarcinoma of the prostate cancer. Progressive metastatic CRPC as defined: 1) castrate levels of serum testosterone \\\u003C 50 ng\u002FdL AND 2) progressive disease as defined by PCWG3 criteria.\n25. Taxane-naive CRPC subjects (Phase 2a Cohort 12, 16, 17 ONLY)\n\n    * Pathologically documented metastatic adenocarcinoma of the prostate cancer. Progressive metastatic CRPC as defined: 1) castrate levels of serum testosterone \\\u003C 50 ng\u002FdL AND 2) progressive disease as defined by PCWG3 criteria.\n\n      26, PROC subjects (Phase 2a Cohort 14 ONLY)\n    * Subjects must have a confirmed diagnosis of OC, primary peritoneal cancer, or fallopian tube cancer, all of which with high-grade serous or endometrioid histology..\n    * Subjects must have platinum-resistant disease:\n    * Received at least 1 but ≤ 3 lines of prior systemic anticancer therapy and have radiographic progressed on or after their most recent line of therapy.\n\n27\\. CSPC with suboptimal PSA response (Phase 2a Cohort 18 ONLY)\n\n* Pathologically documented adenocarcinoma of the prostate cancer.\n* Having advanced\u002Funresectable, or metastatic disease and confirmed by imaging (e.g., CT and\u002For bone scan).\n* Having received ADT and enzalutamide or abiraterone for ≥4 months, with suboptimal PSA response.\n\n  28\\. Additional inclusion criteria for DDI cohort: has a study treatment expectancy of \\>= 2.5 months. Able to withhold CYP3A\u002FP-gp\u002FOATP1B inhibitors or substrates or CYP3A inducers as concomitant treatments for certain period.\n\nExclusion Criteria:\n\nUnless otherwise specified, the exclusion criteria are common to both Phase 1 and Phase 2a. Subjects who meet any of the following criteria will be excluded from the study:\n\n1. Prior treatment with B7-H3 targeted therapy.\n2. Prior treatment with antibody drug conjugate with topoisomerase inhibitor (e.g., trastuzumab deruxtecan).\n3. Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] classes II-IV) or serious cardiac arrhythmia requiring treatment.\n4. Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.\n5. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \\> 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.\n6. Use of concomitant medications known to prolong the QT interval. If the use is deemed necessary, they should be administered with caution and closely monitoring the QT interval, after discussed with the Sponsor.\n7. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.\n8. Has a history of underlying pulmonary disorder including, but not limited to, pulmonary emboli within 3 months of the start of study treatment, severe asthma, severe COPD, restrictive lung disease, and other clinically significant pulmonary compromise or requirement for supplemental oxygen.\n9. Clinically significant gastrointestinal disorder including, but not limited to, history of gastrointestinal fistulation that need long-term intravenous nutrition; gastrointestinal dysfunction that need long-term enteral nutrition through the tube feeding; gastrointestinal obstruction\u002Fperforation that not recovered within 6 months prior to the enrollment.\n10. Untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or high risk of bleeding; A prior bleeding event due to esophageal and\u002For gastric varices within 6 months prior to initiation of study treatment (Only applicable to HCC patients).\n11. Metastatic disease that involves major airways or blood vessels (e.g., patients with vascular invasion of the major portal vein and inferior vena cava).\n12. Clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to the enrollment.\n13. Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjögren's, sarcoidosis) where there is documented, or a suspicion of pulmonary involvement at the time of screening.\n14. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.\n15. Know human immunodeficiency virus (HIV) infection.\n16. Subjects have active viral (any etiology) hepatitis are excluded. However, subjects with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen \\[HBsAg\\] test or a positive hepatitis B core antibody test) who have a viral load below the limit quantification (e.g., HBV DNA titer \\\u003C 1000 cps\u002FmL or 200 IU\u002FmL) and are willing to and maintain antiviral treatment if required, are eligible. However, subjects with a history of hepatitis C virus (HCV) infection who have completed curative antiviral treatment and have a viral load below the limit of quantification are eligible for study entry.\n17. Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by pregnancy tests performed within 7 days prior to enrollment.\n18. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study randomization.\n19. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE version 5.0, grade ≤ 1 or baseline. Subjects with chronic Grade 2 toxicities (e.g., Grade 2 neuropathy) may be eligible based on the discussion and agreement between Investigator and Sponsor.\n20. Has multiple primary malignancies within 3 years before enrollment, except adequately resected non-melanoma skin cancer (e.g., resected basal or squamous cell skin cancer), curatively treated in-situ disease (e.g., carcinoma in situ of the cervix or breast), other solid tumors curatively treated (e.g., superficial bladder cancer), or contralateral breast cancer.\n21. Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation or evaluation of the clinical study in the opinion of the investigator.\n22. Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product.\n23. Patients with other reasons that, in the opinion of the Investigator, make them unsuitable to participate in this study.\n24. Additional exclusion criteria for DDI cohort: Has a contraindication for receiving lopinavir, ritonavir or itraconazole according to the prescribing information is not able to take lopinavir, ritonavir or itraconazole by oral intake.",{"count":239,"type":20},862,[23,24],"This is a dose-escalation and dose-expansion Phase 1\u002F2a trial to evaluate the safety and tolerability of DB-1311\u002FBNT324 in subjects with advanced solid tumors.",[243],"Advanced Solid Tumors",[79,245,246,247,248,85,249,250,251,252,253,254],"SCLC (small cell lung cancer)","NSCLC (non-small cell lung cancer)","ESCC (esophageal squamous cell carcinoma)","CRPC (castration-resistant prostate cancer)","HCC (Hepatocellular Carcinoma)","HNSCC (Head and neck squamous cell carcinomas)","CC (Cervical Cancer)","PROC (platinum-resistant ovarian cancer)","PC (prostate cancer)","CSPC (castration-sensitive prostate cancer)","2025-11-18",{"date":257,"type":32},"2025-11-21",{"date":175,"type":32},{"date":260,"type":20},"2028-05",{"name":38,"class":39},107,""]