[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AP Biosciences Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,69],{"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":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100605634","phase-1-a-study-of-ap601-in-patients-with-locally-unresectable-advanced-or-metastatic-solid-tumors-100605634",false,"NCT07165067","A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors","A Phase 1, Open-label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP601 in Patients With Solid Tumors.","Inclusion Criteria: 1. Patients with histologically or cytologically proven locally unresectable advanced or metastatic solid tumors. Patients must be relapsed or refractory to at least one standard-of-care therapy, and\u002For have refused standard-of-care therapy.\n\n2\\. Eastern Cooperative Oncology Group performance status of 0 to 1 at Screening, with an estimated life expectancy of at least 3 months.\n\n3\\. Disease must have at least 1 assessable (long diameter ≥1 cm) lesion for evaluation of response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n\n4\\. Patients with adequate organ and bone marrow function, in the absence of growth factors, including the specific laboratory findings of Absolute neutophil count, platelet count, Haemoglobin, AST, ALT, Serum total Bilirubin, Alkaline phosphatase, prothrombin time, INR or activated partial thromboplastin time, creatinine and albumin.\n\n5\\. Female Volunteers must be of nonchild bearing potential i.e, surgically sterilised at least 6 weeks before Screening Visit or postmenopausal.\n\n6\\. Females of childbearing potential must have a negative pregnancy test, agree not to attempt to become pregnant or donate Ova and agree to use contraception from one month prior to Screening until at least 90 days after last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle.\n\nMale Vonuteers:\n\n* Must agree not to donate sperm from signing the ICF until at aleast 90 days after the last dose of the study drug.\n* If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception.\n* Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n\nExclusion Criteria:\n\n1. Has received concurrent antitumor treatment or IPs within 28 days of C1D1. The antitumor treatments include chemotherapy, radiotherapy, immunotherapy, targeted therapy, hormonal therapy, or cytokine therapy.\n2. Has received prior CD73-targeted and\u002For CD137-targeted therapeutics.\n3. Has had major surgery within 28 days prior to C1D1 (excluding prior diagnostic biopsy).\n4. Any unresolved toxicity (except alopecia) from prior therapy of ≥CTCAE Grade 1, prior to the day of the first dose of IP. Participants with Grade 2 toxicity that is not CS (e.g., alopecia, vitiligo), or that is deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.\n5. History of any other malignancy, which has been active or treated within the past 2 years, with the exception of thyroid cancer, cervical intraepithelial neoplasia, basal cell carcinoma and squamous cell carcinoma.\n6. Prior history of an irAE with immunotherapy-related toxicities that resulted in discontinuation of prior immunotherapy.\n7. Current symptomatic leptomeningeal disease or uncontrolled, untreated brain metastasis.\n8. Has received any organ transplantation including allogeneic stem cell transplantation.\n9. Has received blood transfusions or growth factor support ≤ 14 days prior to screening.\n10. Has any significant acute or chronic infections including:\n\n    1. Infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before first dose of AP601.\n    2. Known active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.\n11. Current active, or history of, any autoimmune disease that may relapse or immunodeficiencies.\n12. Any condition that required systemic treatment with either corticosteroids (\\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of AP601.\n13. Known severe hypersensitivity reactions to monoclonal antibodies.\n14. Breastfeeding (or planning to breastfeed) at any time during the study, and for 90 days following study completion.\n15. Participants with a current or recent (within the past 12 months) diagnosis of alcohol or non-prescribed drug abuse, as defined by local guidelines.\n16. Evidence of cardiac dysfunction (defined as myocardial infarction within the last 6 months, New York Heart Association Class II\u002FIII\u002FIV heart failure, unstable angina, unstable cardiac arrhythmias, or known left ventricular ejection fraction \\[LVEF\\] \\\u003C55%) or other CS cardiac pathology likely to impair the participants ability to participate in the study.\n17. Uncontrolled intercurrent illness including, but not limited to, uncontrolled hypertension, uncontrolled diabetes, uncontrolled endocrinopathy, severe active peptic ulcer disease or gastritis.\n18. Has received a live (or live attenuated) vaccination within 28 days of the first dose of AP601 and during the study period.\n19. Any other condition or prior therapy that in the opinion of the PI (or delegate) would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","A Phase 1, Open-Label Study of the Safety, Tolerability,Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP601 in Patients with Solid Tumours.The study is designed to find the highest dose of AP601 that can be given safely. Participants will be assigned to one of six cohorts. Each cohort will receive a different dose of the study medication, AP601, based on the body weight. Each cohort will initially enrol 1-3 participants. If no serious side effects are seen in the first participant(s), the next cohort will receive the next dose level.",[26],"Solid Tumours",[28,29,30],"solid tumours","advanced or metastatic solid tumours","open label","RECRUITING","2025-12-22",{"date":34,"type":35},"2025-12-29","ACTUAL",{"date":37,"type":20},"2026-01-21",{"date":39,"type":20},"2028-01-30",{"name":41,"class":42},"AP Biosciences Inc.","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":5},"100567575","phase-1-a-study-of-ap402-in-her2-positive-patients-with-locally-or-advanced-solid-tumors-100567575","NCT06669975","A Study of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors","A Phase 1\u002F2, Open-label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients with histologically or cytologically proven locally unresectable advanced or metastatic HER2-postive solid tumors which no standard therapy suitable.\n2. Adult patients aged ≥ 18 years at the time of signing informed consent form (ICF).\n3. Written informed consent by the patients or the patient's legally authorized representative prior to Screening.\n4. Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at study enrollment and an estimated life expectancy of at least 3 months.\n5. Disease must have at least 1 measurable (long diameter ≥ 1cm) lesion by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Tumor lesions situated in a previously irradiated area are not considered assessable unless there has been demonstrated progression in the lesion. Imaging tests outside the screening period are valid if performed not more than 2 weeks before consent signature and otherwise fulfil protocol criteria.\n6. Patients with adequate organ function defined by the following:\n\n   1. Absolute neutrophil count ≥ 1.5 × 109 \u002FL.\n   2. Platelet count ≥ 100 × 109 \u002FL.\n   3. Hemoglobin ≥ 9 g\u002FdL.\n   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or \\\u003C 5 × ULN if hepatic metastases present.\n   5. Serum total bilirubin ≤ 1.5 × ULN (or \\\u003C 3 × ULN for patients with Gilbert's syndrome).\n   6. Alkaline phosphatase ≤ 2.5 × ULN or \\\u003C 5 × ULN if bone metastases present.\n   7. Prothrombin time ≤ 1.5 × ULN.\n   8. International normalized ratio (INR) ≤ 2.0 or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Exception: INR 2 to ≤ 3 is acceptable for patients on a stable dose of anticoagulants.\n   9. Estimated creatinine clearance \\> 45 mL\u002Fmin according to the Cockcroft Gault formula.\n   10. Albumin ≥ 28 g\u002FL NOTE: Patients must not have required blood transfusions or growth factor support ≤ 14 days before sample collection at Screening.\n7. Females must not be pregnant or lactating, and must use acceptable, highly effective double contraception from Screening until 90 days after study completion, including the Follow-up period. Effective forms of contraception are defined in Section 7.3.2. Females with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day 1 and be willing to have additional pregnancy tests as required throughout the study. Women not of childbearing potential must be postmenopausal for ≥12 months (postmenopausal status is to be confirmed through testing of FSH levels ≥ 40 IU\u002FL at Screening for amenorrhoeic female patients).\n8. Males must be surgically sterile (\\>30 days since vasectomy with no viable sperm), or if engaged in sexual relations with a WOCBP, either his partner must be surgically sterile (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or an acceptable, highly effective contraceptive method (see Section 7.3.2) must be used from Screening until study completion, including the Follow-up period. Males with same-sex partners (abstinence from penile-vaginal intercourse) or are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Males must not donate sperm from the first dose of IP until at least 90 days after the last dose of IP.\n\nExclusion Criteria:\n\n1. Patients who have received concurrent antitumor treatment or investigational products within 28 days or 5 half-lives before the start of IP, whichever comes earlier. The antitumor treatments include chemotherapy, radiotherapy (with the exception of palliative bone directed radiotherapy), immunotherapy, targeted therapy, hormonal therapy, or cytokine therapy except for erythropoietin.\n2. Patients who had received CD137-targeted therapeutics within 28 days or 5 half-lives before the start of IP, whichever comes earlier.\n3. Patients who had major surgery within 28 days before the start of IP (excluding prior diagnostic biopsy).\n4. Patients who had continuance of toxicities due to prior antitumor agents that have not resolved to Grade ≤ 1 per NCI CTCAE version 5.0, except alopecia, and\\\u003C Grade 2 sensory neuropathy.\n5. Patients with a history of immune mediated AE of any grade that resulted in discontinuation of prior immunotherapy.\n6. Patients with previous malignant disease other than the target malignancy to be investigated in this study within the last 2 years with the exception of resected basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix or breast.\n7. Patients with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Patients with a history of treated and, at the time of Screening, stable central nervous system (CNS) metastases are eligible, provided they meet all the following:\n\n   1. Brain imaging at Screening shows no evidence of interim progression, patient is clinically stable for at least 2 weeks and without evidence of new brain metastases.\n   2. Measurable disease outside the CNS.\n   3. No ongoing requirement for corticosteroids as therapy for CNS disease; off steroids 2 weeks before the first dose of AP402; anticonvulsants at a stable dose are allowed.\n8. Patients who received any organ transplantation including allogeneic stem cell transplantation.\n9. Patients with significant acute or chronic infections including, among others:\n\n   1. Infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before first dose of AP402.\n   2. Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n   3. Note: An HIV serology test (including antigen and\u002For antibodies) will be conducted at baseline for the patients with unknown HIV status and patients with positive HIV test will be excluded.\n   4. Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV deoxyribonucleic acid (DNA) \\> 500 IU\u002FmL (or \\> 2500 copies\u002FmL) at Screening.\n   5. NOTE: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA \\\u003C 500 IU\u002FmL or \\\u003C 2500 copies\u002FmL) can be enrolled. Patients with detectable HBsAg or detectable HBV DNA should be managed per treatment guidelines. Patients receiving antivirals at Screening should have been treated for \\> 2 weeks before the first dose of AP402.\n   6. Patients with active hepatitis C.\n   7. NOTE: Patients with a negative hepatitis C virus (HCV) antibody test at Screening or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at Screening are eligible. The HCV RNA test will be performed only for patients testing positive for HCV antibody. Patients receiving antivirals at Screening should have been treated for \\> 2 weeks before the first dose of AP402.\n10. Patients with active or history of any autoimmune disease that may relapse (patients with diabetes Type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies. Any condition that required systemic treatment with either corticosteroids (\\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of AP402.\n11. Patients with known severe hypersensitivity reactions to monoclonal antibodies.\n12. Patients with pregnancy or lactation period. Note: a negative pregnancy test is required for WOCBP.\n13. Patients with known alcohol or drug abuse.\n14. Patients with clinically significant (ie, active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to the first dose of AP402), myocardial infarction (\\\u003C 6 months prior to the first dose of AP402), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication, or baseline QTcF interval \\> 480 msec.\n15. Patients with a left ventricular ejection fraction (LVEF) lower than 55% at Screening.\n16. Patients with any psychiatric condition that would prohibit the understanding or rendering of informed consent.\n17. Patients with live (or live attenuated) vaccination within 28 days of the first dose of AP402 and during the study period.\n18. NOTE: COVID-19 vaccinations are permitted while a patient is on the study.\n19. Patients with all other significant diseases, in the opinion of the Investigator, might impair the patient's tolerance of the IP.",{"count":51,"type":20},85,[23,53],"PHASE2","This is a Phase 1\u002F2, multi-regional, multi-center, open-label, first-in-human (FIH), dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of AP402 in HER2-positive patients with locally or advanced solid tumors.",[56],"Advanced Solid Tumor",[58,59,60],"HER2-positive","local solid tumors","advanced solid tumors","2025-04-23",{"date":63,"type":35},"2025-04-25",{"date":65,"type":35},"2025-04-22",{"date":67,"type":20},"2027-12-01",{"name":41,"class":42},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100475609","phase-1-a-study-to-investigate-the-safety-pharmacokinetics-and-clinical-activity-of-ap203-in-patients-with-locally-advanced-or-metastatic-solid-tumors-and-expansion-to-selected-malignancies-100475609","NCT05473156","A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies","A Phase 1\u002F2, Open-label Study of the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies","APT-CUBE","* Dose escalation Phase and Dose expansion Phase Inclusion Criteria:\n\n  1. Written informed consent by the participants or the participant's legally authorized representative prior to screening.\n  2. Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at study enrollment and an estimated life expectancy of at least 3 months.\n  3. Disease must have at least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Tumor lesions situated in a previously irradiated area are not considered measurable unless there has been demonstrated progression in the lesion. Imaging tests outside the screening period are valid if performed not more than 2 weeks before consent signature and otherwise fulfil protocol criteria.\n  4. Participants with adequate organ function defined by the following:\n\n     Participants must not have required blood transfusion or growth factor support ≤ 14 days before sample collection at screening:\n     1. Absolute neutrophil count ≥ 1.5 × 109 \u002FL.\n     2. Platelet count ≥ 100 × 109 \u002FL.\n     3. Hemoglobin ≥ 9 g\u002FdL.\n     4. Alanine aminotransferase and AST ≤ 2.5 × ULN or \\\u003C 5 × ULN if hepatic metastases present.\n     5. Serum total bilirubin ≤ 1.5 × ULN (or \\\u003C 3 × ULN for participants with Gilbert's syndrome).\n     6. Alkaline phosphatase ≤ 2.5 × ULN or \\\u003C 5 × ULN if bone metastases present.\n     7. Prothrombin time ≤ 1.5 × ULN.\n     8. International normalized ratio (INR) ≤ 2.0 or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Exception: INR 2 to ≤ 3 is acceptable for participants on a stable dose of anticoagulants.\n     9. Estimated creatinine clearance \\> 50 mL\u002Fmin according to the Cockcroft Gault formula\n  5. Participants with highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists.\n* Dose escalation Phase specific Inclusion Criterion:\n\n  1. Participants with histologically or cytologically proven locally unresectable advanced or metastatic solid tumors, which are refractory or intolerant to standard therapy or for which no standard therapy exists.\n* Dose expansion Phase specific Inclusion Criteria:\n\n  1. Participants who have histologically or cytologically confirmed diagnosis of relapsed or refractory, locally unresectable advanced or metastatic NSCLC, HNSCC, ESCC, who received at least one line of systemic treatment including anti-PD-1 or anti-PD-L1 therapy.\n  2. Only participants who have evaluable PD L1 expression results are eligible.\n  3. NSCLC cohort:\n\n     * Documented histologically or cytologically squamous or non-squamous stage IV NSCLC.\n     * Documented evidence of tumors expressing PD L1 (TPS ≥ 1%) for the determination of PD L1 expression in NSCLC.\n     * No sensitive epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) rearrangement.\n     * No known actionable genomic alterations of ROS1 rearrangement, BRAF V600E mutation, MET mutation, NTRK1\u002F2\u002F3 gene fusion, and\u002For RET rearrangement.\n  4. HNSCC cohort:\n\n     • Documented histologically or cytologically squamous cell carcinoma of the head and neck. Nasopharynx is excluded.\n\n     • Refractory or intolerant to platinum based chemotherapy or concurrent chemoradiation.\n     * PD L1 expression: Documented evidence of Combined Positive Score (CPS) ≥ 1 for PD L1.\n  5. ESCC cohort:\n\n     * Documented histologically or cytologically squamous carcinoma.\n     * PD L1 expression: Documented evidence of CPS ≥ 1 for PD L1.\n* Dose escalation Phase and Dose expansion Phase Exclusion Criteria:\n\n  1. Participants who have received concurrent antitumor treatment or investigational products within 28 days or 5 half lives, whichever is shorter before the start of study intervention (e.g., chemotherapy, radiotherapy \\[with the exception of palliative bone directed radiotherapy\\], immunotherapy, targeted therapy, hormonal therapy, or cytokine therapy except for erythropoietin).\n  2. Participants who had major surgery within 28 days before the start of study intervention (excluding prior diagnostic biopsy).\n  3. Participants who had continuance of toxicities due to prior antitumor agents that have not resolved to Grade ≤ 1 per NCI CTCAE version 5.0, except alopecia, \\\u003C Grade 2 sensory neuropathy.\n  4. Participants with a history of immune mediated AE of any grade that resulted in discontinuation of prior immunotherapy.\n  5. Participants with previous malignant disease other than the target malignancy to be investigated in this study within the last 2 years with the exception of resected basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix or breast.\n  6. Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated and, at the time of screening, stable central nervous system (CNS) metastases are eligible, provided they meet all the following:\n\n     a. Brain imaging at screening shows no evidence of interim progression, participant is clinically stable for at least 2 weeks and without evidence of new brain metastases.\n\n     b. Measurable disease outside the CNS. c. No ongoing requirement for corticosteroids as therapy for CNS disease; off steroids 2 weeks before the first dose of AP203; anticonvulsants at a stable dose are allowed.\n  7. Participants who received any organ transplantation including allogeneic stem cell transplantation.\n  8. Participants with significant acute or chronic infections including, among others:\n\n     o Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n\n     Note: An HIV serology test (including antigen and\u002For antibodies) will be conducted at baseline for the participants with unknown HIV status and participants with positive HIV test will be excluded.\n\n     o Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV deoxyribonucleic acid (DNA) \\> 500 IU\u002FmL (or \\> 2500 copies\u002FmL) at screening.\n\n     Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA \\\u003C 500 IU\u002FmL or \\\u003C 2500 copies\u002FmL) can be enrolled. Participants with detectable HBsAg or detectable HBV DNA should be managed per treatment guidelines. Participants receiving antivirals at screening should have been treated for \\> 2 weeks before the first dose of AP203.\n\n     o Participants with active hepatitis C. Note: Participants with a negative hepatitis C virus (HCV) antibody test at screening or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening are eligible. The HCV RNA test will be performed only for participants testing positive for HCV antibody. Participants receiving antivirals at screening should have been treated for \\> 2 weeks before the first dose of AP203.\n  9. Participants with active or history of any autoimmune disease that may relapse (participants with diabetes Type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies.\n  10. Participants with known severe hypersensitivity reactions to monoclonal antibodies.\n  11. Participants with pregnancy or lactation period. (Note: a negative pregnancy test is required for WOCBP.)\n  12. Participants with known alcohol or drug abuse.\n  13. Participants with clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to the first dose of AP203), myocardial infarction (\\\u003C 6 months prior to the first dose of AP203), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication.\n  14. Participants with any psychiatric condition that would prohibit the understanding or rendering of informed consent.\n  15. Participants with live vaccination within 28 days of the first dose of AP203 and while on study is prohibited.\n  16. Participants with all other significant diseases, in the opinion of the Investigator, might impair the participant's tolerance of the study intervention.\n* Dose expansion Phase specific Exclusion Criterion:\n\n  1. Participants who have received prior therapy with any PD-L1 x CD137 bispecific antibody.",{"count":78,"type":20},168,[23,53],"This is a multi-regional, multi center, open label, first in human (FIH), dose-escalation, and dose-expansion study of AP203 to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and antitumor activities of AP203 in adult patients with locally advanced or metastatic solid tumors.",[82,83,84,85],"Locally Advanced or Metastatic Solid Tumors","Non Small Cell Lung Cancer (NSCLC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","Esophageal Squamous Cell Carcinoma (ESCC)","2025-03-23",{"date":88,"type":35},"2025-03-26",{"date":90,"type":35},"2023-07-24",{"date":92,"type":20},"2027-12",{"name":41,"class":42},1,""]