[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"GigaGen, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100594837","phase-1-a-study-to-assess-the-safety-tolerability-and-pharmacokinetics-of-giga-2339-in-participants-with-chronic-hepatitis-b-virus-infection-100594837",false,"NCT07024641","A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection","A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 Administered as a Single Ascending Dose and Multiple Ascending Doses in Participants With Chronic Hepatitis B Virus Infection","Key Inclusion Criteria:\n\n* Hepatitis B envelope antigen (HBeAg) negative chronic HBV infection for ≥ 6 months, defined as presence of Hepatitis B surface antigen (HBsAg) in serum for ≥ 6 months.\n* Serum HBsAg concentration between ≥ 100 international units per milliliter (IU\u002FmL) and 2000 IU\u002FmL at screening.\n* Currently on stable dose of nucleot(s)ide analogues (NAs) (≥ 6 months) and expected to continue while participating in the study, or are not received NAs.\n* Have serum HBV deoxyribonucleic acid (DNA) concentration ≤ 50 IU\u002FmL at screening (for those who are on NAs); or have serum HBV DNA concentration ≤ 2000 IU\u002FmL at screening (for those who are NOT on NAs).\n* Male participants must refrain from donating spermatozoa and agree to use highly effective contraception.\n* Female participants must not be pregnant, or breastfeeding; either should not be a woman of childbearing potential (WOCBP) or if WOCBP should use highly effective contraceptive methods.\n\nKey Exclusion Criteria:\n\n* Positive for co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), and\u002For hepatitis D virus (HDV) at screening.\n* Participants that weigh less than 50 kilograms (kg) and\u002For have a body mass index (BMI) less than 18.5.\n* History of documented liver cirrhosis at screening. Patients under liver cirrhosis evaluation at screening will not be eligible until cirrhosis is ruled out.\n* Liver stiffness \\> 8 kilopascal (kPa) at screening.\n* History of chronic liver disease from another cause, immune complex disease, or autoimmune diseases that in the opinion of the investigator would preclude participation.\n* Family history of hepatocellular carcinoma (HCC).\n* Alpha fetoprotein \\> 20 nanograms per milliliter (ng\u002FmL).\n* Presence of a liver imaging reporting and data system (LI-RADS) 4 or 5 liver lesion on imaging 12 months prior to Screening OR, LI-RADS-US findings of US-3 grade on imaging 12 months prior to Screening, OR LIRADS-US grade 3 done prior to the D1 infusion visit, if prior LI-RADS or LI-RADS-US results are not available at Screening.\n* History of hematopoietic stem cell transplant or solid organ transplant.\n* Receipt of anti-HBV monoclonal antibody (mAb)\u002FpAb therapy of any kind in the past (including hepatitis B immunoglobulin \\[HBIG\\]).\n* History of cardiovascular disease (e.g., coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome). Stable hypertension is allowed.\n* Malignancy diagnosed and\u002For treated within 5 years prior to Screening, and\u002For with ongoing treatment for malignancy, with the exception of localized non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix excised with curative intent.\n* Participants requiring anti-coagulation therapies (for example warfarin, Factor Xa inhibitors, or anti-platelet agents like clopidogrel).\n* Male participants with a corrected QT interval using Fridericia's formula (QTcF) \\> 450 milliseconds (msec) and female participants with QTcF \\> 470 msec on ECG recorded at screening. if the participant has evidence of an intraventricular conduction delay, defined as QRS interval greater than 110 msec, a QTcF is \\> 500 msec for both males and females will be excluded.\n* Known hypersensitivity to any GIGA-2339 excipients or any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (nonactive hay fever is acceptable), or a history of drug or other allergy that, in the opinion of the Investigator, contraindicates participation.\n* Received or will receive live-attenuated virus vaccinations such as measles, mumps, rubella or varicella within 4 weeks before and up to three months after administration of investigational product (IP).","ALL","18 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The primary purpose of this study is to assess the safety and tolerability of single and multiple intravenous (IV) doses of GIGA-2339 in participants with chronic Hepatitis B Virus (HBV) infection.",[26],"Hepatitis B Virus Infection","RECRUITING","2026-06-23",{"date":30,"type":31},"2026-06-25","ACTUAL",{"date":33,"type":31},"2024-11-13",{"date":35,"type":20},"2028-11",{"name":37,"class":38},"GigaGen, Inc.","INDUSTRY",18,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100535936","phase-1-a-dose-escalation-and-expansion-study-of-giga-564-in-participants-with-locally-advanced-or-metastatic-solid-tumor-malignancies-100535936","NCT06258304","A Dose Escalation and Expansion Study of GIGA-564 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies","A Phase 1 Dose Escalation and Expansion Study of GIGA-564, a Minimally Blocking Anti-CTLA-4 Monoclonal Antibody, in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies","Inclusion Criteria:\n\n* Willing and able to provide informed consent.\n* Histologically or cytologically confirmed locally advanced or radiographically confirmed metastatic solid tumor malignancies ineligible for standard-of-care or refractory to or relapsing after at least one line of systemic therapy in the metastatic or advanced setting.\n* Measurable disease on imaging as based on Response Evaluation Criteria in RECIST 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.\n* Life expectancy greater than three months.\n* Electrocardiogram (ECG) without evidence of clinically relevant abnormalities in rhythm, conduction, or morphology of resting ECG or active ischemia as determined by the Investigator.\n* Acceptable organ and marrow function including:\n\n  1. Absolute neutrophil count \\>= 1,500 cells\u002F microliters (μL)\n  2. Platelets \\>= 100,000 cells\u002FμL\n  3. Hemoglobin \\>= 9 grams per decilitre (g\u002FdL)\n  4. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (≤ 3 × ULN if attributable to known Gilbert's syndrome)\n  5. Aspartate aminotransferase (AST)\u002F alanine aminotransferase (ALT) ≤ 2.5 × ULN. If liver metastasis is present, AST\u002FALT \\\u003C 5 × ULN\n  6. Measured creatinine clearance ≥ 30 milliliter per minute mL\u002Fmin per Cockcroft-Gault formula\n  7. Prothrombin time or international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 × ULN, unless receiving anti-coagulant therapy.\n* Primary or metastatic lesions that are amenable to biopsy (Phase 1B only).\n* Women of childbearing potential must agree to use highly effective contraception.\n\nExclusion Criteria:\n\n* Investigational therapy and\u002For anti-cancer therapy with the potential for late onset toxicity within 4 weeks or 5 half-lives (whichever is shorter), or nitrosoureas or mitomycin C within 6 weeks. Food and drug administration (FDA)-approved hormonal therapies (e.g., androgen deprivation therapy \\[ADT\\] for prostate cancer, anti-estrogen for breast cancer, somatostatin analogue for neuroendocrine cancer) are allowed.\n* Failure to resolve toxicity from previous anti-cancer therapy (other than National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v5.0 ≤ Grade 2 alopecia, neuropathy or medically controlled endocrinopathies) to NCI CTCAE v5.0 ≤ Grade 1.\n* Prior receipt of therapy directed against CTLA-4.\n* Prior receipt of therapy directed against chemokine (C-C motif) receptor 8 (CCR8), cluster of differentiation 25 (CD25), or T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibition motif domains (TIGIT) with an active Fc domain.\n* Baseline prolongation of corrected QT interval (QTc) QT\u002FQTc interval Fridericia's formula (QTcF \\> 470 millisecond \\[msec\\]).\n* History of hepatitis B (HBV) infection unless viral load is undetectable.\n* Participants with known history of hepatitis C (HCV) infection, unless they have been treated and cured (viral load is undetectable).\n* Active or severe infection such as active tuberculosis.\n* Human immunodeficiency virus (HIV) infection unless participants are stable on anti-retroviral therapy (CD4 count ≥ 200\u002FμL) and have a viral load \\\u003C 400 copies\u002FmL.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater heart failure), myocardial infarction within 3 months prior to initiation of study treatment, or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n* Active or history of autoimmune or primary immunodeficiency disease requiring systemic treatment within 2 years of commencing study (NOTE: participants with autoimmune conditions requiring hormone replacement therapy or topical treatments are eligible).\n* Active or history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n* History of hematopoietic stem cell transplantation (HSCT) or solid organ transplant with the exception of corneal transplants.\n* Pregnant or breastfeeding.\n* Previous hypersensitivity reactions to any component of the investigational product.\n* Concurrent use of systemic steroids (within 10 days of enrollment), except for physiologic doses of systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids (e.g., in participants with exacerbations of reactive airway disease) must have completed therapy ≥ 10 days prior to enrollment. Steroid use to prevent intravenous contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed at any time prior to enrollment and for imaging while on treatment.\n* History of other active malignancy within 3 years of enrollment except for the following: adequately treated localized skin cancer, ductal carcinoma in situ, cervical carcinoma in situ, superficial bladder cancer or other localized malignancy which has been adequately treated.\n* Active or untreated brain metastases that are not stable. Stable is defined as 2 brain images that show no progression, obtained ≥ 4 weeks apart and any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved. Any steroids administered as part of this therapy must be completed ≥ 10 days prior to first dose of study medication.\n* Thymoma or thymic carcinoma (Phase 1A only).\n* Other medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and which, in the judgment of the Investigator or Sponsor, would make the patient inappropriate for the study.",{"count":48,"type":20},60,[23],"The purpose of this study is to assess the safety and tolerability of GIGA-564 and identify the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) level(s) of GIGA-564 in participants with metastatic or locally advanced solid tumor malignancies.",[52],"Advanced or Metastatic Solid Tumor Malignancies",[54],"GIGA-564, CTLA-4","2025-04-09",{"date":57,"type":31},"2025-04-10",{"date":59,"type":31},"2024-05-08",{"date":61,"type":20},"2027-11",{"name":37,"class":38},1,""]