[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fortvita Biologics (USA)Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":133},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,62,82,112],{"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},"100618811","phase-1-a-study-of-ibi3003-in-subjects-with-relapsed-or-refractory-multiple-myeloma-100618811",false,"NCT07336472","A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma","A Phase I\u002FII, Multicenter, Open-label Study of IBI3003 in Participants With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria\n\nParticipants in Parts 1 \\& 2 must satisfy all of the following criteria to be enrolled in the study:\n\n1. Age ≥18 years.\n2. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria.\n\n   Multiple myeloma is defined as clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma, and any one or more of the following myelomadefining events:\n   * Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcemia: serum calcium \\>0.25 mmol\u002FL (\\>1 mg\u002FdL) higher than the upper limit of normal or corrected serum calcium \\>2.75 mmol\u002FL (\\>11 mg\u002FdL) Renal insufficiency: creatinine clearance \\\u003C40 mL\u002Fmin or serum creatinine \\>177 μmol\u002FL (\\>2 mg\u002FdL) Anemia: hemoglobin value of \\>2 g\u002FdL below the lower limit of normal, or a hemoglobin value \\\u003C10 g\u002FdL Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT\n   * Any one or more of the following biomarkers of malignancy:\n\n   Clonal bone marrow plasma cell percentage ≥60% Involved: uninvolved serum free light chain ratio ≥100 (involved FLC level must be\n\n   ≥100 mg\u002FL) \\>1 focal lesions on MRI studies (at least 5 mm in size)\n3. Relapsed or refractory measurable multiple myeloma (R\u002FR MM) following prior treatment with ≥3 lines of systemic anti-myeloma therapy that include at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy, and with limited or no therapeutic options that are likely to offer a favorable risk\u002Fbenefit profile; participants must be relapsed or refractory to their last anti-myeloma regimen.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1\n5. At least one of the following measurable disease indicators:\n\n   * Serum M-protein ≥5 g\u002FL (for IgA and IgD subtypes, quantitative immunoglobin measurements could be used as substitutions for M-protein)\n   * Urine M-protein ≥200 mg\u002F24h\n   * Serum free light chain (FLC) test: affected FLC level ≥100 mg\u002FL and abnormal serum FLC ratio (\\\u003C0.26 or \\>1.65)\n6. Adequate hematologic, hepatic, renal and cardiac function:\n\n   * Blood count: absolute neutrophil count ≥1.0×10\\^9\u002FL, hemoglobin ≥70 g\u002FL, and platelet count ≥50×10\\^9\u002FL (values must be achieved without growth factors or blood transfusions within 7 days prior to first dose)\n   * Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤2.5× upper limit of normal (ULN) and total bilirubin (TBIL) ≤1.5×ULN\n   * Renal function: calculated creatinine ≥30 mL\u002Fmin by the Cockcroft-Gault Equation\n   * Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%\n7. Life expectancy ≥3 months.\n8. Women of childbearing potential and fertile men who are sexually active must agree to use a highly effective method of contraception (\\\u003C1% \u002F year failure rate) during the study and for 90 days after the last dose level of study drug. Contraception must be consistent with local regulations or standards regarding the use of birth control methods by participants participating in clinical trials. Women and men must agree not to donate or bank eggs (ova, oocytes) or sperm, respectively, during the study and for 90 days after the last dose level of study drug.\n9. Participants with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.\n10. Willing and able to adhere to the complete schedule of assessments and all prohibitions and restrictions specified in this protocol\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.\n2. Active amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or solitary plasmacytoma, or smoldering multiple myeloma (MM) as defined by the IMWG criteria.\n3. Spinal cord compression that results in limited self-care at present or within 6 months prior to informed consent, or that is expected to cause such limitations during Study participation.\n4. History of primary immunodeficiency.\n5. Current or previous other malignancy within 3 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.\n6. Allogeneic hematopoietic stem cell transplantation within the last 6 months, or autologous stem cell transplantation within the last 3 months prior to the first administration of the study drug.\n7. History of organ transplantation.\n8. Active graft-versus-host disease.\n9. Thromboembolism or cerebrovascular events (e.g., myocardial infarction, unstable angina, transient ischemic attack, cerebrovascular accident, deep vein thrombosis \\[unless associated with complications of central venous access\\], or pulmonary embolism) within 6 months prior to the first dose of study drug.\n10. Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation.\n11. Known allergies, hypersensitivity, or intolerance to IBI3003 or its excipients (refer to Investigator's Brochure).\n12. Prior toxicities that have not resolved to ≤Grade 1 prior to study treatment administration except for stable chronic toxicities (≤Grade 2) not expected to resolve (e.g., stable Grade 2 peripheral neurotoxicity)\n13. Prior antitumor therapy as follows, prior to the first dose of study drug:\n\n    * Gene modified adoptive cell therapy (e.g., chimeric antigen receptor modified T cells, natural killer cells) within 8 weeks.\n    * Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is longer.\n    * Antibody treatment (e.g., monoclonal antibody, bispecific antibody) for multiple myeloma within 21 days.\n    * Cytotoxic therapy (including antibody-drug conjugates) within 14 days.\n    * Proteasome inhibitor therapy within 14 days Immunomodulatory agent therapy within 7 days.\n    * Radiotherapy within 21 days. However, if the radiation field covered ≤5% of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy.\n    * Cancer vaccine received within 3 months.\n14. Use of immunosuppressive therapy within 28 days of the start date of study treatment.\n\n    Immunosuppressive therapy includes, but is not limited to, cyclosporine A, tacrolimus, and mycophenolate mofetil, but does not include corticosteroids given as part of an antimyeloma regimen. Participants receiving corticosteroids must be at a dose level ≤10 mg\u002Fday of prednisone equivalent for at least 7 days prior to the start of study treatment administration.\n15. Live or live attenuated vaccine administered within 4 weeks prior to start of study treatment, or anticipated need for live or live attenuated vaccine during the study.\n16. Uncontrolled diseases, including:\n\n    * Uncontrolled infection or infection requiring systemic antibiotics, antivirals or antifungals within one week prior to first administration of the study drug;\n    * Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1\u002F2 Ab positive);\n    * For participants in mainland China, acute or chronic active hepatitis B (HBsAg positive and\u002For HBcAb positive with HBV DNA titer ≥104 copies\u002FmL or ≥2000 IU\u002FmL) or C (HCV Ab positive with HCV RNA\\>103 copies\u002FmL). For participants outside of mainland China, active, latent or incompletely treated infection with HBV or HCV;\n    * Failed to complete anti-tuberculosis therapy at any point prior to C1D1; active tuberculosis infection, or still on anti-tuberculosis therapy;\n    * Active syphilis infection requiring treatment;\n    * Symptomatic congestive heart failure Grade II-IV (New York Heart Association \\[NYHA\\]), symptomatic or uncontrolled arrhythmias, QTc interval (calculate using the Fridericia formula) \\>480 ms, or personal or family history of congenital long\u002Fshort QT syndrome;\n    * Uncontrollable hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg);\n    * Active autoimmune diseases, including but not limited to inflammatory bowel disease, autoimmune hepatitis, demyelinating lesions, extensive dermatitis, immunerelated interstitial pneumonia, or Grave's disease requiring antithyroid medication control (vitiligo, or hypothyroidism requiring hormone replacement therapy, type I diabetes requiring only insulin replacement therapy and no other systemic therapy in the past 2 years are eligible); Presence of clinically uncontrolled pleural\u002Fperitoneal effusions (participants who do not require regular drainage or who do not demonstrate significant re-accumulation of effusion for at least 72 hours after the most recent drainage can enroll).\n17. Major surgery within 2 weeks prior to the first dose of study treatment, not fully recovered from any prior surgery, or has non-minor surgery anticipated during the time the participant is expected to receive study drug or within 2 weeks after the last dose of study drug administration.\n18. Participating in any other interventional clinical research except an observational (noninterventional) study or the survival follow-up phase of an interventional study.\n19. Currently pregnant or breastfeeding.\n20. Any condition that would, in the Investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n21. Inability to comprehend or unwilling to sign the ICF","ALL","18 Years",{"count":19,"type":20},360,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a phase 1\u002F2 multicenter, open-label, first-in-human study of IBI3003. It includes a phase 1 dose escalation and expansion section to identify maximum tolerated dose(MTD)\u002Frecommended Phase 2 Dose(RP2D) of IBI3003, plans to enroll 54\\~360 subjects, and a phase 2 stage to explore efficacy, safety and tolerability of IBI3003 at RP2D in multiple myeloma",[27],"Multiple Myeloma","RECRUITING","2026-09-22",{"date":31,"type":32},"2026-09-25","ACTUAL",{"date":34,"type":20},"2026-09-30",{"date":36,"type":20},"2028-09-30",{"name":38,"class":39},"Fortvita Biologics (USA)Inc.","INDUSTRY",6,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100590120","phase-1-study-of-ibi3020-treatment-in-participants-with-late-stage-solid-tumors-100590120","NCT06963281","Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors","A Phase 1, Multicenter, Open-label Study of IBI3020 Treatment in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nParticipants must satisfy all of the following criteria to be enrolled into the study:\n\n1. Participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;\n2. Male or female participants ≥ 18 years old. For Part 1, age ≥ 18 years and ≤ 75 years;\n3. Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumors which have received available standard therapies and have disease progression, or unacceptable toxic effects, or contraindications;\n4. At least 1 measurable lesion as defined per RECIST v1.1 within 28 days prior to the first dose of IBI3020;\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;\n6. Minimum life expectancy of 12 weeks;\n7. Adequate bone marrow and organ function confirmed at screening period;\n8. Participants, both male and female, who are not of childbearing potential or who agree to use at least 1 highly effective method of contraception during the study.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Previous treatment with CEACAM5-targeted therapy;\n2. Prior anti-cancer therapy within the wash-out period;\n3. Received live vaccines within 4 weeks or cancer vaccine within 3 months;\n4. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives;\n5. Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI CTCAE v5.0;\n6. Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients;\n7. Undergone major surgery within 4 weeks, or who have severe unhealed wounds;\n8. Known symptomatic central nervous system (CNS) metastases;\n9. Uncontrolled diseases or conditions;\n10. History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases;\n11. History of thromboembolic event within 6 months;\n12. Under neurological, psychiatric or social condition;\n13. Women who are pregnant, have positive results in pregnancy test or are lactating;\n14. Not eligible to participate in this study at the discretion of the investigator;\n15. Participating in any other interventional clinical research.","75 Years",{"count":50,"type":20},285,[23],"The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and\u002For the recommended dose for expansion (RP2D) of IBI3020.",[54],"Solid Tumors",{"date":31,"type":32},{"date":57,"type":32},"2025-04-29",{"date":59,"type":20},"2028-03-31",{"name":38,"class":39},9,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100542941","phase-1-ibi3001-in-participants-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100542941","NCT06349408","IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors","A Phase 1 Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n1. Male or female participants ≥ 18 years old;\n2. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;\n3. Has an anticipated life expectancy of ≥ 12 weeks;\n4. Adequate bone marrow and organ function:\n5. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion.\n6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks.\n\nKey Exclusion Criteria:\n\n1. Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that consists of Exatecan;\n2. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also not have an impact on tumor assessment throughout the study;\n3. Pyloric obstruction and\u002For persistent recurrent vomiting (≥ 3 times in 24 hours);\n4. Gastrointestinal perforation and\u002For fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;\n5. Known symptomatic central nervous system (CNS) metastases.\n6. History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;\n7. History of endotracheal or gastrointestinal stent implantation;\n8. Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;\n9. Esophageal or gastric varices requiring immediate intervention;\n10. Not eligible to participate in this study at the discretion of the investigator;\n11. Do not have adequate treatment washout period before study drug administration. -",{"count":70,"type":20},250,[23],"This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD\u002FRP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.",[74],"Locally Advanced Solid Tumor",{"date":31,"type":32},{"date":77,"type":32},"2025-01-10",{"date":79,"type":20},"2027-12-31",{"name":38,"class":39},27,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100657604","phase-1-a-study-of-ibi3042-in-healthy-adult-participants-100657604","NCT07842393","A Study of IBI3042 in Healthy Adult Participants","A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of IBI3042 in Healthy Adult Participants","Inclusion Criteria:\n\n* Aged 18 to 55 years, inclusive.\n* BMI ≥20 and \\\u003C32 kg\u002Fm² and body weight ≥50 kg;\n* Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose.\n* Able and willing to comply with study procedures and voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to any component of the study drug or to GLP-1 receptor agonists.\n* History of diabetes or abnormal glycemic parameters at screening.\n* Personal or family history of thyroid C-cell carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2A or 2B), or calcitonin ≥20 ng\u002FL at screening.\n* History of acute or chronic pancreatitis, or clinically significant pancreatic enzyme elevation at screening.\n* Use of medications that may significantly affect gastrointestinal motility, appetite, or drug absorption within 3 months prior to screening.\n* Clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may increase study-related risk or interfere with study assessments.\n* Clinically significant abnormalities in physical examination or laboratory tests at screening.\n* History of malignancy within 5 years, except for basal cell or squamous cell skin cancer.\n* Use of prescription or over-the-counter medications, or dietary supplement vitamins within 2 weeks or 5 half-lives, whichever is greater, prior to screening; or use of any herbal products within 4 weeks prior to screening.\n* Participation in another drug or medical device clinical study within 3 months prior to screening or within 5 half-lives of the investigational drug, as applicable.\n* Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study.",true,"55 Years",{"count":92,"type":20},32,[23],"This is a randomized, investigator- and participant-blinded, placebo-controlled, parallel-group, dose-escalation Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of single ascending oral doses of IBI3042, in healthy adult participants. Approximately 32 healthy participants will be enrolled across 4 single ascending dose groups, with 8 participants per group randomized in a 6:2 ratio to receive a single oral dose of IBI3042 or matching placebo. A sentinel-dosing design is used for the first dose cohort. Safety and PK data are assessed to support dose escalation decisions by the Safety Review Committee.",[96],"Healthy Volunteers (HV)",[98,99,100,101,102],"Glucagon-Like Peptide 1 Receptor Agonists","Healthy Volunteers","Phase 1 Clinical Trials","Pharmacokinetics","Safety","NOT_YET_RECRUITING","2026-09-21",{"date":31,"type":32},{"date":107,"type":20},"2026-09-29",{"date":109,"type":20},"2027-02-03",{"name":38,"class":39},1,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":89,"sex":16,"minAge":17,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":111},"100602201","phase-1-a-study-of-ibi3032-in-healthy-participants-100602201","NCT07120425","A Study of IBI3032 in Healthy Participants","A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBI3032 in Healthy Participants","Inclusion Criteria:\n\n* Healthy male or females, as determined by medical history\n* Have safety laboratory results within normal reference ranges\n\nExclusion Criteria:\n\n* Have known allergies toIBI3032， glucagon-like peptide-1 (GLP-1) analogs, related compounds\n* Abnormal electrocardiogram (ECG) at screening\n* Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.","65 Years",{"count":92,"type":20},[23],"This is a randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, and PK of a single dose of IBI3032 in healthy participants. This is a single ascending dose (SAD) study. Approximately 32 healthy participants are expected to be enrolled in this study.\n\nThe screening period is 4 weeks. Eligible participants will be divided into 4 cohorts. Each cohort consisted of 8 healthy participants who will be randomized in a 6:2 ratio to receive a single dose of IBI3032 or placebo. The safety follow-up period is 15 days. This study is for research purposes only, and is not intended to treat any medical condition.",[124],"Healthy","2025-09-11",{"date":127,"type":32},"2025-09-17",{"date":129,"type":32},"2025-09-10",{"date":131,"type":20},"2025-11-13",{"name":38,"class":39},""]