[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Generate Biomedicines\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,78],{"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":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100630157","phase-1-study-of-gb-4362-with-enfortumab-vedotin-and-pembrolizumab-for-advanced-urothelial-cancer-100630157",false,"NCT07484022","Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer","A Phase 1, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of GB-4362 Administered With Enfortumab Vedotin and Pembrolizumab in Participants With Advanced Urothelial Cancer","Inclusion Criteria\n\n* Planned to receive standard-of-care treatment with enfortumab vedotin (EV) (starting dose 1.25 mg\u002Fkg) in combination with pembrolizumab for locally advanced or metastatic urothelial cancer.\n* Age ≥18 years.\n* ECOG Performance Status score of 0 or 1 (ECOG 2 excluded in Dose Escalation but allowed in Dose Expansion).\n* Weight ≥50 kg at screening.\n* Life expectancy ≥3 months, as determined by the investigator.\n* Participants must provide written informed consent before any study-related activities are carried out and must be able to understand the nature and purpose of the study, including potential risks and adverse effects.\n* Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n\nExclusion Criteria\n\n* Previously received enfortumab vedotin (EV) or other MMAE-based antibody-drug conjugates (ADCs).\n* Received anti-cancer treatment with chemotherapy, biologics, or investigational agents within 4 weeks before the first dose of EV\u002Fpembrolizumab.\n* Uncontrolled diabetes.\n* Active CNS metastases. Participants with treated CNS metastases are permitted if all of the following criteria are met:\n* CNS metastases have been clinically stable for at least 4 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis.\n* The participant is on a stable dose of ≤10 mg\u002Fday of prednisone or equivalent for at least 2 weeks (if requiring steroid treatment).\n* The participant does not have leptomeningeal disease.\n* Ongoing clinically significant toxicity associated with prior treatment (including radiotherapy or surgery) that has not resolved to Grade ≤1 or returned to baseline.\n* History of a severe (Grade ≥3) allergic or infusion-related reaction to any monoclonal antibody.\n* Another underlying medical condition that, in the opinion of the investigator, would impair the ability of the participant to receive or tolerate the planned treatment and follow-up.\n* Known psychiatric or substance abuse disorders that would interfere with cooperating with study requirements","ALL","18 Years",{"count":19,"type":20},37,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to evaluate the safety and tolerability of an investigational drug called GB-4362 when it is given together with enfortumab vedotin and pembrolizumab in adults with advanced or metastatic urothelial cancer. GB-4362 is a monoclonal antibody designed to bind and neutralize free monomethyl auristatin E (MMAE), a chemotherapy payload released from enfortumab vedotin that is associated with side effects such as peripheral neuropathy.",[26,27],"Advanced Urothelial Cancer","Metastatic Urothelial Carcinoma",[29,30,31,32,33,34,35,36,37],"GB-4362","Enfortumab Vedotin","Pembrolizumab","Peripheral Neuropathy","Antibody-Drug Conjugate","MMAE","Phase 1 Oncology","Dose Escalation","Dose Expansion","RECRUITING","2026-06-17",{"date":41,"type":42},"2026-06-18","ACTUAL",{"date":44,"type":20},"2026-06",{"date":46,"type":20},"2027-12",{"name":48,"class":49},"Generate Biomedicines","INDUSTRY",10,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100614217","phase-3-a-study-to-investigate-gb-0895-adjunctive-therapy-in-adults-and-adolescents-with-severe-uncontrolled-asthma-solairia-1-100614217","NCT07276724","A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma","1. Adults and adolescents ≥ 12 and ≤ 80 years of age.\n2. Documented physician diagnosis of asthma for ≥ 2 years.\n3. Subjects must be on medium to high dose ICS for ≥ 12 months before Screening Visit 1 plus at least 1 additional asthma controller (e.g., LABA, LAMA) ≥ 3 months before Screening Visit 1 with no change in ICS or controller(s) for at least three months.\n4. Subjects must have a well-documented history of at least two asthma exacerbations requiring systemic corticosteroid treatment despite the use of medium-to-high dose ICS in the past 12 months before Screening Visit 1.\n5. Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1 \\\u003C80% predicted at Screening Visit 1.\n6. Adolescents 12 to \\\u003C 18 years of age at Screening Visit 1: A pre-BD FEV1 \\\u003C 90% predicted OR, FEV1:Forced Vital Capacity (FVC) ratio \\\u003C 0.80.\n7. Positive BD responsiveness test: Increase of at least 12% and 200 mL in FEV1 between 15 and 60 minutes after the administration of a short-acting β2-agonist (SABA) at least once during the screening period.\n8. ACQ-6 score ≥ 1.5 at the Screening Visit.\n9. Weight ≥40 kg at the Screening Visit 1\n\nExclusion Criteria:\n\n1. Subjects who experience a clinically significant asthma exacerbation within 12 weeks before the Screening Visit or during the run-in period and require a change in asthma maintenance therapy.\n2. Other concurrent respiratory disease other than asthma, including (but not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, tuberculosis, diagnosis of chronic pulmonary disease (including but not limited to emphysema and\u002For chronic bronchitis), or a history of lung cancer.\n3. Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis, eosinophilic esophagitis).\n4. Any cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could affect subject safety, influence study findings or interpretation, or impede completion of the study.\n5. Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment.\n6. A current malignancy or previous history of cancer within 5 years before screening.\n7. Clinically significant infection that is not resolved before study enrollment.\n8. Subjects with a known, pre-existing helminth parasitic infestation within 6 months before Screening Visit 1.\n9. Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes.\n10. Former smokers with a smoking history of \\\u003C10 pack-years and users of vaping\u002Fe-cigarette products must have stopped for at least 6 months before Screening Visit 1 to be eligible.\n11. Hepatitis B, C, or HIV.\n12. Major surgery within 8 weeks before Screening Visit 1 or planned surgical procedures requiring general anesthesia or inpatient status for \\>1 day during the study.\n13. Use of any anti-IL-5 therapy (e.g., mepolizumab, reslizumab, benralizumab, depemokimab) within 12 months before Screening Visit 1 or other monoclonal antibodies used for asthma within 4 months or 5 half-lives.\n14. Prior use (at any time) of any anti-TSLP or anti-TSLP receptor biologics, approved (e.g., tezepelumab) or investigational.\n15. Treatment with systemic immunosuppressive\u002Fimmunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization.\n16. Receipt of an investigational biologic within 4 months or 5 half-lives, OR receipt of an investigational non-biologic within 30 days or 5 half-lives before Screening Visit 1.\n17. Known history of sensitivity to any component of the study treatment formulation.\n18. History of life-threatening anaphylaxis following any biologic therapy.\n19. Concurrent enrollment in another clinical study involving investigational product (IP).\n20. Subject has been randomized in the current study or previous GB-0895 studies.\n21. Any clinically meaningful abnormal finding in physical examination, vital signs, ECG, hematology, serum chemistry, or urinalysis that, in the opinion of the Investigator, may put the subject at risk, influence study results, or impede study completion.\n22. Cirrhosis (with or without hepatic dysfunction) or other active or clinically significant liver disease.\n23. Receipt of immunoglobulin or blood products within 30 days before Screening Visit 1.\n24. Receipt of live attenuated vaccines within 30 days before randomization and during the study, including the follow-up period.\n25. Receipt of the T2 cytokine inhibitor suplatast tosilate within 15 days before Screening Visit 1.\n26. Subjects treated with bronchial thermoplasty in the last 12 months before Screening Visit 1.\n27. Unwillingness or inability to follow study procedures, including poor adherence to asthma controller medications, in the opinion of the Investigator.\n28. Women who are pregnant, lactating, or planning to become pregnant during the study.\n29. History (or suspected history) of alcohol misuse or substance abuse within 2 years before Screening Visit 1.","12 Years","80 Years",{"count":61,"type":20},786,[63],"PHASE3","The objective of this study is to assess the potential for GB-0895 treatment to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers.\n\nThe study details include:\n\nStudy treatment: randomized to receive either GB-0895 or placebo administered every 6 months over 52 weeks.\n\nVisit frequency: every 1-2 months after the first month.",[66],"Severe Asthma",[68,66],"Asthma","2026-06-09",{"date":71,"type":42},"2026-06-11",{"date":73,"type":42},"2025-12-03",{"date":75,"type":20},"2028-12",{"name":48,"class":49},35,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":64,"conditions":85,"keywords":86,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100620609","phase-3-a-study-to-investigate-gb-0895-adjunctive-therapy-in-adults-and-adolescents-with-severe-uncontrolled-asthma-solairia-2-100620609","NCT07359846","A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)",{"count":61,"type":20},[63],[66],[68,66],"2026-05-14",{"date":89,"type":42},"2026-05-18",{"date":91,"type":42},"2026-01-20",{"date":93,"type":20},"2029-01",{"name":48,"class":49},14,""]