[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Suzhou Forlong Biotechnology Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100603029","phase-1-a-study-of-fl115-in-combination-with-a-pd-1-antibody-in-advanced-solid-tumors-100603029",false,"NCT07131202","A Study of FL115 in Combination With a PD-1 Antibody in Advanced Solid Tumors","A Phase Ib\u002FII, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Pharmacodynamics of FL115 in Combination With a PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male or female subjects aged 18 years or older and up to 80 years old.\n2. Phase 1b：Patients with specific advanced solid tumors confirmed by histology or cytology who have failed all standard therapies, have no available standard treatment options, or are currently not suitable for standard treatment.\n\n   Phase 2：Patients with advanced solid tumors of specific types, either previously treated with or naïve to standard therapies.\n3. With at least one measurable lesion (according to RECIST v1.1).\n4. ECOG score: 0 - 1.\n5. Expected survival period ≥ 12 weeks (judged by the investigator).\n6. Sufficient organ function.\n7. Voluntary written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations.\n8. Fertile subjects (male and female) and their partners agree to use acceptable, investigator-approved contraception during the study-required period.\n\nExclusion Criteria:\n\nIf any of the following criteria are met, the subjects will be excluded from the study:\n\n1. History of previous anti-tumor treatment:\n\n   1. Previous use of IL-2 or IL-15 agonists, including but not limited to rhIL-15 (NCI), ALT-803 (ALTOR), NKTR-214 (Nektar).\n   2. Subjects who received any anti-tumor investigational drugs, approved therapies, biologics, radiotherapy, or immunotherapy within 4 weeks before the first dose (except HRT(Hormoral Replacement Therapy), testosterone, oral contraceptives, ADT for prostate cancer, or endocrine therapy for breast cancer), endocrine therapy within 2 weeks, or palliative local radiotherapy within 14 days.\n   3. Within 2 weeks before the first administration of the study drug, received traditional Chinese medicine for anti-tumor indications.\n   4. Subjects who received oral fluoropyrimidines or small-molecule targeted therapies discontinued the treatment ≤2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug.\n   5. Subjects who received mitomycin C or nitrosourea treatment discontinued the medication ≤6 weeks prior to the first dose of the study drug.\n2. History of other previous treatments and toxicity recovery:\n\n   1. Known or suspected allergies to FL115 and its excipients; known history of grade 3-4 allergic reactions to interleukin treatment or other fusion proteins.\n   2. Known allergies to indomethacin, acetaminophen, diphenhydramine, ranitidine, cimetidine and\u002For famotidine.\n   3. Received systemic immunosuppressants within 4 weeks before first dose, except for: ≤10 mg\u002Fday prednisone-equivalent, local\u002Finhaled\u002Fnasal steroids, ≤7.5 mg\u002Fday for adrenal replacement, or one-time use for contrast allergy before imaging.\n   4. Received treatment with granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), thrombopoietic agents (e.g., thrombopoietin \\[TPO\\], romiplostim, eltrombopag), or erythropoiesis-stimulating agents (e.g., erythropoietin \\[EPO\\]) within 14 days prior to screening.\n   5. History of allogeneic organ or PBSC\u002Fbone marrow transplant.\n   6. Received live viral vaccine within 4 weeks before first dose.\n   7. Prior ≥Grade 3 or treatment-discontinuing irAEs, except for hypothyroidism, type 1 diabetes, or mild skin irAEs (excluding SJS, TEN, or severe dermatitis).\n   8. All AEs from prior anti-tumor therapy have not resolved to baseline or ≤Grade 1 (per NCI CTCAE v5.0). Exceptions: hair loss (any grade) and ≤Grade 2 peripheral neuropathy are allowed; hypothyroidism that are well controlled with hormone replacement therapy or other conditions eligible per inclusion\u002Fexclusion criteria may be enrolled. Other ≤Grade 2 AEs may be allowed if deemed acceptable by the investigator and inclusion should be discussed with the sponsor's medical monitor.\n3. Past medical history and surgical history:\n\n   1. Malignant tumors of the blood system (such as acute lymphocytic leukemia, acute myeloid leukemia, myelodysplastic syndrome, chronic lymphocytic leukemia, chronic myeloid leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, and multiple myeloma).\n   2. Subjects with active central nervous system (CNS) metastatic lesions or meningeal metastasis. Exception: Asymptomatic subjects with CNS metastatic tumors if the clinical condition is controlled.\n   3. Subjects who had other malignant tumors within 2 years before screening. Subjects with curable local tumors (such as basal or squamous cell skin cancer, cervical or breast carcinoma in situ), can be included after clear cure.\n   4. Have active autoimmune diseases or a history of autoimmune diseases requiring systemic steroids or immunosuppressants, such as rheumatoid arthritis, lupus, Wegener's granulomatosis, Sjogren's syndrome, IBD, multiple sclerosis, myasthenia gravis, myositis, autoimmune hepatitis, vasculitis, immune thrombocytopenia, autoimmune hemolytic anemia, or glomerulonephritis.\n\n      Exception: subjects with well-controlled endocrine disorders treated with HRT (e.g., hypothyroidism, type 1 diabetes).\n   5. Subjects had any of the following pulmonary toxic reactions\u002Fdiseases in the past:\n\n      Significantly clinically significant severe pulmonary-specific diseases, including but not limited to: pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), history of drug-induced pneumonia.\n\n      Active interstitial lung disease (ILD) or interstitial pneumonia; history of requiring hormone or other immunosuppressant treatment for ILD or (non-infectious) pneumonia.\n\n      Found by history or CT examination that there was active tuberculosis infection within 1 year before enrollment or more than 1 year ago with no regular treatment.\n   6. Judged by the investigator to have uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion.\n   7. Have a significant clinical history of cardiovascular diseases.\n   8. Underwent major surgery within 4 weeks prior to signing the informed consent form.\n4. Infectious Disease History:\n\n   1. Severe infections within 4 weeks before first dose.\n   2. Any history of confirmed active HBV, HCV, HIV, or active tuberculosis infection\n5. Other Conditions.\n\n   1. Pregnant or breastfeeding women.\n   2. Known, documented, or suspected substance abuse. Exceptions: Prescribed opioids for pain control or other investigator-approved, medically justified cases (pending sponsor medical lead agreement).\n   3. Any other conditions deemed by the investigator to render the subject unsuitable for participation.","ALL","18 Years","80 Years",{"count":20,"type":21},130,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is an open-label, multicenter, Phase Ib\u002FII clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of FL115 in combination with the anti-PD-1 monoclonal antibody, in participants with advanced solid tumors. All enrolled participants will receive FL115 and Sintilimab via intravenous (IV) infusion. Treatment will continue until disease progression (excluding pseudoprogression), unacceptable toxicity, or other protocol-specified criteria for study or treatment discontinuation, whichever occurs first.\n\nThe study consists of two parts: a dose-escalation phase (Phase Ib) and a cohort-expansion phase (Phase II). The Phase 2 part will explore the preliminary efficacy and safety of the combination therapy in patients with advanced solid tumors across different tumor types.",[28],"Advanced Solid Tumors","RECRUITING","2026-01-06",{"date":32,"type":33},"2026-01-08","ACTUAL",{"date":32,"type":21},{"date":36,"type":21},"2028-12-05",{"name":38,"class":39},"Suzhou Forlong Biotechnology Co., Ltd","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100602354","phase-1-a-study-of-intravesical-fl115-alone-or-in-combination-with-bcg-in-non-muscle-invasive-bladder-cancer-100602354","NCT07122414","A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer","A Phase I\u002FII, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Intravesical FL115 Alone or in Combination With BCG in Subjects With Non-Muscle Invasive Bladder Cancer, Including Dose Escalation and Cohort Expansion","Inclusion Criteria:\n\n1. Male or female subjects aged 18 years or older.\n2. Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).\n3. Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1 disease) or histologically confirmed presence of BCG-unresponsive high-grade Ta or T1 disease.\n4. Absence of resectable disease after transurethral resection (TURBT) procedures (residual carcinoma in situ (CIS) acceptable; patients with T1 tumors must undergo repeat resection and biopsy \\[inclusive of muscularis propria\\] if initial biopsy did not include muscularis propria). Patients with high-grade Ta and\u002For T1 disease should have complete resection before study treatment.\n5. Subjects refuse or are judged by the investigator not suitable for radical cystectomy.\n6. ECOG score 0-2.\n7. Expected survival ≥ 2 years (judged by the investigator).\n8. Adequate organ function.\n9. Voluntary written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations.\n\nExclusion Criteria:\n\n1.Prior Anti-Cancer Treatment History:\n\n1. Have previously received IL-2 or IL-15 agonist therapy, including but not limited to rhIL-15 (NCI), ALT-803 (FL-115), and NKTR-214 (Nektar).\n2. Have previously undergone any of the following NMIBC-related treatments:\n\n   1. Received extensive pelvic radiotherapy (involving \\>30% of bone marrow) within 2 years prior to the first dose.\n   2. Received systemic therapy aimed at treating NMIBC (e.g., radiotherapy, chemotherapy, immunosuppressive therapy) within 4 weeks prior to the first dose.\n   3. Received intravesical instillation aimed at treating NMIBC within 4 weeks prior to the first dose, including intravesical local treatment delivered transurethrally.\n   4. Underwent TURBT or other surgical procedures targeting bladder lesions within 2 weeks prior to the first dose.\n\n   2\\. Prior therapies and recovery from related toxicities：\n\na) Known or suspected allergy to FL115, its excipients, interleukin-based therapies, or fusion proteins (Grade 3-4), or to BCG\u002Fexcipients (for Phase Ib\u002FII).\n\nb) Systemic immunosuppressive therapy within 4 weeks before first dose, except: ≤10 mg\u002Fday prednisone equivalent, local\u002Finhaled\u002Fintranasal steroids, adrenal replacement ≤7.5 mg\u002Fday prednisone, or single-dose prophylaxis for contrast allergy.\n\nc) Prior allogeneic organ or PBSC\u002Fbone marrow transplantation. d) Live virus vaccination within 4 weeks prior to first dose. e) Prior ≥ Grade 3 or treatment-discontinuation irAE due to immunotherapy, except controlled hypothyroidism, type 1 diabetes, or limited skin irAEs.\n\nf) Unresolved AEs from prior anti-tumor therapy that have not returned to baseline or ≤ Grade 1 (per CTCAE v5.0) prior to first dose, except alopecia, ≤ Grade 2 neuropathy, or controlled hypothyroidism. Other ≤ Grade 2 AEs require PI and sponsor medical review.\n\n3.Medical and Surgical History:\n\n1. History or current diagnosis of muscle-invasive (T2-T4), locally advanced (T3\u002FT4, any N), or metastatic bladder cancer.\n2. History or evidence of upper urinary tract (kidney, renal pelvis, ureter) or prostatic urethral tumors.\n3. Known vesicoureteral reflux or evidence of bladder perforation.\n4. Active urinary tract infection.\n5. Discontinuation of prior BCG therapy due to severe adverse events such as sepsis, systemic infection requiring treatment, or urinary incontinence (Phase Ib and II applicable).\n6. Post-TURBT complications that preclude intravesical instillation, per investigator judgment.\n7. Clinically significant polyuria (e.g., 24-hour urine volume \\>4000 mL).\n8. History of other malignancies within 2 years prior to screening that have shown progression or required active treatment.\n9. Active or prior autoimmune disease requiring systemic immunosuppressants or corticosteroids.\n10. History of severe pulmonary toxicity.\n11. History or imaging evidence of active pulmonary TB within 1 year prior to enrollment, or prior TB infection not adequately treated.\n12. Uncontrolled pleural, pericardial, or peritoneal effusion deemed clinically significant by the investigator (e.g., requiring repeated drainage \\>once\u002Fmonth).\n13. History of significant cardiovascular disease.\n14. Major surgery within 4 weeks prior to signing informed consent.\n\n    4.Infectious Disease History\n\na) Severe infections within 4 weeks before first dose. b) Any history of confirmed active HBV, HCV, HIV, or active tuberculosis infection.\n\n5.Other Conditions\n\n1. Pregnant or breastfeeding women.\n2. Known, documented, or suspected substance abuse. Exceptions: Prescribed opioids for pain control or other investigator-approved, medically justified cases (pending sponsor medical lead agreement).\n3. Any other conditions deemed by the investigator to render the subject unsuitable for participation.",{"count":49,"type":21},80,[24,25],"The study is to evaluate the safety and tolerability of intravesical FL115 alone or in combination with BCG in the patients with NMIBC, and to determine the RP2D of FL115 in combination with BCG.\n\nTo evaluate the preliminary efficacy of FL115 alone or in combination with BCG in the treatment of NMIBC.\n\nThe study consists of three parts: FL115 monotherapy dose escalation (Phase Ia), FL115 combined with BCG dose escalation (Phase Ib), and FL115 combined with BCG cohort expansion (Phase II).\n\nEach subject will receive FL115 alone or in combination with intravesical BCG, administered over three treatment periods: induction, enhanced induction\u002Fmaintenance 1, and maintenance 2.",[53],"Non-muscle Invasive Bladder Cancer (NMIBC)","2025-08-12",{"date":56,"type":33},"2025-08-14",{"date":58,"type":33},"2024-08-16",{"date":60,"type":21},"2028-10-10",{"name":38,"class":39},12,""]