[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fgfr-gene-alterations\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fgfr-gene-alterations":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100592611","phase-2-efficacy-and-safety-of-tyra-300-in-participants-with-fgfr3-altered-low-grade-intermediate-risk-non-muscle-invasive-bladder-cancer-100592611",false,"NCT06995677","Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer","A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302)","SURF302","Inclusion Criteria:\n\n* Participants age 18 and over of informed consent and willing and able to comply with all requires study procedures\n* Able to understand and given written informed consent\n* Participants with histologically confirmed low-grade NMIBC within 6 weeks prior to randomization with prior diagnostic biopsy\u002FTURBT to confirm stage and grade and with at least 3 mm and no more than 12 mm total (1\u002F2 a resectoscope loop to 2 loops, refer to Section 8.1.5) residual visible tumor as a marker lesion(s) left behind:\n\n  1. Ta low grade\n  2. T1 low grade\n* Participants must have intermediate risk NMIBC, defined as having any of the following characteristics (AUA Guidelines, 2024)\n\n  1. Recurrence within 1 year, LG Ta\n  2. Solitary LG Ta \\>3cm\n  3. LG Ta, multifocal\n  4. LG T1\n* Documented activating FGFR3 mutation or fusion (Appendix 4)\n* Have undergone bladder mapping and identification of visible marker lesion(s) within 6 weeks prior to randomization (refer to Inclusion Criterion #3)\n* No evidence of urothelial carcinoma of the upper urinary tract (confirmed by imaging) or prostatic urethra within 6 months of randomization\n* No prior BCG administration within 1 year of date of consent.\n* No intravesical chemotherapy within 8 weeks prior to C1D1.\n* ECOG 0-1\n* Pathology consistent with pure urothelial carcinoma; if mixed histology, ensure that at least 80% of the sample is urothelial\n* Adequate bone marrow, liver, and renal function:\n\n  b. Bone marrow function: i. Absolute neutrophil count (ANC) \\> or = 1,500\u002Fmm3 ii. Platelet count \\> or = 75,000\u002Fmm3 iii. \u002Fhemoglobin \\> or = 10.0 g\u002FdL e. Liver function: i.Total bilirubin \\\u003C or = ULN ii. Alanine aminotransferase (ALT) \\\u003C or = ULN iii. Aspartate aminotransferase (AST) \\\u003C or = ULN f. Renal function: i. estimated glomerular filtration rate \\>60 mL\u002Fmin calculated using the modification of diet in renal disease equation or CKD-EPI formula ii. Serum Phosphate level \\\u003C or = ULN prior to starting treatment g. Coagulation i. International normalized ratio (INR) \\\u003C or = 1.5 x ULN\n* Ability to swallow tablets\n* Participants (male and female) of child-bearing potential (including females who are post-menopausal for less than 1 year) must be willing to practice effective contraception while on treatment and be willing and able to continue contraception for 3 months (males) and 6 months (females) after the last dose of study treatment. Potential male participants should consider the potential impact of TYRA-300 on their ability to father a child and discuss options with the site study staff.\n* Potential participants who are positive for human immunodeficiency virus (HIV) must have a viral load below the limits of detection and on stable antiretroviral therapy for at least 3 months prior to C1D1. NOTE: some of the compounds in antiretroviral therapy may be on the prohibited medications list. Allowances will be made to ensure the participant's HIV treatment continues uninterrupted following a discussion with the Sponsor's medical monitor. A discussion of the impact of the antiretroviral therapy on TYRA- 300 needs to be discussed with the potential participant prior to C1D1.\n* Potential participants with chronic hepatitis B virus (HBV) infection with active disease should be on a suppressive antiviral therapy prior to C1D1.\n* Potential participants patients with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment and must have a HCV viral load below the limit of quantification.\n* Potential participants with a history of HCV infection and on current treatment must have a HCV viral load below the limit of quantification\n\nExclusion Criteria:\n\n* Presence of tumor in ureter or prostatic urethra:\n* Current or previous history of muscle invasive bladder cancer\n* Current or previous history of lymph node positive and\u002For metastatic bladder cancer\n* Evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder\n* Currently receiving systemic cancer therapy (cytotoxic, immunotherapy, targeted)\n* Currently receiving treatment with a prohibited therapy (refer to Section 6.7.1)\n* Current or prior history of pelvic external beam radiotherapy\n* Current or history of receiving a prior FGFR inhibitor\n* Systemic immunotherapy within 6 months prior to randomization\n* Treatment with an investigational agent within 30 days or 5 half-lives from randomization, whichever is shorter; compounds with an unknown half-life will default to the 30 days.\n* Prior treatment with an intravesical agent within 8 weeks prior to C1D1\n* Current ongoing toxicity from previous therapy\n* Had major surgery within 4 weeks prior to C1D1\n* Any reason that in the view of the investigator, would substantially impair the ability of the participant to comply with study procedures and\u002For risk to the participant (i.e., uncontrolled diabetes)\n* Females who are pregnant, breastfeeding or planning to become pregnant within 6 months after the last dose of TYRA-300 and males who plan to father a child while enrolled in this study or within 3 months after the last dose of TYRA-300\n* Has impaired wound healing capacity\n* Serum phosphate levels above the upper limit of normal during screening\n* Any ocular condition likely to increase the risk of eye toxicity\n* Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination.\n* History of or current uncontrolled cardiovascular disease\n* Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300\n* Known history of HIV infection, or active hepatitis B or C\n* History of a second primary malignancy within 3 years of signing ICF, except for nonmelanoma skin cancer and cured and active surveillance malignancies (i.e., prostate, breast) .\n* Known allergy to TYRA-300 or any excipients of the formulated product\n* Participants taking strong inhibitors and\u002For inducers of CYP3A4 enzyme\n* History of prolonged QT syndrome or baseline heart rate-corrected QT interval using Fridericia formula (QTcF) interval \\>470 ms","ALL","18 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC",[27,28,29,30,31,32],"Low-grade NMIBC","FGFR Gene Amplification","FGFR Gene Alterations","FGFR3 Gene Alteration","FGFR3 Gene Mutation","FGFR3 Gene Fusions",[34,35,36,37,38],"FGFR3 gene alterations","FGFR3 gene mutations","FGFR3 gene fusions","FGFR3","Non-Muscle Invasive Bladder Cancer","RECRUITING","2026-06-26",{"date":42,"type":43},"2026-06-29","ACTUAL",{"date":45,"type":43},"2025-06-27",{"date":47,"type":21},"2028-09",{"name":49,"class":50},"Tyra Biosciences, Inc","INDUSTRY",45,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":75,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":92,"locationsCount":93},"100586467","phase-1-safety-and-preliminary-anti-tumor-activity-of-tyra-430-in-advanced-hepatocellular-carcinoma-and-other-solid-tumors-with-activating-fgffgfr-pathway-aberrations-100586467","NCT06915753","Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF\u002FFGFR Pathway Aberrations","A Multicenter, Open-label, First-in-Human Study of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF\u002FFGFR Pathway Aberrations","SURF431","Key Inclusion Criteria:\n\nAll Patients:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.\n* Adequate end organ function.\n* Ability to swallow oral formulations.\n* Ability to understand and willingness to sign the ICF.\n\nPart A:\n\n* Histologically confirmed locally advanced unresectable\u002Fmetastatic HCC or histologically confirmed advanced solid tumor with documented FGF\u002FFGFR pathway alterations\n* For participants with histologically confirmed locally advanced or metastatic HCC:\n\n  * Barcelona Clinic Liver Cancer (BCLC) stage B that is not eligible for locoregional therapy, or stage C.\n  * Child-Pugh Score class A\n* Must have previously received SOC appropriate for their tumor type. Any number of prior therapies, including FGFR inhibitors, are permitted.\n* Agree to provide archival tumor tissue no older than 2 years from the time of enrollment, if available. If an archived specimen is not available, a biopsy is not required.\n\nPart B, Cohort 1:\n\n* Histologically confirmed locally advanced\u002Fmetastatic HCC who have previously received standard of care.\n* Barcelona Clinic Liver Cancer (BCLC) stage B that is not eligible for locoregional therapy, or stage C.\n* Child-Pugh Score class A\n* Availability of an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen obtained ≤2 years prior to screening for submission to sponsor-designated central laboratory for FGF19 IHC testing.\n* At least 1 measurable lesion by RECIST v1.1.\n\nPart B, Cohort 2:\n\n* Histologically confirmed advanced solid tumor except FGFR3-altered urothelial carcinoma and primary central nervous system tumors who have previously received standard of care. Note: Participants with confirmed diagnosis of locally advanced or metastatic HCC are not eligible for Cohort 2.\n* Must have an eligible activating gain-of-function alteration in the FGFR3 or FGFR4 gene, or focal amplifications of FGF19\n* Archival tumor tissue biopsy specimen no older than 2 years from the time of enrollment, if available. If a tissue biopsy specimen is not available, a biopsy is not required.\n* At least 1 measurable lesion by RECIST v1.1.\n\nKey Exclusion Criteria:\n\nAll Patients:\n\n* Have disease that is suitable for local therapy administered with curative intent.\n* Have not recovered from reversible toxicity of prior anticancer therapy to \\\u003C Grade 1 or baseline (except toxicities that are not clinically significant or not expected to resolve, including but not limited to, alopecia, fatigue, skin discoloration, or Grade 1 neuropathy).\n* Have received the following anticancer therapy:\n\n  1. Any immunotherapy or other antibody therapy within 28 days prior to the first dose of the study drug.\n  2. A TKI \\\u003C 5 days or 5X the terminal Phase elimination half-lives, whichever is longer, prior to the first dose of TYRA-430.\n  3. Other systemic therapy not listed above \\\u003C 14 days prior to the first dose of the study drug.\n* Participant discontinued a prior anti-FGFR therapy due to significant toxicity, defined as hepatotoxicity ≥ Grade 3 or any Grade 4 toxicity according to CTCAE v5.0.\n* Has a serum phosphorus level \\> upper limit of normal (ULN) during screening that remains \\>ULN despite medical management.\n* History of or current uncontrolled cardiovascular disease.\n* Active, symptomatic, or untreated brain metastases.\n* Have a diagnosis of primary CNS malignancies.\n* Gastrointestinal disorders that will affect oral administration or absorption of TYRA-430.\n* Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.\n* Any reason that, in the view of investigator, would substantially impair the ability of the participant to comply with study procedures and increase the risk to the participant.\n\nPart B, Cohort 1:\n\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n* Prior treatment with pan-FGFR inhibitors or FGFR4-selective inhibitors.\n\nPart B, Cohort 2:\n\n* Histologically confirmed locally advanced\u002Fmetastatic HCC.\n* Histologically confirmed urothelial cancer.",{"count":61,"type":21},100,[63],"PHASE1","A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary antitumor activity of TYRA-430 in cancers with FGF\u002FFGFR pathway aberrations, including locally advanced\u002Fmetastatic hepatocellular carcinoma and other advanced solid tumors.",[66,67,68,28,29,30,31,69,70,71,72,73,32,74],"Metastatic Hepatocellular Carcinoma","Solid Tumors","Solid Tumor, Adult","Advanced Solid Tumors","FGFR4 Gene Mutation","FGFR4 Gene Fusions","FGF19 Gene Amplification","FGF19 Gene Overexpression","Locally Advanced Unresectable Hepatocellular Carcinoma",[76,77,78,79,80,34,81,82,83,35,36,84,85],"Hepatocellular Carcinoma","metastatic cancer","solid tumors","FGF19 gene amplifications","FGFR4 gene alterations","FGF19 gene alterations","FGFR4 gene mutations","FGFR4 gene fusions","FGF19 gene overexpression","locally advanced unresectable cancer","2025-11-18",{"date":88,"type":43},"2025-11-20",{"date":90,"type":43},"2025-04-24",{"date":47,"type":21},{"name":49,"class":50},16,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":101,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":123},"100436409","phase-2-ncch2006mk010-trial-fortune-trial-100436409","NCT04962867","NCCH2006\u002FMK010 Trial (FORTUNE Trial)","Multicenter Investigator-initiated Phase II Trial of E7090 in Patients With Advanced or Recurrent Solid Tumor With Fibroblast Growth Factor Receptor (FGFR) Gene Alteration (FORTUNE Trial)","Inclusion Criteria:\n\n1. Participants with histologically or cytologically confirmed metastatic, unresectable, or recurrent solid tumor who agree to provide an archival tumor sample, a residual biopsy sample, or a fresh tumor biopsy sample\n2. Ineffective to or intolerant to initial treatment, or for which standard treatment is no longer available\n3. Participants with an FGFR gene alteration detected by NGS panel, who fall under one of the categories of groups A to C and E defined as below\n\n   Group A: FGFR1-3 fusion\n\n   Group B and E: FGFR1-3 specific activating mutations as below;\n\n   FGFR1: P150S, T340M, R445W, N546K, K656E\n\n   FGFR2: C62Y, A67V, N82K, D101Y, E160K, E163K, M186T, R203H, R210Q, Q212K, R251Q, S252W, P253R, P253L, A264T, W290C, K310R, Y328N, G364E, Y375C, C382R, A389T, V392A, R399Q, H416R, I422V, H544Q, N549H, N549K, N549D, N549S, L560F, K659E, K659N, R664W, E718K, S791T\n\n   FGFR3: G380E, G380R, A391E, K650T, K650E, K650Q, K650N\n\n   Group C: FGFR1-3 activating mutation not applicable to group B, or FGFR1, 2 gene amplification\n4. For Group D, participants with cholangiocarcinoma who have previously received a selective FGFR inhibitor other than E7090 and have demonstrated progressive disease or resistance\n5. Karnofsky Performance Status (KPS) \\>= 70 for patients with primary CNS tumors. Performance Status (ECOG) 0-1 for patients with non-primary CNS tumors\n6. For patients with non-primary CNS tumors, they have at least 1 lesion of \\>= 10 millimeter (mm) in the longest diameter for a non-lymph node or \\>= 15 mm in the short-axis diameter for a lymph node that is considered as serially measurable according to RECIST v1.1 using computerized tomography or magnetic resonance imaging (CT or MRI) within 28 days of enrollment. However, lesions that have received local treatment such as external-beam radiation therapy (EBRT) or radiofrequency ablation (RFA) must have progressed after these local treatment to count as measurable lesion\n7. Participants with primary CNS tumors must meet all of the following criteria:\n\n   1. Have received prior treatment including radiation and\u002For chemotherapy, as recommended or appropriate for the CNS tumor type\n   2. Have \\>= 1 site of bi-dimensionally measurable disease (confirmed by magnetic resonance imaging (MRI) and evaluable by RANO criteria), with the size of at least one of the measurable lesions \\>= 1 cm in each dimension and noted on more than one imaging slice. Imaging study performed within 28 days before enrollment\n   3. Must be neurologically stable based on neurologic exam at least for the last 7 days prior to enrollment. (based on medical examination\u002Finterview)\n8. Corrected calcium \\\u003C= 10.1 mg\u002FdL\n9. Phosphate \\\u003C= 4.6 mg\u002FdL\n10. Required treatment washout period, from the last day of prior treatment until enrollment of this trial, is as follows:\n\n    1. Antibody and other investigational drugs: \\>= 28 days\n    2. Prior chemotherapy (excluding small-molecule targeted therapy), surgical therapy, radiation therapy: \\>= 21 days (\\>= 90 days from the date of the last radiation therapy for primary CNS tumors)\n    3. Endocrine therapy, immunotherapy, small-molecule targeted therapy: \\>=14 days\n\nExclusion Criteria:\n\n1. Participants with brain, subdural or leptomeningeal metastases\n2. Participants with primary CNS tumor located in either cerebellum, brainstem, spinal cord, pituitary gland, optic nerve or olfactory nerve\n3. Positive for either human immunodeficiency virus (HIV) antibody, HBs antigen, or HCV antibody (patients with positive HCV antibody but no detectable HCV-RNA are not excluded)\n4. Negative for HBs antigen, but positive for HBs antibody or HBc antibody, and also positive for HBV-DNA quantification (not excluded if HBV-DNA is below detection sensitivity)\n5. Child-Pugh score B or C\n6. Participants with pericardial effusion, pleural effusion, or ascites requiring treatment\n7. Have any of the following ocular diseases\n\n   1. Grade 2 or higher corneal disorders\n   2. Active retinopathy (e.g., age-related macular degeneration, central serous chorioretinal disease, retinal tear)\n8. Participants whose toxicity of previous treatment has not recovered to Grade 1 or lower per Common Terminology Criteria for Adverse Events (CTCAE v5.0), except for alopecia, infertility, and the laboratory test results listed in the inclusion criteria\n9. Participants who received a prior selective FGFR inhibitor in the recurrent\u002Fmetastatic disease setting; except for patients with cholangiocarcinoma harboring FGFR2 fusion (Group D). Note that prior use of a multi-kinase inhibitor which includes anti-FGFR activity is acceptable after review by the lead investigator\n10. Participants who need the use of drugs that strongly inhibits or induces the metabolizing enzyme cytochrome P450 (CYP) 3A\n11. The presence of FGFR gatekeeper mutations as follows: FGFR1 V561, FGFR2 V564\u002F565, FGFR3 V555\u002F557, FGFR4 V550\n12. The presence of any of the following coexisting driver gene abnormalities:\n\n    1. Genetic mutations (excluding VUS): KRAS, NRAS, EGFR, or BRAF V600\n    2. Gene translocations: ALK, ROS1, or NTRK","20 Years",{"count":103,"type":21},75,[24],"This is a single-arm, open-label, multicenter, investigator-initiated Phase 2 trial to evaluate the efficacy and safety of E7090 in patients with advanced or recurrent solid tumors harboring FGFR genetic alterations (including fusion, mutation, amplification).",[107,29],"Advanced or Recurrent Solid Tumors",[109,110,111,112],"E7090","Solid tumor","Fibroblast Growth Factor Receptor (FGFR)","FGFR inhibitor","2025-09-29",{"date":115,"type":43},"2025-10-03",{"date":117,"type":43},"2021-06-15",{"date":119,"type":21},"2028-03-31",{"name":121,"class":122},"National Cancer Center, Japan","OTHER_GOV",7]