[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Telix Pharmaceuticals (Innovations) Pty Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":314},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,61,96,138,176,198,237,268,290],{"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":27,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100556073","phase-3-the-study-of-177lu-tlx591-plus-soc-versus-soc-alone-in-patients-with-mcrpc-prostact-global-100556073",false,"NCT06520345","The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)","A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination With Standard of Care Versus Standard of Care Alone in Patients With PSMA Positive Metastatic Castration-Resistant Prostate Cancer Previously After Androgen Receptor Pathway Inhibitor Treatment","Inclusion Criteria:\n\n* Be a male, at least 18 years old, with documented adenocarcinoma of the prostate defined by histological \u002F pathological confirmation.\n* Be of ECOG Performance Status 0, 1, or 2 and have an estimated life expectancy of ≥6 months from Day 1.\n* Have metastatic disease (defined as ≥1 metastatic lesion present on baseline CT, MRI or bone scintigraphy).\n* Have castration-resistant PC (defined as disease progressing despite castration by orchiectomy or ongoing use of luteinizing hormone-releasing hormone \\[LHRH\\] analogues) and must have a castrate level of serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL) at Screening\n* Must have received a minimum of 12 weeks of prior therapy on an ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide), received in either the mCSPC, nmCRPC, or mCRPC treatment settings, with documented evidence of disease progression while receiving this ARPI. Progression must have occurred on the most recent ARPI. A prior ARPI may have been utilized, but no progression on the prior ARPI is allowed (e,g, ARPI was switched due to poor tolerability or due to adverse events). No washout period is required prior to enrollment into this trial. Participants may have received docetaxel in the mCSPC setting as per the CHAARTED or STAMPEDE treatment regimens (up to 6 cycles of docetaxel), provided the last dose of docetaxel was ≥ 6 months prior to screening and ≥ 4 cycles of docetaxel were administered.\n* Have a disease that is progressing at study entry, despite a castrate testosterone level (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL), by the demonstration of at least one of the following:\n* Two consecutive rising PSA values assessed sequentially at least one week apart, with the final measurement required to be a minimum of 2.0 ng\u002FmL for study entry. Only the last measurement must meet or exceed 2.0 ng\u002FmL.\n* Progressive disease or new lesion(s) in the viscera or lymph nodes as per RECIST1.1 or in bone as per PCWG3. Any ambiguous results are to be confirmed by other imaging modalities (e.g., CT or MRI scan).\n* Have disease that is PSMA-positive, as demonstrated by a 68Ga-PSMA-11 PET\u002FCT or PET\u002FMRI scan and confirmed as eligible by the Sponsor's appointed BICR.\n\nImaging-based eligibility review will be performed in two stages:\n\n1. Presence of metastases for exclusion: Screening CT and MRI will be assessed to exclude participants with brain metastasis with long-axis\\>1cm\n2. PSMA PET eligibility: Screening 68Ga-PSMA-11 PET\u002FCT or PET\u002FMRI will be assessed along with CT, MRI, and bone scans utilizing tumor to liver ratio (TLR) for PSMA positivity-based exclusion. TLR is defined as the ratio of tumor lesion SUVmax to liver SUVmean derived from a 3 cm 3D spherical region of interest (ROI).\n\nPSMA positivity is defined as : At least 1 lesion with PSMA TLR≥2.\n\nPSMA exclusion critieria: The presence of any of the following will result in the patient being ineligible for this trial:\n\ni) visceral metastatic lesions that are ≥1 cm that have a PSMA TLR\\\u003C 1 ii) Lytic bone metastatic lesions with a soft tissue component of at least 1 cm with a TLF \\\u003C1.\n\niii) At least one metastatic lymph node lesion with short axis ≥2.5 cm with a TLF\\\u003C1.\n\n* Must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e., surgery, local radiotherapy, ARPI, chemotherapy, etc.) with the exception of alopecia. Specific conditions may be discussed with the medical monitor as needed.\n* Have adequate organ function at Screening:\n\nBone marrow:\n\n* Platelets ≥150×109\u002FL.\n* Absolute neutrophil count ≥1.5 x 109\u002FL.\n* Hemoglobin \\>10g\u002FdL (with no red blood cell transfusion in the previous 4 weeks).\n\nLiver function:\n\n* Total bilirubin ≤ 1.5× the upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3× ULN is permitted.\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3× ULN.\n\nRenal function:\n\n* Creatinine clearance ≥45 mL\u002Fmin determined using the Cockcroft-Gault formula.\n* Must understand the study and agree to adhere to all protocol requirements.\n* Participants must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution to protect their contacts and the public, especially if a female partner of the participant is or could be pregnant.\n* Must agree to practice adequate precautions to prevent pregnancy in a partner and to avoid potential problems associated with radiation exposure to the unborn child (Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1 \\[Clinical Trial Coordination Group {CTCG, 2024}\\]).\n\nExclusion Criteria:\n\n* Is unable to understand or is unwilling to sign a written informed consent document or to follow investigational procedures in the opinion of the Investigator.\n* Has PC associated with pathological findings consistent with small cell or any histology other than adenocarcinoma of the prostate. If there are minor (\\\u003C20%) elements of neuroendocrine histology, this is acceptable.\n* Participants with a history of other malignancies that could significantly impact life expectancy or interfere with disease assessment will be excluded. Exceptions apply to participants with:\n\n  1. Prior malignancy that has been adequately treated and has remained disease-free for at least 3 years (maybe confirmed by a scan, etc.).\n  2. Adequately treated non-melanoma skin cancer.\n  3. Superficial (non-muscle invasive) bladder cancer that is controlled and stable.\n* Has received prior treatment with monoclonal antibody (mAb) J591 or HuJ591 or any other PSMA targeted therapy.\n* Have received chemotherapy in the mCRPC or non-metastatic prostate cancer (nmCRPC) settings (note: prior docetaxel use in the mCSPC setting with CHAATERED or STAMPEDE regimens is permitted if the last dose of therapy was ≥6 months prior to screening and ≥4 cycles of docetaxel were administered).\n* Has known allergies, hypersensitivity, or intolerance to the investigational drug or its excipients.\n* Has received prior systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, or biological therapy) and\u002For radiation therapy within 4 weeks of enrolment (excluding ARPI and\u002For LHRH analogues).\n\nOR are receiving other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.\n\n* Has received prior treatment with radioisotopes, including but not limited to: 89Strontium, 153Samarium, 186Rhenium, 188Rhenium, 223Radium, or hemi-body irradiation within 6 months prior to enrolment.\n* Has received other investigational therapy within 4 weeks of enrolment.\n* Has known brain metastases with long-axis ≥1cm, or liver metastases with long-axis ≥1cm, or lytic bone metastases with long-axis ≥1cm.\n* Has a history of seizure and\u002For stroke within the past 6 months.\n* Has clinical or radiologic findings indicative of impending spinal cord compression or experience symptomatic spinal cord compression.\n* Has evidence of a serious active or sub-clinical infection or angina pectoris (New York Heart Association \\[NYHA\\] Class III or IV), significantly prolonged QT interval or other serious illness(es) involving the cardiac, respiratory, central nervous system, renal, hepatic or hematological organ systems, that might impair the ability to complete this study or could interfere with determination of causality of any adverse effects experienced in this study, or which require treatment that could interact with study treatment, particularly with enzalutamide.\n* Has received treatment with any PARP inhibitors (i.e., Olaparib) or with any platinum based anti-neoplastic drugs.","MALE","18 Years",{"count":19,"type":20},520,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment",[26],"Metastatic Castration-resistant Prostate Cancer",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47],"Radiographic Progression Free Survival","Overall Survival","ARPI","Docetaxel","Prostate Cancer","Radionuclide therapy","TLX591","ProstACT Global","PSMA- targeting agent","mCRPC","177Lu-TLX591","mCSPC","nmCRPC","rosopatamab tetraxetan","Lutetium","177-Lutetium","Objective Response Rate (ORR)","PSA","68Gallium-PSMA-PET","Radio-Labelled Antibody Drug Conjugate (rADC)","RECRUITING","2026-06-16",{"date":51,"type":52},"2026-06-18","ACTUAL",{"date":54,"type":52},"2024-07-26",{"date":56,"type":20},"2030-12",{"name":58,"class":59},"Telix Pharmaceuticals (Innovations) Pty Limited","INDUSTRY",31,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":69,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100608137","phase-1-samarium-optimized-for-long-lasting-analgesia-in-cancerous-end-stage-bone-pain-100608137","NCT07197645","Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain","A Phase 1 Pharmacokinetic, Dosimetry, Safety, and Dose Optimization Study for a Single Dose of TLX090-Tx (153SmDOTMP) to Treat Metastatic Bone Pain","SOLACE","Inclusion Criteria:\n\n* Participants have had disease progression while on anti-cancer treatment, and are not eligible for the treatments, or their lesions are not amenable to palliative EBRT.\n* Participants must have a histologically confirmed diagnosis of malignancy at any time prior to their participation in this clinical trial with multiple metastatic bone lesions with at least 1 metastatic painful osteoblastic tumor that causes a minimum pain score of 4 on the NRS11.\n* Participants must have bone cancer in one or more skeletal locations as identified by a 99mTc-diphosphonate bone scan within 60 days of dosing. At least one lesion must be osteoblastic. If described as osteosclerotic, radiology confirmation that the lesion is osteoblastic is required. Adequate organ function, including:\n* Renal function, defined as a measured creatinine clearance (CrCl) ≥30 mL\u002Fmin as per Cockroft Gault or based on radioisotope glomerular filtration rate (GFR).\n* Hematologic function, defined as a platelet count of \\>100,000 cells\u002Fmm3 and an Absolute neutrophil count (ANC) of \\>1000 cells\u002Fmm3.\n* Hemoglobin ≥8 g\u002FdL.\n* Liver function:\n* Total bilirubin ≤1.5 × the upper limit of normal (ULN).\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 × ULN with participants with known liver metastases.\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 × ULN with participants with Gilbert's Syndrome.\n* Life expectancy of at least 16 weeks from the date of study drug administration (Day 1).\n* Karnofsky performance status \\>60%, assessed during the screening period prior to study drug administration.\n\nExclusion Criteria:\n\n* Participants are pregnant or breastfeeding.\n* Participants who have received maximum tolerable radiation to the spinal cord, have untreated pathologic bone fracture, spinal cord compression, unstable spine, or imminent long bone fracture.\n* Participants with a bone scan pattern showing diffuse, intense skeletal uptake with absent or faint kidney \u002F bladder activity, typically indicating widespread bone metastases or high bone turnover from metabolic or hematologic diseases (Superscan) pattern on Technetium 99-m bone scan scintigraphy - defined as diffusely increased skeletal uptake with absent or markedly reduced renal and soft tissue visualization - are excluded from the study.\n* Participants with impending or suspected or at high risk for spinal cord compression.\n* Participants with neurogenic pain or significant pain associated with soft tissue lesions or other pain that, in the opinion of the Investigator, might interfere with the assessment of pain relief for bone tumors.\n* Participants who require surgery over their trial period that would require pain medication or analgesia.\n* Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.\n* History of unstable angina (defined as angina at rest) or new-onset angina diagnosed within the 3 months prior to screening.\n* History of myocardial infarction within 3 months prior to screening, as determined by medical history \u002F Baseline ECG.\n* Uncontrolled cardiac arrhythmias (≥Grade 3 CTCAE version 5.0) or any history of ≥Grade 3 arrhythmia.\n* Congestive heart failure ≥New York Heart Association Class 2.\n* Clinically significant abnormalities on ECG at screening including corrected QT interval (Fridericia's formula) \\>450 msec for males or 470 msec for females at screening.\n* Inability to complete the needed investigational and standard imaging examinations due to any reason (eg, severe claustrophobia, inability to lie still for the entire imaging time).\n* Presence of any other condition that may increase the risk associated with study participation or interfere with the interpretation of study results, and, in the opinion of the study Investigator, would make the participant inappropriate for entry into the study.\n* Participants with active infections (human immunodeficiency virus, human papillomavirus. Hepatitis A, Hepatitis B, and Hepatitis C).","ALL",{"count":71,"type":20},33,[73],"PHASE1","This is an open label, 2-part early phase study designed to evaluate the safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy of TLX090-Tx in patients with painful bone metastases.",[76,77,78],"Bone Pain","Metastatic Bone Tumor","Bone Metastases in Subjects With Advanced Cancer",[80,81,82,83,84,85,86],"samarium","radioligand","radioisotope","metastatic bone pain palliation","Samarium-153","DOTMP","bone-seeking radiopharmaceutical","2026-05-12",{"date":89,"type":52},"2026-05-14",{"date":91,"type":52},"2025-10-21",{"date":93,"type":20},"2027-07-05",{"name":58,"class":59},6,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":69,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":115,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},"100600687","phase-3-study-of-tlx101-tx-plus-standard-of-care-soc-versus-soc-alone-for-the-treatment-of-patients-with-recurrent-glioblastoma-100600687","NCT07100730","Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma","A Global, Multicenter, Prospective, Controlled, Open-Label Pivotal Study of Iodofalan (131I) Solution for Injection (TLX101-Tx) Plus Lomustine Versus Lomustine Alone in Patients With Radiographically Confirmed Recurrent Glioblastoma at First Recurrence (IPAX BrIGHT [IPAX-3])","IPAX BrIGHT","Inclusion Criteria:\n\n1. Previously confirmed neuropathological diagnosis of glioblastoma, IDH-wildtype according to the WHO 2021 classification.\n2. Radiographic evidence of first recurrence or progressive glioblastoma according to RANO 2.0 criteria after first-line treatment with biopsy or maximal safe resection and standard radiotherapy or chemoradiotherapy having occurred at least 3 months after the end of prior radiotherapy. Prior first-line therapy may include a combination of:\n\n   1. Any systemic antineoplastic treatment other than nitroureas\n   2. Tumor-treating fields\n   3. Conventionally fractionated or abbreviated (minimum 15 fractions) radiotherapy\n3. Increased \\[18F\\]\\]FET PET tracer uptake inside or in the vicinity of tumor. Specifically, amino acid-based molecular imaging using \\[18F\\]FET PET will be evaluated following co-registration with MRI. The allocated physician\u002Freader will assess whether the observed pathologically increased amino acid uptake is located within the tumor or in the vicinity. This determination will serve as a guidance to confirm whether the uptake is tumor-associated. The uptake must be clearly discernible from background activity and measurable per PET RANO 1.0 criteria, as determined by central review.\n4. Tumor debulking for recurrent, progressive disease is allowed. The patient must have post-surgical (4-6 weeks) radiographic evidence for residual tumor according to RANO 2.0 with increased \\[18F\\] FET PET uptake and measurable disease according to PET RANO 1.0.\n5. 18 years or older\n6. Have the capacity to understand the study and be willing to comply with all protocol requirements.\n7. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 or KPS≥70\n8. Patients on stable, not increasing dose of steroids in the previous 7 days can be included in the study\n9. Adequate hematological, liver and renal function at the time of screening.\n10. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of investigational drug product; must not be breast-feeding; and must agree to use a highly effective method of contraception during treatment and for 6 months following last dose of investigational product.\n11. Male patients must agree to use condoms during sex during the treatment period and for 3 months after the last dose of the investigational drug product and must not make semen donations during treatment and for 6 months following last dose of investigational drug product. For male patients with female partners of childbearing potential, females must agree to use a highly effective method of contraception during the treatment period and for 6 months following last dose of investigational drug product.\n\nExclusion Criteria:\n\n1. Prior course with external beam radiation to the brain in the past 3 months. Prior treatment with brachytherapy in the brain.\n2. Treatment with bevacizumab within the prior 6 weeks.\n3. Known contraindication to imaging tracer or any product of contrast media and MRI contraindications including implanted medical devices. Unable to lie still for at least 20 min or the duration of the MRI and PET imaging or the need for general anesthesia as part of the imaging procedure.\n4. History or evidence of delayed-type hypersensitivity-dependent chronic infection (ie, tuberculosis, systemic fungal or parasitic infection).\n5. Radiographic progression based on RANO 2.0 associated with clinical deterioration and life expectancy less than 3 months.\n6. Hemostaseologic conditions, precluding catheterization or invasive procedures.\n7. Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.\n8. Known liver or kidney disease, such as hepatitis, cirrhosis, renal failure.\n9. Severe chronic or active infections (including active tuberculosis, hepatitis B virus, or hepatitis C virus infection) requiring systemic therapy.\n10. Ongoing toxicity \\> Grade 2 NCI-CTCAE (version 5.0) from previous standard or investigational therapies.\n11. Administration of another investigational product within 90 days prior to screening.\n12. Expected non-compliance with longer-term admission at isolated nuclear medicine ward per regional regulations.\n13. Inability to complete the needed investigational and standard imaging examinations due to any reason (ie, severe claustrophobia, inability to lie still for the entire imaging time).\n14. Patients with known phenylketonuria.\n15. Presence of any other condition that may increase the risk associated with study participation or interfere with the interpretation of study results, and, in the opinion of the study investigator, would make the patient inappropriate for entry into the study.",{"count":105,"type":20},50,[23],"This global clinical trial which evaluates the efficacy and safety of TLX101-Tx, an investigational radiopharmaceutical therapy, in combination with lomustine versus lomustine alone in adult patients with first recurrence of glioblastoma. TLX101-Tx delivers targeted radiation to glioblastoma cells. The trial is conducted in two parts: Part 1 assesses safety and radiation dosing; Part 2 is a randomized comparison of the combination therapy against standard care.",[109,110,111,112,113,114],"Neoplastic Disease","Glioblastoma","Glioblastoma (GBM)","Glioblastoma Multiform","Glioblastoma Multiforme, Adult","Glioblastoma Multiforme (GBM) WHO Grade IV",[116,117,118,119,120,121,110,122,123,124,125,126,127,128],"Lomustine","Radiation Therapy","Radiopharmaceuticals","Positron-Emission Tomography","Brain Neoplasms","Glioblastoma Multiforme","GBM","Neoplasm Recurrence, Local","Central Nervous System Neoplasms","Brain cancer","Recurrent brain tumor","Brain tumor recurrence","LAT-1 targeted therapy","2026-04-15",{"date":131,"type":52},"2026-04-16",{"date":133,"type":52},"2025-11-02",{"date":135,"type":20},"2027-11",{"name":58,"class":59},4,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":69,"minAge":17,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":149,"conditions":150,"keywords":157,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},"100608132","phase-3-phase-3-study-to-assess-safety-and-efficacy-of-177lu-tlx250-in-advanced-relapsed-or-recurrent-ccrcc-100608132","NCT07197580","Phase 3 Study to Assess Safety and Efficacy of 177Lu-TLX250 in Advanced Relapsed or Recurrent ccRCC","A Phase 3, Randomized, Multi-Center, Open-Label Study to Compare 177Lu-TLX250 (Lutetium (177Lu) Girentuximab Tetraxetan) With the Investigator's Choice of a Single Agent Therapy in Participants With Carbonic Anhydrase 9 (CAIX) Expressing, Advanced Relapsed or Recurrent Clear Cell Renal Cell Carcinoma (ccRCC)","LUTEON","Inclusion Criteria:\n\n* be aged ≥ 18 years.\n* have provided written informed consent, dated and signed by the participant prior to any study-specific procedure;\n* have relapsed or recurrent, locally advanced, or metastatic RCC with histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer Staging Manual (Edge SB et al., 2017), with or without sarcomatoid features;\n* have received at least 2 and no more than 3 prior lines of systemic therapies for locally advanced or metastatic ccRCC including a PD-1\u002FPD-L1 inhibitor (at least 2 administrations) and a VEGF\u002FVEGFR-targeting agent (including TKI or mAb) in sequence or in combination;\n* have had radiographic disease progression occurring during or after the most recent line of therapy or intolerance to most recent line of therapy;\n* have at least one measurable lesion according to RECIST, version 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions;\n* be CAIX-positive at Screening defined as having at least 1 lesion with a tumor-lesion CAIX ratio of the maximum standardized uptake value (SUVmax) to liver mean standardized uptake value SUVmean) ≥ 1.5 as determined by BICR of 89Zr-TLX250 PET outcomes;\n* have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1;\n* have recovered from the AEs related to prior lines of therapy or returned to baseline with the exception of Grade 2 neurotoxicity. Ongoing, controlled AEs, such as hypothyroidism or hypertension, are permitted;\n* have adequate organ function, defined as:\n* Bone Marrow:\n\n  * leukocytes ≥ 3,000\u002FµL;\n  * absolute neutrophil count ≥ 1500\u002FµL (administration of granulocyte colony stimulating factor is not allowed within 4 weeks prior to the first administration of 177Lu-TLX250;\n  * platelets ≥ 100,000\u002FµL (platelet transfusion is not allowed within 4 weeks prior to the first administration of 177Lu-TLX250); and\n  * hemoglobin ≥ 9g\u002FdL (red blood cell transfusion is not allowed within 2 weeks prior to the first administration of 177Lu-TLX250).\n* Liver Function:\n\n  * total bilirubin ≤ 1.5 × the upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 × ULN is permitted; and\n  * alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5.0 × ULN for participants with liver metastases.\n* Renal Function:\n\n  * creatinine clearance ≥ 40 mL\u002Fmin as measured by Cockroft-Gault formula or directly calculated by 24h urine;\n  * have negative pregnancy test for women of childbearing potential (serum); and\n\nExclusion Criteria:\n\n* have any of the following:\n\n  * visceral metastatic lesions that are ≥ 1 cm that have a CAIX TLR \\\u003C 1;\n  * lytic bone metastatic lesions with a soft tissue component of at least 1 cm with a TLR \\\u003C 1; and\u002For\n  * at least one metastatic lymph node lesion with short axis ≥ 2.5 cm with a TLR \\\u003C1;\n* received prior 177Lu-TLX250 therapy, any other radioligand therapy, or any prior CAIX-targeting therapy;\n* have any known hypersensitivity to compounds of similar chemical or biologic composition to girentuximab, DFO or DOTA linker, zirconium or lutetium, and\u002For any excipient in the study drug or radiographic contrast-agents;\n* has received G-CSF or erythropoietin within 4 weeks prior to laboratory evaluations at Screening;\n* be currently receiving or have received:\n\n  * any radionuclide within 10 half-lives of the radionuclide prior to 89Zr-TLX250 administration;\n  * any type of systemic anticancer therapy within 2 weeks before the first administration of 177Lu-TLX250;\n  * prior radiotherapy within 2 weeks prior to the first administration of 177Lu-TLX250 (must have recovered from all radiation-related toxicities and not currently require steroid treatment); and\u002For\n  * prior palliative radiation (≤2 weeks of radiotherapy) within 1-week of the first administration of 177Lu-TLX250 for non-central nervous system disease; NOTE: If the investigator feels that the patient is continuing to receive some clinical benefit from standard-of-care (SOC) therapy, the patient may continue SOC therapy up until 2 weeks prior to dosing with 177Lu-TLX250.\n* have known brain metastases, unless these have been treated and stabilized for at least 4 weeks prior to the first administration of 177Lu-TLX250; Note: Participants with a history of brain metastases must have either a head CT with contrast-or brain MRI performed at Screening to document stable disease prior to the first administration of 177LuTLX250.\n* Have experienced any major trauma including major surgery (such as abdominal\u002F cardiac\u002Fthoracic surgery) within 3 weeks of administration of the first administration of 177LuTLX250;\n* be pregnant or intend to become pregnant, breastfeed, or conceive a child during the study period and for at least 42 days after last administration of 89Zr-TLX250 or 6 months after last administration of 177Lu-TLX250, depending on which study drug is administered last to the respective participant;\n* Note: Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies (see Appendix 10.4).\n* be planning to breastfeed during the study period and for 28 days after last administration of 89ZrTLX250 or 75 days after last administration of 177Lu-TLX250, depending on which study drug is administered last to the respective participant;\n* have active and uncontrolled infections requiring systemic therapy or other severe concurrent disease, which, in the opinion of the investigator, would place the participant at undue risk or interfere with the study;\n* have a history of concurrent malignancy with a life expectancy of ≤ 2 years or requirement of systemic anti-cancer therapy or requirement of local therapy that would confound study results; however; participants with the following malignancies can be enrolled into the study:\n\n  * basal cell or squamous cell carcinoma of the skin;\n  * carcinoma in situ of the cervix, breast or bladder; and\u002For\n  * incidental histologic finding of prostate cancer;\n* have a serious, non-healing wound, ulcer, or bone fracture;\n* be unable to stay in the scanner bed with the arms resting out of the thoracic and abdominal fields (i.e., arms alongside the body or raised arm position) for the duration of the scan;\n* have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, and\u002For stable Grade 2 sensory neuropathy, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0;\n* have inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, etc.);\n* have a life expectancy shorter than 3 months;\n* have bleeding or thrombotic disorders or subjects at risk for severe hemorrhage;\n* have experienced any clinically significant bleeding, including hemoptysis or tumor bleeding within 2 weeks prior to the first administration of 177Lu-TLX250;\n* has evidence of a serious active or sub-clinical infection or angina pectoris (New York Heart Association \\[NYHA\\] Class III or IV), significantly prolonged QT interval or other serious illness(es) involving the cardiac, respiratory, central nervous system, renal, hepatic or hematological organ systems, that might impair the ability to complete this study or could interfere with determination of causality of any adverse effects experienced in this study, or which require treatment that could interact with study treatment; or\n* have any medical or other condition that in the opinion of the investigator(s) would preclude the subject's participation in a clinical study.",{"count":147,"type":20},40,[23],"Multicenter Phase 3 study of 177Lu-TLX250 in adult participants with CAIX-expressing advanced, relapsed or recurrent clear cell renal cell carcinoma (ccRCC). Part 1 will evaluate two dosing regimens to determine the recommended Phase 3 dose (RP3D). Part 2 will compare 177Lu-TLX250 with investigator's choice of monotherapy aligned with Australian standard-of-care.",[151,152,153,154,155,156],"ccRCC","Renal Cell Carcinoma (Kidney Cancer)","Renal Cell Carcinoma (RCC)","Renal Cell Cancer Metastatic","Renal Cell Cancer, Recurrent","Clear Cell Renal Cell Cancer (ccRCC)",[158,159,160,151,161,162,163,164,165,119,117,118,166],"Carbonic anhydrase 9","Clear Cell Renal Cell Cancer","Kidney Cancer","CA9","CA-9","CAIX","Girentuximab","CA9 target therapy","Targeted Radiation","2026-03-26",{"date":169,"type":52},"2026-04-01",{"date":171,"type":52},"2026-03-25",{"date":173,"type":20},"2029-02-28",{"name":58,"class":59},5,{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":69,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":187,"conditions":188,"keywords":189,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":95},"100473888","phase-1-131i-tlx-101-for-treatment-of-newly-diagnosed-glioblastoma-ipax-2-100473888","NCT05450744","131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)","A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma","IPAX-2","Inclusion Criteria:\n\n1. Understand and voluntarily sign the informed consent form prior to any study related procedure and\u002For assessments being conducted.\n2. Are Male or Female, and aged 18 years or older, at the time of signing the informed consent.\n3. Have histologically confirmed intracranial glioblastoma (per WHO 2021 definition) following surgical resection. Tumours primarily localised in the infratentorial compartment will be excluded.\n4. Have had prior surgery for glioblastoma, but no systemic therapy or radiation therapy for GBM.\n5. Have a Karnofsky Performance Status ≥70.\n6. Plan to begin chemoradiation therapy 3-6 weeks after surgical resection with Stupp regimen.\n7. Have adequate organ function at Screening:\n\n   7.1 Bone marrow: 7.1.1 Leukocytes ≥3,000\u002FmL 7.1.2 Absolute neutrophil count ≥1500\u002FmL 7.1.3 Platelets ≥100,000\u002FmL 7.1.4 Haemoglobin ≥9g\u002FdL 7.2 Liver function: 7.2.1 Total bilirubin ≤1.5×the upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤3×ULN is permitted 7.2.2 Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5×ULN 7.3 Renal function: 7.3.1 Serum\u002Fplasma creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin\n8. Have at least 6 slides without staining or a tissue block (frozen or paraffin-embedded) available from a previous biopsy or surgery (tumour sample previously archived).\n9. Have the capacity to understand the study and be able and willing to comply with all protocol requirements, including compliance with the radiation protection guidelines (including hospital admissions and isolation) that are applied by the treating institution to protect their contacts and the public.\n10. Agree to practice adequate precautions to prevent pregnancy to avoid potential problems associated with radiation exposure to the unborn child.\n11. Females must have a negative pregnancy test at screening and on dosing day, must not be lactating.\n\nExclusion Criteria:\n\n1. Are unable to provide signed informed consent\n2. Have had prior treatment for glioma, excluding surgery.\n3. Are unable to undergo contrast-enhanced MRI.\n4. Intend to be treated with tumor-treating fields prior to progression.\n5. Have a history or evidence of delayed-type hypersensitivity (DTH)-dependent chronic infection (e.g., tuberculosis, systemic fungal or parasitic infection), potentially exacerbating under systemic corticoid therapy.\n6. Have a known history of allergy TMZ, any excipient in the study medication or any other intravenously administered human proteins\u002Fpeptides\u002Fantibodies.\n7. Have haemostaseologic conditions, precluding catheterisation or invasive procedures.\n8. Have had phenylketonuria diagnosis previously\n9. Have any medical condition that in the opinion of the Investigator may interfere with the participant's ability to adhere to the study or may impose a risk to the participant's health.\n10. Major trauma including major surgery (such as abdominal\u002Fcardiac\u002Fthoracic surgery) within 3 weeks of administration of study treatment except surgery on primary tumour.\n11. Pregnant, breastfeeding or planning to get pregnant during the duration of the study.\n12. Requirement of chronic administration of high dose corticosteroids or other immunosuppressant drugs. Limited or occasional use of corticosteroids to treat or prevent acute adverse reactions is not considered an exclusion criterion.\n13. Have presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the participant at undue risk or unable to comply with study requirements. HIV-positive participants may be included in the study if they are on a stable dose of anti-retroviral therapy.\n14. Have concurrent malignancies unless the patient has been disease-free without intervention for at least 2 years.\n15. Have taken growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment.\n16. Have serious, non-healing wound, ulcer, or bone fracture.\n17. Have a requirement of concurrent use of other anti-cancer treatments or agents other than study medication.\n18. Have received any other IMP within 90 days prior to the planned administration of study drug.\n19. Have uncontrolled Hashimoto's or Grave's disease\n20. Have on-going and unresolved Grade ≥ 1 AEs following surgical resection",{"count":185,"type":20},12,[73],"This is an open label, single arm, parallel-group, multicentre, and dose finding study to evaluate the safety of ascending radioactive dose levels of 131I-TLX101 administered intravenously in combination with best standard of care in newly diagnosed GBM patients.",[109,110,121],[110],"2026-01-16",{"date":192,"type":52},"2026-01-21",{"date":194,"type":52},"2023-04-01",{"date":196,"type":20},"2026-06",{"name":58,"class":59},{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":206,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":21,"phases":209,"briefSummary":210,"conditions":211,"keywords":220,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},"100596956","phase-3-psma-pet-combined-with-mri-for-the-detection-of-pca-100596956","NCT07052214","PSMA PET Combined With MRI for the Detection of PCa","A Single Arm, Multicenter, Prospective, Open Label, Longitudinal Phase 3 Study of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) Combined With Magnetic Resonance Imaging (MRI) Compared to Standard of Care (SOC) for the Detection of Prostate Cancer (PCa).","BiPASS","Inclusion Criteria:\n\n1. Male, at least 18 years old.\n2. Have a clinical suspicion of PCa, and will undergo template biopsy, based on either: an initial MRI examination (PI-RADS 3-4) within 3 months (92 days) before enrollment, or no MRI evidence (PI-RADs 1-2) within 3 months (92 days) before enrollment, but a clinician indicated intent to proceed with template biopsy due to non-imaging risk factors.\n\nThese are non-imaging risk factors that would lead a patient to be considered for a template biopsy (including but not exclusive to):\n\n1. Persistently elevated or rising PSA i. PSA ≥ 3.0 ng\u002FmL ii. Rising PSA velocity (e.g., \\>0.35-0.75 ng\u002FmL\u002Fyear over 2-3 years) is also considered suspicious, especially in men with PSA\\\u003C10ng\u002FmL.\n2. High PSA density (PSAD) i. PSA density \\> 0.15 ng\u002FmL\u002Fcm³ is considered high-risk for csPCa. ii. Calculated as PSA (ng\u002FmL) divided by prostate volume (from MRI).\n3. Abnormal digital rectal examination (DRE) i. abnormal findings include:\n\n   1. Nodules\n   2. Induration\n   3. Asymmetry\n   4. Fixation of the prostate ii. An abnormal DRE in any PSA range (including \\\u003C3 ng\u002FmL) increases cancer suspicion.\n\nb) Strong family history of prostate cancer: i. First-degree relative (father or brother) with PCa ii. Any relative diagnosed at \\\u003C65 years of age iii. Multiple affected relatives iv. Known hereditary cancer syndromes (e.g., BReast CAncer gene \\[BRCA\\]1\u002F2, Homeobox protein Hox-B13 \\[HOXB13\\] mutations) c) Other high-risk biomarkers i. 4Kscore: ≥ 7.5-10% risk of high-grade PCa ii. PHI (Prostate Health Index): ≥ 35 suggests elevated risk iii. Prostate Cancer Antigen 3 (PCA3) Score: ≥ 35 considered positive and associated with increased risk of PCa.\n\niv. Any other established biomarker with values in the high-risk range d) Clinical presentation i. Symptoms suggestive of locally advanced disease (e.g., urinary obstruction, bone pain) ii. Prior negative MRI with ongoing clinical concern 3. Prostate biopsy naïve participants. 4. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 per FDA guidelines. 5. Have the capacity to understand the study and be able and willing to comply with all protocol requirements. 6. Provides consent for anatomical template with\u002Fwithout targeted biopsy based on clinical risk, MRI and PSMA PET result. 7. Participants must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution to protect their contacts and the general public, especially if a female partner of the participant is or could be pregnant.\n\n8\\. Must agree to practice adequate precautions to prevent pregnancy in a female partner and to avoid potential problems associated with radiation exposure to the unborn child (Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1, (CTFG \\[Clinical Trial Facilitation Group\\], 2020). Details of contraceptive measures to be taken by male participants and their female partners are described in Appendix 4 of the Protocol.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Has had prior treatment for PCa or prior diagnosis of csPCa.\n2. Obvious metastatic disease on prior conventional imaging.\n3. Previous diagnosis of cancer of any primary origin (excluding basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy).\n4. Active prostate infection, or urinary test results suggestive of an active urinary tract infection, evident on medical history, within 4 weeks of enrollment.\n5. Prior pelvic irradiation\n6. Demonstrate radiographic findings of PI-RADS 5.\n7. Has abnormalities in physical examination and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance; and\u002For is deemed not suitable for participating in this trial in the opinion of the investigator.\n8. Unable to understand or is unwilling to sign a written informed consent document or to follow investigational procedures in the opinion of the investigator.\n9. Is unable to attain or remain in a supine position while a PET\u002FCT scan is being performed or unable to tolerate a PET\u002FCT scan\n10. Unable or unwilling to undergo clinical prostate biopsy, has known allergies, hypersensitivity, or intolerance to the investigational drug\u002Fcomparator or its excipients.\n11. Have prior use of radionuclides with an interval of less than 10 effective half-lives before the administration of 68Ga-PSMA-11.\n12. Is participating or plans to participate in any experimental drug or device trial during the study period that are considered outside of therapeutic SOC. Studies involving modifications of sequencing or timing of therapeutic regimens\u002Finterventions would be deemed eligible to enroll",true,{"count":208,"type":20},204,[23],"This is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).",[212,32,213,214,215,216,217,218,219],"PCA","Prostatic Neoplasm","PSMA PET","Diagnostic Imaging","Elevated PSA","Positron Emission Tomography","Prostate Biopsy","Carcinoma of the Prostate",[221,222,223,224,225,118,226,227],"Molecular Imaging","Biopsy Naive","Magnetic Resonance Imaging","Biopsy","Targeted Biopsy","Cancer Detection","Urologic Oncology","2025-09-03",{"date":230,"type":52},"2025-09-10",{"date":232,"type":52},"2025-08-18",{"date":234,"type":20},"2026-11",{"name":58,"class":59},1,{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":69,"minAge":17,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":21,"phases":246,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":267},"100573756","phase-3-89zr-tlx250-for-petct-imaging-of-ccrcc---zircon-cp-study-100573756","NCT06750419","89Zr-TLX250 for PET\u002FCT Imaging of ccRCC - ZIRCON-CP Study","A Confirmatory, Open-label, Single-arm, Multi-centre Study to Evaluate Safety, Tolerability and Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) to Non-invasively Detect Clear Cell Renal Cell Carcinoma (ccRCC) by Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT) Imaging in Chinese Patients With Indeterminate Renal Masses (ZIRCON-CP Study)","Inclusion Criteria:\n\n1. Written and voluntarily given informed consent.\n2. Mainland Chinese male or female, aged ≥ 18 years.\n3. Imaging evidence of a single IRM of ≤ 7 cm in largest diameter (tumour stage cT1), on SoC imaging based on national standards, not older than 90 days on Day 0, but performed before any screening procedure.\n4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned IV 89Zr-TLX250 administration.\n5. Negative serum pregnancy tests in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.\n6. Sufficient life expectancy to justify nephrectomy.\n7. Consent to practise highly effective contraception until a minimum of 42 days after IV 89Zr-TLX250 administration.\n\nExclusion Criteria:\n\n1. A biopsy procedure only (rather than partial or total nephrectomy) is planned for histological species delineation of IRM.\n2. Renal mass known to be a metastasis of another primary tumour.\n3. Active non-renal malignancy requiring therapy during the time frame of the study participation.\n4. Multiple unilateral or bilateral IRM.\n5. Chemotherapy, radiotherapy, targeted therapy or immunotherapy within 4 weeks prior to the planned administration of 89Zr -TLX250 or continuing adverse effects (\\> grade 1) from such therapy (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0).\n6. Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).\n7. Exposure to murine or chimeric antibodies within the last 5 years.\n8. Previous administration of any radionuclide within 10 half-lives of the same.\n9. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the study subject, as judged by the investigator.\n10. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.\n11. Exposure to any experimental diagnostic or therapeutic drug within 4 weeks or 5 half-lives (whichever is longer) from the date of planned administration of 89Zr-TLX250.\n12. Women who are pregnant or breastfeeding.\n13. Known hypersensitivity to girentuximab or desferoxamine (DFO).\n14. Renal insufficiency with glomerular filtration rate (GFR) ≤ 45 mL\u002Fmin\u002F1.73 m².\n15. Vulnerable patients (e.g., being in detention).",{"count":245,"type":20},82,[23],"89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma, and this Phase 3 bridging study in mainland Chinese patients is intended to support the successful ZIRCON data (ZIRCON Clinicaltrial.gov ID: NCT03849118)",[249],"Clear Cell Renal Cell Carcinoma",[251,252,253,254,255,256,257,258],"89Zr-DFO-girentuximab","89Zr-girentuximab","89Zr-DFO-TFP-GTX","Clear Cell Renal Cell Carcinoma (ccRCC)","Indeterminate Renal Mass (IRM)","ZIRCON-CP study","89Zirconium-labelled girentuximab","89Zr-TLX250","2024-12-19",{"date":261,"type":52},"2024-12-27",{"date":263,"type":52},"2024-11-06",{"date":265,"type":20},"2026-06-30",{"name":58,"class":59},8,{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":21,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":267},"100504364","phase-3-68ga-psma-11-efficacy-in-detecting-bcr-prostate-cancer-in-chinese-patients-100504364","NCT05847348","68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients","A Prospective, Open-Label, Single-Arm, Multi-center Study to Evaluate the Diagnostic Efficacy and Safety of 68Ga-PSMA-11 PET\u002FCT or PET\u002FMRI in Patients With Biochemical Recurrent Prostate Cancer","Inclusion Criteria:\n\n1. Are able to understand and provide written informed consent document.\n2. Are Chinese males aged ≥ 18 years.\n3. Have histopathologically confirmed prostate adenocarcinoma and have undergone radical prostatectomy and\u002For radical radiotherapy and experienced biochemical recurrence (PSA should be measured within 30 days of screening).\n\n   1. Post radical prostatectomy (RP) PSA ≥0.2 ng\u002FmL measured 6 weeks after RP\n   2. Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng\u002FmL rise in PSA;\n4. Have a Karnofsky performance status ≥ 60 (or ECOG\u002FWHO equivalent).\n5. Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration.\n6. Are willing and able to comply with scheduled\n\nExclusion Criteria:\n\n1. Have a prior history of any other malignancy within the last year, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.\n2. Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-11.\n3. Are participating or plan to participate in any drug or device clinical study during the study period.\n4. Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11.\n5. Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.\n6. Have prior history of salivary gland disease or Paget's disease.\n7. Have a history of fracture and anemia within the last year.\n8. Have abnormalities in physical examination, ECG, and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance.\n9. Is deemed not suitable for participating in this trial in the opinion of the investigator.",{"count":276,"type":20},110,[23],"This is a prospective, open-label, single-arm, multicenter bridging study in Chinese patients with prostate cancer. This multicenter study is planned to be conducted in patients with biochemical recurrence (BCR) of elevated PSA after radical prostatectomy or radical radiotherapy. This study investigates how well 68Ga-PSMA-11 PET\u002FCT works in detecting BCR prostate cancer in Chinese patient. 68Ga-PSMA-11, developed by Telix, is a new molecular entity tracer with the trade name Illuccix®, which is approved by FDA for the examination of: 1) patients with suspected metastatic PC who are scheduled for initial treatment; 2) patients with biochemical recurrence of elevated PSA levels after initial radical radiotherapy.",[280,32,281],"Biochemical Recurrence of Malignant Neoplasm of Prostate","BCR Prostate Carcinoma","2024-06-29",{"date":284,"type":52},"2024-07-03",{"date":286,"type":52},"2023-07-19",{"date":288,"type":20},"2026-07-30",{"name":58,"class":59},{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":69,"minAge":17,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":305,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":175},"100505960","phase-1-combination-of-177lu-tlx250-and-peposertib-in-patients-with-carbonic-anhydrase-ix--expressing-solid-tumors-100505960","NCT05868174","Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX -Expressing Solid Tumors","A Phase 1b Dose Escalation\u002FExpansion Study of the Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX (CAIX)-Expressing Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed advanced or metastatic solid tumor that has progressed on or during\u002Fafter recognized standard of care therapies and are not eligible for resection, or patients that are not eligible or not consenting to recognized standard of care therapies.\n* At least one measurable lesion on CT\u002FMRI according to RECIST 1.1 with corresponding 89Zr-TLX250 uptake (i.e., CAIX positive).\n* CAIX positivity in at least 75% of the total lesion volume (defined as 89Zr- TLX250 uptake with intensity significantly greater than normal liver \\[i.e., standardized uptake value \\[SUV\\]max at least 1.5 times SUV of normal liver\\]).\n* ECOG status 0 or 1.\n* Have adequate organ function during screening\n* Must have a life expectancy of at least 6 months.\n\nExclusion Criteria:\n\n* Prior 177Lu-TLX250 or other radioligand therapy; or any prior CAIX targeting therapy.\n* Known hypersensitivity to compounds of similar chemical or biologic composition to peposertib, girentuximab radiolabelled by zirconium or lutetium, any excipient in the study medication or any other intravenously administered human proteins\u002Fpeptides\u002Fantibodies.\n* Administration of any radionuclide within 10 half-lives of the radionuclide prior to signature of the ICF.\n* Patients who have had chemotherapy, definitive radiation, biological cancer therapy, or investigational agent\u002Fdevice within 28 days of first planned dose of study therapy.\n* Patients who had \\> 2 prior lines of cytotoxic chemotherapy or had Grade 4 neutropenia or Grade 3\u002FGrade 4 thrombocytopenia (both of a duration of at least 48 hours) during the last line of therapy. Note: This criterion may be removed in total or in part by the SRC upon review of the safety data from the initial dose level(s).\n* Patients who cannot discontinue concomitant medications or herbal supplements that are strong inhibitors or strong inducers of cytochrome P450 (CYP) isoenzymes CYP3A4\u002F5, CYP2C9, and CYP2C19. Concomitant use of CYP3A4\u002F5 substrates with a narrow therapeutic index are also excluded.\n* Patients who cannot discontinue concomitant H2-blockers or proton-pump inhibitors (PPIs). Patients may confer with the investigator to determine if such medications can be discontinued. These must be discontinued ≥ 5 days prior to study treatment. Patients do not need to discontinue calcium carbonate.\n* Patients who are receiving therapeutic doses of anticoagulation, including but not limited to low-molecular weight heparin in therapeutic dosing or platelet aggregation inhibitors. Note: This criterion may be removed by the SRC upon review of the safety data from the initial dose level(s).\n* Patients with ≥ 5 bone metastases and\u002For bulky (\\> 3cm in diameter) pelvic or femoral tumors, and\u002For metastases\u002Ftumor in the vertebral spine involving \\> 3 vertebrae.\n* Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol, in the opinion of the investigator.\n* Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.\n* Requirement of concurrent use of other anti-cancer treatments or agents other than study medications. Supportive care therapies are permitted.",{"count":298,"type":20},36,[73],"This is an open label, single-arm, multicentre dose escalation (Part 1) and dose expansion (Part 2) study to evaluate different combinations of 3 radioactive dose levels of 177Lu-TLX250 administered intravenously with 3 different doses of peposertib in patients with CAIX-expressing solid tumors.",[302,303,304],"Solid Tumor, Adult","Advanced Solid Tumor","Advanced Renal Cell Carcinoma",[163],"2024-04-29",{"date":308,"type":52},"2024-05-01",{"date":310,"type":52},"2023-05-23",{"date":312,"type":20},"2026-12",{"name":58,"class":59},""]