[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clear-cell-renal-cell-cancer-ccrcc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clear-cell-renal-cell-cancer-ccrcc":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,56,93,124,166,187],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100437528","phase-1-gi-101gi-101a-as-a-single-agent-or-in-combination-with-pembrolizumab-or-lenvatinib-in-advanced-solid-tumors-100437528",false,"NCT04977453","GI-101\u002FGI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors","A Phase 1\u002F2, Open-label, Dose-escalation, Dose-optimization and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101\u002FGI-101A as a Single Agent and in Combination With Pembrolizumab or Lenvatinib in Patients With Advanced or Metastatic Solid Tumors (Keynote B59)","Key Inclusion Criteria:\n\n* Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.\n* Has adequate organ and marrow function as defined in protocol.\n* Measurable disease as per RECIST v1.1.\n* ECOG performance status 0-1.\n* Adverse events related to any prior chemotherapy, radiotherapy, immunotherapy, other prior systemic anti-cancer therapy, or surgery must have resolved to Grade ≤1, except alopecia and Grade 2 peripheral neuropathy.\n* HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection\u002Fdisease as defined in protocol.\n\nKey Exclusion Criteria:\n\n* Has known active CNS metastases and\u002For carcinomatous meningitis.\n* An active second malignancy\n* Has active or a known history of Hepatitis B or known active Hepatitis C virus infection.\n* Has active tuberculosis or has a known history of active tuberculosis\n* Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration.\n* History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years.\n* Previous immunotherapies related to mode of action of GI-101.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive medications within 2 weeks prior to Cycle 1 Day 1.\n* Administration of prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.\n* Radiotherapy within the last 2 weeks before start of study treatment administration, with exception of limited field palliative radiotherapy\n* Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.\n* Known hypersensitivity to any of the components of the drug products and\u002For excipients of GI-101\u002FGI-101A, pembrolizumab or lenvatinib.\n\nOther protocol defined inclusion exclusion criteria may apply. Cancer type and part-specific inclusion criteria are described in the study protocol.","ALL","18 Years",{"count":19,"type":20},317,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101\u002FGI-101A as a single agent or in combination with pembrolizumab or lenvatinib over a range of advanced and\u002For metastatic solid tumors.",[27,28,29,30,31,32],"Advanced Solid Tumor","Metastatic Solid Tumor","Cervical Cancer","Urothelial Carcinoma","Clear Cell Renal Cell Cancer (ccRCC)","Squamous Cell Non Small Cell Lung Cancer",[34,35,36,37,38,39,40,41,42],"GI-101\u002FGI-101A","CD80-IgG4 Fc-IL2 variant","Immunotherapy","IL-2","Interleukin-2","Pembrolizumab","Lenvatinib","CPI-refractory","Immunocytokine","RECRUITING","2026-05-13",{"date":46,"type":47},"2026-05-15","ACTUAL",{"date":49,"type":47},"2021-08-02",{"date":51,"type":20},"2028-06-30",{"name":53,"class":54},"GI Innovation, Inc.","INDUSTRY",12,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100635787","18f-t2-petct-imaging-for-caix-positive-solid-tumors-100635787","NCT07557225","18F-T2 PET\u002FCT Imaging for CAIX Positive Solid Tumors","Evaluation of Diagnostic Value of 18F-T2 PET\u002F CT Imaging for Tumors Likely to Express High Levels of CAIX","Inclusion Criteria:\n\nAll participants must meet the following criteria:\n\n1. Written and voluntarily given Informed Consent.\n2. Male or female ≥18 years of age at time of consent.\n3. Have the capacity to understand the study and be willing and able to comply with all protocol requirements.\n4. Participants with histologically confirmed or suspected tumors of the following types, but not limited to:\n\nClear Cell Renal Cell Cancer; Urothelial Carcinoma; Colorectal Cancer; Cervical Cancer; Ovarian Cancer; Head and Neck Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma; Non Small Cell Lung Cancer; Small Cell Lung Cancer; Breast Cancer; Pancreatic Cancer; Endometrial Cancer; Von Hippel Lindau Disease.\n\nExclusion Criteria:\n\nParticipants will be excluded from participation in the study if one or more of the following criteria are met:\n\n1. Have any 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 participant, as judged by the Investigator.\n2. Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study.\n3. Be a female who is pregnant or breastfeeding.",true,{"count":65,"type":20},200,[67],"NA","The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 18F-T2 in PET\u002FCT imaging in participants with solid tumors. It will also assess the safety, tolerability and radiation dosimetry of 18F-T2.",[31,70,71,29,72,73,74,75,76,77,78,79,80,81],"Urothelial Carcinoma (UC)","Colorectal Cancer","Ovarian Cancer","Head and Neck Cancer","Hepatocellular Carcinoma (HCC)","Cholangiocarcinoma","Non Small Cell Lung Cancer","Small Cell Lung Cancer","Breast Cancer","Pancreatic Cancer","Endometrial Cancer","Von Hippel Lindau Disease","2026-05-12",{"date":84,"type":47},"2026-05-14",{"date":86,"type":47},"2026-04-27",{"date":88,"type":20},"2029-03",{"name":90,"class":91},"Peking University First Hospital","OTHER",1,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":92},"100596296","phase-2-zanzalintinib-for-metastatic-clear-cell-renal-cell-carcinoma-with-bone-metastases-100596296","NCT07043608","Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases","A Phase II Study of Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases in Patients Previously Treated With Immune Checkpoint Inhibitors","ZAMBONI","Inclusion Criteria:\n\n1. Participants must have unresectable advanced or metastatic RCC with a predominant clear cell histologic component .\n2. At least three bone metastases are present and detectable on bone scan, and at least one bone metastasis is NOT planned to be treated with radiation therapy.\n3. Previously treated with 1-3 prior lines of therapy in at least one of the following settings:\n\n   1. Metastatic setting; must have received combination therapy containing either programmed cell death protein 1 (PD-1) inhibitor\u002Fcytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor or PD-1 inhibitor\u002Fvascular endothelial growth factor receptor (VEGFR)-targeting tyrosine kinase inhibitors (TKI).\n   2. Adjuvant setting; must have received pembrolizumab and have had documented progression of disease within 1 year of the first dose of pembrolizumab .\n4. Age ≥18 years.\n5. Has seen a dentist within 90 days prior to enrollment and been cleared to receive bone-strengthening agents.\n6. Availability of a representative formalin fixed, paraffin embedded tumor specimen or fresh frozen tissue specimen that enables the definitive diagnosis of RCC, accompanied by an associated pathology report. If stored specimens are not available, an optional biopsy may be performed and specimens can be collected by surgical resection or biopsy of the primary tumor or biopsy or resection of a metastatic lesion.\n7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n8. Demonstrates adequate organ function as defined below within 14 days prior to first study treatment:\n\n   1. Absolute neutrophil count (ANC) \\>=1,500\u002F μL (without granulocyte colony stimulating factor support within 2 weeks prior to Cycle 1, Day 1).\n   2. Platelets ≥100,000\u002F μL (without transfusion within 2 weeks prior to Cycle 1, Day 1).\n   3. White Blood Cell count (WBC) counts ≥ 2500\u002FμL.\n   4. Lymphocyte count ≥ 500\u002FμL.\n   5. Hemoglobin ≥9.0 g\u002FdL.\n\n      Participants may be transfused or receive erythropoietic treatment to meet this criterion:\n   6. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN). Participants with known Gilbert disease who have serum bilirubin level \\\u003C= 3 x ULN may be enrolled.\n   7. Aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) ≤2.5 X institutional upper limit of normal.\n   8. Alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase (SGPT) ≤2.5 X institutional upper limit of normal.\n   9. Alkaline phosphatase ≤2.5 X institutional upper limit of normal. For participants with documented liver metastases: AST and\u002For ALT ≤ 5 x ULN. For participants with documented liver or bone metastases: alkaline phosphatase ≤ 5 x ULN.\n   10. Creatinine ≤ 1.5 x within institutional upper limit of normal OR creatinine clearance ≥ 40 mL\u002Fmin by institutional standard AND urine protein-creatinine ratio (UPCR) 1mg\u002Fmg.\n   11. International Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. This applies only to participants who are not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose.\n   12. Serum ionized calcium above lower limit of normal and ≤ 1.5 x ULN.\n9. If any Grade ≥1 toxicities occurred in relation to prior treatment, patients must have recovered to baseline or ≤ Grade 1 unless adverse events are clinically insignificant or stable on supportive medication if needed.\n10. Ability to understand and the willingness to sign a written informed consent document.\n11. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n12. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n13. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n14. Sexually active fertile subjects and their partners must agree to use highly effective method of contraception (defined in Appendix 4) during the course of the study and for the following durations after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.\n\n    a. Through 186 days after the last dose of zanzalintinib for women of childbearing potential (WOCBP) or through 96 days after the last dose of zanzalintinib for men.\n15. Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating hormone (FSH) level \\> 40 milli-international units per millilitre (mIU\u002FmL) to confirm menopause). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff. Exception: women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and\u002For uterus).\n\nExclusion Criteria:\n\n1. Prior treatment with zanzalintinib for RCC.\n2. Receipt of any small molecule kinase inhibitor (including investigational) or vascular endothelial growth factor (VEGF)-targeted therapy within 2 weeks before the first dose of study treatment.\n3. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed.\n4. Participants requiring whole brain radiotherapy (WBRT).\n5. Incomplete healing from prior radiotherapy as determined by the treating radiation oncologist or treating investigator.\n6. Participation in an experimental drug study within 28 days of study enrollment.\n7. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.\n8. Pregnant and lactating women are excluded from this study because zanzalintinib is an investigational product with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with zanzalintinib, breastfeeding should be discontinued if the mother is treated with zanzalintinib.\n9. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Cycle 1, Day 1.\n10. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation); Clinically significant hematuria, hematemesis, or hemoptysis of \\>0.5 tsp (2.5ml) of red blood or other history of significant bleeding within 12 weeks before first dose of study treatment.\n11. Clinical signs or symptoms of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding.\n12. Evidence of abdominal free air not explained by paracentesis or recent surgical procedure.\n13. Concomitant anticoagulation with coumarin agents, direct thrombin inhibitors, factor Xa inhibitor betrixaban, or platelet inhibitors. Other anticoagulants are allowed.\n\n    1. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n    2. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\n    i. Participants who have known brain metastases and who require therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban are not eligible for this study.\n\n    ii. Participants with known brain metastases and who are taking prophylactic low-dose aspirin for cardioprotection or low-dose (prophylactic-dose) low molecular weight heparin are eligible.\n\n    Note: Subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.\n14. Previously identified allergy or hypersensitivity to components of the treatment.\n15. Malignancy that requires anti-cancer directed therapy within the last 3 years. Exceptions include those cancers that are considered cured by local therapy (e.g. Basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of breast, bladder, or cervix) or other cancers that have low malignant potential and do not require systemic therapy (e.g. Gleason grade \\\u003C6 prostate adenocarcinoma).\n16. Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.\n17. Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n18. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed.\n19. Any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n20. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n    1. Congestive heart failure New York Heart Association Class 3 or 4, class 2 or higher, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes).\n    2. Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n    3. Stroke (including transient ischemic attack (TIA)), myocardial infarction, or other clinically significant arterial thrombotic and\u002For ischemic event within 6 months before first dose of study treatment.\n    4. Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment.\n\n       Note: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\n       Note: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator.\n    5. Prior history of myocarditis.\n    6. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n    i. Tumors invading the GI-tract from external viscera. ii. Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis.\n\n    iii. Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic.\n\n    iv. Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n\n    v. Known gastric or esophageal varices. vi. Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks.\n21. Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment.\n22. Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).\n23. Lesions invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. Note: Subjects with intravascular tumor extension (e.g., tumor thrombus in renal vein or inferior V. cava) may be eligible following Principal Investigator approval.\n24. Other clinically significant disorders that would preclude safe study participation.\n\n    1. Active infection requiring systemic treatment. Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.\n    2. Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness except for subjects meeting all of the following criteria: (1) on stable anti-retroviral therapy; (2) Cluster of differentiation 4 positive (CD4+) T cell count ≥ 200\u002FµL; and (3) an undetectable viral load. Note: HIV testing will be performed at screening if and as required by local regulation. Note: To be eligible, participants taking Cytochrome P450, family (CYP) inhibitors (e.g., zidovudine, ritonavir, cobicistat, didanosine) or Cytochrome P450, family 3 (CYP3) inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose. Note: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider.\n    3. Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n\n    i. Complete healing of intra-abdominal abscess must be confirmed before the first dose of study treatment d. Malabsorption syndrome. e. Pharmacologically uncompensated, symptomatic hypothyroidism. f. Moderate to severe hepatic impairment (Child-Pugh B or C). g. Requirement for hemodialysis or peritoneal dialysis. h. History of solid organ or allogeneic stem cell transplant.\n25. Major surgery (as defined in Section 6.6.2.3; e.g., GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to first dose of study treatment. Prior laparoscopic surgeries (i.e. nephrectomy) within 4 weeks prior to first dose of study treatment. Minor surgery (e.g., simple excision, tooth extraction) within 5 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment.\n\n    Note: Fresh tumor biopsies should be performed at least 5 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n26. Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment.\n\n    Note: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility.\n27. History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.\n28. Patients who are ineligible for CT contrast AND who are unable to undergo MRI for any reason.\n29. Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.\n30. Other conditions, which in the opinion of the Investigator, would compromise the safety of the participant or the participant's ability to complete the study.",{"count":102,"type":20},20,[24],"This is a single-institution, phase 2 trial of zanzalintinib plus investigator-choice bone-strengthening agent in patients with metastatic renal cell carcinoma (RCC) with bone metastases whose disease has advanced on 1-3 prior lines of therapy, including at least one immune oncology-based (IO) therapy in the adjuvant or first-line metastatic setting.",[31,106,107,108,109,110,111,112,113,114],"Clear Cell Renal Carcinoma","Clear Cell Renal Cell Carcinoma Metastatic","Clear Cell Renal Cancer","Bone Metastases of a Malignant Tumor","Clear Cell Renal Cell Carcinoma","Bone, Metastatic Cancer","Metastatic Cancer","Metastatic Renal Cell Carcinoma","Metastases to Bone","NOT_YET_RECRUITING",{"date":117,"type":47},"2026-05-01",{"date":119,"type":20},"2026-05-30",{"date":121,"type":20},"2030-02-28",{"name":123,"class":91},"Kelly Fitzgerald, MD",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":136,"conditions":137,"keywords":143,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"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":133,"type":20},40,[135],"PHASE3","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.",[138,139,140,141,142,31],"ccRCC","Renal Cell Carcinoma (Kidney Cancer)","Renal Cell Carcinoma (RCC)","Renal Cell Cancer Metastatic","Renal Cell Cancer, Recurrent",[144,145,146,138,147,148,149,150,151,152,153,154,155],"Carbonic anhydrase 9","Clear Cell Renal Cell Cancer","Kidney Cancer","CA9","CA-9","CAIX","Girentuximab","CA9 target therapy","Positron-Emission Tomography","Radiation Therapy","Radiopharmaceuticals","Targeted Radiation","2026-03-26",{"date":158,"type":47},"2026-04-01",{"date":160,"type":47},"2026-03-25",{"date":162,"type":20},"2029-02-28",{"name":164,"class":54},"Telix Pharmaceuticals (Innovations) Pty Limited",5,{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":183,"leadSponsor":185,"locationsCount":4},"100612641","phase-2-a-clinical-trial-of-envafolimab-combined-with-lenvatinib-for-kidney-cancer-with-liver-spread-100612641","NCT07256223","A Clinical Trial of Envafolimab Combined With Lenvatinib for Kidney Cancer With Liver Spread","A Single-Arm, Multicenter, Prospective Clinical Study of Envafolimab Combined With Lenvatinib as First-Line Therapy in Renal Cell Carcinoma Patients With Liver Metastases","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for enrollment in the study:\n\nProvide written informed consent prior to any study-specific procedures.\n\nAged between 18 and 75 years, inclusive.\n\nHistologically confirmed clear cell renal cell carcinoma with radiologically documented liver metastases, and having received no prior systemic antitumor therapy.\n\nPresence of at least one measurable liver metastasis lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (with the longest diameter ≥ 10 mm on computed tomography scan for non-lymph node lesions).\n\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\nLife expectancy of ≥ 3 months.\n\nVoluntarily agree to participate in the study with good compliance.\n\nAdequate organ and bone marrow function, defined as follows:\n\nHematological:Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count (PLT) ≥ 70 × 10⁹\u002FL; Hemoglobin (HGB) ≥ 90 g\u002FL.\n\nHepatic:Serum total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; Serum albumin ≥ 28 g\u002FL; Alkaline phosphatase (ALP) ≤ 5 × ULN. (Subjects who meet the above criteria after conventional liver-protecting therapy and remain stable for at least one week, as assessed by the investigator, may be enrolled.)\n\nRenal:Serum creatinine (Cr) ≤ 1.5 × ULN, or calculated creatinine clearance ≥ 50 mL\u002Fmin (using the standard Cockcroft-Gault formula).\n\nCoagulation:International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN, and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. (For subjects receiving anticoagulant therapy, enrollment is permitted if the PT and INR are within the therapeutic range intended by the anticoagulant medication.)\n\nExclusion Criteria:\n\nHistory of or concurrent other malignancies, except for appropriately treated carcinoma in situ or non-melanoma skin cancer with evidence of cure.\n\nPrior systemic antitumor therapy for advanced disease (including antiangiogenic agents and immunotherapy), with the exception of palliative radiotherapy or preoperative PD-1 neoadjuvant therapy.\n\nPresence of metastatic lesions meeting any of the following: unifocal organ metastasis numbering more than 3, or total systemic metastatic foci exceeding 5.\n\nKnown history of hypersensitivity to any component of the investigational drug products.\n\nPoorly controlled cardiac symptoms or diseases, including: (1) heart failure of New York Heart Association (NYHA) Class II or higher; (2) unstable angina pectoris; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n\nActive infection, or unexplained fever \\> 38.5°C occurring during the screening period or before the first dose (subjects with fever determined by the investigator to be tumor-related may be enrolled).\n\nAdministration of live vaccines within 4 weeks prior to the first dose of study treatment or anticipated during the study period.\n\nHistory of substance abuse, drug addiction, or chronic alcohol abuse.\n\nAny condition that, in the judgment of the investigator, would preclude participation in the study. This includes severe concomitant conditions (including psychiatric disorders) requiring treatment, significant laboratory abnormalities, or social\u002Ffamilial factors that could compromise subject safety or adherence to protocol requirements, including data and sample collection\n\n.\n\nActive hepatitis B infection.\n\nActive systemic autoimmune diseases.",{"count":174,"type":20},30,[24],"This is an open-label, single-arm, prospective, multicenter clinical study designed to evaluate the efficacy and safety of envafolimab in combination with lenvatinib for the treatment of patients with clear cell renal cell carcinoma (ccRCC) accompanied by liver metastases. The Department of Urology at Fudan University Shanghai Cancer Center serves as the primary research center.",[31,178],"Liver Metastasis","2025-11-20",{"date":181,"type":47},"2025-12-01",{"date":181,"type":20},{"date":184,"type":20},"2028-05-30",{"name":186,"class":91},"Fudan University",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":21,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":212,"locationsCount":214},"100493513","phase-1-a-study-to-assess-safety-tolerability-and-imaging-characteristics-of-68gaga-dpi-4452-and-to-assess-safety-tolerability-and-efficacy-of-177lulu-dpi-4452-in-participants-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100493513","NCT05706129","A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","A Multicenter, Open-Label, Non-Randomized Phase 1\u002F2 Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nPart A, B, and C:\n\n* Written informed consent, dated and signed by the patient prior to any study-specific procedure.\n* Part B and C are not conducted in the United States of America.\n* Has histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors of:\n* Clear cell renal cell cancer (ccRCC) - participants must have received at least one line containing Tyrosine kinase inhibitor (TKI) treatment and at least one line containing immune checkpoint inhibitor treatment in metastatic setting, meaning at least two lines of treatment in metastatic setting.\n* Pancreatic ductal adenocarcinoma (PDAC) - participants must have received at least one line of platinum- and\u002For gemcitabine-based regimen.\n* Colorectal cancer (CRC) - participants must have received at least one line of FOLFIRINOX or FOLFOX\u002FFOLFIRI in two lines in combination with anti-Vascular Endothelial Growth Factor (VEGF) or anti-Epidermal Growth Factor Receptor (EGFR).\n* Participants with CRC or PDAC: availability of fresh biopsy, OR an archival biopsy\u002Fsurgical specimen of the tumor (preferably, taken after last prior line of therapy).\n* For Part B and C only: Urothelial cancer (UC) patients must have received all available standard of care if eligible, including one line of platinum-based chemotherapy, enfortumab vedotin and pembrolizumab.\n* Presence of at least 1 non-irradiated tumor lesion detected at conventional imaging (computed tomography \u002F magnetic resonance imaging (CT\u002FMRI)) documented within 4 weeks prior to the \\[68Ga\\]Ga-DPI-4452 administration.\n* Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nPart D:\n\nParticipants with imaging evidence of a single indeterminate renal mass (IDRM) of ≤ 7 cm in largest diameter (tumor stage cT1) on any conventional diagnostic imaging technique, suspicious for ccRCC and planned for total or partial nephrectomy, or interventional diagnostic (cystoscopy and retrograde pyelography or biopsy) within 90 days from planned \\[68Ga\\]Ga-DPI-4452 administration.\n\nPart E:\n\nRegardless of lines of treatment, participants with histologically or cytologically confirmed progressive, unresectable locally advanced or metastatic solid tumors of\n\n* UC, including MIBC\n* H\\&N cancer\n* TNBC\n* Squamous NSCLC\n* Any other indication with confirmed carbonic anhydrase IX (CA IX) expression excluding ccRCC, PDAC and CRC, upon Sponsor agreement.\n\nPresence of at least 1 non-irradiated tumor lesion detected at conventional imaging (CT\u002FMRI) documented within 4 weeks prior to the \\[68Ga\\]Ga-DPI-4452 administration (for scans dated more than 4 weeks prior to D1, the Sponsor should be contacted to assess conventional imaging suitability)\n\nExclusion Criteria:\n\n* Any major surgery within 12 weeks before enrolment.\n* Inability 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\nPart A:\n\n* Has known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Bladder outflow obstruction or unmanageable urinary incontinence.\n* Participants who 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\\]).\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Previous Carbonic anhydrase (CA) IX-targeting treatment.\n* Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow, as judged by the Investigator.\n\nPart B and Part C:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Bladder outflow obstruction or unmanageable urinary incontinence.\n* Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, active clinically significant cardiac disease, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, or stable Grade 2 sensory neuropathy, according to NCI-CTCAE).\n* Administration of a radiopharmaceutical with therapeutic intent within a period of 6 months prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Any previous CA IX-targeting treatment for non-oncological indication within 3 months prior to the \\[177Lu\\]Lu-DPI-4452 infusion; any previous CA IX-targeting treatment for any oncological indication.\n* Participants who received any systemic antineoplastic therapy for the underlying disease and\u002For other investigational agents within a period which is ≤5 half-lives or ≤4 weeks (whichever is shorter).\n* Inflammatory bowel disease (e.g Crohn's disease, ulcerative colitis, etc).\n\nPart D:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Any previous CA IX-targeting treatment within 3 months prior to the \\[68Ga\\]Ga-DPI-4452 injection.\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Malignant disease, other than that being treated in this study. Exceptions include the following: malignancies that were treated curatively and have not recurred within 2 years prior to screening; treated basal cell or localized squamous skin carcinomas, localized or low grade (e.g., Gleason 3+3 or 3+4 with low prostate specific antigen) prostate cancer, superficial (non-muscle invasive) urothelial cancer, localized thyroid gland microcarcinoma, other in-situ carcinoma, or other malignancy for which participants are not on active antineoplastic therapy.\n* Ongoing treatment with sulfonamides and\u002For coumarin derivatives (e.g., acenocoumarol, warfarin, phenprocoumon) within 2 weeks (or 5 half-lives, whichever is longer) prior to the \\[68Ga\\]Ga-DPI-4452 injection.\n\nPart E:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Any previous CA IX-targeting treatment within 3 months prior to \\[68Ga\\]Ga-DPI-4452 injection.\n* EBRT to more than 25% of the bone marrow, as judged by the Investigator.\n* Malignant disease, other than that being treated in this study. Exceptions include the following: malignancies that were treated curatively and have not recurred within 2 years prior to screening; treated basal cell or localized squamous skin carcinomas, localized or low grade (e.g., Gleason 3+3 or 3+4 with low prostate specific antigen) prostate cancer, superficial (non-muscle invasive) urothelial cancer, localized thyroid gland microcarcinoma, other in-situ carcinoma, or other malignancy for which participants are not on active antineoplastic therapy.\n\nNote: Other inclusion\u002Fexclusion criteria mentioned in the protocol may apply.",{"count":195,"type":20},270,[23,24],"The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of \\[68Ga\\]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC); Part B: is to determine the recommended phase 2 dose (RP2D) \\[maximum tolerated dose (MTD) or lower dose\\] for \\[177Lu\\]Lu-DPI-4452 for each tumor type such as ccRCC, PDAC, CRC, and urothelial carcinoma (UC); Part C: is to evaluate the preliminary antitumor activity of \\[177Lu\\]Lu-DPI-4452 as monotherapy for each tumor type such as ccRCC, PDAC, CRC, and UC; Part D: is to assess the diagnostic concordance between \\[68Ga\\]Ga-DPI-4452 Positron Emission Tomography (PET) and the histopathology result of the Indeterminate Renal Mass (IDRM); Part E: is to assess \\[68Ga\\]Ga-DPI-4452 uptake in each tumour type such as UC, muscle invasive bladder cancer (MIBC), head and neck cancer (H\\&N), triple negative breast cancer (TNBC), squamous non-small cell lung cancer (NSCLC), and any other tumor with locally confirmed carbonic anhydrase (CA) IX expression except ccRCC, CRC and PDAC.",[31,199,200,70,201,202,203,204,205],"Pancreatic Ductal Adenocarcinoma (PDAC)","Colorectal Cancer (CRC)","Indeterminate Renal Mass (IDRM)","Muscle Invasive Bladder Cancer (MIBC)","Head and Neck Cancer (H&N)","Triple Negative Breast Cancer (TNBC)","Squamous Non-Small Cell Lung Cancer (NSCLC)","2025-10-16",{"date":208,"type":47},"2025-10-20",{"date":210,"type":47},"2023-03-14",{"date":88,"type":20},{"name":213,"class":54},"ITM Oncologics GmbH",10]