[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable-solid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable-solid-tumor":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,48,74,102,126,160,190,223,248,271,354,379,405,419],{"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":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100633256","phase-1-study-of-rgt-490-in-patients-with-pik3ca-mutated-advanced-solid-tumors-100633256",false,"NCT07524322","Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors","A Phase 1\u002F1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic PIK3CA-Mutated Solid Tumors Including HR+\u002FHER2- Breast Cancers","Inclusion Criteria:\n\n* Adults with metastatic or locally advanced, unresectable solid tumors that have progressed on or after at least one available therapy.\n* Presence of one or more documented activating PIK3CA mutation in tumor tissue and\u002For blood.\n* At least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* An ECOG performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Diabetes mellitus requiring anti-hyperglycemic medication.\n* Prior treatment with PI3Kα inhibitors\n* Symptomatic, untreated, or uncontrolled central nervous system metastases.\n* Receipt of any local or systemic anticancer therapy or investigational anticancer agent within a protocol-defined washout period prior to study treatment.\n* Unresolved clinically significant toxicities from prior anticancer therapy\n* History of a another malignancy within 2 years prior to screening (exception adequately treated cancers).","ALL","18 Years",{"count":19,"type":20},63,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a phase 1\u002F1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer.\n\nParticipants enrolled in the study have advanced disease that is not amendable to curative treatment and whose tumors harbor alterations in the PI3KCA gene.",[26,27,28,29,30,31,32,33,34],"Breast Cancer","Ovarian Cancer","Endometrial Cancer","PIK3CA Mutation","HER2- Negative Breast Cancer","Advanced Breast Cancer","Unresectable Solid Tumor","Hormone Receptor Positive Tumor","Cervical Cancer","RECRUITING","2026-06-30",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":20},"2026-06",{"date":43,"type":20},"2028-10",{"name":45,"class":46},"Regor Pharmaceuticals Inc.","INDUSTRY",5,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100645357","phase-1-first-in-human-trial-of-ds1025a-in-participants-with-advanced-solid-tumors-100645357","NCT07681882","First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors","A Phase 1, Multicenter, Open-label, First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors","To be eligible to participate in this trial, an individual must meet all the following criteria:\n\n1. Sign and date the main ICF, prior to the start of any trial-specific procedures.\n2. Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old).\n3. Histologically documented, advanced, metastatic, or unresectable solid tumors.\n4. Relapsed or refractory disease, following at least 1 line of therapy, not amenable to standard therapy.\n5. Is willing to provide a newly obtained tumor tissue sample at screening, if not clinically contraindicated and at an acceptable risk as determined by the Investigator. If a fresh tumor biopsy is not clinically feasible or would pose unacceptable risk, an archival tumor tissue sample (obtained within 24 months of consent) must be submitted.\n6. Has measurable disease based on local CT\u002FMRI imaging as assessment by the Investigator using RECIST v1.1; radiographic tumor assessment must be performed within 28 days prior to initiation of trial intervention.\n7. ECOG PS of 0 or 1 assessed no more than 28 days prior to initiation of trial intervention.\n8. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention as defined in the protocol.\n9. A WOCBP is eligible to participate if the following conditions are met:\n\n   * Participant is not pregnant as confirmed by highly sensitive pregnancy test\n   * Participant does not plan to breastfeed during the Trial Intervention Period and for at least 8 months after last dose of trial intervention.\n   * Participant agrees to adhere to a contraceptive method that is highly effective with low user dependency only and agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore eggs during the Treatment Period and for at least the time needed to eliminate the trial intervention after the last dose.\n10. A male participant capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate the trial intervention:\n\n    * Avoid donating sperm.\n    * Adhere to approved contraception method as specified in the protocol.\n\nAn individual who meets any of the following criteria will be excluded from participation in this trial:\n\n1. Prior treatment with an anti-CD25 therapy.\n2. Treatment discontinuation history due to toxicity to a DXd-ADC agent and considered not able to tolerate DS1025a based on the discussion between the investigator and the Sponsor (for participants who have DXd-ADC treatment history).\n3. Inadequate washout period before initiation of trial intervention as specified in the protocol.\n4. Has spinal cord compression or clinically active central nervous system tumors, including metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n5. Uncontrolled or significant cardiovascular disease as specified in the protocol.\n6. Any of the following within the past 6 months prior to initiation of trial intervention: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n7. Participants with any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening.\n8. Lung-specific intercurrent clinically significant illnesses as specified in the protocol.\n9. Has clinically significant pulmonary compromise or requirement for supplemental oxygen.\n10. History of other active malignancy within 3 years prior to initiation of trial intervention, with the exception of those with a negligible risk of metastasis or death (eg, 5-year OS rate \\>90%) and treated with expected curative outcome\n11. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v 6.0, Grade ≤1 or baseline.\n12. History of hypersensitivity to any excipients in DS1025a or any known contraindication to treatment with, including hypersensitivity to, the trial intervention.\n13. Has a known history of HLH.\n14. Has a known active infection, or reactivation of latent following infections as specified in the protocol among participants who received treatment such as antivirals, antifungals, or IV antibiotics within 14 days prior to first dose of trial intervention.\n15. Has active or uncontrolled HBV infection.\n16. Has active or uncontrolled HCV infection.\n17. Has active or uncontrolled HIV infection.\n18. Has an active, known, or suspected autoimmune disease.\n19. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\>10 mg daily prednisone equivalents) or any other form of immunosuppressive therapy within 14 days prior to the trial intervention.",{"count":56,"type":20},45,[23],"This clinical trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy signals of DS1025a, given as a single agent to participants with advanced, metastatic, or unresectable solid tumors.",[60,61,32],"Advanced Solid Tumor","Metastatic Solid Tumor",[60,61,32,63],"DS1025a","NOT_YET_RECRUITING","2026-06-26",{"date":38,"type":39},{"date":68,"type":20},"2026-08-03",{"date":70,"type":20},"2029-01-21",{"name":72,"class":46},"Daiichi Sankyo",3,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100642168","phase-1-fortras-a-study-of-msk-tcr5-in-people-with-solid-tumor-cancers-100642168","NCT07638371","FORTRAS: A Study of MSK-TCR5 in People With Solid Tumor Cancers","FORTRAS: Phase I, Investigator Initiated, Dose-escalation Clinical Trial Evaluating a CD8 Alpha\u002FBeta Armored RAS G12D\u002FHLA-A*11:01-specific T-cell Receptor Therapy (MSK-TCR5) in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\nPart A: Prior to cell collection all of the following inclusion criteria must be met:\n\n* Age ≥18 years.\n* Histologically confirmed advanced or metastatic, unresectable solid tumor\n* Positive for RAS G12D mutation and HLA-A\\*11:01 allele\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease after at least 1 line of systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options. Subjects with stable disease (SD), or that present lack of clinical benefit from previous therapy (including treatment suspension due to toxicity) may be considered eligible for enrollment. :\n\n  1. For CRC: Patients harboring genomic aberrations such as BRAFV600E mutations, HER2 amplifications, or VEGF expression for which FDA-approved targeted therapies are available must have received prior treatment with applicable FDA-approved targeted therapies, including multi-kinase inhibitors. Patients whose tumors have deficient mismatch repair (dMMR)\u002Fhigh microsatellite instability (MSI-H) must have received an immune checkpoint inhibitor prior to enrolling in this study.\n  2. For NSCLC: Patients harboring genomic aberrations such as non-resistant EGFR mutations, ALK rearrangement, ROS rearrangement, and BRAF V600E mutation for which FDA-approved targeted therapies are available must have received prior treatment with the applicable FDA-approved targeted therapies. Patients with the appropriate PD-L1 expression score must have received treatment with an FDA-approved checkpoint inhibitor with or without chemotherapy consistent with the FDA-approved label.\n  3. Any other solid tumors, including PDAC: Patients harboring genomic aberrations for which FDA-approved targeted therapies are available must have received prior treatment with the applicable FDA-approved targeted therapies. Patients whose tumors have dMMR\u002FMSI-H must have received an immune checkpoint inhibitor prior to enrolling in this study.\n\nPart B: Prior to treatment with MSK-TCR5 all of the following inclusion criteria must be met:\n\n* Measurable disease per RECIST version 1.1. Note: a previously irradiated or locoregionally treated lesion can be considered a target lesion if it progressed post-treatment.\n* ECOG performance status of 0 or 1\n* Adequate organ and bone marrow function based on the following laboratory values:\n\n  1. ANC ≥1000\u002Fmm3 without granulocyte colony-stimulating factor support (filgrastim within 7 days or peg-filgrastim within 14 days of screening)\n  2. Platelets ≥75,000\u002Fmm3 without transfusion within the preceding 7 days of screening.\n  3. Hemoglobin ≥8.0 g\u002FdL (≥80 g\u002FL); blood transfusion permitted within 7 days of screening.\n  4. AST, ALT, and ALP ≤ 3x ULN, or ≤ 5x ULN if liver or bone metastases present.\n  5. Total bilirubin ≤ 1.5x ULN or ≤ 3x ULN in the presence of documented Gilbert's Syndrome\n  6. CrCl ≥50 mL\u002Fmin by Cockcroft-Gualt equation\n\nExclusion Criteria:\n\nPart A: Participant Exclusion Criteria prior to cell collection\n\n* Previous allogeneic stem cell transplantation or prior organ transplantation\n* History of primary immunodeficiency, autoimmune, or inflammatory disease including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, or Grave's disease that in the past year has required systemic treatment with corticosteroids \\> 10mg\u002Fday of prednisone or equivalent doses of other corticosteroids or immunosuppressive drugs. Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal\u002Fpituitary insufficiency is not considered a form of systemic treatment and allowed)\n* Primary brain tumor\n* Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression. Patients previously treated for CNS metastases that are radiographically and neurologically stable and off steroids for at least 2 weeks prior to enrollment are eligible.\n* Surgery or catheter-based interventions such as transarterial chemoembolization or percutaneous coronary intervention within 2 weeks.\n* Uncontrolled significant intercurrent or recent illness including, but not limited to the following conditions:\n\n  a. Significant cardiovascular abnormalities as defined by any one of the following: uncontrolled congestive heart failure or hypertension, clinically significant hypotension, symptomatic coronary artery disease, or a documented ejection fraction (EF) of \\\u003C 50% as assessed by echocardiogram or multigated acquisition scan (MUGA).\n* Uncontrolled active bacterial, viral, fungal, or mycobacterial infection not responding to antibiotics, antimycotics, or antifungal agents, as well as long-term oral treatment with any of these agents.\n* Subject has had radiotherapy or systemic anti-cancer therapy within at least 2 weeks or 3 half-lives, whichever is shorter.\n* Pregnant or lactating women; women of childbearing age, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while receiving study treatment and for at least 12 months after all treatment is finished. Sexually active males, unless they are willing to use a condom during intercourse while receiving study treatment and for at least 12 months after all treatment is finished.\n* Previously identified allergy, hypersensitivity, or known contraindication to cyclophosphamide, fludarabine, or any other agent associated with LDC or MSK-TCR5.\n* Positive serologic test results for HIV.\n* Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.\n* Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR\n* Patient\u002Fparent\u002FLAR unable to give informed consent\n\nPart B: Participant Exclusion Criteria prior to MSK-TCR5 infusion\n\n* Any exclusion criterion listed in Part A.",{"count":82,"type":20},16,[23],"The purpose of this study is to test the safety of MSK-TCR5 in participants with advance solid tumor cancer that has a KRAS, HRAS, or NRAS G12D mutation.",[86,87,60,32,61],"Solid Tumor","Solid Carcinoma",[86,87,60,32,61,89,90,91],"MSK-TCR5","Memorial Sloan Kettering Cancer Center","26-083","2026-06-11",{"date":94,"type":39},"2026-06-15",{"date":96,"type":39},"2026-06-09",{"date":98,"type":20},"2030-06-09",{"name":90,"class":100},"OTHER",7,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100539344","phase-1-pemigatinib--afatinib-in-advanced-refractory-solid-tumors-100539344","NCT06302621","Pemigatinib + Afatinib in Advanced Refractory Solid Tumors","A Phase Ia\u002FIb Study of the Combination of the FGFR Inhibitor Pemigatinib and the EGFR Inhibitor Afatinib in Advanced Refractory Solid Tumors","Inclusion Criteria:\n\nAll Patients\n\n* Unresectable or metastatic, histologically confirmed advanced solid tumor, where standard curative or palliative measures are no longer effective or are not considered appropriate or safe in the opinion of the investigator.\n* FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions on tumor profiling in tumor tissue as determined by testing routinely performed at a Clinical Laboratory Improvement Amendments (CLIA) or other similarly certified laboratory. If the FGFR alteration is present on circulating tumor DNA (ctDNA) analysis alone, the patient may be eligible with principal investigator approval. Additional mutations may be considered with principal investigator approval.\n* Eastern Cooperative Oncology Group (ECOG) 0-1.\n* At least 18 years of age.\n* Ability to swallow tablets.\n* Life expectancy \\>\u002F=3 months\n* Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation.\n* Patients with cholangiocarcinoma must have adequate biliary drainage (per investigator's discretion), with no evidence of ongoing infection.\n* Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following the last dose of study treatment.\n* Measurable or non-measurable disease as determined by RECIST 1.1.\n* Adequate organ function defined as:\n\n  * ALT or AST ≤ 3 × the ULN in the absence of liver metastases, OR ≤ 5 × ULN with documented liver metastases\n  * Total bilirubin ≤ 2.0 × ULN in the absence of Gilbert's Disease, OR ≤ 3 × ULN with Gilbert's Disease provided direct bilirubin is ≤ ULN\n  * Serum Creatinine ≤ 1.5 × ULN OR calculated creatinine clearance ≥ 60ml\u002Fmin\n  * Hemoglobin ≥ 9 g\u002FdL (≥ 90 g\u002FL)\n  * Absolute Neutrophil Count ≥ 1.5 x 109\u002FL\n  * Platelets ≥ 75 x 109\u002FL\n  * INR or PT, aPTT or PTT ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy\n  * NOTE: Transfusions to increase a patient's hemoglobin level or initiation of erythropoietin or G-CSF therapy to meet enrollment criteria are not allowed in the 14 days preceding the first dose of study drug. If a patient receives transfusions, erythropoietin, or G-CSF therapy ≥ 14 days prior to the first dose, the hematologic criteria listed above must be met following the 14-day window and prior to the first dose of study therapy\n\nDose expansion cohort 1: Patients should fulfill the eligibility criteria above for all patients in addition to the following:\n\n* Histologically or cytologically confirmed diagnosis of advanced or metastatic cholangiocarcinoma\n* No prior treatment with a selective FGFR inhibitor treatment\n* FGFR2 fusion, in-frame rearrangement, or extracellular domain in-frame deletion on tumor profiling in tumor tissue as determined by testing routinely performed on tumor biopsy at a CLIA or other similarly certified laboratory. If the FGFR alteration is present on ctDNA analysis alone, the patient may be eligible with principal investigator approval.\n* An archived tumor tissue sample is available in patients not undergoing fresh tumor biopsy. Patients who do not have adequate archival tumor tissue available are required to undergo a fresh tumor biopsy. If a fresh biopsy cannot be safely performed, the patient may be eligible with principal investigator approval.\n\nDose expansion cohort 2: Patients should fulfill the eligibility criteria above for all patients in addition to the following:\n\n* Histologically or cytologically confirmed diagnosis of advanced or metastatic cholangiocarcinoma\n* Prior FGFR inhibitor treatment at any time prior to treatment start is required\n* FGFR2 fusion, in-frame rearrangement, or extracellular domain in-frame deletion for which they derived clinical benefit (objective response of any duration or stable disease for at least 6 months) from prior FGFR inhibitor therapy, as determined by testing routinely performed on tumor biopsy at a CLIA or other similarly certified laboratory. If the FGFR alteration is present on ctDNA analysis alone, the patient may be eligible with principal investigator approval\n* An archived tumor tissue sample after progression on or intolerance of prior FGFR inhibitor available in patients not undergoing fresh tumor biopsy. Patients who do not have adequate archival tumor tissue available are required to undergo a fresh tumor biopsy. If a fresh biopsy cannot be safely performed, the patient may be eligible with principal investigator approval.\n\nExclusion Criteria:\n\n* Known hypersensitivity to afatinib or pemigatinib or excipients of pemigatinib\n* For patients treated with a prior FGFR inhibitor, those with known activating mutation(s) in the FGFR2 kinase domain on ctDNA or biopsy analysis within 8 weeks of start of study drugs; activating mutations in the FGFR2 kinase domain seen on ctDNA or biopsy analysis prior to the 8-week timepoint may be allowed after discussion with the study PI.\n* Systemic or liver-directed anticancer therapy within 2 weeks; or anticancer monoclonal antibody within 4 weeks prior to planned start of pemigatinib and afatinib.\n* Patient has adverse events from prior therapy that have not resolved to ≤ grade 1; exceptions for non-clinically meaningful adverse events (AEs) can be made with input from the principal investigator.\n* Major surgery within 4 weeks prior to planned start of pemigatinib and afatinib (tumor biopsy, biliary stent or catheter placement, and feeding tube placement are not considered major surgical procedures).\n* Received prior palliative non-CNS radiation within 2 weeks or extended-field radiation administered within 4 weeks of first dose of study drug. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. Fibrotic pulmonary disease from prior radiotherapy is permissible with approval of the study PI.\n* Known pre-existing interstitial lung disease\n* Current hypovitaminosis D requiring supraphysiologic (eg 50,000 IU\u002Fweekly) to replenish the deficiency. Vitamin D supplements are allowed.\n* History and\u002For current evidence of clinically significant ectopic mineralization\u002Fcalcification or non-tumor related alteration of calcium-phosphorus homeostasis.\n* History and\u002For current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmological examination\n* Child-Pugh B and C cirrhosis\n* Chronic nausea, vomiting, or diarrhea considered to be clinically significant in the opinion of the investigator. This includes significant or recent gastrointestinal disorders with diarrhea as a major symptom\n* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.\n* Patients with a history of another primary malignancy that is currently clinically significant, and has potential for metastases or currently requires active intervention (except for gonadotropin-releasing hormone (GnRH) or luteinizing hormone-releasing hormone (LH-RH) agonists in prostate cancer or hormonal therapy in breast cancer\n* Have history of hepatic encephalopathy of any grade\n* Patients with ascites requiring serial paracenteses\n* Active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate provided that they are stable for ≥ 2 months. Patients with suspected or confirmed leptomeningeal disease are not eligible even if treated. Patients with glioblastoma multiforme (GBM) are not eligible.\n* Clinically significant, active cardiovascular disease such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia, or history of myocardial infarction within 6 months prior to planned start of pemigatinib and afatinib\n* Fridericia's corrected QT interval (QTcF) \\> 480 ms on ECG conducted during Screening, or history of torsades de pointes or personal or family history of prolonged QT syndrome.Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.\n* Active uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and the sponsor-investigator makes it undesirable for the patient to participate in the trial. Screening for chronic conditions is not required.\n* Active hepatitis B virus (HBV)\n\n  \\-- Note: Controlled (treated) hepatitis will be allowed if they meet the following criteria: antiviral therapy for HBV must be given for at least 1 month prior to first dose of study drug, and HBV viral load must be less than 2000 IU\u002Fml (104 copies\u002Fml) prior to the first dose of study drug. Those on active HBV therapy with viral loads under 2000 IU\u002Fml (104 copies\u002Fml) should stay on antiviral therapy throughout the study treatment.\n* Known human immunodeficiency virus (HIV) and on anti-retroviral therapy for HIV(excluded due to potential drug-drug interactions between anti-retroviral medications and study treatment but HIV itself is not an exclusion).\n* Known or suspected active drug or alcohol use\n* Concomitant treatment with known strong p-gp inhibitor.\n* Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment.\n\n  \\-- Note: Moderate CYP3A4 inhibitors are not prohibited\n* Pregnancy during the study or within 30 days of the last dose of study intervention. Also excluded are any persons of childbearing potential, including men who are able to father a child, who are unwilling to use a medically acceptable method of contraception during the trial (see below section 3.3). Lactation and breastfeeding during the study or within 30 days of the last dose of study intervention is also not allowed. Female patients must have a negative pregnancy test (B-HCG test in urine or serum) prior to commencing study treatment.\n* Unable to swallow pills\n* Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug. Patients unable or deemed by the investigator as unlikely to comply with the protocol are also excluded.",{"count":110,"type":20},70,[23],"This study is researching whether the combination of Afatinib and Pemigatinib is safe and effective in FGFR altered unresectable or metastatic advanced solid tumors.\n\nThe study is also trying to discover the highest doses of the study drugs that can be administered without causing any intolerable side effects.\n\nThis research study involves the study drugs Afatinib and Pemigatinib.",[60,32,61,114],"Cholangiocarcinoma",[60,32,61,114],"2026-05-12",{"date":118,"type":39},"2026-05-15",{"date":120,"type":39},"2024-04-17",{"date":122,"type":20},"2027-12-01",{"name":124,"class":100},"Massachusetts General Hospital",1,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":138,"conditions":139,"keywords":146,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100534895","phase-1-a-study-evaluating-fmc-376-in-participants-with-kras-g12c-mutated-solid-tumors-100534895","NCT06244771","A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors","An Open-Label, Phase 1\u002F2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants With KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors","PROSPER","Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation\n* Received and progressed or been intolerant to prior standard therapy OR standard therapy is considered inappropriate OR an investigational agent is considered standard of care\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Adequate hematological, renal, and hepatic function\n* Agrees not to participate in another interventional study while receiving study drug\n\nExclusion Criteria:\n\n* Leptomeningeal disease or carcinomatous meningitis\n* Clinically significant toxicity resulting from prior cancer therapies\n* Known or suspected hypersensitivity to FMC-376 or any components of the study drug\n* Condition that would interfere with study drug absorption\n* Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data",{"count":135,"type":20},403,[23,137],"PHASE2","The goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated.",[140,141,32,61,142,143,144,145],"Advanced Solid Tumors With KRAS G12C Mutations","Solid Tumor, Adult","Non Small Cell Lung Cancer","Colorectal Cancer","KRAS G12C","Pancreatic Cancer",[147,148,149],"Lung Cancer","KRAS","G12C","2026-03-16",{"date":152,"type":39},"2026-03-18",{"date":154,"type":39},"2024-02-12",{"date":156,"type":20},"2028-04",{"name":158,"class":46},"Frontier Medicines Corporation",26,{"id":161,"slug":4,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":125},"100503155","NCT05831579","Palliative Spatially Fractionated (GRID) Radiotherapy Using Intensity Modulated Proton Therapy","A Phase I Trial of Palliative Spatially Fractionated (GRID) Radiotherapy Using Intensity Modulated Proton Therapy","Inclusion Criteria:\n\n* Histologically or cytologically confirmed cancer diagnosis.\n* Planning to undergo palliative radiotherapy to unresectable or metastatic target lesion ≥ 4.5 cm in any dimension as measured with radiographic imaging or with calipers by clinical exam.\n\n  * Cohort A: 10 patients with lesions that have been previously irradiated.\n  * Cohort B: 10 patients with lesions that have not been previously irradiated.\n* ECOG performance status ≤ 3\n* At least 18 years of age.\n* Radiotherapy is known to be teratogenic. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 6 months after completion of the study\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* Patients with tumors in need of urgent surgical intervention, such as life-threatening bleeding or those at high risk for pathologic fracture and amenable to surgical intervention.\n* Patients with a superficial target lesion ≤ 1 cm deep to skin surface who initially had a superficial lesion irradiated, if the target lesion was in the area of the prior irradiation.\n* Currently receiving any cytotoxic cancer therapy regimens or VEGF inhibitors that will overlap with the proton GRID administration.\n* Cytotoxic chemotherapy and VEGF inhibitors prior to radiotherapy or planned after radiotherapy delivery are allowed at the discretion of the treating radiation oncologist. This includes continuing a treatment plan which was initiated prior to the start of radiotherapy. A 2-week washout is recommended, but not required.\n* Pregnant. Women of childbearing potential must have a negative pregnancy test within 20 days of study entry.\n* Patients with HIV are eligible unless their CD4+ T-cell counts are \\\u003C 350 cells\u002FmcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.",{"count":167,"type":20},24,[169],"NA","Spatially fractionated radiotherapy (SFRT or GRID) addresses some limitations of traditional stereotactic body radiation therapy by relying on beam collimation to create high-dose \"peaks\" and intervening low-dose \"valleys\" throughout the target volume. Standard palliative radiotherapy regimens provide limited durability of response, and there are challenges with delivery to large tumors or in previously irradiated fields. In this study, Proton GRID radiotherapy will be used to deliver three-fraction palliative radiotherapy to patients with tumors needing palliative radiation. The safety and efficacy of this approach will be assessed. It is hypothesized that GRID is highly effective, immunogenic, and associated with low rates of toxicity.",[32,172],"Metastatic Cancer",[174,175,176,177,178,179,180],"proton","palliative radiotherapy","spatially fractionated radiotherapy","GRID","stereotactic body radiotherapy (SBRT)","stereotactic ablative radiotherapy (SABR)","cancer","2026-03-04",{"date":183,"type":39},"2026-03-06",{"date":185,"type":39},"2023-05-12",{"date":187,"type":20},"2027-06-30",{"name":189,"class":100},"Washington University School of Medicine",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":208,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100575944","phase-1-a-study-of-clsp-1025-in-adult-patients-with-solid-tumors-that-harbor-the-p53-r175h-mutation-100575944","NCT06778863","A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation","GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation","GUARDIAN-101","Key Inclusion Criteria:\n\n* Patients must be at least 18 years of age at the time of signing the informed consent.\n* Patients must be willing and able to provide written informed consent\n* Patients must have locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists\n* Tumors must harbor a TP53 R175H variant mutation confirmed by an accredited laboratory-based test\n* Patients must be HLA-A\\*02:01 positive by central assay\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment\n* Adequate hematological, renal and hepatic function\n* Per Investigator judgement, patient is willing and able to complete study visits and\u002For procedures per the protocol and comply with study requirements for study participation\n\nKey Exclusion Criteria:\n\n* Patients with Li-Fraumeni syndrome or other known germline p53 R175H mutation\n* Patients who have received other p53 R175H-directed therapies\n* Patients who have not fully recovered from adverse events due to previous anticancer therapies\n* Patients with active infection requiring systemic antimicrobial therapy\n* Any other primary malignancy within the 2 years prior to enrollment (except for non- melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or prostate cancer in remission.\n* Known active central nervous system metastases and\u002For carcinomatous meningitis",{"count":199,"type":20},90,[23],"Phase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A\\*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.",[60,32,61,203,204,147,27,26,205,206,207],"Colorectal Adenocarcinoma","Pancreatic Adenocarcinoma","Head and Neck Squamous Cell Carcinoma","Prostate Cancer","Bladder Cancer",[209,210,211,212],"CLSP-1025","T Cell Engager","TCE","TP53","2026-02-12",{"date":215,"type":39},"2026-02-13",{"date":217,"type":39},"2025-02-28",{"date":219,"type":20},"2028-06",{"name":221,"class":46},"Clasp Therapeutics, Inc.",21,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":21,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100530227","phase-1-a-dose-escalation-and-expansion-study-of-177lulu-sn201-in-participants-with-advanced-cancer-100530227","NCT06184035","A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer","Ph I\u002FIIa Escalation\u002FExpansion FIH, Open, Multi Center, Single Arm Study Evaluating Safety, Dosimetry and Early Efficacy of 177Lu-SN201 in Progressive\u002FTreatment-refractory, Locally Advanced, Unresectable Metastatic or Recurrent Solid Tumors","Tumorad","Inclusion criteria:\n\n1. Male or female participants ≥ 18 years of age on the day of signing informed consent.\n2. Histologically or cytologically documented, recurrent, locally advanced, or metastatic solid malignancy that has failed at least one prior systemic standard therapy, or for which standard therapy is not appropriate, or for which no standard therapy exists.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n4. Life expectancy ≥ 3 months.\n5. Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements, to be conducted within 28 days before the start of the study IMP administration:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL (transfusions are allowed).\n   2. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3.\n   3. Platelet count ≥ 100,000 mm3.\n   4. Total bilirubin ≤ 2.5 x upper limit of normal (ULN) (in participants with liver metastases ≤ 5 ULN).\n   5. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 5 x ULN.\n6. On a stable dose of anti-coagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and prothrombin\u002Finternational normalized ratio and partial thromboplastin time (PT\u002FINR and PTT, respectively) test results are compatible with the acceptable benefit-risk ratio at the Investigator's discretion.\n7. Serum creatinine ≤ 1.5 x ULN and estimated glomerular filtration rate (eGFR) \\> 30 mL\u002Fmin\u002F1.73 m2 (per local values).\n8. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n   1. Male participants must agree to use a highly effective method of birth control as defined in ICH M3(R2) starting with the first dose of study medication through 120 days after the last dose of study medication.\n   2. Female participants of childbearing potential\\* must have a negative pregnancy test documented at Screening and Baseline and be willing to use a highly effective method of contraception\\*\\* or practice abstinence starting from ICF signature through to 120 days after the last dose of study medication.\n\n      * A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., had had menses at any time in the preceding 24 consecutive months).\n\n        * Effective contraception is defined as contraceptive methods with a failure rate of \\\u003C 1% to prevent pregnancy (combined \\[estrogen and progestogen containing\\] hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal, transdermal\\], progestogen-only hormonal contraception associated with inhibition of ovulation \\[oral, injectable, implantable\\], intrauterine device \\[IUD\\] or intrauterine hormone-releasing system).\n9. Written informed consent to study participation.\n10. Be able to understand and comply with the requirements of the study, as judged by the Investigator.\n11. Phase I: At least one lesion as per RECIST v1.1.\n12. Phase IIa: At least one measurable lesion as per RECIST v1.1.\n\nExclusion criteria:\n\n1. Unstable systemic disease (including but not limited to active infection, hepatic, renal, or metabolic disease).\n2. Clinically significant cardiac disease including any of the following:\n\n   1. Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2).\n   2. LVEF of \\\u003C 50%, as determined by MUGA or ECHO.\n   3. Uncontrolled hypertension, defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy.\n   4. History or presence of clinically significant ventricular arrhythmias or atrial fibrillation.\n   5. Clinically significant resting bradycardia.\n   6. Unstable angina pectoris ≤ 3 months before the start of study treatment.\n   7. Acute myocardial infarction ≤ 3 months before the start of study treatment.\n   8. Mean triplicate QT interval corrected for heart rate using Fridericia's formula (QTcF) value \\> 480 msec (as specified in Section 10.5).\n3. Known hypersensitivity to pegylated drugs or vaccines (e.g., covid-19 vaccines).\n4. Concurrent or active solid or hematologic malignancy within the last 2 years with a distinct primary site or histology from the cancer being evaluated in this study except for the following cancer types: cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis).\n5. Infections not responding to therapy or active clinically serious infections.\n6. Known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection requiring treatment. Participants with chronic HBV or HCV infection are eligible at the Investigator's discretion provided that the disease is stable and sufficiently controlled under treatment.\n\n   NB: Participants with CNS metastases may be included after discussion with Sponsor, except for the sentinel participants.\n7. Chemotherapy, experimental cancer therapy, biologic therapy, or immunotherapy within 2 weeks (or 5 half-lives, whatever is shortest) before the start of the study IMP administration.\n8. Palliative radiotherapy completed less than 2 weeks before the start of the study IMP administration will be allowed as long as no more than 10% of the participant's bone marrow was irradiated.\n9. Not recovered to Grade 1 from any prior anti-cancer therapy, excluding alopecia.\n10. Previous high-dose chemotherapy needing hemopoietin-stem-cell-rescue.\n11. Major surgery, open biopsy, or significant trauma within 4 weeks before the start of study treatment.\n12. A psychiatric or functional disorder that prevents participants from providing informed consent or following protocol instructions.\n13. A participant that has a condition or is in a situation, in the Investigator's opinion may put the individual at significant risk, may confound the study results, or may interfere significantly with their participation in the study.\n14. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks or 5 half-lives of the agent, whichever is the shortest.",{"count":199,"type":20},[23,137],"The purpose of this first-in-human (FIH) study is to determine the maximum tolerated dose (MTD) and to characterize the safety, tolerability, PK, and dosimetry profile of \\[177Lu\\]Lu-SN201 in adult participants with advanced solid tumors who have no standard of care treatment options.\n\n\\[177Lu\\]Lu-SN201 is a radiolabeled, nanomedical investigational medicinal product (IMP) whose mechanism of delivery is based on the Enhanced Permeability and Retention (EPR) effect.",[86,172,32,235,236,237],"Recurrent Solid Tumor","Locally Advanced Solid Tumor","Refractory Cancer","2025-11-17",{"date":240,"type":39},"2025-11-20",{"date":242,"type":39},"2023-12-06",{"date":244,"type":20},"2027-12-31",{"name":246,"class":46},"Spago Nanomedical AB",2,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":21,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":270},"100455889","phase-1-first-in-human-study-of-mutant-selective-pi3k-inhibitor-rly-2608-as-a-single-agent-in-patients-with-advanced-solid-tumors-and-in-combination-with-endocrine-therapy---a-cdk46-or-cdk4-inhibitor-in-patients-with-advanced-solid-tumors-or-advanced-breast-cancer-100455889","NCT05216432","First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +\u002F- a CDK4\u002F6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer","Key Inclusion Criteria\n\nPatient has ECOG performance status of 0-1\n\nOne or more documented primary oncogenic PIK3CA mutation(s) in blood and\u002For tumor per local assessment\n\nOther potentially oncogenic PIK3CA mutations may be considered but must be approved by the Sponsor prior to enrollment.\n\nPart 1 \\[Escalation\\] - Ability to provide archived tumor tissue or be willing to undergo pretreatment tumor biopsy to assess PIK3CA status retrospectively Part 2 \\[Expansion\\] - Submit tumor tissue prior to study drug initiation for determination of PIK3CA mutation retrospectively.\n\nKey Inclusion for RLY-2608 Single Agent Arm\n\n* \\[For Part 1: Escalation\\]: Evaluable disease per RECIST v1.1\n* \\[For Part 2: Expansion\\]: Measurable disease per RECIST v1.1\n* Disease that is refractory to standard therapy, intolerant to standard therapy, or has declined standard therapy.\n* Part 1- histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor\n* Part 2 - Unresectable or metastatic solid tumor with PIK3CA mutation(s) and one of the following tumor types:\n\nGroup 1: clear cell ovarian cancer Group 2: head and neck squamous cell carcinoma Group 3: cervical cancer Group 4: other solid tumors, excluding colorectal, clear cell ovarian, head and neck squamous cell, and cervical cancers Group 5: unresectable or metastatic solid tumors with PIK3CA double mutations In addition, the SRC (with Sponsor approval) may choose to open additional group(s) of 20 participants to study the clinical activity, safety, and PK\u002FPD with other specified solid tumor types.\n\nKey Inclusion for Combination Arms:\n\n* Doublet combination arms \\[Part 1 and Part 2\\]: Evaluable disease per RECIST v1.1\n* Triplet combination arms:\n* \\[Part 1 and Part 2 Dose Expansion, Group 1\\]: Evaluable disease per RECIST.\n* \\[Part 2 Dose Expansion, Group 2\\]: Measurable disease per RECIST. Bone-only lytic or lytic\u002Fblastic disease with at least 1 measurable soft-tissue component per RECIST may be eligible.\n* \\[For Part 1 and Part 2\\]: Male or female with histologically or cytologically confirmed diagnosis of HR+, HER2- unresectable or metastatic breast cancer that is not amenable to curative therapy. Females may be postmenopausal, premenopausal, or perimenopausal. Premenopausal or perimenopausal females must have a histologically or cytologically confirmed diagnosis of HR+ HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy and must have initiated treatment with a gonadotropin-releasing hormone (GnRH) agonist at least 4 weeks prior to start of study drug with continuation of GnRH agonist for the duration of study treatment (GnRH agonist recommended for males).\n* Had previous treatment for breast cancer with: \\[Does not apply to triplet combination arms, Part 2 Dose Expansion, Group 2\\]:\n\n  1. ≤1 line of chemotherapy in the metastatic setting\n  2. ≥1 CDK4\u002F6 inhibitor in either the adjuvant and\u002For metastatic setting\n  3. ≥1 antiestrogen therapy in either adjuvant and\u002For metastatic setting, including, but not limited to, selective estrogen-receptor degraders (eg, fulvestrant), selective estrogen receptor modulators (eg, tamoxifen), and aromatase inhibitors (AI) (letrozole, anastrozole, exemestane), and\n  4. ≥1 PARP inhibitor, if appropriate, if documented germline BRCA1\u002F2 mutation Note: Systemic local, loco-regional, or adjuvant treatment with chemotherapy and PARP inhibitors is not to be included in enumeration or previous treatment\n\n\\[For double combination arm; Part 2 Dose Expansion, Group 2\\]: Received prior treatment with a PI3Kα, AKT, or mTOR inhibitor and discontinued the inhibitor due to intolerance and not disease progression, where intolerance is defined as treatment discontinuation due to treatment related AE (eg. hyperglycemia, rash, diarrhea, stomatitis) other than severe hypersensitivity reaction and\u002For life-threatening reactions, such as anaphylaxis and Stevens-Johnson syndrome.\n\n\\[For triple combination arms; Part 1 dose escalation\\]: Participants who had previous treatment for breast cancer with PI3Kα, AKT, mTOR inhibitors and discontiuned due to participant\u002Fphysician decision, intolerance, or disease progression will be considered.\n\n\\[For triple combination arms, Part 2 Dose Expansion, Group 2\\]: Participants must be intolerant to or have declined standard therapy for locally advanced or metastatic HR+\u002FHER2- PIK3CA-mutated breast cancer. Prior endocrine therapy and CDK4\u002F6inhibitors are allowed as follows:\n\n1. Participants must have progressed during (neo)adjuvant endocrine therapy or within12 months of completing (neo)adjuvant endocrine therapy with an AI or tamoxifen.\n2. If a CDK4\u002F6 inhibitor was included as part of (neo)adjuvant therapy, disease must have recurred\u002Fprogressed \\>12 months after completion of the CDK4\u002F6 inhibitor portion of (neo)adjuvant therapy\n\nKey Exclusion Criteria\n\nPrior treatment with:\n\n1. PI3Kα, AKT, or mTOR inhibitors (all arms except for doublet RLY-2608 + fulvestrant arm, Part 2, Group 2; and triplet combinations, Part 1 dose escalation).\n2. Immune checkpoint inhibitors.\n3. Triplet combinations RLY-2608 + CDK4 or CDK4\u002F6 inhibitor + fulvestrant, Part 2 expansion, Group 2 only:\n\ni. Prior systemic chemotherapy or antibody drug conjugate for locally advanced or metastatic disease. ii. Prior CDK2, CDK4, or CDK4\u002F6 inhibitor as treatment for locally advanced or metastatic disease.\n\niii. Prior treatment with fulvestrant or any selective ER degrader, with the exception of patients who have received fulvestrant or any selective ER degrader as part of neoadjuvant therapy only and with treatment duration ≤6 months.\n\nType 1 or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥140 mg\u002FdL and glycosylated hemoglobin (HbA1c) ≥7.0%.\n\nHistory of allergy or hypersensitivity to any components or excipients of PI3K inhibitors. For combination arms only: allergy or hypersensitivity to any components or excipients of fulvestrant, palbociclib, ribociclib, and\u002For PF-07220060 as appropriate for the combination.\n\nPast medical history of or ongoing ILD, or pneumonitis requiring intervention. Participants with past history of resolved Grade 1 pneumonitis may be considered, except in triple combination arms.\n\nThe following cardiac criteria:\n\n* Mean resting corrected QT interval (QTc) \\>460 msec\n* For triple combination arm with ribociclib: Mean QTcF ≥450 msec (this is what we confirmed is shown in the redacted version of the protocol.\n\nCNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms",{"count":255,"type":20},930,[23],"This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic subunit alpha (PIK3CA) mutation in blood and\u002For tumor per local assessment. The study will evaluate RLY-2608 as a single agent for patients with unresectable or metastatic solid tumors. It will also evaluate RLY-2608 in combination RLY-2608 + fulvestrant and in triple combination RLY-2608 + fulvestrant + CDK4\u002F6 inhibitor (palbociclib or ribociclib) or CDK4 inhibitor (PF-07220060) for patients with HR+ HER2- locally advanced or metastatic breast cancer. The RLY-2608 single agent arm, RLY-2608 + fulvestrant combination arm, and triple combination arms will have 2 parts: a dose escalation (Part 1) and a dose expansion (Part 2).",[29,141,259,26,260,31,32],"HER2-negative Breast Cancer","Metastatic Breast Cancer","2025-09-17",{"date":263,"type":39},"2025-09-22",{"date":265,"type":39},"2021-12-08",{"date":267,"type":20},"2027-04-30",{"name":269,"class":46},"Relay Therapeutics, Inc.",37,{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":282,"conditions":283,"keywords":313,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":353},"100445919","phase-1-a-beta-only-il-2-immunotherapy-study-100445919","NCT05086692","A Beta-only IL-2 ImmunoTherapY Study","A Phase 1\u002F2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors","ABILITY-1","Key Inclusion Criteria:\n\n1. Aged at least 18 years (inclusive at the time of informed consent).\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)\n5. Demonstrated adequate organ function\n6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and\u002For MRI.\n7. Life expectancy of ≥ 12 weeks.\n8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.\n9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.\n\nKey Exclusion Criteria:\n\n1. Last administration of prior antitumor therapy:\n\n   * Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.\n   * Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\\\u003C2 weeks of radiotherapy) to non-CNS disease.\n   * Radiation therapy to the lung that is \\> 30Gy within 6 months prior to start of treatment.\n   * Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.\n2. Has known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.\n3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.\n4. Condition requiring long-term systemic treatment with either corticosteroids \\> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.\n5. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.\n6. Severe pulmonary, cardiac or other systemic disease.\n7. Known hepatitis B or C virus infection.\n8. Females who are pregnant or lactating or planning to become pregnant during the study.\n9. Has had an allogeneic tissue\u002Fsolid organ transplant.\n10. Active infection requiring systemic therapy.\n11. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol\n12. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.\n13. Known severe hypersensitivity to any component of study drug(s).\n14. Inability to comply with study and follow up procedures as judged by the Investigator.",{"count":280,"type":20},115,[23,137],"This is a Phase 1\u002F2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.",[60,32,284,285,286,287,288,289,34,290,207,291,292,293,294,295,296,86,141,297,298,299,300,301,302,303,304,305,306,27,307,308,309,310,311,312,28],"Clear Cell Renal Cell Carcinoma","Triple Negative Breast Cancer","Non-Small Cell Lung Cancer Squamous","Non-Small Cell Lung Cancer Non-squamous","Colorectal Cancer (MSI-H)","Gastric Cancer","Basal Cell Carcinoma","Merkel Cell Carcinoma","Squamous Cell Carcinoma of Head and Neck","Cutaneous Squamous Cell Carcinoma","Pleural Mesothelioma","Esophageal Cancer","Endometrial Carcinoma","MSI-H Solid Malignant Tumor","Cancer With A High Tumor Mutational Burden","Epithelial Ovarian Carcinoma","Primary Peritoneal Cancer","Gastroesophageal Junction (GEJ) Cancer","Acral Melanoma","Mucosal Melanoma","Cutaneous Melanoma","DMMR Solid Malignant Tumor","Fallopian Tube Cancer","MSI-H Cancer","DMMR Cancer","Pancreas Adenocarcinoma (MSI-H)","Skin Cancer","Viral Cancer","Cervical Cancers",[314,315,316,180,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343],"IL-2","IL2","Interleukin-2","metastatic","ccRCC","TNBC","NSCLC","CRC","GEJ","intrahepatic","extrahepatic","MCC","SCCHN","CSCC","Gastroesophageal Junction","advanced","unresectable","MSI-H","dMMR","Microsatellite Instability-High","Mismatch Repair Deficient","PD-1","immunotherapy","anti-PD-1","BCC","RCC","HCC","Tumor Mutation Burden High","TMB-H","PDAC","2025-07-03",{"date":346,"type":39},"2025-07-09",{"date":348,"type":39},"2021-08-27",{"date":350,"type":20},"2026-12-30",{"name":352,"class":46},"Medicenna Therapeutics, Inc.",27,{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":21,"phases":363,"briefSummary":364,"conditions":365,"keywords":366,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":125},"100597350","phase-1-csb-321-ph-1-in-immunotherapy-for-the-treatment-of-cancer-100597350","NCT07057349","CSB-321 Ph 1 in Immunotherapy for the Treatment of Cancer","Phase 1 Multi-cohort Evaluation of [18F]CSB-321 PET Imaging in Participants Receiving Immunotherapy for the Treatment of Cancer","Inclusion Criteria:\n\n1. Participants 18 years of age and older.\n2. Participants with either proven metastatic cancer that are going to be treated with one or more checkpoint inhibitors or immunotherapy under the licensed indications for the cancer type. Checkpoint inhibitors include PD-1, PD-L1, CTLA-4 and LAG-3 inhibitors OR Participants with unresectable or metastatic uveal melanoma planned to be treated with tebentafusp-tebn\n3. Participants must have at least one lesion ≥ 15 mm in diameter or with two lesions both ≥ 15mm in diameter, when an optional biopsy is planned from one of the lesions. Lesion measurements are taken from a diagnostic quality computerized tomography (CT) or Magnetic Resonance Imaging (MRI).\n4. ECOG performance status ≤ 2 (Karnofsky ≤ 60%).\n5. Life expectancy of greater than 6 months.\n6. If female, not of childbearing potential or must have a negative pregnancy test prior to each radiotracer injection.\n7. Willing and able to undergo all study procedures.\n8. Need archival lesion tissue ideally available within 90 days of enrollment either from biopsy or surgery without intervening therapy.\n\nExclusion Criteria:\n\n1. Participants for whom adverse events due to agents administered more than 4 weeks earlier have not resolved to Grade 1 or less, except for immune checkpoint inhibitor related endocrinopathies except for immune checkpoint inhibitor related endocrinopathies or deemed unlikely to be clinically significant by the investigator.\n2. Participants in cohort 2 (ipilimumab with nivolumab) who have received or are expected to receive an investigational compound within 90 days prior to \\[18F\\]CSB-321 PET imaging. This includes immunotherapies that are not approved by the US FDA for the indications in this protocol.\n3. Participants who have received a prior checkpoint inhibitor in the last year except for participants in cohort 3 (Prior checkpoint inhibitors are allowed for this cohort).\n4. Participants who have received chemotherapy in the prior 6 months or are anticipated to receive chemotherapy in the 6 months following the initial \\[18F\\]CSB-321 injection for cohorts 2 and 3.\n5. Any acute or chronic inflammatory disease or medical conditions that in the investigator's opinion may interfere with the study procedures or the interpretation of the study results such as infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.\n6. History of allergic reactions to compounds of similar chemical or biologic composition to \\[18F\\]CSB-321.\n7. Current treatment with systemic steroids, or immunosuppressive agents. Participants with a condition requiring systemic treatment with either corticosteroids (\\\u003C 10 mg daily prednisone equivalent) inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n8. Participants who are unwilling or unable to have a CT scan.\n9. Males and females unwilling to use adequate contraception prior to study and during study participation.\n10. If female, nursing.\n11. Unwilling and\u002For unable to sign a written informed consent document.\n12. Laboratory values\n\n    1. Leukocytes \\\u003C 2000\u002FmcL (CTCAE grade 3)\n    2. Absolute neutrophil count \\\u003C 1000 mcL (CTCAE grade 3)\n    3. Platelets \\\u003C 75,000 mcL (CTCAE grade 2)\n    4. Total bilirubin \\> 1.5 x ULN, unless participant has Gilbert' disease.\n    5. AST\u002FALT \\> 5 x ULN (CTCAE grade 3)\n    6. Albumin \\\u003C 2 g\u002FdL\n    7. Alkaline phosphatase \\> 5 ULN (CTCAE grade 3)\n    8. eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2 Participants who are stable but have values outside the specified ranges may be included with approval of the study medical monitor.\n13. Participants with a QTcF of greater than 470 ms as measured by 12-lead ECG.",{"count":362,"type":20},40,[23],"Single-center with the option to expand to multi-center, international, open label, non-randomized, multiple-dose, multi-cohort study, in participants with metastatic or unresectable cancer. Eligible participants will receive an initial injection of \\[18F\\]CSB-321 followed by PET imaging prior to administration of the I-O therapy and a second and third injection post treatment each with PET imaging. The images will be analyzed for the distribution of radioactivity. Participants will be followed for adverse events up to 3-4 hours post injection. Available clinical, imaging, and histology data will be collected at follow-up to establish the disease progression for evaluation of \\[18F\\]CSB-321.",[172,32],[367,368,369,370],"cancer immunotherapy","biomarkers, tumor","positron-emission tomography","Granzymes","2025-06-30",{"date":346,"type":39},{"date":374,"type":20},"2025-09-01",{"date":376,"type":20},"2029-02",{"name":378,"class":46},"Cytosite Biopharma Inc.",{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":388,"phases":4,"briefSummary":389,"conditions":390,"keywords":393,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":125},"100474727","avapritinib-in-the-treatment-of-unresectable-or-recurrent-metastatic-gist-non-exon18-mutations-of-pdgfra-100474727","NCT05461664","Avapritinib in the Treatment of Unresectable or Recurrent Metastatic GIST Non-exon18 Mutations of PDGFRA","Avapritinib in the Treatment of Unresectable or Recurrent Metastatic Gastrointestinal Stromal Tumors Non-exon18 Mutations of PDGFRA:A Real-world Study","Inclusion Criteria:\n\n* Patients who are aged ≥ 18 years.\n* Gastrointestinal stromal tumors confirmed by histopathological examination, and CD- and\u002For DOG-1-positive by immunohistochemistry.\n* Presence of mRECIST v1.1-compliant lesions with at least one measurable lesion (non-lymphadenopathy ≥1.0 cm or ≥2-fold scan slice thickness).\n* Treatment with Avapritinib.\n* Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at screening.\n* Patient informed consent and signed written consent form.\n* The patient was compliant and voluntarily scheduled for follow-up, treatment, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* KIT or PDGFRA wild type.\n* Failure to complete continuous atorvastatin for at least 15 days due to intolerability or disease progression.\n* Other serious acute or chronic physical or mental problems, or laboratory abnormalities, may increase the risk associated with participation in the study or use of drugs, or interfere with the judgment of the study results and, in the judgment of the investigator, are not considered appropriate for participation in the investigator.",{"count":387,"type":20},74,"OBSERVATIONAL","This is a prospective, multicenter, observational real-world study to explore the Avapritinib therapy in GIST patients who definited Non-exon18 Mutations of PDGFRA.",[391,32,392],"Gastrointestinal Stromal Tumors","Recurrent Metastatic Malignant Neoplasm",[394,395],"Avapritinib","Genetic testing","2025-02-24",{"date":398,"type":39},"2025-02-26",{"date":400,"type":39},"2022-07-10",{"date":402,"type":20},"2025-12-31",{"name":404,"class":100},"Xinhua Zhang, MD",{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":409,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":388,"phases":4,"briefSummary":411,"conditions":412,"keywords":413,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":418,"locationsCount":125},"100474974","a-multicenter-study-of-avapritinib-efficacy-and-safety-of-metastatic-or-unresectable-gastrointestinal-stromal-tumors-100474974","NCT05464875","A Multicenter Study of Avapritinib Efficacy and Safety of Metastatic or Unresectable Gastrointestinal Stromal Tumors",{"count":387,"type":20},"This is a prospective, multicenter, observational real-world study to explore the therapy patterns and clinical outcomes of Avapritinib in patients with metastatic or unresectable gastrointestinal stromal tumors.",[391,32,392],[394,395],{"date":398,"type":39},{"date":416,"type":39},"2022-07-09",{"date":402,"type":20},{"name":404,"class":100},{"id":420,"slug":421,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":21,"phases":429,"briefSummary":431,"conditions":432,"keywords":435,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":125},"100530344","phase-2-coldfire-iii-trial-efficacy-of-irreversible-electroporation-and-stereotactic-body-radiotherapy-for-perivascular-and-peribiliary-colorectal-liver-metastases-100530344","NCT06185556","COLDFIRE-III Trial: Efficacy of Irreversible Electroporation and Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases","COLDFIRE-III Trial: Perivascular and Peribiliary Colorectal Liver Metastases (0-5cm): Irreversible Electroporation Versus Stereotactic Body Radiotherapy","COLDFIRE-III","Inclusion Criteria:\n\n* Histological documentation of primary colorectal tumor is available;\n* 1-3 CRLM visible on ceCT and\u002For MRI, size 0-5 cm and not eligible for resection or thermal ablation due to location close to a vessel or bile duct;\n* Additional CRLM are allowed if considered either resectable or ablatable with a maximum of 10 CRLM. In patients with extrahepatic disease, a maximum of 5 additional CRLM is allowed;\n* No or limited extrahepatic disease (1 extrahepatic lesion is allowed, with some exclusions mentioned in the exclusion criteria);\n* Prior focal liver treatment is allowed;\n* Subjects should preferably be treated with neo-adjuvant systemic therapy;\n* Subjects with recurrent (either local or distant-hepatic) CRLM after previous focal treatment who are unsuitable for (further) systemic therapy (further downsizing or conversion to resectable disease improbable);\n* Adequate bone marrow, liver and renal function as assessed by laboratory requirements to be conducted within 7 days prior to definite inclusion;\n* ASA classification 0 - 3;\n* Age \\>18 years;\n* Written informed consent;\n\nExclusion Criteria:\n\n* Radical treatment unfeasible or unsafe (e.g. insufficient FLR);\n* \\>10 CRLM; \\>5 CRLM when extra-hepatic disease is present;\n* Positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis;\n* Subjects who have progressive disease after neo-adjuvant systemic therapy;\n* History of epilepsy;\n* History of cardiac disease:\n* Uncontrolled hypertension. Blood pressure must be ≤160\u002F95 mmHg at the time of screening on a stable antihypertensive regimen;\n* Compromised liver function (e.g. signs of portal hypertension, INR \\> 1,5 without use of anticoagulants, ascites);\n* Pregnant or breast-feeding subjects;\n* Immunotherapy ≤ 2 weeks prior to the procedure;\n* Chemotherapy and\u002For targeted therapy ≤ 2 weeks prior to the procedure;\n* Severe allergy to contrast media not controlled with premedication;\n* Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study.",{"count":428,"type":20},78,[137,430],"PHASE3","The primary objective of this phase IIb\u002FIII, prospective, randomized clinical trial is to compare the efficacy of irreversible electroporation (IRE) with stereotactic body radiotherapy (SBRT) in patients with perivascular or peribiliary colorectal liver metastases (CRLM), that are not amenable for surgical resection or thermal ablation. Efficacy is assessed in terms of local control at 2 years.",[143,433,434,32],"Liver Metastases","Liver Metastasis Colon Cancer",[436,437],"Colorectal liver metastases","colorectal hepatic metastases","2024-08-21",{"date":440,"type":39},"2024-08-23",{"date":442,"type":39},"2024-08-20",{"date":444,"type":20},"2031-09-01",{"name":446,"class":100},"Amsterdam UMC, location VUmc"]