[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thyroid-gland-anaplastic-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thyroid-gland-anaplastic-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100360599","phase-1-dabrafenib-trametinib-and-imrt-in-treating-patients-with-braf-mutated-anaplastic-thyroid-cancer-100360599",false,"NCT03975231","Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer","A Phase I Trial of Concurrent Intensity Modulated Radiation Therapy (IMRT) and Dabrafenib\u002FTrametinib in BRAF Mutated Anaplastic Thyroid Cancer","Inclusion Criteria:\n\n* Pathologic (histologic or cytologic) diagnosis of anaplastic thyroid cancer (a diagnosis that is noted to be ?consistent with anaplastic thyroid cancer? with the presence of a thyroid mass is acceptable; pathology showing additional types of thyroid cancer is allowed)\n\n  * Note: Tissue collection for central review is mandatory, but central review is not required for eligibility. Due to the aggressiveness of this disease, treatment will be started prior to central review.\n* Presence of BRAF mutation (V600E or V600K) in tumor tissue.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C 2.\n* Absolute neutrophil count \\> 1,000\u002FmcL.\n* Hemoglobin \\>= 9.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 9.0 g\u002Fdl is acceptable).\n* Platelets \\> 75,000\u002FmcL.\n* Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (unless due to Gilbert?s disease).\n* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) \\\u003C 2.5 x institutional upper limit of normal.\n* Serum creatinine \\\u003C 1.5 x institutional upper limit of normal.\n* Female patients of childbearing potential are required to have a negative serum pregnancy test within 14 days prior to the first dose of study medication.\n* Females are required to use an effective method of contraception from the time of negative serum pregnancy test, throughout the study duration, and for 4 months after the last dose of study medication. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to study enrollment, for the duration of study participation, and for 16 weeks after completion of the last dose of study drug.\n* Specific contraception requirements for females: Female subjects of childbearing potential must not become pregnant and are required to be sexually inactive by abstinence or use contraceptive methods with a failure rate of \\\u003C 1%. Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception. Contraceptive methods with a failure rate of \\\u003C 1% include the following:\n\n  * Intrauterine device (IUD) or intrauterine system (IUS) that meets the \\\u003C 1% failure rate as stated in the product label,\n  * Male partner sterilization (vasectomy with documentation of Azoospermia) prior to the female subject's entry into the study, and this male is patient?s sole sexual partner. For this definition, ?documented? refers to the outcome of the investigator's\u002Fqualified physician designee?s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject?s medical records.\n  * Double barrier method: condom and occlusive cap (diaphragm or cervical\u002Fvault caps) plus spermicidal agent (foam, gel, film, cream, suppository) These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring subjects understand how to properly use these methods of contraception.\n* Specific contraception requirements for males: To prevent pregnancy in a female partner or to prevent exposure of any partner to the investigational product from a male subject?s semen, male subjects must use one of the following contraceptive methods during the study and for a total of 16 weeks following the last dose of study drug (based upon the lifecycle of sperm):\n\n  * Abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject for 14 days prior to first dose of study drug, through the dosing period, and for at least 16 weeks after the last dose of study drug. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n  * Condom (during non-vaginal intercourse with any partner - male or female) OR\n  * Condom and occlusive cap (diaphragm or cervical\u002Fvault caps) plus spermicidal agent (foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) (during sexual intercourse with a female).\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients with resectable stage IVA anaplastic thyroid cancer who are candidates for surgery and wish to proceed with surgery.\n* Patients who have had external beam radiotherapy to neck or chest for cancer that would result in overlap of radiation therapy fields.\n* Patients who have had cytotoxic chemotherapy, stereotactic brain radiation or external beam radiation within 2 weeks prior to study treatment initiation.\n* Patients who have had oral multikinase inhibitors within 1 week prior to study treatment initiation.\n* Patients that have not recovered from adverse events related to prior therapy for cancer to Common Terminology Criteria for Adverse Events (CTCAE) 4.03 grade 2 or less except for alopecia.\n* Patients previously treated with potent BRAF inhibitor or MEK inhibitor. Previous treatment with sorafenib is permitted.\n* Patients that are receiving any other investigational agent.\n* Patients that are currently taking any prohibitive medication.\n* Patients with a history of other active malignancy requiring cancer treatment.\n* Patients with uncontrolled brain metastases. Patients who are on a stable dose of corticosteroids for more than 1 week or off corticosteroids for 2 weeks prior to study enrollment can be enrolled. Enzyme-inducing anti-epileptic drugs are not permitted.\n* Patients with a known history of retinal vein occlusion (RVO), central serous retinopathy (CSR), uncontrolled glaucoma or ocular hypertension.\n* Patients with class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.\n* Corrected QT (QTc) interval greater than or equal to 480 msecs (\\>= 500 msec for subjects with Bundle Branch Block).\n* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous (IV) antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women and nursing women are excluded from this study because dabrafenib has the potential for teratogenic or abortifacient effects. In embroyfetal developmental studies in rats, developmental toxicities including reduced fetal body weight, embryo-lethality, cardiac ventricular septal defect malformations, delayed skeletal development and variation in thymic shape have been observed.\n* Known human immunodeficiency virus (HIV)-positive patients or those on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with study drugs.","ALL","18 Years",{"count":19,"type":20},6,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This trial studies how well dabrafenib, trametinib, and intensity modulated radiation therapy (IMRT) work together in treating patients with BRAF mutated anaplastic thyroid cancer. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving dabrafenib, trametinib, and IMRT together may kill more tumor cells.",[26,27,28],"BRAF NP_004324.2:p.V600E","BRAF V600K Mutation Present","Thyroid Gland Anaplastic Carcinoma","RECRUITING","2026-04-02",{"date":32,"type":33},"2026-04-08","ACTUAL",{"date":35,"type":33},"2020-09-14",{"date":37,"type":20},"2027-10-05",{"name":39,"class":40},"City of Hope Medical Center","OTHER",3,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100565208","early-phase-1-177lulu-akir001-first-in-human-study-100565208","NCT06639191","[177Lu]Lu-AKIR001 First-in-human Study","A Phase 1 Prospective, Open-label, First-in-human Study to Evaluate the Safety, Tolerability and Biodistribution of [177Lu]Lu-AKIR001 and Its Anti-tumour Effect in Adult Patients With CD44v6 Expressing Solid Tumours","AKIR001","Inclusion Criteria:\n\n1. Participant must be 18 years of age or older\n2. Willing and able to provide written informed consent\n3. Participant has one of the following histologically confirmed metastatic or locally advanced irresectable CD44v6 expressing (confirmed in pre-screening according to the pathology manual (Appendix III) solid malignancy in one of the following groups, with documented disease progression in the last 8 weeks during\u002Fafter available standard of care treatment options as mentioned below:\n\n   * For anaplastic, poorly differentiated and radioiodine refractory differentiated thyroid cancer (ATC, PDTC, RAI-R DTC):\n\n     * For BRAFv600E mutated tumours: BRAF\u002FMEK inhibitors.\n     * For BRAF-wildtype tumours at least one of the following: anthracycline- or taxane containing chemotherapy\u002F chemoradiotherapy, or other targeted therapies including vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors (TKI), targeted therapies aimed at specific moleculo-pathological features (e.g., targeting NTRK, RET, ALK, PD-L1)\n     * For PDTC or RAI-R DTC: Radio-iodine refractory disease as deemed by treating physician and disease progression after at least one line of systemic targeted therapy (including VEGF, TKI, NTRK, RET, BRAF inhibitors)\n   * For HNSCC:\n\n     \\- At least one prior treatment with combination chemotherapy (either platinum based + 5-Fluorouracil or platinum based + taxane) together with PD1-inhibitor pembrolizumab if combined positive score (CPS) ≥1 or EGFR-inhibitor if CPS \\\u003C1 (or if immunotherapy is contraindicated)\n   * For NSCLC\n\n     \\- Treatment with at least two lines of systemic therapy, including checkpoint inhibitor based on PD-L1 status and chemotherapy with a platinum-based regimen.\n   * For vulvar SCC:\n\n     \\- After treatment with first line platinum\u002Fpaclitaxel+\u002F-bevacizumab +\u002F- pembrolizumab (the latter in case of PD-L1 positivity), and second line with weekly paclitaxel\n   * For cervical SCC:\n\n     * After treatment with first line systemic therapy with platinum\u002Fpaclitaxel+\u002F-pembrolizumab (the latter in case of PD-L1 positivity)\n4. Measurable disease per Response Criteria for Solid Tumours (RECIST) v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n6. Life expectancy of at least three months as estimated by the investigator.\n7. Adequate organ and bone marrow function within eight days before the first \\[177Lu\\]Lu-AKIR001 infusion:\n\n   * Peripheral white blood cells (WBC) ≥3.0 x 109\u002FL\n   * Absolute neutrophil count (ANC) ≥ 2,000\u002Fmm3\n   * Platelet \\> 100 x 109\u002FL\n   * Hemoglobin \\> 100 g\u002FL.\n   * Serum creatinine of ≤ 1.5x ULN or calculated creatinine clearance of ≥ 60 mL\u002Fmin\u002F1.73 m2 by Cockcroft- Gault\n   * Total serum bilirubin ≤ 1.5x ULN (unless due to Gilbert's syndrome, in which case direct bilirubin must be normal)\n   * Serum AST and ALT ≤1.5x ULN (or ≤ 5x ULN if participant has liver metastases)\n   * Left Ventricular Ejection Fraction \\>50% on echocardiography\n8. Contraceptives\n\n   * Females of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study treatment Phase and for six months after the last dose of study drug. Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone- releasing intrauterine devices (IUDs), and copper IUDs. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception. Women must refrain from donating eggs during this same period. Should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. If a female participant is of child-bearing potential (females are considered not of childbearing potential if they are at least one year postmenopausal and\u002For surgically sterile), she must have a documented negative serum pregnancy test before any \\[177Lu\\]Lu-AKIR001 infusion.\n   * Male participant must agree to practice effective barrier contraception (condom) during the entire study treatment period and through four months after the last dose of study drug or agree to completely abstain from heterosexual intercourse.\n\nExclusion Criteria:\n\n1. Symptomatic brain metastases that are not previously treated and\u002For that require ongoing steroid-treatment\n2. Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\n3. Chemo-, targeted or radiotherapy within the last 4 weeks before enrolment in the study.\n4. Ongoing toxicities graded according to the Common Terminology Criteria for Adverse Events (CTCAE) \\> 1 from previous anti-cancer treatments.\n5. Pregnancy or lactation\n6. Uncontrolled hypertension, heart, liver, or kidney disease or other medical\u002F psychiatric disorders.\n7. Severe skin diseases requiring systemic anti-inflammatory treatment, including plaque psoriasis, Stevens Johnsons syndrome or dermatomyositis.\n8. A known history of Human Immunodeficiency Virus (HIV) infection, hepatitis B (HBsAg reactive) or hepatitis C (HCV RNA detected) infection or active tuberculosis.",{"count":51,"type":20},15,[53],"EARLY_PHASE1","The goal of this clinical trial is to evaluate the safety and tolerability of increasing doses of \\[177Lu\\]Lu-AKIR001, both in relation to tolerable activity of lutetium-177 and the absorbed protein mass dose of AKIR-001 in patients with irresectable or metastatic CD44v6-expressing solid malignancies for whom no reasonable systemic treatment options are be available. The main question it aims to answer is:\n\n• What is the toxicity profile of the study drug \\[177Lu\\]Lu-AKIR001 according to the rate of Dose Limiting Toxicities and (Severe) Adverse Events? Participants will receive one \\[177Lu\\]Lu-AKIR001 infusion followed by a 6-week safety follow-up period, which can be extended up to 12 weeks. Possible additional infusions of the trial drug, up to a maximum number of four, can be given when clinical benefit is noted and toxicity is deemed acceptable.",[28,56,57,58,59,60],"Poorly Differentiated Thyroid Carcinoma","Cancer Head and Neck","Cervix Carcinoma","Vulvar Cancer, Stage IV","Non-small Cell Lung Cancer Stage IV",[62,63,64,65,66],"Radiopharmaceutical","first-in-human","CD44v6","Lutetium-177","177Lu-AKIR001","2026-01-28",{"date":69,"type":33},"2026-01-30",{"date":67,"type":33},{"date":72,"type":20},"2028-11-01",{"name":74,"class":40},"Karolinska University Hospital",1]