[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-lymphoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,111,135,157],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100533263","phase-1-studying-tak-243-in-patients-with-advanced-cancer-100533263",false,"NCT06223542","Studying TAK-243 in Patients With Advanced Cancer","A Phase I Study to Investigate the Safety of the Ubiquitin Activating Enzyme Inhibitor TAK-243 in Adult Solid Tumor and Lymphoma Patients","Inclusion Criteria:\n\n* Patients with histologically documented advanced or metastatic solid tumors with relapsed or refractory disease who have received standard-of-care or approved therapies known to confer clinical benefit, or patients with aggressive lymphomas who have received ≥ 2 prior lines of lymphoma-directed therapy and who do not have remaining effective treatment options (including transplant). Additionally, patients with indolent lymphomas must meet criteria for treatment.\n* Patients must have measurable or evaluable disease\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Hemoglobin \\>= 9 g\u002FdL (patients may be transfused to achieve this value; elevated indirect bilirubin due to post-transfusion hemolysis is allowed)\n* Absolute neutrophil count \\>= 1,000\u002FmcL\n* Platelets \\>= 75,000\u002FmcL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN OR =\\\u003C 5 x institutional upper limit of normal for patients with liver metastases at baseline\n* Creatinine =\\\u003C 1.5 x institutional ULN OR creatinine clearance \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 by Cockcroft-Gault\n* Any prior therapy must have been completed \\>= 4 weeks, or \\>= 5 half-lives of the prior agent (whichever is shorter) prior to enrollment on protocol. Prior definitive radiation should have been completed \\>= 4 weeks prior to enrollment; prior palliative radiation should have been completed \\>= 2 weeks prior to enrollment. Patients must be \\>= 2 weeks since any investigational agent administered as part of a Phase 0 study (where a sub-therapeutic dose of drug is administered) and should have recovered to grade 1 or baseline from any toxicities\n* Female patients who:\n\n  * Are postmenopausal (age-related amenorrhea \\>= 12 consecutive months or follicle-stimulating hormone \\> 40 mIU\u002FmL), for at least 1 year before the screening visit, OR\n  * Are surgically sterile (i.e., who had undergone hysterectomy or bilateral oophorectomy), OR\n\nIf they are of childbearing potential:\n\n* Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), or\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)\n\n  * Male patients, even if surgically sterilized (i.e., status postvasectomy), who:\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (female and male condoms should not be used together), or\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[eg, calendar, ovulation, symptothermal, postovulation methods for the female partner\\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)\n\n  * The effects of TAK-243 on the developing human fetus are unknown. For this reason and because ubiquitin-activating enzyme inhibitors are known to be teratogenic, women of child-bearing 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 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 the study, for the duration of study participation, and 4 months after completion of TAK-243 administration\n  * Ability to understand and the willingness to sign a written informed consent document\n  * Willingness to provide blood for research purposes\n  * For expansion phase patients, willingness to undergo 2 core needle biopsy procedures for research purposes if there is a lesion or lesions amenable to repeat biopsy\n  * Patients on anticoagulation therapy are eligible for this study in the absence of anticipated drug-drug interactions (DDI) between the anticoagulation agent and TAK-243. If DDI are anticipated and another anticoagulation agent that is compatible with TAK-243 exists, the patient will be transitioned to this alternative, TAK-243-compatible anticoagulation agent\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Life-threatening illness unrelated to cancer\n* Patients with uncontrolled coagulopathy or bleeding disorder\n* Known hepatic cirrhosis or severe pre-existing hepatic impairment\n* Known cardiopulmonary disease defined as:\n\n  * Unstable angina pectoris;\n  * Congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV);\n  * Myocardial infarction (MI) within 6 months prior to first dose (patients who had ischemic heart disease such as a \\[acute coronary syndrome (ACS)\\], MI, and\u002For revascularization greater than 6 months before screening and who are without cardiac symptoms may enroll);\n  * Cardiomyopathy\n* Clinically significant arrhythmia:\n\n  * History of polymorphic ventricular fibrillation or torsade de pointes,\n  * Permanent atrial fibrillation (a fib), defined as continuous a fib for \\>= 6 months,\n  * Persistent a fib, defined as sustained a fib lasting \\> 7 days and\u002For requiring cardioversion in the 4 weeks before screening,\n  * Grade 3 a fib defined as symptomatic and incompletely controlled medically, or controlled with device (e.g., pacemaker) or ablation, and\n  * Patients with paroxysmal a fib or \\\u003C grade 3 a fib for period of at least 6 months are permitted to enroll provided that their rate is controlled on a stable regimen\n* Prolonged rate corrected QT (QTc) interval \\>= 470 m\u002Fsec, calculated according to institutional guidelines\n* Uncontrolled high blood pressure (i.e., systolic blood pressure \\> 180 mm Hg, diastolic blood pressure \\> 95 mm Hg)\n* Known moderate to severe chronic obstructive pulmonary disease, interstitial lung disease, and pulmonary fibrosis\n* Major surgery within 14 days before the first dose of any study drug\n* Female patients who intend to donate eggs (ova) during the course of this study or 4 months after receiving their last dose of study drug(s)\n* Male patients who intend to donate sperm during the course of this study or 4 months after receiving their last dose of study drug(s)\n* Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for \\>= 1 month after treatment of the brain metastases. Patients on anti-seizure medications may be enrolled at the discretion of the principal investigator\n* TAK-243 is primarily metabolized by CYP3A4\u002F5. Therefore, the concomitant use of strong inhibitors of CYP3A4\u002F5 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir and saquinavir) and strong inducers of CYP3A4\u002F5 (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) is not permitted from 14 days prior to enrollment until the end of the study\n\n  * TAK-243 is a substrate for both organic anion transporting polypeptides (OATP) in human hepatocytes and the drug efflux transporter BCRP (ABCG2). Therefore, concomitant use of drugs that are strong inhibitors of BCRP or OATP is not permitted from 14 days prior to enrollment until the end of the study\n  * Other medications that are prohibited while on TAK-243 treatment include herbal medications\u002Fpreparations (except for vitamins). Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of\n  * As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Patients undergoing vaccination with live vaccines and live attenuated vaccines in the 30 days prior to receiving TAK-243, during the study, and for 100 days after the last dose of study drug. Inactivated vaccines are permitted\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAK-243\n* Patients with evidence of chronic hepatitis B virus (HBV) infection who are currently on treatment are eligible if they have an undetectable HBV viral load\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Known human immunodeficiency virus (HIV)-positive patients who meet the following criteria will be considered eligible:\n\n  * CD4 count \\> 350 cells\u002Fmm\\^3\n  * Undetectable viral load for 6 months prior to enrollment\n  * Maintained on modern therapeutic regimens utilizing non-CYP-interactive agents\n  * No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections\n* Pregnant and lactating\u002Fbreast-feeding women are excluded from this study because TAK-243 is a UAE-inhibiting agent with the potential for teratogenic or abortifacient effects and there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TAK-243","ALL","18 Years",{"count":19,"type":20},95,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial studies the side effects and best dose of ubiquitin-activating enzyme (UAE) inhibitor TAK-243 (TAK-243) in treating patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) and in patients with lymphoma. TAK-243 is a drug that binds to and inhibits the ubiquitin-activating enzyme, an enzyme that is more active on cancer cells than healthy cells, inhibiting tumor cell proliferation and survival.",[26,27,28,29,30,31],"Advanced Lymphoma","Advanced Malignant Solid Neoplasm","Indolent Non-Hodgkin Lymphoma","Metastatic Malignant Solid Neoplasm","Recurrent Malignant Solid Neoplasm","Refractory Malignant Solid Neoplasm","RECRUITING","2026-05-12",{"date":35,"type":36},"2026-05-13","ACTUAL",{"date":38,"type":36},"2025-03-24",{"date":40,"type":20},"2027-04-15",{"name":42,"class":43},"National Cancer Institute (NCI)","NIH",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":110},"100513775","phase-2-at-home-cancer-directed-therapy-versus-in-clinic-for-the-treatment-of-patients-with-advanced-cancer-100513775","NCT05969860","At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer","Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic","Inclusion Criteria:\n\n* Female or male patients with histologically confirmed malignancy. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis along; histologic confirmation is not required.\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines.\n\n  * Note, patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Patients may receive any combination of any above listed medications or regimens:\n  * Eligible disease cancer types:\n\n    * Anal cancer\n    * Appendiceal carcinoma\n    * Basal cell carcinoma\n    * Bladder cancer\n    * Biliary cancer\n    * Breast cancer\n    * Central Nervous System malignancy including glioblastoma\n    * Cervical cancer\n    * Cholangiocarcinoma\n    * Colorectal carcinoma\n    * Endometrial cancer\n    * Fallopian tube cancer\n    * Gastroesophageal cancer \\[including gastric, esophageal, and gastroesophageal junction (GEJ) cancers\\]\n    * Germ cell carcinoma\n    * Head and Neck cancer\n    * Hepatocellular Carcinoma\n    * Liver\n    * Lung\n    * Lymphoma\n    * Melanoma\n    * Merkel Cell\n    * Multiple Myeloma\n    * Myelodysplastic syndrome\n    * Myeloid Disorders\n    * Neuroendocrine carcinoma\n    * Ovarian cancer\n    * Pancreatic adenocarcinoma\n    * Penile carcinoma\n    * Peritoneal carcinoma\n    * Prostate cancer\n    * Renal cell cancer\n    * Sarcoma\n    * Squamous cell Carcinoma of the Skin\n    * Testicular cancer\n    * Urethral carcinoma\n    * Vaginal carcinoma\n    * Vulvar carcinoma\n  * Eligible Regimens\n\n    * Fluorouracil (5-FU) +\u002F- leucovorin +\u002F- bevacizumab +\u002F- trastuzumab\n    * 5FU +\u002F- leucovorin +\u002F- bevacizumab +\u002F- nivolumab\n    * Atezolizumab +\u002F- bevacizumab\n    * Atezolizumab +\u002F- bevacizumab + cobimetinib, atezolizumab +\u002F- bevacizumab + vemurafenib, atezolizumab +\u002F- bevacizumab + cobimetinib + vemurafenib\n    * Avelumab\n    * Avelumab + axitinib\n    * Bevacizumab\n    * Bevacizumab + capecitabine\n    * Bevacizumab + irinotecan (+\u002F- capecitabine)\n    * Bevacizumab + olaparib, bevacizumab + lenvatinib, bevacizumab + niraparib, bevacizumab + rucaparib\n    * Bevacizumab + Temozolomide, Bevacizumab + Lomustine, or Bevacizumab + everolimus\n    * Bevacizumab + trifluridine\u002Ftipiracil\n    * Bortezomib\n    * Bortezomib + cyclophosphamide, bortezomib + lenalidomide, bortezomib + pomalidomide, bortezomib + selinexor\n    * Bortezomib + venetoclax\n    * Carfilzomib\n    * Carfilzomib + cyclophosphamide, carfilzomib + lenalidomide, carfilzomib + pomalidomide, carfilzomib + selinexor\n    * Carfilzomib + venetoclax\n    * Cemiplimab\n    * Cisplatin\n    * Cisplatin\u002F5-FU\n    * Cisplatin\u002Fetoposide\n    * Cisplatin + durvalumab\n    * Cisplatin + gemcitabine\n    * Cisplatin + gemcitabine + durvalumab\n    * Daratumumab (+ oral \\[PO\\] cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Daratumumab + bortezomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Daratumumab + carfilzomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Degarelix\n    * Durvalumab\n    * Durvalumab + tremelimumab\n    * Eribulin\n    * FOLFIRI +\u002F- bevacizumab (5FU +\u002F- leucovorin + irinotecan)\n    * Fam-trastuzumab deruxtecan\n    * Fulvestrant\n    * Fulvestrant + ribociclib, fulvestrant + abemaciclib, fulvestrant + palbociclib, fulvestrant + alpelisib, or fulvestrant + capivasertib\n    * Gemcitabine\n    * Gemcitabine + durvalumab\n    * Gemcitabine + paclitaxel protein-bound\n    * Goserelin acetate\n    * Irinotecan\n    * Irinotecan + capecitabine\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + cabozantinib\n    * Nivolumab-relatlimab\n    * Octreotide\n    * Paclitaxel\n    * Pembrolizumab\n    * Pembrolizumab + axitinib, pembrolizumab + lenvatinib, pembrolizumab + capecitabine, pembrolizumab + dabrafenib +\u002F- trametinib, pembrolizumab + trametinib)\n    * Pemetrexed\n    * Pertuzumab\n    * Pemetrexed + pembrolizumab\n    * Rituximab\n    * Trastuzumab + paclitaxel\n    * Trastuzumab with or without pertuzumab maintenance (SQ or IV) (+\u002F- tucatinib +\u002F- capecitabine)\n    * Decitabine\n    * These regimens can be used only if patients are receiving one of the regimens above:\n\n      * Darbepoetin-alfa\n      * Epoetin\n      * Filgrastim\n* Note: Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the above eligible regimens may receive supportive care medications for treatment or prevention of bone metastases, including agents such as:\n\n  * Zoledronic acid\n  * Denosumab\n* Patient has had adequate tolerability of their clinical standard of care cancer treatment in the opinion of their treating physician and no drug-related infusion reactions prior to consent\n* Patients who according to documentation from their treating provider plan to continue the treatment regimen they are currently prescribed for at least 24 weeks from the start of cycle following randomization.\n* Residing within the area serviced by supplier and paramedic network\n* Residence has wireless fidelity (wifi) to enable a reliable connection with the remote Command Center or it is suitable for connection through a wireless network solution\n* Age \\>= 18 years at time of registration\n* Signed informed consent form by patient\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2\n* Ability to complete questionnaire(s) by themselves or with assistance\n* RANDOMIZATION ELIGIBILITY CRITERIA: In addition to the criteria above, confirmation by the CCBW Command Center that the patient has adequate tolerability to the standard of care cancer therapy and no drug-related infusion reactions since pre-registration and prior to registration\n\nExclusion Criteria:\n\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Note: Patients are permitted concomitant standard of care oral drugs such as ribociclib, abemaciclib, or palbociclib in combination with endocrine therapy (e.g., Leuprolide, fulvestrant intramuscular \\[IM\\], etc.); tucatinib and capecitabine in combination with trastuzumab and pertuzumab for HER2 positive breast cancer; dexamethasone, cyclophosphamide, lenalidomide or pomalidomide for multiple myeloma; temozolomide, lomustine, or afinitor in combination with avastin for glioblastoma. In addition, all oral anti-hormonal agents for breast and prostate cancer are permitted (e.g., tamoxifen, arimidex, abiraterone, etc.) if used in combination with any of the drugs\n* Requiring 24\u002F7 assistance with activities of daily living (ADLs)\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction =\\\u003C 6 months\n  * Wound healing disorder\n  * Or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":53,"type":20},220,[55],"PHASE2","This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings. This separation adds to the physical, emotional, social, and financial burden for patients and their families. The logistics and costs of navigating cancer treatments have become a principal contributor to patients' reduced quality of life. It is therefore important to reduce the burden of cancer in the lives of patients and their caregivers, and a vital aspect of this involves moving beyond traditional hospital and clinic-based care and evaluate innovative care delivery models with virtual capabilities. Providing cancer treatment at-home, versus in the clinic, may help reduce psychological and financial distress and increase treatment compliance, especially for marginalized patients and communities.",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,27,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,26,87,88,89,90,91,92,93,94,95,96,97,98,99],"Advanced Anal Carcinoma","Advanced Biliary Tract Carcinoma","Advanced Bladder Carcinoma","Advanced Breast Carcinoma","Advanced Carcinoid Tumor","Advanced Cervical Carcinoma","Advanced Colorectal Carcinoma","Advanced Gastric Carcinoma","Advanced Glioblastoma","Advanced Head and Neck Carcinoma","Advanced HER2 Positive Breast Carcinoma","Advanced Lung Carcinoma","Advanced Lung Small Cell Carcinoma","Advanced Malignant Germ Cell Tumor","Advanced Neuroendocrine Carcinoma","Advanced Ovarian Carcinoma","Advanced Pancreatic Carcinoma","Advanced Prostate Small Cell Neuroendocrine Carcinoma","Advanced Prostate Carcinoma","Hematopoietic and Lymphoid System Neoplasm","Multiple Myeloma","Myelodysplastic Syndrome","Advanced Basal Cell Carcinoma","Advanced Cholangiocarcinoma","Advanced Endometrial Carcinoma","Advanced Esophageal Carcinoma","Advanced Fallopian Tube Carcinoma","Advanced Hepatocellular Carcinoma","Advanced Liver Carcinoma","Advanced Malignant Testicular Neoplasm","Advanced Melanoma","Advanced Merkel Cell Carcinoma","Advanced Penile Carcinoma","Advanced Primary Malignant Central Nervous System Neoplasm","Advanced Renal Cell Carcinoma","Advanced Sarcoma","Advanced Skin Squamous Cell Carcinoma","Advanced Urethral Carcinoma","Advanced Vaginal Carcinoma","Advanced Vulvar Carcinoma","Advanced Appendix Carcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","2026-04-15",{"date":102,"type":36},"2026-04-20",{"date":104,"type":36},"2023-08-23",{"date":106,"type":20},"2027-01-01",{"name":108,"class":109},"Mayo Clinic","OTHER",2,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":134},"100439214","phase-1-first-in-human-dose-escalation-study-of-an4005-100439214","NCT04999384","First in Human, Dose Escalation Study of AN4005","Clinical Study Protocol AN4005X0101 An Open-Label, Multicenter, Phase 1 Study of AN4005 in Patients With Advanced Tumors","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years at the time of informed consent and have provided signed informed consent for the trial.\n\n  2\\. Willing and able to comply with all aspects of the protocol.\n\n  3\\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\n  4\\. Life expectancy ≥ 3 months.\n\n  5\\. Subjects with histologically or cytologically confirmed advanced solid tumors that are metastatic or unresectable, or relapsed or refractory (r\u002Fr) lymphoma, and for whom standard life-prolonging measures are not available. Types of lymphoma may include, but are not limited to, natural killer (NK)\u002FT-cell lymphoma, classic Hodgkin lymphoma (cHL), peripheral T-cell lymphoma (PTCL), and diffuse large B-cell lymphoma (DLBCL).\n\n  6\\. No standard therapy available or standard therapy is considered unsuitable or intolerable according to the Investigator.\n\n  7\\. Patients with or without measurable disease are considered eligible. Patients who have measurable disease as assessed by the local site investigator and\u002For radiologist. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\n  8\\. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. If previously treated with anti-PD-1\u002FPD-L1 therapy, tumor tissue sample obtained following the most recent anti-PD-1\u002FPD-L1 therapy is required. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. For patients with specific types of lymphomas, bone marrow biopsy will be required as appropriate.\n\n  9\\. Left ventricular ejection fraction (LVEF) greater than 50% on echocardiography or multiple gated acquisition (MUGA) scan.\n\n  10\\. Patient has organ function as shown by the following:\n  1. Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL.\n  2. Hemoglobin ≥8 g\u002FdL (which may be reached by transfusion).\n  3. Platelets ≥100 x 109\u002FL (which may be reached by transfusion).\n  4. International normalized ratio (INR) ≤1.5.\n  5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x upper limit of normal (ULN) or \\\u003C5.0 x ULN if liver metastases are present.\n  6. Total serum bilirubin ≤ ULN or ≤1.5 x ULN if liver metastases are present; or total bilirubin ≤3.0 x ULN with direct bilirubin below or within normal range in patients with well documented Gilbert's Syndrome. Gilbert's syndrome is defined as presence of episodes of unconjugated hyperbilirubinemia with normal results from cells blood count (including normal reticulocyte count and blood smear), normal liver function test results, and absence of other contributing disease processes at the time of diagnosis.\n  7. Creatinine clearance (CrCL) \\>60 mL\u002Fmin calculated by the Cockcroft-Gault Equation.\n\n     11\\. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  \u003C!-- -->\n\n  1. Not a woman of childbearing potential Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks prior to Screening. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment, is she considered not of child-bearing potential.\n  2. Woman of childbearing potential who agrees to follow contraceptive guidance during the treatment period and for at least 90 days after the last dose of study treatment.\n\nHighly effective contraception is defined as either:\n\n* Total abstinence: When this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n* Female sterilization: When the female study patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.\n* Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female study patients, the vasectomized male partner should be the sole partner for that patient.\n* Using a combination of any two of the following:\n\n  * Placement of an intrauterine device (IUD) or intrauterine system (IUS), and\n  * Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository.\n  * Hormonal contraception methods (e.g., oral, injected, implanted).\n\n    12\\. A male participant must agree to use contraception during the treatment period and for at least 90 days after the last dose of the study treatment.\n\nExclusion Criteria:\n\n1. Have been discontinued treatment due to a Grade 3 or higher immune-related AE (irAE) from prior anti-PD-1or anti-PD-L1 therapy, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).\n2. Have received prior systemic anti-cancer therapy including investigational oncology agents within 4 weeks or 5 half-lives, whichever is shorter.\n\n   Note: Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or returned to baseline. Participants with ≤ Grade 2 neuropathy or alopecia may be eligible.\n3. At least 6 weeks must have elapsed since CAR-T infusion and subjects must have experienced disease progression, and not have residual circulating CAR-T cells in peripheral blood (based on local assessment). Any encountered treatment-related toxicities must have resolved to Grade ≤1.\n4. Have received prior palliative radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-central nervous system (CNS) disease.\n5. Uncontrolled tumor-related pain.\n6. Have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Non live COVID vaccinations or boosters should not occur within 30 days prior to the first dose of study drug and during Cycle 1.\n7. Are currently participating in a study of an investigational agent or investigational device within 4 weeks or less than 5 half-lives, prior to the first dose of study treatment.\n\n   Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been at least 4 weeks after the last dose of the previous investigational agent (see Number 2 above).\n8. Have had an allogenic tissue (e.g., bone marrow or stem cells)\u002Fsolid organ transplant within the past 5 years.\n9. Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.\n10. With a history of another primary malignancy within the past 2 years, with the following exceptions: basal or squamous cell skin cancer, or carcinoma in situ of the cervix or breast that has undergone potentially curative therapy; or patients with a prior history of or clinically stable concurrent malignancy provided the malignancy is clinically insignificant, no treatment is required, and the patient is clinically stable.\n11. Have known severe hypersensitivity to study treatment components.\n12. Have an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n13. Have a history of (non-infectious) pneumonitis that has required steroids or have current pneumonitis.\n14. Have an active infection requiring systemic therapy within 2 weeks prior to the first dose of the study drug.\n15. Significant cardiovascular (CV) impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of the study drug; or cardiac arrhythmia requiring medical treatment (including oral anticoagulation). Patients who meet the following criteria should be excluded: a) A marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\>470 milliseconds (ms) using Fredericia's QT correction formula). b) A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). c) The use of concomitant medications that prolong the QT\u002FQTc interval.\n16. Major surgery within 4 weeks before the first dose of the study drug. Note: If participant received major surgery, they must have recovered adequately from surgery and the toxicity and\u002For complications requiring the intervention prior to starting study treatment.\n17. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the oral bioavailability of the investigational drugs.\n18. Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n19. Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study, e.g. history of or active major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, or history of suicidal attempt or ideation, homicidal ideation (e.g., risk of doing harm to self or others), or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders \\[DSM V\\]) are not eligible. Note: For patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous six weeks prior to start of study drug.\n20. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study treatment.\n21. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures \\>\u002F=1 time per month.\n22. Leptomeningeal disease.\n23. Spinal cord compression not definitively treated with surgery and\u002For radiation, or previously diagnosed and treated but without evidence that disease has been clinically stable for \\>\u002F=2 weeks prior to the first dose of the study drug.\n24. Oral or IV antibiotics within 2 weeks prior to the first dose of the study drug (except for prophylactic dose).\n25. Active tuberculosis.\n26. Patient is currently being treated with drugs known to be strong cytochromes P450 (CYP)3A4, inhibitors or inducers; UGT inducers or inhibitors; inhibitors of P-gP; sensitive substrates for CPY3A4, CYP2C9, CPY2C19 or P-gP (Appendix 4: List of Concomitant Drugs to Avoid Two Weeks Prior to and During Patient Enrollment) and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.\n27. Patient has a history of non-compliance to any medical regimen or inability to grant consent.",{"count":119,"type":20},31,[23],"Open-label, multicenter, phase 1 study to investigate the safety, tolerability, and PK of AN4005 in patients with advanced tumors. This study is a first-in-human, dose escalation study with the objective to establish the MTD and\u002For RP2D of AN4005.\n\nExcept for Dose Level 0 (50 mg), a traditional \"3 + 3 design\" will be utilized for dose finding with dose escalation and\u002For de-escalation as appropriate.",[123,26],"Advanced Solid Tumor","2025-11-17",{"date":126,"type":36},"2025-11-18",{"date":128,"type":36},"2021-09-27",{"date":130,"type":20},"2026-12",{"name":132,"class":133},"Adlai Nortye Biopharma Co., Ltd.","INDUSTRY",7,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100460720","phase-1-a-study-of-cs5001-in-patients-with-advanced-solid-tumors-and-lymphomas-100460720","NCT05279300","A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas","A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activities of CS5001, an Anti-ROR1 Antibody-Drug Conjugate, Used as A Single Agent and in Combination With Systemic Therapies in Patients With Advanced Solid Tumors and Lymphomas","Inclusion Criteria:\n\n* For solid tumor patients of dose escalation, they must have pathologically confirmed, unresectable advanced solid tumor with disease progression on or after at least 1 line of prior systemic therapy.\n* For Lymphoma patients of dose escalation, they must have pathologically confirmed Hodgkin and non-Hodgkin B-cell lymphoma as defined per 2016 World Health Organization(WHO) classification, with disease progression on or after at least 2 lines of prior systemic therapy.\n* For mono-therapy cohorts, eligible patients must have pathologically confirmed relapsed\u002Frefractory (R\u002FR) lymphomas or advanced solid tumors, and have demonstrated failure with previous line(s) of standard-of-care treatment. Patients in the solid tumor cohort must exhibit ROR1-positive expression in their baseline tumor tissues. For combination therapy cohorts, DLBCL patients must either be treatment-naïve or have experienced failure with at least one prior line of standard-of-care therapy to qualify for treatment with CS5001 in combination with first-line or subsequent standard-of-care therapies for DLBCL. Solid tumor patients must have pathologically confirmed disease, be naïve to PD-1\u002FPD-L1 inhibitors, and have at least failed first-line therapy or standard-of-care treatment.\n* For dose escalation, with at least one evaluable lesion as defined per Response Evaluation Criteria in Solid Tumours(RECIST) v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively. For dose expansion, with at least one measurable lesion as defined per RECIST v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively.\n* Life expectancy \\> 3 months.\n* Eastern Cooperative Oncology Group(ECOG) performance status 0-2.\n* Have adequate organ function.\n\nExclusion Criteria:\n\n* Has disease that is suitable for local treatment administered with curative intent. For lymphoma, candidacy for hematopoietic stem cell transplantation based on the Investigator's judgment.\n* Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.\n* For dose expansion: Participation in other studies involving therapies targeting ROR1 prior to study entry and\u002For during study participation.\n* Has known central nervous system (CNS) lymphoma or solid tumor CNS metastasis that is either symptomatic, untreated, or requires therapy.\n* Has other acute or chronic medical or psychiatric conditions.\n* Has a diagnosis of immunodeficiency, or has an active autoimmune disease or other conditions that require systemic steroid therapy.\n* Has peripheral edema, pericardial effusion, or ascites indicated for medical intervention or limiting activity of daily life. Or with a known history of peripheral vasculopathies.\n* Patients with any active infections requiring systemic therapy within 2 weeks prior to the administration of the first dose of the study drug.\n* Patients known to be human immunodeficiency virus (HIV)-positive or have acquired immune deficiency syndrome (AIDS).\n* Significant cardiovascular disease within 6 months prior to the first dose of the study drug.\n* Significant screening electrocardiogram (ECG) abnormalities.\n* Has received major surgery, chemotherapy, definitive radiotherapy, target therapy, immunotherapy, or other anti-cancer therapy within 21 days prior to the administration of the first dose of the study drug.\n* Administration of a live vaccine within 28 days prior to the administration of the first dose of the study drug.\n* Has active graft versus host disease.\n* With known active alcohol or drug abuse.\n* Women who are pregnant or breastfeeding.",{"count":143,"type":20},480,[23],"This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug CS5001 used as a single agent and in combination with systemic therapies in patients with advanced hematological and solid tumors.",[123,26],"2025-08-06",{"date":149,"type":36},"2025-08-11",{"date":151,"type":36},"2022-03-28",{"date":153,"type":20},"2027-12-31",{"name":155,"class":133},"CStone Pharmaceuticals",38,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":163,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":21,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":44},"100503333","phase-2-clinical-study-of-xpo1-inhibitor-selinexor-combined-with-copl-in-newly-diagnosed-advanced-nkt-cell-lymphoma-100503333","NCT05833893","Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK\u002FT-cell Lymphoma","Inclusion Criteria:\n\n* Age≥14 years, male or female;\n* Pathologically confirmed newly diagnosed NK\u002FT cell lymphoma according to WHO classification criteria 2016;\n* At least one measurable lesion, defined as bidimensionally measurable, intranodal lesion \\> 1.5 cm in short axis and extranodal lesion \\> 1.0 cm in short axis;\n* ECOG score 0\\~2;\n* Clinical stage III\\~IV;\n* Normal major organ function, meeting the following definitions: Hematology: WBC ≥ 3.5 x 10 9\u002FL, PLT ≥ 75 x 10 9\u002FL, Hb ≥ 80 g\u002FL; Liver and kidney function: AST and ALT ≤ 3.0 ULN; TBIL ≤ 2.0 mg\u002FdL; CCr ≥ 60 mL\u002Fmin; liver and kidney function impairment caused by tumor compression is not limited by this; Fibrinogen: normal at first cycle\n* Expected survival \\> 6 months\n* Agree to use effective contraception;\n* Understand and voluntarily sign written informed consent\n\nExclusion Criteria:\n\n* Prior allogeneic HCT (allo-HCT)\n* Active autoimmune disease\n* Primary central nervous system lymphoma;\n* Patients with infection which requiring treatment. Could be re-enrollment after infection control;\n* Known history of human immunodeficiency virus (HIV) infection\n* Known hypersensitivity to the study drug or any of its excipients;\n* Presence of other active malignancy requiring treatment that could interfere with this study;\n* Patients with other conditions not suitable for enrollment as judged by the investigator.","14 Years",{"count":165,"type":20},10,[55],"Patients with newly diagnosed, pathologically confirmed NK\u002FT-cell lymphoma of stage III-IV treated with XCOPL regimen. 3 weeks for a cycle, with a total of 6-8 cycles.",[169,170,26],"nk\u002FT-cell Lymphoma","Newly Diagnosed","2023-04-18",{"date":173,"type":36},"2023-04-27",{"date":175,"type":20},"2023-05-01",{"date":177,"type":20},"2026-12-31",{"name":179,"class":109},"Chinese PLA General Hospital"]