[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-malignant-solid-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-malignant-solid-neoplasm":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,43,54,85,141,164,196,223,255,281,318,363,382,406,427,448],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100054268","phase-2-testing-the-use-of-neratinib-or-the-combination-of-neratinib-and-palbociclib-targeted-treatment-for-her2-solid-tumors-a-combomatch-treatment-trial-100054268",false,"NCT06126276","Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)","A Randomized Trial of Neratinib, A Pan-ERBB Inhibitor, Alone or in Combination With Palbociclib, a CDK4\u002F6 Inhibitor, in Patients With HER2+ Gynecologic Cancers and Other Solid Tumors: A ComboMATCH Treatment Trial","Inclusion Criteria:\n\n* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N5 based on the presence of an actionable mutation as defined in EAY191\n* Patients must have a HER2 amplified solid tumor except breast cancer.\n\n  * If IHC is 0 or 1+, patient (pt) is NOT ELIGIBLE regardless of in situ hybridization (ISH)\u002FFISH or next generation sequencing (NGS) status\n  * If IHC is 3+, pt IS ELIGIBLE regardless of ISH\u002FFISH or NGS status\n  * If IHC is 2+, ISH\u002FFISH OR NGS must be positive for the patient to be ELIGIBLE. Otherwise, pt is NOT ELIGIBLE\n  * If IHC is unknown and…\n\n    * ISH\u002FFISH is positive, independent of NGS results, the patient IS ELIGIBLE\n    * ISH\u002FFISH is negative and NGS positive with ≥ 7 copies, the patient IS ELIGIBLE\n* Patients must have recurrent or persistent disease\n* No known evidence of RB1 loss or deletion including copy number loss or deleterious mutation\n* Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191)\n* Patients must have measurable disease based on RECIST 1.1. A second measurable lesion outside of the biopsiable lesion is required\n* Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression for 3 months or more and patient is not on steroids and is asymptomatic\n* No known leptomeningeal disease\n* Patients may have received up to 5 prior lines of systemic therapy\n* Prior therapy with trastuzumab or pertuzumab, either alone or in combination, antibody drug conjugates (ADC) such as DS8201a or T-DM1 is allowed\n* No prior therapy with HER2 targeting tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib\n* No prior therapy with CDK4\u002F6 inhibition\n* No cancer directed therapy within 3 weeks prior to registration. For oral therapy, the washout can be reduced to greater than or equal to 5 half lives of the drug. No HER2 targeting ADCs within 30 days prior to registration\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2\n* Not pregnant and not nursing\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 9 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 9 g\u002Fdl is acceptable)\n* Creatinine clearance (CrCL) of ≥ 30 mL\u002Fmin by the Cockcroft-Gault formula\n* Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional upper limit of normal (ULN)\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* No active infection requiring parenteral antibiotics\n* No current evidence of intra-abdominal abscess, abdominal\u002Fpelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and\u002For need for drainage nasogastric or gastrostomy tube\n* No current evidence of malabsorption or chronic diarrhea or any other significant gastro-intestinal disease (e.g gastrectomy, ileal bypass, Crohn's disease, gastroparesis), associated with moderate to severe diarrhea (grade 2 or more) or inability to tolerate oral therapy\n* No lung disease causing dyspnea at rest\n* No interstitial lung disease with ongoing signs and symptoms at the time of registration\n* No history of allergic reaction to the study agents, compound of similar chemical or biologic composition of the study agents or any of their excipients","ALL","18 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2.",[26,27,28,29],"Malignant Female Reproductive System Neoplasm","Malignant Solid Neoplasm","Recurrent Malignant Female Reproductive System Neoplasm","Recurrent Malignant Solid Neoplasm","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2024-05-07",{"date":38,"type":20},"2027-02-20",{"name":40,"class":41},"National Cancer Institute (NCI)","NIH",188,{"id":44,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":21,"phases":46,"briefSummary":24,"conditions":47,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":51,"completionDateStruct":52,"leadSponsor":53,"locationsCount":42},"100525787",{"count":19,"type":20},[23],[26,27,28,29],"2026-07-01",{"date":50,"type":34},"2026-07-02",{"date":36,"type":34},{"date":38,"type":20},{"name":40,"class":41},{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100482618","phase-2-targeted-therapy-directed-by-genetic-testing-in-treating-patients-with-locally-advanced-or-advanced-solid-tumors-the-combomatch-screening-trial-100482618","NCT05564377","Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial","Molecular Analysis for Combination Therapy Choice (ComboMATCH)","Inclusion Criteria:\n\n* Patient must have measurable disease\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of \\>= 50% or Karnofsky performance status of \\>= 50%\n* Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider\n* All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL)\n* Patients must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria:\n\n  * Patients must have progressed on at least one line of standard systemic therapy OR\n  * Patients whose disease has no standard treatment that has been shown to prolong overall survival\n* Patient must meet one of the following requirements:\n\n  * Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR\n  * Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:\n\n    * Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial\n    * Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response \\[CR\\] or partial response \\[PR\\]) to any intervening therapy after collection of the tissue\n    * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR\n  * Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:\n\n    * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available\n  * NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection and submission of the blood specimens for the integrated studies will be performed under the consent authority of the specific treatment trial protocol to which the patient is registered. No procedures to collect specimens for research only are to be performed for patients registered to the EAY191 Registration Trial only\n* NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial",{"count":62,"type":20},2900,[23],"This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.",[66,67,68,69,26,70,71,72,73,28,29,74,75,76,77],"Advanced Malignant Solid Neoplasm","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Locally Advanced Malignant Solid Neoplasm","Metastatic HER2-Negative Breast Carcinoma","Metastatic Malignant Solid Neoplasm","Recurrent Endometrial Carcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma","Unresectable HER2-Negative Breast Carcinoma","Unresectable Malignant Solid Neoplasm",{"date":50,"type":34},{"date":80,"type":34},"2023-04-07",{"date":82,"type":20},"2030-07-01",{"name":40,"class":41},481,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":98,"conditions":99,"keywords":121,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":140},"100431714","phase-1-study-of-onivyde-with-talazoparib-or-temozolomide-in-children-with-recurrent-solid-tumors-and-ewing-sarcoma-100431714","NCT04901702","Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma","A Randomized Phase I\u002FII Study of Talazoparib or Temozolomide in Combination With Onivyde in Children With Recurrent Solid Malignancies and Ewing Sarcoma","Inclusion Criteria\n\nPatients must be \\> 12 months and \\\u003C 30 years at the time of enrollment on study.\n\nPhase I\n\n* Patients with refractory or recurrent non-central nervous system (CNS) solid tumors not amenable to curative treatment are eligible. Patients must have had histologic verification of malignancy at original diagnosis or at the time of relapse. Patients eligible for the expansion cohort, A2, will include non-ES patients with refractory or recurrent non-CNS solid tumors with a deleterious alteration in germline or somatic genes involved in HR repair and DSBs signaling, germline or somatic assessed by prior comprehensive sequencing performed in a CLIA-approved (or equivalent) facility.\n\nPhase II\n\n* Patients with refractory or recurrent Ewing sarcoma (during or after completion of first-line therapy). Refractory disease is defined as progression during first line treatment or within 12 weeks of completion of first line treatment. Recurrent disease includes patients who received first line treatment and experienced disease progression at any time point \\>12 weeks from the completion of first line therapy.\n* Patients must have a histologic diagnosis of Ewing sarcoma with EWSR1- FLI1 translocation or other EWS rearrangement at the time of initial diagnosis. Repeat biopsy at the time of disease recurrence is strongly encouraged but it is not required\u002Fmandated for enrollment.\n\nDisease status\n\n* Patients must have either measurable or evaluable disease (see Section 7.0 for definitions). Measurable disease includes soft tissue disease evaluable by cross-sectional imaging (RECIST). Patients with bone disease without a measurable soft tissue component or bone marrow disease only are eligible for the phase 1 and phase 2 study but will not be included in the OR endpoint.\n* Performance level: Karnofsky \\> 50% for patients \\> 16 years of age and Lansky \\> 50% for patients \\\u003C 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\nPrior therapy\n\nPhase I Patients who have received prior therapy with an irinotecan-based or temozolomide-based regimen are eligible. Patients who have received prior therapy with a PARP inhibitor other than talazoparib are eligible.\n\nPhase II\n\n* Patients should have received first line therapy and developed either refractory or recurrent disease (first relapse).\n* Organ function: Must have adequate organ and bone marrow function as defined by the following parameters:\n* Patients with solid tumors not metastatic to bone marrow:\n* Peripheral absolute neutrophil count (ANC) \\>1,000\u002Fmm3 (1x109\u002FL)\n* Platelet count \\> 75,000\u002Fmm3 (75x109\u002FL) (no transfusion within 7 days of enrollment)\n* Hemoglobin \\> 9 g\u002FdL (with or without support)\n\nIn the phase I study, patients with solid tumors metastatic to bone marrow or with bone marrow hypocellularity defined as \\\u003C30% cellularity in at least one bone marrow site will be eligible for study, but they will not be evaluable for hematologic toxicity. These patients must not be refractory to red cell or platelet transfusions. At least 2 of every cohort of 3 patients (in the phase I study) must be evaluable for hematologic toxicity. If dose limiting hematologic toxicity is observed at any dose level, all subsequent patients enrolled at that dose level must be evaluable for hematologic toxicity.\n\n* Adequate renal function defined as: Creatinine clearance or radioisotope GFR \\> 60ml\u002Fmin\u002F1.73m2 or a serum creatinine maximum based on age\u002Fsex: age 6months to \\\u003C1 year, creatinine 0.4; 1 to \\\u003C 2 years, creatinine 0.6; 2 \\\u003C 6 years, creatinine 0.8; 6 \\\u003C 10 years, creatinine 1; 10 to \\\u003C13 years, creatinine 1.2; 13 to \\\u003C 16 years creatinine 1.5 (males) or 1.4 (females); \\> 16 years, creatinine 1.7 (males) 1.4 (females)\n* Adequate liver function defined as: normal liver function as defined by SGPT (ALT) concentration \\\u003C5x the institutional ULN, a total bilirubin concentration \\\u003C2x the institutional ULN for age, and serum albumin \\> 2g\u002FdL.\n* Adequate pulmonary function defined as no evidence of dyspnea at rest and a pulse oximetry \\> 94% if there is a clinical indication for determination. Pulmonary function tests are not required.\n* Patients must have fully recovered from the acute toxic effects of chemotherapy, immunotherapy, surgery, or radiotherapy prior to entering this study:\n* Myelosuppressive chemotherapy: Patient has not received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (8 weeks if received prior myeloablative therapy).\n* Hematopoietic growth factors: At least 7 days must have elapsed since the completion of therapy with a growth factor. At least 14 days must have elapsed after receiving pegfilgrastim.\n* Biologic (anti-neoplastic agent): At least 7 days must have elapsed since completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur.\n* Monoclonal antibodies: At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody or 28 days have elapsed since last dose of the monoclonal antibody with complete resolution of symptoms related to treatment.\n* Radiotherapy: At least 2 weeks must have elapsed since any irradiation; at least 6 weeks must have elapsed since craniospinal RT, 131I-mIBG therapy or substantial bone marrow irradiation (e.g., \\>50% pelvis irradiation).\n* Female participant who is post-menarchal must have a negative urine or serum pregnancy test and must be willing to have additional serum and urine pregnancy tests during the study.\n* Female or male participant of reproductive potential must agree to use effective contraceptive methods at screening and throughout duration of study treatment.\n\nExclusion Criteria\n\nPregnant or breastfeeding\n\n* Pregnant or breast-feeding women will not be entered on this study. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two methods of birth control: a medically accepted barrier of contraceptive method (e.g., male or female condom) and a second method of birth control during protocol therapy. Two highly effective methods of contraception are required for female patients during treatment and for at least 7 months after completing therapy. Male patients with female partners of reproductive potential and\u002For pregnant partners are advised to use two highly effective methods of contraception during treatment and for at least 4 months after the final dose.\n* Male and female participants must agree not to donate sperm or eggs, respectively, after the first dose of study drug through 105 days and 45 days after the last dose of study drug. Females considered not of childbearing potential include those who are surgically sterile (bilateral salpingectomy, bilateral oophorectomy, or hysterectomy).","12 Months","30 Years",{"count":95,"type":20},90,[97,23],"PHASE1","The phase I portion of this study is designed for children or adolescents and young adults (AYA) with a diagnosis of a solid tumor that has recurred (come back after treatment) or is refractory (never completely went away). The trial will test 2 combinations of therapy and participants will be randomly assigned to either Arm A or Arm B. The purpose of the phase I study is to determine the highest tolerable doses of the combinations of treatment given in each Arm.\n\nIn Arm A, children and AYAs with recurrent or refractory solid tumors will receive 2 medications called Onivyde and talazoparib. Onivyde works by damaging the DNA of the cancer cell and talazoparib works by blocking the repair of the DNA once the cancer cell is damaged. By damaging the tumor DNA and blocking the repair, the cancer cells may die. In Arm B, children and AYAs with recurrent or refractory solid tumors will receive 2 medications called Onivyde and temozolomide. Both of these medications work by damaging the DNA of the cancer call which may cause the tumor(s) to die.\n\nOnce the highest doses are reached in Arm A and Arm B, then \"expansion Arms\" will open. An expansion arm treats more children and AYAs with recurrent or refractory solid tumors at the highest doses achieved in the phase I study. The goal of the expansion arms is to see if the tumors go away in children and AYAs with recurrent or refractory solid tumors. There will be 3 \"expansion Arms\". In Arm A1, children and AYAs with recurrent or refractory solid tumors (excluding Ewing sarcoma) will receive Onivyde and talazoparib. In Arm A2, children and AYAs with recurrent or refractory solid tumors, whose tumors have a problem with repairing DNA (identified by their doctor), will receive Onivyde and talazoparib. In Arm B1, children and AYAs with recurrent or refractory solid tumors (excluding Ewing sarcoma) will receive Onivyde and temozolomide.\n\nOnce the highest doses of medications used in Arm A and Arm B are determined, then a phase II study will open for children or young adults with Ewing sarcoma that has recurred or is refractory following treatment received after the initial diagnosis. The trial will test the same 2 combinations of therapy in Arm A and Arm B. In the phase II, a participant with Ewing sarcoma will be randomly assigned to receive the treatment given on either Arm A or Arm B.",[100,101,102,103,29,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120],"Recurrent Solid Tumor","Recurrent Ewing Sarcoma","Recurrent Hepatoblastoma","Recurrent Malignant Germ Cell Tumor","Recurrent Neuroblastoma","Recurrent Osteosarcoma","Recurrent Peripheral Primitive Neuroectodermal Tumor","Recurrent Rhabdoid Tumor","Recurrent Rhabdomyosarcoma","Recurrent Soft Tissue Sarcoma","Recurrent Wilms Tumor","Refractory Ewing Sarcoma","Refractory Hepatoblastoma","Refractory Malignant Germ Cell Tumor","Refractory Malignant Solid Neoplasm","Refractory Neuroblastoma","Refractory Osteosarcoma","Refractory Peripheral Primitive Neuroectodermal Tumor","Refractory Rhabdoid Tumor","Refractory Rhabdomyosarcoma","Refractory Soft Tissue Sarcoma",[122,123,124,125,126,127,128,129],"Pediatric Cancer","Childhood Cancer","Ewing Sarcoma","PARP inhibitor","Solid tumor","Irinotecan","Onivyde","Talazoparib","2026-05-18",{"date":132,"type":34},"2026-05-19",{"date":134,"type":34},"2021-06-09",{"date":136,"type":20},"2026-12-31",{"name":138,"class":139},"St. Jude Children's Research Hospital","OTHER",10,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100533263","phase-1-studying-tak-243-in-patients-with-advanced-cancer-100533263","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",{"count":149,"type":20},95,[97],"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.",[153,66,154,71,29,114],"Advanced Lymphoma","Indolent Non-Hodgkin Lymphoma","2026-05-12",{"date":157,"type":34},"2026-05-13",{"date":159,"type":34},"2025-03-24",{"date":161,"type":20},"2027-04-15",{"name":40,"class":41},1,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":195},"100563756","phase-1-testing-the-addition-of-an-anti-cancer-drug-dt2216-to-the-usual-chemotherapy-treatment-for-relapsed-or-refractory-solid-tumors-and-fibrolamellar-carcinoma-100563756","NCT06620302","Testing the Addition of an Anti-cancer Drug, DT2216, to the Usual Chemotherapy Treatment for Relapsed or Refractory Solid Tumors and Fibrolamellar Carcinoma","DT2216 in Combination With Irinotecan for Children, Adolescents and Young Adults With Relapsed or Refractory Solid Tumors: A Phase I Study With Phase II Feasibility Cohort for Fibrolamellar Carcinoma","Inclusion Criteria:\n\n* PHASE 1: Patients between ≥ 1 year and ≤ 21 years of age at the time of study enrollment\n* PHASE 2: Patients between ≥ 1 year and ≤ 39 years of age at the time of study enrollment\n* PHASE 1: Patients with recurrent\u002Frefractory solid tumors excluding primary central nervous system tumors\n* PHASE 2: Patients with (FLC), which must include genomic confirmation of the DNAJB1:PRKACA fusion performed at a Clinical Laboratory Improvement Act (CLIA)-certified laboratory\n* PHASE 1: Patients must have either measurable or evaluable disease\n* PHASE 2: Patients must have measurable disease\n* PHASE 1: Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life\n* PHASE 2: Patients must have FLC which is recurrent\u002Frefractory to at least one line of prior systemic therapy\n* Patients with FLC that is unresectable at initial diagnosis but is not recurrent\u002Frefractory to at least one prior line of systemic therapy nor metastatic are NOT eligible for either phase 1 or phase 2\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients ≤ 16 years of age\n* Patients must have fully recovered (grade \\\u003C 2) from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, eg, blood count criteria, the patient is considered to have recovered adequately\n\n  * Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: See Developmental Therapeutics (DVL) homepage on the Children's Oncology Group (COG) members site for commercial and investigational agent classifications. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\n\n    * Solid tumor patients: ≥ 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea). Please refer to the table of myelosuppressive\u002Fanticancer agents on the COG website\n  * Anti-cancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil count \\[ANC\\] counts): ≥ 7 days after the last dose of agent. See the DVL homepage on the COG Members site for commercial and investigational agent classifications. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\n  * Antibodies: ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade ≤ 1\n  * Corticosteroids: If used to modify immune adverse events related to prior therapy, ≥ 14 days must have elapsed since last dose of corticosteroid\n  * Hematopoietic growth factors: ≥ 14 days after the last dose of a long-acting growth factor (eg, pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\n  * Interleukins, interferons and cytokines (other than hematopoietic growth factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\n  * Stem cell Infusions (with or without total body irradiation \\[TBI\\]):\n\n    * Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: ≥ 84 days after infusion and no evidence of graft versus host disease (GVHD)\n    * Autologous stem cell infusion including boost infusion: ≥ 30 days\n  * Cellular therapy: ≥ 30 days after the completion of any type of cellular therapy (eg, modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.)\n  * Radiotherapy (XRT)\u002Fexternal beam irradiation including protons: ≥ 14 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis; ≥ 42 days if other substantial bone marrow (BM) radiation\n  * Radiopharmaceutical therapy (eg, radiolabeled antibody, lobenguane I-131 \\[131I-MIBG\\]): ≥ 42 days after systemically administered radiopharmaceutical therapy\n  * Patients must not have received prior Bcl-xL specific therapy (e.g. navitoclax, DT2216). Prior therapy with irinotecan or other topoisomerase 1 inhibitors and\u002For other BH3 mimetics which are not Bcl-xL selective (e.g. venetoclax) are acceptable\n* For patients with solid tumors without known bone marrow involvement: Peripheral absolute neutrophil count (ANC) ≥ 1000\u002FµL\n* For patients with solid tumors without known bone marrow involvement: Platelet count ≥ 100,000\u002FµL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n* Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity\n* A creatinine based on age\u002Fgender as follows:\n\n  * 1 to \\\u003C 2 years: Maximum serum creatinine (mg\u002FdL) 0.6 (male), 0.6 (female)\n  * 2 to \\\u003C 6 years: Maximum serum creatinine (mg\u002FdL) 0.8 (male), 0.8 (female)\n  * 6 to \\\u003C 10 years: Maximum serum creatinine (mg\u002FdL) 1 (male), 1 (female)\n  * 10 to \\\u003C 13 years: Maximum serum creatinine (mg\u002FdL) 1.2 (male), 1.2 (female)\n  * 13 to \\\u003C 16 years: Maximum serum creatinine (mg\u002FdL) 1.5 (male), 1.4 (female)\n  * 16 to ≤ 39 years: Maximum serum creatinine (mg\u002FdL) 1.7 (male), 1.4 (female)\n\n    * OR a 24 hour urine creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m\\^2\n    * OR a glomerular filtration rate (GFR) ≥ 70 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard). Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility\n* Patients with solid tumors: Bilirubin (sum of conjugated + unconjugated or total) ≤ 1.5 x upper limit of normal (ULN) for age\n* Patients with solid tumors: Alanine aminotransferase (ALT) ≤ 3 x ULN, unless attributed to tumor involvement then ALT ≤ 5 x ULN\n\n  * Note: For the purposes of this study the ULN for ALT is defined as 45 U\u002FL\n* Patients with solid tumors: Aspartate aminotransferase (AST) ≤ 3 x ULN, unless attributed to tumor involvement then AST ≤ 5 x ULN\n\n  * Note: For the purposes of this study the ULN for AST is defined as 50 U\u002FL\n* Patients with solid tumors: Albumin ≥ 2 g\u002FdL\n* Patients with solid tumors: International normalized ratio (INR) ≤ 2.5\n* Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled as evidenced by no increase in seizure frequency in the prior 7 days. If needed, evaluate use of enzyme-inducing anticonvulsants\n* Nervous system disorders (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\]5) resulting from prior therapy must be ≤ grade 2, with the exception of decreased tendon reflex (DTR). Patient with any grade of tendon reflex decrease are eligible\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies, OR because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (eg, male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control. Patients who could become pregnant should use highly effective contraception during therapy and for 6 months after the last irinotecan dose or 120 days after the last dose of DT2216, whichever is longer. Patients with partners who could become pregnant should use condoms during therapy and for 3 months after the last dose irinotecan or 120 days after the last dose of DT2216, whichever is longer\n* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, ≥ 14 days must have elapsed since last dose of corticosteroid\n* Patients who are currently receiving another investigational drug are not eligible\n* Patients who are currently receiving other anti-cancer agents are not eligible\n* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\n* Patients who have received drugs that are strong inducers or inhibitors of CYP3A4 within 14 days prior to study enrollment are not eligible\n* Patients with lymphoma are excluded\n* Patients who have an uncontrolled infection are not eligible\n* Patients with grade ≥ 2 diarrhea at baseline are not eligible\n* Patients who have received a prior solid organ transplantation are not eligible\n* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible\n* Dedicated central nervous system (CNS) imaging is not required but patients with current active CNS metastasis whether symptomatic or discovered incidentally without clinical symptoms, are not eligible\n* Patients with grade \\> 2 corrected QT interval (i.e. electrocardiogram \\[EKG\\] showing corrected QT interval \\[QTc\\] \\> 480 ms) at baseline are not eligible\n* Surgical procedure\n\n  * Central line placement, open or core needle biopsy of sites other than liver: \\\u003C 2 days prior to enrollment.\n  * Open or laparoscopic biopsies or core needle biopsies of liver \\\u003C 7 days prior to enrollment.\n  * All other surgeries \\\u003C 14 days prior to enrollment","1 Year","39 Years",{"count":174,"type":20},81,[97,23],"This phase I\u002FII trial tests the safety, side effects and best dose of DT2216 in combination with irinotecan and how well it works in treating children, adolescents and young adults with solid tumors and fibrolamellar cancer that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). DT2216 is an anti-apoptotic protein B-cell lymphoma-extra large targeted protein degrader. It may stop the growth of tumor cells by blocking Bcl-xL, a protein needed for tumor cell survival. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid repair and may kill tumor cells. Giving DT2216 in combination with irinotecan may be safe, tolerable, and\u002For effective in treating children, adolescents and young adults with relapsed or refractory solid tumors or fibrolamellar cancer.",[178,179,180,181,29,182,183,184,114],"Childhood Fibrolamellar Carcinoma","Recurrent Childhood Fibrolamellar Carcinoma","Recurrent Childhood Malignant Solid Neoplasm","Recurrent Fibrolamellar Carcinoma","Refractory Childhood Fibrolamellar Carcinoma","Refractory Childhood Malignant Solid Neoplasm","Refractory Fibrolamellar Carcinoma","2026-05-01",{"date":187,"type":34},"2026-05-05",{"date":189,"type":34},"2025-06-12",{"date":191,"type":20},"2031-12-30",{"name":193,"class":194},"Children's Oncology Group","NETWORK",21,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":92,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":221,"locationsCount":222},"100429351","phase-1-cbl0137-for-the-treatment-of-relapsed-or-refractory-solid-tumors-including-cns-tumors-and-lymphoma-100429351","NCT04870944","CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma","A Phase 1\u002F2 Trial of CBL0137 (NSC# 825802) in Patients With Relapsed or Refractory Solid Tumors Including CNS Tumors and Lymphoma","Inclusion Criteria:\n\n* Parts A and B: Patients must be \\>= 12 months and =\\\u003C 21 years of age at the time of study enrollment\n* Patients must have had histologic verification of malignancy at original diagnosis or relapse, except in patients with diffuse intrinsic brain stem tumors, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers, including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)\n\n  * Part A: Patients with relapsed or refractory solid tumors or lymphoma, including patients with CNS tumors or known CNS metastases (including untreated or progressive) are eligible\n  * Part B: Patients with progressive or recurrent DIPG (diagnosed by biopsy or imaging characteristics) and other H3 K27-altered DMG previously treated with radiation therapy\n* Part A: Patients must have either measurable or evaluable disease\n* Part B: Patients must have measurable disease\n* Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life\n* Patients must have a performance status corresponding to Easter Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age. Patients must have a Karnofsky or Lansky score \\>= 50%\n* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately\n\n  * Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\n\n    * Solid tumor patients: \\>= 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\n  * Anti-cancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil count \\[ANC\\] counts): \\>= 7 days after the last dose of agent\n  * Antibodies: \\>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\\\u003C 1\n  * Corticosteroids: If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid. Patients with CNS tumors receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment\n  * Hematopoietic growth factors: \\>= 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\n  * Interleukins, interferons and cytokines (other than hematopoietic growth factors): \\>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\n  * Stem cell Infusions (with or without total body irradiation \\[TBI\\]):\n\n    * Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: \\>= 84 days after infusion and no evidence of graft versus host disease (GVHD)\n    * Autologous stem cell infusion including boost infusion: \\>= 30 days\n  * Cellular therapy: \\>= 42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.)\n  * Radiation therapy \\[XRT\\]\u002Fexternal beam irradiation including protons: \\>= 14 days after local XRT; \\>= 150 days after TBI, craniospinal XRT or if radiation to \\>= 50% of the pelvis; \\>= 42 days if other substantial bone marrow (BM) radiation\n  * Radiopharmaceutical therapy (e.g., radiolabeled antibody, I-131 metaiodobenzylguanidine \\[131I MIBG\\]): \\>= 42 days after systemically administered radiopharmaceutical therapy\n  * Patients must not have received prior exposure to CBL0137\n* For patients with solid tumors without known bone marrow involvement:\n\n  * Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL (performed within 7 days prior to enrollment unless otherwise indicated)\n  * Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity\n* For patients with solid tumors without known bone marrow involvement:\n\n  * Platelet count \\>= 100,000\u002FuL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (performed within 7 days prior to enrollment unless otherwise indicated)\n  * Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a creatinine based on age\u002Fsex as follows (performed within 7 days prior to enrollment unless otherwise indicated):\n\n  * Age: Maximum serum creatinine (mg\u002FdL)\n  * 1 to \\\u003C 2 years: 0.6 (male); 0.6 (female)\n  * 2 to \\\u003C 6 years: 0.8 (male); 0.8 (female)\n  * 6 to \\\u003C 10 years: 1 (male); 1 (female)\n  * 10 to \\\u003C 13 years: 1.2 (male); 1.2 (female)\n  * 13 to \\\u003C 16 years: 1.5 (male); 1.4 (female)\n  * \\>= 16 years: 1.7 (male); 1.4 (female)\n* Patients with solid tumors:\n\n  * Bilirubin (sum of conjugated + unconjugated or total) =\\\u003C 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment unless otherwise indicated)\n* Patients with solid tumors:\n\n  * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL (performed within 7 days prior to enrollment unless otherwise indicated)\n* Shortening fraction of \\>= 27% by echocardiogram (performed within 7 days prior to enrollment unless otherwise indicated) or\n* Ejection fraction of \\>= 50% by gated radionuclide study (performed within 7 days prior to enrollment unless otherwise indicated)\n* Corrected QT (QTC) \\\u003C 480 msec (performed within 7 days prior to enrollment unless otherwise indicated)\n* Patients with seizure disorder may be enrolled if seizures well controlled without the use of enzyme-inducing anti-convulsant agents. Well controlled is defined by no increase in seizure frequency in the prior 7 days\n* Nervous system disorders (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\]5) resulting from prior therapy must be =\\\u003C grade 2, with the exception of decreased tendon reflex (DTR). Any grade of DTR is eligible\n* Patients have consented to receive a central venous catheter prior to the administration of CBL0137. A central line is required for CBL0137 administration\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies, OR because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control\n* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid\n* Patients who are currently receiving another investigational drug are not eligible\n* Patients who are currently receiving other anti-cancer agents are not eligible (except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy)\n* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\n* Patients who are receiving drugs that are strong inducers or inhibitors of CYP3A4, CYP2B6 (e.g., carbamazepine) and CYP1A2 (e.g., ciprofloxacin, enoxacin, fluvoxamine, smoking) are not eligible. These agents are to be avoided for 7 days prior to the start of CBL0137 and for the duration of the protocol therapy. Sensitive substrates of CYP2D6 (e.g., atomoxetine, desipramine, dextromethorphan, eliglustat, nebivolol, nortriptyline, perphenazine, tolterodine, R-venlafaxine) should also be avoided for the duration protocol therapy\n* Patients who are receiving drugs associated with a known risk of Torsades de Pointes (TdP) are not eligible. Drugs associated with known risk of Torsades de Pointes (TdP) are to be avoided for 7 days prior to the start of CBL0137 and for duration of the protocol therapy\n* Patients with known peripheral vascular disease are excluded\n* Patients with a history of pro-thrombotic disorder are not eligible\n* Patients who have an uncontrolled infection are not eligible\n* Patients who have received a prior solid organ transplantation are not eligible\n* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible","21 Years",{"count":205,"type":20},63,[97,23],"This phase I\u002FII trial evaluates the best dose, side effects and possible benefit of CBL0137 in treating patients with solid tumors, including central nervous system (CNS) tumors or lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Drugs, such as CBL0137, block signals passed from one molecule to another inside a cell. Blocking these signals can affect many functions of the cell, including cell division and cell death, and may kill cancer cells.",[209,210,211,212,213,29,214,215,114,216],"Diffuse Midline Glioma, H3 K27-Altered","Metastatic Malignant Neoplasm in the Central Nervous System","Recurrent Diffuse Intrinsic Pontine Glioma","Recurrent Diffuse Midline Glioma, H3 K27-Altered","Recurrent Lymphoma","Recurrent Primary Malignant Central Nervous System Neoplasm","Refractory Lymphoma","Refractory Primary Malignant Central Nervous System Neoplasm",{"date":187,"type":34},{"date":219,"type":34},"2022-01-28",{"date":136,"type":20},{"name":193,"class":194},35,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":92,"maxAge":93,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":195},"100427831","phase-1-tegavivint-for-the-treatment-of-recurrent-or-refractory-solid-tumors-including-lymphomas-and-desmoid-tumors-100427831","NCT04851119","Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors","A Phase 1\u002F2 Study of Tegavivint (NSC#826393) in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors","Inclusion Criteria:\n\n* PART A: Patients must be \\>= 12 months and =\\\u003C 21 years of age at the time of study enrollment\n* PART B: Patients must be \\>= 12 months and =\\\u003C 30 years of age at the time of study enrollment\n* Patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse\n* PART A: Patients with relapsed or refractory solid tumors, including patients with non-Hodgkin lymphoma and desmoid tumors\n* PART B: Patients with recurrent or refractory Ewing sarcoma, desmoid tumors, osteosarcoma, liver tumors (HCC and hepatoblastoma), Wilms tumor, and tumors with Wnt pathway aberrations. For the Wnt pathway aberrations cohort we will include the most common CTNNB1 mutations (S37F, S45F, T41A, S45P, S33C, S37C, D32Y, S33F, T41I, G34R, G34V, D32N, S33P, G34E, D32G) as well as any loss of function mutations in the APC, Axin2FBXW7, TCF7L2, and RNF43 genes or any gain-of-function mutations in the GSK3B, LRP6, and LGR5 genes. For patients without prior sequencing, immunohistochemistry (IHC), is required. IHC showing strong nuclear beta-catenin staining will be accepted for the following tumor types: colorectal carcinoma, melanoma, endometrial cancer, ovarian cancer, neuroblastoma, non-Hodgkin lymphoma, pancreatic ductal adenocarcinoma, and solid pseudopapillary tumor of the pancreas\n* PART A: Patients must have either measurable or evaluable disease. For desmoid tumors, the patient must have disease that the investigator deems unresectable or sufficiently morbid or potentially life-threatening that there is favorable risk\u002Fbenefit to the patient to participate in the trial\n* PART B: Patients must have measurable disease. For desmoid tumors, the patient must have measurable disease that the investigator deems unresectable or sufficiently morbid or potentially life-threatening that there is favorable risk\u002Fbenefit to the patient to participate in the trial\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age\n* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately.\n\n  * Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\n\n    * Solid tumor patients: \\>= 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\n    * Non-Hodgkin lymphoma patients\n\n      * A waiting period prior to enrollment is not required for patients receiving standard maintenance chemotherapy (i.e., corticosteroid, vincristine, thioguanine \\[6MP\\], and\u002For methotrexate)\n      * \\>= 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy\n      * NOTE: Cytoreduction with hydroxyurea must be discontinued \\>= 24 hours prior to the start of protocol therapy\n  * Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil counts \\[ANC\\]): \\>= 7 days after the last dose of agent\n  * Antibodies: \\>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\\\u003C 1\n  * Corticosteroids: If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid\n  * Hematopoietic growth factors: \\>= 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\n  * Interleukins, interferons and cytokines (other than hematopoietic growth factors): \\>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\n  * Stem cell Infusions (with or without total-body irradiation \\[TBI\\]):\n\n    * Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: \\>= 84 days after infusion and no evidence of graft versus host disease (GVHD)\n    * Autologous stem cell infusion including boost infusion: \\>= 42 days.\n  * Cellular therapy: \\>= 42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.).\n  * External beam radiation therapy (XRT)\u002Fexternal beam irradiation including protons: \\>= 14 days after local XRT; \\>= 150 days after TBI, craniospinal XRT or if radiation to \\>= 50% of the pelvis; \\>= 42 days if other substantial bone marrow (BM) radiation\n  * Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 \\[131I MIBG\\]): \\>= 42 days after systemically administered radiopharmaceutical therapy\n  * Patients must not have received prior exposure to tegavivint\n* PATIENTS WITH SOLID TUMORS WITHOUT KNOWN BONE MARROW INVOLVEMENT: Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL (within 7 days prior to enrollment)\n* PATIENTS WITH SOLID TUMORS WITHOUT KNOWN BONE MARROW INVOLVEMENT: Platelet count \\>= 100,000\u002FuL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (within 7 days prior to enrollment)\n* PATIENTS WITH SOLID TUMORS WITHOUT KNOWN BONE MARROW INVOLVEMENT: Hemoglobin \\>= 8.0 g\u002FdL at baseline (may receive red blood cell \\[RBC\\] transfusions) (within 7 days prior to enrollment)\n* Patients with known bone marrow metastatic disease will be eligible for study provided they meet blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled on Part A must be evaluable for hematologic toxicity\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a creatinine based on age\u002Fgender as follows (within 7 days prior to enrollment):\n\n  * Age; maximum serum creatinine\n  * Age 1 to \\\u003C 2 years; 0.6 mg\u002FdL (male); 0.6 mg\u002FdL (female)\n  * Age 2 to \\\u003C 6 years; 0.8 mg\u002FdL (male); 0.8 mg\u002FdL (female)\n  * Age 6 to \\\u003C 10 years; 1 mg\u002FdL (male); 1 mg\u002FdL (female)\n  * Age 10 to \\\u003C 13 years; 1.2 mg\u002FdL (male); 1.2 mg\u002FdL (female)\n  * Age 13 to \\\u003C 16 years; 1.5 mg\u002FdL (male); 1.4 mg\u002FdL (female)\n  * Age \\>= 16 years; 1.7 mg\u002FdL (male); 1.4 mg\u002FdL (female)\n* PATIENTS WITH SOLID TUMORS: Bilirubin (sum of conjugated + unconjugated or total) =\\\u003C 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)\n* PATIENTS WITH SOLID TUMORS: Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL (within 7 days prior to enrollment)\n* PATIENTS WITH SOLID TUMORS: Albumin \\>= 2 g\u002FdL (within 7 days prior to enrollment)\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women will not be entered on this study because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control\n* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid\n* Patients who are currently receiving another investigational drug are not eligible\n* Patients who are currently receiving other anti-cancer agents are not eligible\n* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\n* Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to the 1st dose of tegavivint to the end of the study\n* Patients who have received bisphosphonates within 4 weeks prior to study enrollment will be excluded\n* Patients who have received denosumab within 180 days prior to study enrollment will be excluded\n* Patients with primary brain tumors are ineligible\n* Patients with known central nervous system (CNS) metastasis, except for craniopharyngeal tumors, will be excluded\n* Patients with a known metabolic bone disease (ex: hyperparathyroidism, Paget's disease, osteomalacia) are not eligible\n* Patients with a disorder associated with abnormal bone metabolism will be excluded\n* Patients with grade \\>= 2 hypocalcemia that is not corrected with oral calcium supplementation will be excluded\n* Patients with vitamin D \\\u003C 20 ng\u002FmL will require supplementation, or will otherwise be excluded. Patients must agree to take vitamin D +\u002F- calcium supplements (if necessary) according to institutional or published guidelines. Additional calcium supplementation is not required if adequate dietary intake can be ascertained\n* Patients with pre-existing grade 3 osteoporosis are excluded\n* Patients who have an uncontrolled infection are not eligible\n* Patients who have received a prior solid organ transplantation are not eligible\n* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible",{"count":231,"type":20},147,[97,23],"This phase I\u002FII trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating patients with solid tumors that has come back (recurrent) or does not respond to treatment (refractory). Tegavivint interferes with the binding of beta-catenin to TBL1, which may help stop the growth of tumor cells by blocking the signals passed from one molecule to another inside a cell that tell a cell to grow.",[235,236,237,238,239,240,241,101,102,242,29,243,105,244,111,112,245,114,246,116,247,248],"Colorectal Carcinoma","Endometrial Carcinoma","Melanoma","Neuroblastoma","Ovarian Carcinoma","Pancreatic Ductal Adenocarcinoma","Recurrent Desmoid Fibromatosis","Recurrent Hepatocellular Carcinoma","Recurrent Non-Hodgkin Lymphoma","Refractory Desmoid Fibromatosis","Refractory Hepatocellular Carcinoma","Refractory Non-Hodgkin Lymphoma","Solid Pseudopapillary Neoplasm of the Pancreas","Wilms Tumor",{"date":187,"type":34},{"date":251,"type":34},"2021-11-08",{"date":253,"type":20},"2028-06-30",{"name":193,"class":194},{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":264,"phases":4,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":163},"100538832","clonal-hematopoiesis-and-therapy-emergent-myeloid-neoplasms-in-patients-with-cancers-chances-study-100538832","NCT06295965","Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study","Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers (CHANCES)","Inclusion Criteria:\n\n* Subjects who have or have had ovarian, peritoneal, or fallopian tube carcinoma who have a life expectancy of greater than 6 months and:\n\n  * Have completed or plan to complete at least 5 cycles of platinum-based chemotherapy\n\nOR\n\n* Subjects who have or have had a solid tumor diagnosis and any of the following:\n\n  * At least 4 months of exposure to a PARP inhibitor\n  * Diagnosis of a blood disorder including, but not limited to, clonal hematopoiesis of indeterminate potential, cytopenia of unknown significance, or therapy-related myeloid neoplasm\n\nExclusion Criteria:\n\n* Individuals with a life expectancy of less than 6 months",{"count":263,"type":20},2000,"OBSERVATIONAL","This study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian or other solid cancers. Researchers want to identify risk factors for developing these blood cancers as well as if there is\u002Fare a genetic\u002Fenvironmental component(s) to developing blood cancer.",[73,74,75,29,267,268,269,270,239,271],"Clonal Cytopenia of Undetermined Significance","Clonal Hematopoiesis","Idiopathic Cytopenia of Undetermined Significance","Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder","Myeloid Neoplasm Post Cytotoxic Therapy","2026-04-14",{"date":274,"type":34},"2026-04-17",{"date":276,"type":34},"2024-01-02",{"date":278,"type":20},"2031-12-31",{"name":280,"class":139},"University of Washington",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":288,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":317},"100371641","phase-1-gene-modified-immune-cells-after-conditioning-regimen-for-the-treatment-of-stage-iiic-or-iv-melanoma-or-metastatic-solid-tumors-100371641","NCT04119024","Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors","Phase I Dose Escalation Study of Systemically Administered IL13Ra2 Chimeric Antigen Receptor (CAR) T Cells After a Nonmyeloablative Conditioning Regimen in Patients With Metastatic Melanoma and Other Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed malignancy that is considered surgically incurable with either:\n\n  * Stage IIIC melanoma including locally relapsed, satellite, in-transit lesions or bulky draining node metastasis\n  * Stage IV melanoma including patients with known brain metastases\n  * Other metastatic, non-central nervous system (CNS) solid tumor relapsed or refractory after all standard-of-care systemic therapies for which the patient is eligible\n* Confirmed IL13Ralpha2 tumor expression by immunohistochemistry (immunohistochemical assay \\[IHA\\] H-Score \\>= 50 in at least 10% of the total tumor specimen and in at least two high-power fields)\n* Age greater than or equal to 18 years old and less than 75 years old\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* A minimum of one measurable lesion defined as:\n\n  * Meeting the criteria for measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), OR\n  * Skin lesion(s) selected as non-completely biopsied target lesion(s) that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s)\n* Absolute neutrophil count (ANC) \\>= 1 x 10\\^9 cells\u002FL (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Platelets \\>= 75 x 10\\^9\u002FL (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Hemoglobin \\>= 9.5 g\u002FdL (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Aspartate and alanine aminotransferases (AST, ALT) =\\\u003C 2.5 x upper limit of normal (ULN) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Total bilirubin =\\\u003C 2 x ULN (except patients with documented Gilbert's syndrome) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Creatinine \\\u003C 2 mg\u002FdL (or a glomerular filtration rate \\> 45) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Patients with melanoma must have progressed following \\>= 1 line of systemic therapy, including immune checkpoint inhibitor and a BRAF inhibitor in combination with MEK inhibitor for patients with BRAF V600-activating mutation and is not considered to have an alternate treatment option with curative intent\n* Must be willing and able to accept at least one leukapheresis procedure (This does not apply for patients receiving a second infusion of IL13R a2 CAR T cells as they will not undergo leukapheresis)\n* Must be willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Inability to purify \\>= 1 x 10\\^7 T cells from leukapheresis product (this does not apply to patients receiving a second infusion of IL13Ra2 CAR T cells as they will not undergo leukapheresis)\n* Previously known hypersensitivity to any of the agents used in this study; known sensitivity to cyclophosphamide or fludarabine\n* Received systemic treatment for cancer, including immunotherapy, within 14 days prior to initiation of conditioning chemotherapy administration within this protocol\n* Clinically active brain metastases. Radiological documentation of absence of active brain metastases at screening is required for all patients. Prior evidence of brain metastasis successfully treated with surgery or radiation therapy will not be exclusion for participation as long as they are deemed under control at the time of study enrollment\n* Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 2 weeks prior to enrollment; not including patients with primary or secondary adrenal insufficiency who require physiologic replacement with steroids, or patients on inhaled or topical steroids at standard doses\n* Human immunodeficiency virus (HIV) seropositivity or other congenital or acquired immune deficiency state, which would increase the risk of opportunistic infections and other complications during chemotherapy-induced lymphodepletion. If there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and\u002For infectious disease specialist\n* Hepatitis B or C seropositivity with evidence of ongoing liver damage, which would increase the likelihood of hepatic toxicities from the chemotherapy conditioning regimen and supportive treatments. If there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and\u002For infectious disease specialist\n* Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol\n* A Tiffeneau-Pinelli index \\\u003C 70% of the predicted value. Subjects will be excluded if pulmonary function tests indicate they have insufficient pulmonary capability\n* Patients will be excluded if they have a history of clinically significant electrocardiography (ECG) abnormalities, symptoms of cardiac ischemia or arrhythmias and have a left ventricular ejection fraction (LVEF) \\\u003C 45% on a cardiac stress test (stress thallium, stress multigated acquisition scan (MUGA), dobutamine echocardiogram, or other stress test)\n* Patients with ECG results of any conduction delays (PR interval \\> 200 ms, corrected QT (QTC) \\> 480 ms), sinus bradycardia (resting heart rate \\\u003C 50 beats per minute), sinus tachycardia (HR \\> 120 beats per minute) will be evaluated by a cardiologist prior to starting the trial. Patients with any arrhythmias, including atrial fibrillation\u002Fatrial flutter, excessive ectopy (defined as \\> 20 ventricular premature complex \\[PVC\\]s per minute), ventricular tachycardia, 3rd degree heart block will be excluded from the study unless cleared by a cardiologist\n* Pregnancy or breast-feeding. Female patients must be surgically sterile or be postmenopausal for two years, or must agree to use effective contraception during the period of treatment and for 6 months afterwards. All female patients with reproductive potential must have a negative pregnancy test (serum\u002Furine) at screening and again within 14 days from starting the conditioning chemotherapy. The definition of effective contraception will be based on the judgment of the study investigators. Patients who are breastfeeding are not allowed on this study\n* A concomitant active malignancy that would be considered to interfere with the assessment of the primary or secondary endpoints of the study","75 Years",{"count":290,"type":20},18,[97],"This phase I trial studies the side effects and best dose of modified immune cells (IL13Ralpha2 CAR T cells) after a chemotherapy conditioning regimen for the treatment of patients with stage IIIC or IV melanoma or solid tumors that have spread to other places in the body (metastatic). The study agent is called IL13Ralpha2 CAR T cells. T cells are a special type of white blood cell (immune cells) that have the ability to kill tumor cells. The T cells are obtained from the patient's own blood, grown in a laboratory, and modified by adding the IL13Ralpha2 CAR gene. The IL13Ralpha2 CAR gene is inserted into T cells with a virus called a lentivirus. The lentivirus allows cells to make the IL13Ralpha2 CAR protein. This CAR has been designed to bind to a protein on the surface of tumor cells called IL13Ralpha2. This study is being done to determine the dose at which the gene-modified immune cells are safe, how long the cells stay in the body, and if the cells are able to attack the cancer.",[71,294,295,296,29,114,297,298,299,300,301,302,303,304,305,306,307],"Metastatic Melanoma","Pathologic Stage IIIC Cutaneous Melanoma AJCC v8","Pathologic Stage IV Cutaneous Melanoma AJCC v8","Uveal Melanoma","Acral Melanoma","Neuroendocrine Tumors","Paraganglioma","Pheochromocytoma","Adrenocortical Carcinoma","Pancreatic Neuroendocrine Tumor","Thyroid Cancer","Breast Cancer","Lung Adenocarcinoma","Head and Neck Squamous Cell Carcinoma","2026-03-13",{"date":310,"type":34},"2026-03-17",{"date":312,"type":34},"2025-10-07",{"date":314,"type":20},"2026-10",{"name":316,"class":139},"Anusha Kalbasi",3,{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":264,"phases":4,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":317},"100542959","immune-checkpoint-inhibitor-response-in-solid-tumors-using-a-live-tumor-diagnostic-platform-100542959","NCT06349642","Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform","Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform","ELEPHAS-04","Inclusion Criteria:\n\nSubjects must meet one of the following criteria:\n\n* Subjects suspected of or diagnosed with the following Stage IV\u002Fmetastatic or recurrent malignancies:\n\n  * Lung: Non-small Cell Lung Cancer (NSCLC)\n  * Skin: Cutaneous Malignancy, excluding Uveal Melanoma\n  * Esophageal Cancer\n  * Cervical Cancer\n  * Endometrial Cancer\n  * Colon Cancer: Mismatch repair deficient (dMMR) CRC only\n  * All solid tumors with high tumor mutation burden (TMB)\n  * All solid tumors that are microsatellite instability high (MSI-H)\n  * All mismatch repair deficient (dMMR) solid tumors\n  * Liver Cancer\n  * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with immune checkpoint inhibitor (ICI) therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate laboratory developed tests (LDTs) that, per clinician, render the patient eligible for ICI therapy, either frontline or a later line.\n\nOR\n\n* Subjects suspected of or diagnosed with the following Stage III per provider discretion or IV\u002Fmetastatic malignancies:\n\n  * Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)\n  * Bladder: Urothelial Carcinoma (UC)\n  * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line\n\nOR\n\n* Patients who will be receiving neoadjuvant CPI for the following resectable early-stage malignancies:\n\n  * Breast Cancer: Triple negative breast cancer (TNBC)\n  * Lung: Non-small cell lung cancer (NSCLC)\n\n    * NOTE: Patients with suspected NSCLC who would be eligible for neoadjuvant checkpoint inhibitor (CPI) are eligible to enroll per provider discretion\n  * Any solid tumor that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line\n* LOCALLY ADVANCED\u002FMETASTATIC PATIENTS: Measurable disease as defined per protocol NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible.\n* NEOADJUVANT PATIENTS: Subjects must be eligible based on investigator discretion to receive approved CPI therapy.\n* Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy.\n* Subjects who are Stage I, II, or III and have progressed to metastatic cannot have received any anti-cancer treatment for at least 2 - 4 weeks (depending upon the washout period of prior anti-cancer treatment) prior to biopsy as per the agents used.\n* ECOG Performance Status (PS) 0, 1 or 2.\n* Negative pregnancy test done ≤7 days prior to enrollment, for persons of childbearing potential only\n* Female subjects must not be pregnant or breastfeeding and must use appropriate methods of contraception when applicable.\n* Subjects must be clinically able, at investigator discretion, and willing to undergo either:\n\n  * additional biopsy passes during their standard of care biopsy, OR\n  * a biopsy for research only, if applicable.\n  * NOTE: These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to biopsies per the clinician.\n* Subjects with a known secondary cancer diagnosis are eligible to participate if participation does not interfere with systemic anti-cancer standard of care treatment for suspected primary diagnosis.\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant women because this study involves a greater than minimal risk procedure (biopsy)\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 for the biopsy\n* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * ongoing or active infection\n  * psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Subjects who are enrolled or plan to be enrolled in a blinded cancer therapeutic treatment trial",{"count":327,"type":20},324,"This study is being done to collect tissue samples to test how accurately a tumor response platform, Elephas, can predict clinical response across multiple types of immunotherapies, chemoimmunotherapy and tumor types.",[330,331,332,333,334,335,336,337,338,339,71,340,341,342,343,344,345,346,347,348,349,72,350,351,352,353,29],"Early Stage Triple-Negative Breast Carcinoma","Metastatic Bladder Urothelial Carcinoma","Metastatic Cervical Carcinoma","Metastatic Clear Cell Renal Cell Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Esophageal Carcinoma","Metastatic Liver Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Skin Neoplasm","Resectable Lung Non-Small Cell Carcinoma","Early Stage Lung Non-Small Cell Carcinoma","Resectable Malignant Solid Neoplasm","Resectable Triple-Negative Breast Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Recurrent Cervical Carcinoma","Recurrent Colorectal Carcinoma","Recurrent Esophageal Carcinoma","Recurrent Liver Carcinoma","Recurrent Lung Non-Small Cell Carcinoma","Recurrent Malignant Skin Neoplasm","2026-03-11",{"date":356,"type":34},"2026-03-12",{"date":358,"type":34},"2024-04-24",{"date":360,"type":20},"2027-05",{"name":362,"class":139},"Mayo Clinic",{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":21,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":163},"100415732","phase-1-talazoparib-and-palbociclib-axitinib-or-crizotinib-for-the-treatment-of-advanced-or-metastatic-solid-tumors-talacom-trial-100415732","NCT04693468","Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial","Modular Phase 1B Hypothesis-Testing, Biomarker-Driven, Talazoparib Combination Trial (TalaCom)","Inclusion Criteria:\n\n1. Pathogenic or likely pathogenic germline or somatic gene defect as determined by local assessment and classification in at least one of the following:\n\n   * Defect in DNA Damage Response (DDR) genes specified below for each cohort or other related genes at the discretion of the principal investigator in consultation with the MD Anderson Cancer Center Institute for Personalized Cancer Therapy Precision Oncology Decision Support (PODS) group. See below for additional eligibility guidance for Arms A - C:\n   * Eligibility for Arm A (Talazoparib + Palbociclib):\n\n     * Solid tumors with defects in DDR genes such as: BRCA1\u002F2, PALB2, RAD51C\u002FD, or other related genes at the discretion of the principal investigator, or\n     * MYC-aberrant solid tumors (e.g. overexpression, amplification, mutation)\n   * Eligibility for Arm B (Talazoparib + Axitinib):\n\n     * Solid tumors with defects in DDR genes such as: BRCA1\u002F2, PALB2, RAD51C\u002FD, or other related genes at the discretion of the principal investigator, or\n     * Participants with BRCA1\u002F2 wild-type high-grade serous ovarian cancer, or\n     * Participants with metastatic castration-resistant prostate cancer without a specific and\u002For selected mutation\n   * Eligibility for Arm C (Talazoparib + Crizotinib):\n\n     * Solid tumors with defects in DDR genes such as: BRCA1\u002F2, PALB2,36 RAD51C\u002FD, or other related genes at the discretion of the principal investigator, or\n     * Solid tumors with defects in MET, ALK or ROS1 (e.g. MET mutations or amplifications, high MET expression, ALK translocations, ROS1 translocations) NOTE: Participants who are eligible for more than one Arm will be assigned according to physician preference.\n2. Histological or cytological diagnosis of a solid tumor that is advanced\u002Fmetastatic, intolerable to standard therapy, resistant to effective standard therapy, or for which no standard therapy is available.\n3. Availability of a fresh or recent tumor tissue sample from a diagnostic biopsy\u002Fsurgery or a metastatic tumor biopsy; the sample must have been obtained within 12 months prior to study enrollment. When only bone disease is present, an archival tumor tissue sample obtained within 5 years prior to study enrollment may be accepted for non-prostate cancer patients and a fresh bone biopsy may be accepted for prostate cancer patients only.\n\n   NOTE: A fresh biopsy should be encouraged for all participants at time of enrollment even if a previous biopsy is available. Optional on-treatment and at-progression biopsies will be encouraged for all participants. With agreement of the PI, if the archived tissue is not available and\u002F or it is unsafe to obtain a fresh biopsy at screening, the participant is eligible.\n4. Have measurable disease at study enrollment as defined by RECIST v1.1 with at least 1 measurable lesion that has not previously been irradiated; or participants may have bone metastatic disease evaluable by Prostate Cancer Working Group 2 (PCWG2) for participants with metastatic castration-resistant prostate cancer (mCRPC), or according to the tumor evaluation criteria best suited and accepted for the tumor type being evaluated).\n5. Age . 18 years old.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1.\n7. Adequate bone marrow function (without hematopoietic growth factor or transfusion support within 14 days prior to study enrollment), including:\n\n   * Absolute Neutrophil Count (ANC) ≥ 1,500\u002Fmm3 or ≥ 1.5 x 109\u002FL\n   * Platelets ≥ 100,000\u002Fmm3 or ≥ 100 x 109\u002FL\n   * Hemoglobin ≥ 9 g\u002FdL (≥ 5.6 mmol\u002FL).\n8. Adequate renal function defined by an estimated creatinine clearance (CRCL) ≥ 60 mL\u002Fmin OR normal creatinine as assessed by 24h urine assessment (not both) will be required during the dose-escalation phase.\n\n   * Calculate CRCL according to the Cockcroft-Gault formula as: CRCL = \\[(140-age) × weight)\\]\u002F(72 x SCR)\\] × 0.85 (if female), where CRCL (creatinine clearance) is measured in mL\u002Fmin, age is expressed in years, weight in kilograms (kg), and SCR (serum creatinine) in mg\u002FdL 24h urine assessment:\n   * 24h urine assessment will be performed to assess whether creatinine is within normal limits\n   * In the event that 24h urine is used, then CRCL does not require to be calculated NOTE: Patients with moderate renal impairment (30 - 59 mL\u002Fmin) will be considered during the dose expansion phase. A reduced starting dose for talazoparib will be considered in these patients. If the dose for dose expansion is 1 mg once daily, the dose will be reduced to 0.75 mg once daily. If the expanded dose is 0.75 mg once daily, the dose will be reduced to 0.5 mg once daily.\n9. Adequate liver function including:\n\n   * Total serum bilirubin ≤ 1.5 x the upper limit of normal range (ULN)\n   * Aspartate and Alanine aminotransferase (AST and ALT) ≤ 5 x ULN.\n10. Female participants of childbearing potential must have negative serum pregnancy or urine pregnancy test at screening. Female participants of non-childbearing potential must meet at least one of the following criteria:\n\n    * Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state\n    * Have undergone a documented hysterectomy and\u002For bilateral oophorectomy\n    * Have medically confirmed ovarian failure All other female participants are considered to be of childbearing potential.\n11. Evidence of a personally signed and dated informed consent document, within 28 days prior to enrollment, indicating that the participant has been informed of all pertinent aspects of the study.\n12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n13. Able to swallow the study drug, have no known intolerance to study drugs or excipients, and comply with study requirements.\n\nExclusion Criteria:\n\n1. Prior anti-cancer therapy within 2 weeks prior to study enrollment or prior radiation therapy within 2 weeks prior to study enrollment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed at least 2 days prior to study enrollment and no clinically significant toxicities are expected (e.g. mucositis, esophagitis).\n2. Major surgery within 4 weeks prior to study enrollment.\n3. Participants with known hypersensitivity to either talazoparib or the additional study drug to be received per treatment arm: palbociclib (Arm A), axitinib (Arm B), crizotinib (Arm C).\n4. Diagnosis of myelodysplastic syndrome (MDS).\n5. Known symptomatic brain metastases requiring steroids. Participants with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 2 weeks, and are neurologically stable. Of note, participants who required a single dose of corticosteroids on days receiving radiation treatment do not require a 2-week washout.\n6. Persisting toxicity related to prior therapy (NCI CTCAE v5.0 Grade \\> 1). However, alopecia and sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 adverse events not constituting a safety risk, based on the investigators judgement, are acceptable.\n7. Active infection requiring systemic therapy. Minor infections, e.g. periodontal infection or urinary tract infection (UTI), which may be treated with short term oral antibiotics are allowed.\n8. Participants with known uncontrolled HIV virus or Acquired immunodeficiency syndrome. Note: Patients with history of controlled HIV virus will be considered eligible for this trial.\n9. Participants with uncontrolled Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening. Note: Participants with controlled hepatitis B or hepatitis C will be considered eligible for this trial.\n10. Clinically significant cardiovascular disease, including any of the following:\n\n    * Myocardial infarction or symptomatic cardiac ischemia within 6 months before screening;\n    * Congestive heart failure New York Heart Association class III or IV;\n    * History of clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes) within 1 year before screening;\n    * History of Mobitz II second degree or third degree heart block unless a permanent pacemaker is in place;\n    * Hypotension as indicated by systolic blood pressure \\\u003C86 mm Hg at screening;\n\n      * Bradycardia as indicated by a heart rate of \\\u003C45 beats per minute on the screening electrocardiogram;\n      * For part B participants only: Uncontrolled hypertension as indicated by systolic blood pressure \\>140 mm Hg or diastolic blood pressure \\>90 mm Hg despite optimal treatment. Participants can only be on one antihypertensive and stable doses of antihypertensives at discretion of PI.\n11. Current use of potent P-gp inhibitors within 7 days prior to enrollment: amiodarone, carvedilol, clarithromycin, cobicistat, dronedarone, erythromycin, glecaprevir\u002Fpibrentasvir, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, sofosbuvir\u002Fvelpatasvir\u002Fvoxilaprevir, telaprevir, tipranavir, valspodar, and verapamil.\n\n    • NOTE: Participants who have recently been on enzalutamide require a 28 day washout period due to longer elimination half-life of this therapy.\n12. Participants treated within the last 7 days prior to enrollment with:\n\n    • Food or drugs that are known to be strong CYP (cytochrome P-450) 3A4 inhibitors (ie, amprenavir, atazanavir, boceprevir, clarithromycin, conivaptan, delavirdine, diltiazem, erythromycin, fosamprenavir, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, miconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, verapamil, voriconazole, and grapefruit or grapefruit juice).\n\n    Drugs that are known to be strong CYP3A4 inducers (ie, carbamazepine, felbamate, nevirapine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentin, and St. John's wort.\n13. Inability to swallow capsules, known malabsorption syndrome, or other conditions that may impair absorption of study drugs.\n14. Bisphosphonate or denosumab dosage that was not stable (i.e. not the same) for at least 2 weeks before study enrollment for patients receiving these therapies.\n15. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the participant inappropriate for entry into this study.\n16. Medical, psychological, or social conditions that may interfere with the participant's participation in the study, or with the evaluation of the study results.\n17. Diagnosis of any other malignancy within 2 years prior to study enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast, bladder, or cervix, or low grade (Gleason ≤ 6) prostate cancer on surveillance without any plans for treatment intervention (e.g. surgery, radiation, or castration), or other early-stage low risk cancers.\n18. Pregnant female participants; breastfeeding female participants; fertile male participants; and female participants of childbearing potential who are unwilling or unable to use 2 methods of contraception for the duration of the study and for at least 7 months after the last dose of study drugs for female participants or 4 months after the last dose of study drugs for male participants, whichever is later for the individual patient. Male participants are prohibited from sperm donation while enrolled in this study and for 4 months after the last dose of the study drugs.\n\nHighly effective methods of contraception are those that alone or in combination, result in a failure rate of less than 1% per year when used consistently and correctly. These methods include:\n\n* Established use of oral, inserted, or injected or implanted hormonal methods of contraception are allowed provided the participant remains on the same treatment throughout the entire study and has been using that hormonal contraceptive for an adequate period of time to ensure effectiveness.\n* Correctly placed copper containing intrauterine device (IUD).\n* Male condom or female condom used with spermicide (i.e. foam, gel, film, cream or suppository).\n* Male sterilization with appropriately confirmed absence of sperm in the post-vasectomy ejaculate.\n* Bilateral tubal ligation or bilateral oophorectomy.",{"count":371,"type":20},111,[97],"This phase Ib trial is to find out the best dose, possible benefits and\u002For side effects of talazoparib when given in combination with palbociclib, axitinib, or crizotinib in treating patients with solid tumors that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). PARPs are proteins that help repair damaged DNA, the genetic material that serves as the body's instruction book. PARP inhibitors, such as talazoparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Palbociclib, axitinib, and crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving talazoparib in combination with palbociclib, axitinib, or crizotinib may help control locally advanced or metastatic solid tumors.",[66,71,29],{"date":308,"type":34},{"date":377,"type":34},"2020-12-01",{"date":379,"type":20},"2027-12-31",{"name":381,"class":139},"M.D. Anderson Cancer Center",{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":389,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":264,"phases":4,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":405},"100245494","collection-and-storage-of-tissue-and-blood-samples-from-patients-with-cancer-100245494","NCT02474160","Collection and Storage of Tissue and Blood Samples From Patients With Cancer","Patient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)","Inclusion Criteria:\n\n* Patients older than 2 months of age who are being evaluated, treated, or enrolled in a clinical trial for cancer at participating sites\n* Patients with a histologically or cytologically confirmed diagnosis of cancer\n* Patients without histologically or cytologically confirmed diagnosis of cancer, but for whom approval has been requested and received from the coordinating site study coordinator\n\n  * Requests for coordinating site approval should only be made if the patient's existing work-up at the time of the request demonstrates a combination of two or more of the following indicating the greater likelihood of a cancerous process in the assessment of the treating physician:\n\n    * Radiographic imaging (computed tomography \\[CT\\], magnetic resonance imaging \\[MRI\\], etc.)\n    * Elevated tumor markers\n    * Clinical symptoms\n    * Documented risk factors, known genetic changes (mutation, deletion, fusion, etc.), and\u002For known familial cancer history or syndrome\n    * Complete blood count (CBC) w\u002Fdifferential indicative of a probable hematologic malignancy\n  * If the patient will be undergoing surgical resection at a later time and will be accessible to approach for study participation at that time, resected material following cancer diagnosis confirmation is preferred\n  * Important: Additional medical, genetic and\u002For demographic work-up should not be obtained solely for determination of eligibility for protocol 9846 by these criteria. Once available, final histology must be confirmed to the coordinating site detailing the cancer diagnosis for patients enrolled based on the above criteria\n* Patients with a newly diagnosed primary and\u002For metastatic solid tumor or hematologic malignancy for which they have not yet received treatment\n* Patients with a solid tumor or hematologic malignancy that is recurrent, newly metastasized, or progressing while on treatment indicated by:\n\n  * Radiographic evidence of tumor growth, re-growth, and\u002For new metastases, OR\n  * Documentation by the treating physician of clinical disease progression, OR\n  * CBC w\u002Fdifferential and\u002For flow cytometry for hematologic malignancies\n* Patients currently undergoing treatment (adjuvant, neoadjuvant, etc.)\n\n  * Specimen collection should occur as distant in time from the most recent drug administration as possible (e.g., after completion of a treatment cycle and immediately prior to initiation of the next cycle)\n  * Specimens should not be collected from patients between doses within a single treatment cycle\n  * Confirmation of viable residual malignancy and\u002For \\\u003C 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the National Cancer Institute (NCI) coordinating site, as indicated in the final post-operative\u002Fpost-procedure pathology and\u002For flow cytometry report\n* Patients with ongoing partial response (PR) or stable disease (SD) are eligible\n\n  * Confirmation of viable malignancy and\u002For \\\u003C 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the NCI coordinating site, as indicated in the final post-operative\u002Fpost-procedure pathology and\u002For flow cytometry report\n* Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol\n\n  * For pediatric patients, ability and willingness to assent to participation, using an explanation that is understandable\u002Fage appropriate, as well as receiving parental permission. Signature requirements for pediatric patients can be adjusted based on local guidelines\n\nExclusion Criteria:\n\n* Patients with cancer-like syndromes and\u002For blood disorders such as systemic mastocytosis, Langerhans cell histiocytosis, chronic eosinophilic leukemia\u002Fhypereosinophilic syndrome, lymphomatoid granulomatosis, or monoclonal gammopathy of undetermined significance (MGUS)\n* Patients with invasive fungal infections\n* Patients with active and\u002For uncontrolled bacterial, fungal, or viral infections or who are still recovering from an infection\n\n  * Actively febrile patients with uncertain etiology of febrile episode\n  * All antibiotics prescribed for the treatment of a bacterial infection should be completed at least 1 week (7 days) prior to collection\n\n    * Patients with a hematologic malignancy who are treated with an antibiotic, anti-fungal, and\u002For anti-viral medication for an active infection who then remain on the treatment for prophylaxis following resolution of the infection as assessed by the treating physician are not excluded\n  * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics\n  * Patients receiving antibiotics, antifungals, and\u002For antivirals for prophylaxis are permissible\n  * Antibiotics being administered topically at a location distant from the planned tissue collection site or eye drops for a localized infection are permissible\n* Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e., quantifiable hepatitis B virus \\[HBV\\]-deoxyribonucleic acid \\[DNA\\] and\u002For positive hepatitis B surface antigen \\[HbsAg\\], quantifiable hepatitis C virus \\[HCV\\]-ribonucleic acid \\[RNA\\]) or known history of HCV, HBV, or HIV; testing for HBV, HCV, HIV or other infections for eligibility will be performed only if clinically indicated\n* Patients with hepatitis A as indicated by anti-hepatitis A virus (HAV) IgM reactivity\n\n  * Patients that are anti-HAV IgG reactive only are eligible\n* Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR)","2 Months",{"count":391,"type":20},5000,"This study collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn about cancer and to test new cancer drugs.",[394,27,71,29],"Hematopoietic and Lymphatic System Neoplasm","2026-03-04",{"date":397,"type":34},"2026-03-05",{"date":399,"type":34},"2015-05-19",{"date":401,"type":20},"2026-05-04",{"name":403,"class":404},"National Cancer Institute LAO","UNKNOWN",140,{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":413,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":21,"phases":416,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":426,"locationsCount":163},"100443843","parenting-support-intervention-for-families-coping-with-metastatic-or-locally-recurrent-solid-tumor-diagnosis-100443843","NCT05059678","Parenting Support Intervention for Families Coping With Metastatic or Locally Recurrent Solid Tumor Diagnosis","Parenting Support Intervention for Families Coping With an Advanced Cancer Diagnosis","Inclusion Criteria:\n\n* Participants must (1) be diagnosed with a metastatic or locally recurrent solid malignant tumor and on active treatment; (2) be at least 18 years old; (3) have at least one dependent child between the ages of 4 and 16 and currently living with the parent; (4) be able to provide informed consent and (5) have a spousal caregiver over the age of 18 who co-parents the child(ren) (i.e. share custody) and is willing and able to consent to participate.\\*\n\nExclusion Criteria:\n\n* Participants and caregivers who do not read and speak English and who do not have access to the internet.",true,{"count":415,"type":20},120,[417],"NA","This clinical trial examines the acceptability and effect of a parenting support intervention for families coping with solid tumor that has spread to other places in the body (metastatic) or has come back (recurrent). Parenting support program may help to reduce common parenting concerns, improve communication between parents and children about cancer, and improve the overall psychological wellbeing of parents.",[71,29],"2026-02-17",{"date":422,"type":34},"2026-02-19",{"date":424,"type":34},"2021-11-30",{"date":136,"type":20},{"name":381,"class":139},{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":264,"phases":4,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":439,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":163},"100429392","adoption-of-audio-recording-in-the-outpatient-supportive-care-center-100429392","NCT04871477","Adoption of Audio Recording in the Outpatient Supportive Care Center","The Adoption of Audio Recording in the Outpatient Supportive Care Center","Inclusion Criteria:\n\n* Patients with the diagnosis of advanced cancer as defined as locally advanced, recurrent or metastatic cancer. Both solid and liquid tumors are eligible for the study\n* Patients who are seen in the outpatient supportive care center at M.D. Anderson Cancer Center\n* Patients who have access to a recording device or cellphone with recording technology\n* Patients who can be contacted 7 to 11 days from the clinic visit that the recording took place\n* Patients who can sign informed consent\n* Patients who are able to read and write in English\n* Patients 18 years or older\n\nExclusion Criteria:\n\n* Patients who have been diagnosed with delirium or cognitive impairment. This will be defined by chart review along with review of the MD Anderson Symptom Inventory (MDAS) the day of clinic visit. An MDAS of 7 or greater will be considered to define delirium in this study\n* Patients who are unwilling to sign informed consent\n* Patients who have used audio recordings before in clinic visits\n* Patients who have severe hearing impairments without access to assisted devices or programs to aid in listening to the recorded material",{"count":435,"type":20},200,"This study evaluates how patients feel about having an audio recording of their visit to help remember information given to them and share that information with family members and\u002For caregivers not present during a clinic visit. Information from this study may help evaluate the effectiveness of using technology to help improve patient care by recording consultation recommendations.",[66,438,69,71,29],"Hematopoietic and Lymphoid Cell Neoplasm","NOT_YET_RECRUITING","2026-01-13",{"date":442,"type":34},"2026-01-14",{"date":444,"type":20},"2026-01-30",{"date":446,"type":20},"2027-01-30",{"name":381,"class":139},{"id":449,"slug":450,"hasResults":11,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":21,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":163},"100540712","phase-1-axatilimab-in-combination-with-retifanlimab-and-paclitaxel-for-the-treatment-of-patients-with-advanced-or-metastatic-solid-tumors-100540712","NCT06320405","Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors","A Phase Ib\u002FII Study of Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Ability to comprehend the investigational nature of the study and provide informed consent. Written informed consent must be obtained prior to any study specific procedures or interventions\n* Age ≥ 18 years at the time of consent. All participants, irrespective of their gender, gender identity, race, and ethnicity, will be included\n* Certified, documented diagnosis of a metastatic solid tumor based on pathology review\n* Presence of at least one lesion that is measurable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and another lesion that is amenable to tumor biopsy\n* Relapsed from, or refractory to, standard of care (SOC) systemic therapy known to prolong survival or if, in the opinion of the primary treating oncologist, a clinical trial is the best option for the next line of treatment based on response and\u002For tolerability to available therapies\n* Investigational therapy is permitted after a wash-out period of 5 half-lives (if known), or 28 days, whichever is shorter, prior to study day -8. Prior use of an investigational agent for imaging, such as T cell imaging, is permitted\n* Prior treatment with taxanes. A wash-out of period of ≥ 3 months prior to day -8 must be met for enrollment. Prior anti PD-1\u002FPD-L1 therapy is allowed, but not required\n* Eastern Cooperative Oncology Group (ECOG) status (performance status \\[PS\\]) of 0-1\n* Life expectancy of greater than 12 weeks according to certified physician review\n* Hemoglobin (Hb) ≥ 8.5 g\u002FdL\n* Leukocytes ≥ 3,000\u002FmcL\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL\n* Platelets ≥ 100K\u002Fcc mL\n\n  * Values must be obtained without transfusion within 2 weeks\n* Serum creatinine (sCr) \\\u003C 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin (calculated with the Cockcroft-Gault formula) for participants with creatinine (sCr) levels above institutional normal\n* Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN)\n\n  * With the exception of documented Gilbert's syndrome or similar conditions, at the discretion of the principal investigator (PI). Clinical chemistry testing may be adjusted, as clinically indicated\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) or alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 x ULN\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Corrected QT interval Fridericia's formula (QTcF) of \\\u003C 480 ms on a 12 lead electrocardiogram (EKG), except for participants with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid\n* Willingness to modify concomitant drug regimens, at the recommendation and discretion of pharmacy services, including the use of known substrates or inhibitors of CYP2C8 and CYP3A4\n* Physiologic maintenance doses of corticosteroids (≤ 10 mg\u002Fday of prednisone or equivalent) are permitted. Examples include: Asthma treatment; topical ocular, intra-articular, or intranasal steroids with minimal systemic absorption; and brief courses of corticosteroids for prophylaxis\n* Patients with CD4+ T-cell (CD4+) counts ≥ 350 cells\u002FuL are eligible regardless of HIV serology\n\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment are eligible\n  * In the case of ongoing treatment with antiretroviral therapy (ART), medication adjustment may be necessary for the duration of treatment. A wash-out period may be necessary, at the recommendation of the institutional research pharmacy service (RPS)\n* Evidence of chronic hepatitis B virus (HBV) infection (i.e., hepatitis B surface antigen \\[HBsAg\\]-positive, undetectable or low HBV deoxyribonucleic acid \\[DNA\\], and normal ALT) in the absence of HBV therapy, or serologic evidence of a resolved prior HBV infection (i.e., HBsAg-negative and hepatitis B virus core antibody \\[anti-HBc\\]-positive) is permitted\n* History of hepatitis C virus (HCV) infection is permitted given prior curative treatment or undetectable HCV viral load by serology or polymerase chain reaction (PCR) testing\n\n  * Patient who are HCV antibody (Ab) seropositive but HCV ribonucleic acid (RNA) negative due to prior treatment or natural resolution are eligible\n\nExclusion Criteria:\n\n* Secondary malignancy with documented diagnosis by a treating physician \\\u003C 3 years prior to study day -8. The following criteria also apply:\n\n  * New or progressive brain metastases. Patients with brain metastases not requiring immediate central nervous system (CNS) specific treatment or stable for at least 4 weeks prior to study day -8 are eligible at the discretion of the investigator given that neurologic symptoms are resolved.\n  * Patients with active leptomeningeal disease are not eligible\n* Palliative radiation therapy administered within 1 week prior to study day -8, Note: Participants must have recovered from all radiation-related toxicities (to grade \\\u003C 1 or baseline), must not require corticosteroids for this purpose, and must not have had radiation pneumonitis\n* Immunization with a live vaccine within 28 days prior to study day -8\n* History of organ transplantation, including hematopoietic stem cell transplantation (HSCT)\n* Clinical evidence of interstitial lung disease or active non-infectious pneumonia\n* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (≤ 10 mg\u002Fday of prednisone or equivalent is permitted)\n* Prior National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 immune-related adverse event (irAE) that required systemic immunosuppression (endocrinopathies managed by stable doses of supplements and\u002For corticosteroids ≤ 10 mg\u002Fday are permitted)\n* Unresolved toxicities (resolution required to grade 1 or baseline) from prior anticancer therapies. The following exceptions apply:\n\n  * Alopecia, lymphopenia, grade 2 neuropathy (if not resulting in functional deficit), and grade 1 (no supplementation required) or grade 2 endocrinopathies (stable on supplements)\n* Prior allergy or severe hypersensitivity reaction to axatilimab, retifanlimab, paclitaxel, cremaphor-containing agents, and\u002For components of the drug formulations\n* Active infection requiring systemic antibiotic therapy\n* Persons of childbearing potential (PCBP) who are pregnant (i.e., positive pregnancy test within 7 days prior to study day -8) or breastfeeding are not eligible.\n\n  * The effects of the investigational regimen on the developing human fetus are unknown. For this reason, persons of reproductive potential must agree to use a highly effective form of contraception, starting with the time of consent to 4 months after the last dose of retifanlimab or 90 days after the last dose of axatilimab, whichever is longer\n  * Sperm-producing participants must not donate sperm throughout the study period and for 90 days post completion of study treatment\n* Uncontrolled, intercurrent illness and psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, at the discretion of the investigator",{"count":456,"type":20},38,[97,23],"This phase I\u002FII trial tests the safety, side effects, and effectiveness of axatilimab in combination with retifanlimab and paclitaxel for the treatment of 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). Axatilimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Giving axatilimab in combination with retifanlimab and paclitaxel may be safe, tolerable and\u002For effective in treating patients with advanced or metastatic solid tumors.",[66,71,29,114],"2025-12-25",{"date":462,"type":34},"2025-12-29",{"date":464,"type":34},"2024-05-21",{"date":466,"type":20},"2029-04-01",{"name":468,"class":139},"OHSU Knight Cancer Institute"]