[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-solid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-solid-tumor":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100475241","phase-1-safety-and-efficacy-of-cyclophosphamide-sorafenib-bevacizumab-and-atezolizumab-in-pediatric-solid-tumor-patients-100475241",false,"NCT05468359","Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients","ANGIO-A: Safety and Tolerability of Oral Cyclophosphamide and Sorafenib With Intravenous Bevacizumab With the Addition of Atezolizumab in Pediatric Solid Tumor Patients","Inclusion Criteria:\n\n* Age: Patients must be \\\u003C 30 years at the time of enrollment on study.\n* Willingness to enroll on the St. Jude Molecular Analysis of Solid Tumors (MAST) study.\n* Diagnosis\n* Part 1: Patients with refractory or recurrent (relapsed) solid tumors accessible by biopsy for which there is no standard therapy are eligible.\n* Part 2: Patients with one of the following diagnoses:\n* Biopsy accessible refractory or recurrent (relapsed) hepatocellular carcinoma\n* Biopsy accessible refractory or recurrent (relapsed)or FL-HCC, DSRCT or non-CNS MRT.\n* Performance level: Karnofsky \\> 50 for patients \\> 16 years of age and Lansky \\> 50 for patients \\\u003C 16 years of age (See Appendix III). Note: 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* Disease status: Patients must tumors that are unresectable and have either measurable or evaluable disease that is accessible by biopsy\n* Organ function: Must have adequate organ and bone marrow function as defined by the following parameters:\n* Patients with solid tumor not metastatic to bone marrow:\n\n  * Peripheral absolute neutrophil count (ANC) \\>1,000\u002Fmm3\n  * Platelet count \\> 75,000\u002Fmm3 (no transfusion within 7 days of enrollment)\n  * Hemoglobin \\> 8 g\u002FdL (with or without support)\n* Patients with solid tumor metastatic to bone marrow will be eligible for study but not evaluable for hematologic toxicity. These patients must not be known to be refractory to red cell or platelet transfusions. At least 2 of every cohort of 3 patients must be evaluable for hematologic toxicity. If dose limiting hematologic toxicity is observed at any dose level, all subsequent patients enrolled must be evaluable for hematologic toxicity.\n* Adequate renal function defined as serum creatinine based on age as shown in Table 1, or creatinine clearance or radioisotope GFR 50 ml\u002Fmin\u002F1.73m2 (GFR 40 ml\u002Fmin\u002F1.73m2 if \\\u003C 2 years of age).\n* Adequate hepatic function defined as total bilirubin \\\u003C 5x upper limit of normal (ULN) and AST\u002FALT \\\u003C 3 x ULN for age.\n* Adequate cardiac function defined as shortening fraction \\> 28% OR ejection fraction of ≥ 47% by echocardiogram.\n* Adequate blood clotting defined as PT\u002FPTT \\\u003C 1.2 x ULN without factor replacement products for 7 days\n* Females of childbearing potential and males able to father a child must be willing to practice acceptable methods of birth control to prevent pregnancy during the study and for at least 5 months after last dose of therapy.\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 1 weeks of enrollment onto this study (within 2 weeks of estimated therapy start date) (4 weeks if prior nitrosourea).\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 14 days (at least 21 days from therapy start date) must have elapsed since the completion of therapy with a monoclonal antibody.\n* Radiotherapy: At least 1 week (2 weeks from estimated therapy start date) must have elapsed since any irradiation; at least 5 weeks (at least 6 weeks from estimated therapy start date) must have elapsed since craniospinal RT or substantial bone marrow irradiation.\n* Chemoembolization: at least 21 days (28 days from estimated therapy start date) must have elapsed since the completion of chemoembolization\n* Radioembolization: at least 21 days (28 days from estimated therapy start date) must have elapsed since the completion of radioembolization\n* Cardiac disease or hypertension: Patients must not have a history of myocardial - infarction, severe or unstable angina, or severe peripheral vascular disease. Hypertension must be well controlled on stable doses of medication for at least two weeks.\n* Female participant who is post-monarchal must have a negative urine or serum pregnancy test.\n* Life expectancy of at least 8 weeks\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Currently receiving other investigational drugs.\n* Unwilling or unable to comply with the safety monitoring requirements of this protocol.\n* Tumor not safely accessible by biopsy\n* Inability or unwillingness of research participant or legal guardian \u002F representative to give written informed consent.\n* Surgical procedures and serious or non-healing wounds: patients with a documented, chronic non-healing wound, ulcer, or bone fracture or history of a major surgical procedure or significant traumatic injury within 28 days prior to beginning therapy are excluded due to preclinical evidence supporting the potential for delayed wound healing.\n* Minor surgical procedures for minimally invasive biopsies will be allowed. For minor surgeries, the wound must be healed, and 7 days elapsed since surgery. For procedures such as the placement of an indwelling IV catheter, it is recommended that bevacizumab be postponed for at least 24 hours after the procedure.\n* Thrombosis: Patients must not have a deep venous or arterial thrombosis (including pulmonary embolism) within the last three months prior to study entry and must not have a known thrombophilic condition (i.e., protein S, protein C or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia or antiphospholipid antibody syndrome).","ALL","30 Years",{"count":19,"type":20},64,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a phase I\u002FII study to evaluate the safety of combining intravenous (IV) atezolizumab and bevacizumab every three weeks, with daily oral cyclophosphamide and pharmacokinetic (PK)-guided sorafenib in children and adolescent and young adults (AYA) with relapsed or refractory solid malignancies (Part 1), and then evaluate the response rate of this combination in children, AYA with relapsed or refractory fibrolamellar carcinoma (FLC) and other rare solid malignancies (Part 2).\n\nPrimary Objectives Part 1\n\n* To establish the safety associated with the administration of the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab and atezolizumab in children and AYA with relapsed or refractory solid tumors\n* To determine if sorafenib systemic exposure can be successfully targeted to an AUC between 20 and 55 hr·µg\u002FmL by Day 21 of cycle 1 in 60% of evaluable patients, when given in combination with cyclophosphamide, bevacizumab, and atezolizumab in children and AYA with relapsed or refractory solid tumors\n\nPart 2\n\n* To evaluate the response rate (CR+PR) of the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab and atezolizumab in children and AYA with relapsed or refractory FLC following two cycles of therapy\n* To determine if the use of PK-guided sorafenib dosing to maintain a systemic exposure between 20 and 55 reduces the interpatient pharmacokinetic variability of sorafenib and the incidence of sorafenib- induced skin toxicities in children and AYA with relapsed or refractory FLC and other rare solid tumors\n\nParts 1 \\& 2\n\n* To determine if the combination of cyclophosphamide, PK-guided sorafenib and atezolizumab will result in increased intratumoral T-cell infiltration of CD8+C45RO+ cells between baseline and following two courses of therapy in pediatric children and AYA with relapsed or refractory solid tumors following two cycles of therapy\n* To characterize the pharmacokinetics of atezolizumab in combination with cyclophosphamide, PK-guided sorafenib and bevacizumab in children and AYA with relapsed or refractory solid tumors\n* To assess the feasibility of performing contrast enhanced ultrasound and explore the correlation between quantitative CEUS parameters and clinical response.\n\nSecondary Objectives\n\nPart 1\n\n• To describe the response rate (CR+PR) of the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab and atezolizumab in children and AYA with relapsed or refractory solid tumors following two cycles of therapy\n\nPart 2\n\n• To describe the response rate (CR+PR) of the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab and atezolizumab in children and AYA with relapsed or refractory FLC, HCC, desmoplastic small round cell tumor, malignant rhabdoid tumor, and other rare solid tumors following two cycles of therapy\n\nParts 1\\&2\n\n* To describe the number of children with liver tumors, initially judged unresectable at diagnosis, that can have their primary tumor resected after treatment with oral cyclophosphamide and sorafenib with intravenous bevacizumab and atezolizumab\n* To describe changes in immune cells in the peripheral blood at periodic times before and after treatment with this combination chemoimmunotherapy\n* To describe the PFS, EFS, and OS in patients treated with the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab, and atezolizumab in patients with relapsed or refractory FLC, DSRCT, MRT, HCC and other rare solid tumors",[27,28,29,30,31,32],"Refractory Solid Tumor","Hepatocellular Carcinoma","Malignant Solid Tumor","Pediatric Cancer","Pediatric Solid Tumor","Fibrolamellar Carcinoma","RECRUITING","2026-05-18",{"date":36,"type":37},"2026-05-19","ACTUAL",{"date":39,"type":37},"2022-11-07",{"date":41,"type":20},"2037-06",{"name":43,"class":44},"St. Jude Children's Research Hospital","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":68,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100560503","phase-1-safetyefficacy-study-of-cid-078-in-patients-with-advanced-solid-tumor-malignancies-100560503","NCT06577987","Safety\u002FEfficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies","A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Cyclin A\u002FB-RxL Inhibitor CID-078 in Patients With Advanced Solid Tumor Malignancies","Part 1a\u002F1b Inclusion Criteria:\n\nA patient must meet all of the following inclusion criteria to be eligible to participate in this study.\n\n1. Solid tumor malignancy meeting the following criteria:\n\n   * Part 1a Dose Escalation and Part 1b New Formulation Dose Escalation\u002FPilot Food Effect Cohort: locally advanced or metastatic solid tumor malignancy that has progressed or was non responsive to available therapies and for which no standard or available curative therapy exists.\n   * Part 1a and Part 1b Backfill: patients with TNBC, SCLC, and solid tumors harboring a RB1 or CDKN2A\u002FB loss genomic alteration or Rb protein LoF. Additional tumor types or genomic alterations may be considered by the SRC as data become available. Patient must have progressed or was non-responsive to available therapies and for which no standard or available curative therapy exists\n2. Measurable disease per RECIST v1.1.\n3. Age ≥ 18 years.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n5. Life expectancy \\> 12 weeks.\n6. Able to undergo a fresh biopsy if medically feasible.\n7. Ability to swallow capsules by mouth.\n8. Have the following laboratory values:\n\n   1. Calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 by Cockroft-Gault formula (actual body weight must be used for CrCl unless body mass index \\[BMI\\] is \\> 30 kg\u002Fm2, then lean or ideal body weight must be used (based on institutional practice), or estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m2 based alternative methods of determination (e.g., modification of diet in renal disease \\[MDRD\\], 24-hour urine collection) if consistent with local or institutional practice.\n   2. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) unless prior history of Gilbert's syndrome with Sponsor Medical Monitor approval.\n   3. Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN, or ≤ 5 × ULN if due to liver involvement by tumor.\n   4. Hemoglobin ≥ 9.0 g\u002FdL (last transfusion \\> 14 days prior to first dose of study drug).\n   5. Platelets ≥ 100 × 10\\^9 cells\u002FL (last platelet transfusion \\> 14 days prior to first dose of study drug).\n   6. Absolute neutrophil count ≥ 1.2 × 10\\^9 cells\u002FL (last dose of hematopoietic growth factors \\> 14 days from first dose of study drug).\n9. Females of childbearing potential must commit to sexual abstinence or to use two acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, or any form of hormonal contraceptives) for the duration of the study and for four months following the last dose of study treatment. Females who are at least two years postmenopausal or premenopausal with documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or permanent infertility due to alternate medical causes other than above are not considered females of childbearing potential. Male patients must be sterile (biologically or surgically), commit to sexual abstinence or to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for four months following the last dose of study treatment.\n10. Females of childbearing potential must have a negative serum pregnancy test during Screening and a negative urine or serum pregnancy test prior to receiving the first dose of study drug. Females who are at least two years postmenopausal or premenopausal with documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or permanent infertility due to alternate medical causes other than above are not considered females of childbearing potential.\n11. Signed and dated Institutional Review Board (IRB)\u002FEthics Committee (EC)-approved ICF before any protocol-directed screening procedures are performed.\n\n    Part 1b Pilot Food Effect Cohort - Specific Inclusion Criteria\n\n    Patients who consent to participate in the pilot food effect cohort will also be required to meet the following inclusion criteria:\n12. Able to eat a standardized high-fat, high-caloric or low-fat meal (as applicable to the food effect cohort assigned) within 25 minutes.\n\nExclusion Criteria:\n\nA patient who meets any of the following exclusion criteria will be ineligible to participate in this study:\n\n1. Treatment with any of the following:\n\n   1. Targeted therapy ≤ eight days or 5× the terminal phase elimination half-lives, whichever is shorter, prior to the first dose of study drug.\n   2. Systemic anticancer treatment (excluding targeted therapy as described above) ≤ 14 days prior to first dose of study drug.\n   3. Radiotherapy ≤ 28 days and palliative radiation ≤ 14 days prior to the first dose of study drug. If irradiated, lesions must have demonstrated clear-cut progression prior to being eligible for evaluation as target lesions.\n   4. Immunotherapy ≤ 28 days prior to the first dose of study drug.\n   5. Major surgery ≤ 28 days prior to the first dose of study drug.\n2. Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Patients with chronic, but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor Medical Monitor.\n3. Have known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, treated with surgery and\u002For radiation, and has been stable without requiring escalating doses of corticosteroids or anti-convulsant medications for at least four weeks prior for the first dose of study drug.\n4. Prior therapy with CID-078.\n5. Known hypersensitivity to CID-078 or any drugs similar in structure or class.\n6. Past medical history of interstitial lung disease, or any evidence of clinically active interstitial lung disease. Patients with sub-clinical pneumonitis who have received anti-cancer therapy (e.g., immunotherapy, ADC) previously can be included if their condition is stable without any medical intervention.\n7. Patient has a history of congestive heart failure (CHF) Class III\u002FIV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment.\n8. Heart rate corrected QT (QTc) interval (using Fridericia correction calculation) \\> 470 msec.\n9. Current treatment with medication known to prolong the QT\u002FQTc interval (see examples from Table 28) or history of additional risk factors for Torsade de Pointes (e.g., heart failure, Grade ≥ 3 hypokalemia, family history of long QT syndrome). Patient who has adequately controlled condition or requires use of medications from Table 28 may be allowed upon agreement by the Investigator and Sponsor Medical Monitor.\n10. Pregnant or lactating women.\n11. History of another primary malignancy ≤ two years prior to starting study drug, except for adequately treated cancer (e.g., basal, or squamous cell carcinoma of the skin or cancer of the cervix in situ).\n12. Malabsorption syndrome or other conditions (e.g., refractory nausea and vomiting, external biliary diversion, or any significant small bowel resection) that may interfere with adequate absorption of investigational product.\n13. Uncontrolled intercurrent illness including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, active infection (including untreated human immunodeficiency virus \\[HIV\\] and active clinical tuberculosis), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n14. Current endocrinopathies, unless in the opinion of the Investigator, endocrine complications are stable and well controlled and study participation does not jeopardize patient's health and wellbeing. Patients with asymptomatic endocrine disease on endocrine replacement therapy are eligible.\n15. Active hepatitis B infection as defined by a positive hepatitis B surface antigen (HbsAg) test and detectable hepatitis B virus (HBV) DNA. Patients ineligible due to detectable levels of HBV DNA at baseline may be rescreened for enrollment if their HBV DNA levels become undetectable after treatment with antiviral agents, and upon agreement between the Investigator and Sponsor Medical Monitor.\n16. Active hepatitis C infection as defined by a reactive hepatitis C virus (HCV) antibody test and detectable HCV RNA.\n17. For patients with a history of HIV or acquired immunodeficiency syndrome (AIDS):\n\n    1. Must have a CD4+ T-cell count ≥ 350 cells\u002FμL\n    2. Have not had an opportunistic infection within the previous 12 months.\n    3. To be on current antiretroviral therapy (ART) regimen for a minimum of four weeks and have an HIV viral load \\\u003C 400 copies\u002FmL at the time of enrollment.\n    4. Patients who are using concurrent strong cytochrome P450 (CYP)3A4 inhibitors (e.g., ritonavir, cobicistat) or strong CYP3A4 inducers are excluded from the study if their regimen cannot be altered. Otherwise, eligible study patients could be switched to an alternate effective ART before study participation.\n18. Current treatment with a strong CYP3A4 inhibitor or inducer, Pgp inhibitor, or CYP3A4 sensitive substrate within 14 days or five terminal half-lives prior to the first dose of study drug, whichever is shorter.\n19. Active bleeding disorders.\n20. Prior solid organ transplantation.\n21. Is, in the Investigator's opinion, unable or unwilling to comply with the study procedures.\n22. Have any condition or illness that, in the opinion of the Investigator, might compromise patient safety or interfere with the evaluation of the safety of the study drug.\n\nStudy Population (Part 2 Dose Expansion):\n\nInclusion Criteria:\n\nA patient must meet all of the following inclusion criteria to be eligible to participate in this study.\n\n1. Advanced or metastatic solid tumor malignancy that has progressed or was non responsive to available therapies and for which no standard or available curative therapy exists.\n\n   1. Triple negative breast cancer (TNBC) cohort: histologically or cytologically confirmed TNBC per American Society for Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) criteria, based on the most recent analyzed biopsy or other pathology specimen.\n   2. Small cell lung cancer (SCLC) cohort: histologically or cytologically confirmed relapsed\u002Frefractory SCLC.\n   3. Retinoblastoma 1 (RB1)-altered solid tumor cohort: solid tumors harboring a documented RB1 genomic alteration or Rb protein LoF, as identified through assays performed at Clinical Laboratory Improvement Amendments (CLIA)-certified or other similarly certified laboratories.\n2. Patients must have measurable disease by RECIST v1.1.\n3. Age ≥ 12 years and at least 40 kg in body weight.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (patients ≥ 18 years of age), Karnofsky performance status ≥ 70% (patients ≥ 16 to \\\u003C 18 years of age), or Lansky performance status ≥ 70% (patients \\\u003C 16 years of age). Patients who are unable to walk because of paralysis, but who can sit in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score (Appendix 1).\n5. Life expectancy \\>12 weeks.\n6. For patients ≥ 18 years of age: able to undergo a fresh biopsy if medically feasible.\n7. Ability to swallow capsules by mouth.\n8. Have the following laboratory values:\n\n   1. For patients ≥ 18 years of age: calculated CrCl ≥ 60 mL\u002Fmin\u002F1.73 m2 by Cockroft-Gault formula (actual body weight must be used for CrCl unless BMI \\> 30 kg\u002Fm2 then lean or ideal body weight must be used based on institutional practice), or estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m2 based alternative methods of determination (e.g., modification of diet in renal disease \\[MDRD\\], 24-hour urine collection) if consistent with local or institutional practice. For patients \\\u003C 18 years of age: serum creatinine within normal limits (as defined below) or estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m2 based on local institutional practice for determination.\n\n      Age at Screening Maximum Serum Creatinine SI Unit age 12 to \\\u003C 15 years - 0.81 mg\u002FdL; age 15 to \\\u003C 18 years (male) - 1.08 mg\u002FdL; age 15 to \\\u003C 18 years (female) - 0.84 mg\u002FdL\n   2. Total bilirubin ≤ 1.5 × ULN unless prior history of Gilbert's syndrome with Sponsor Medical Monitor approval.\n   3. Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN, or ≤ 5 × ULN if due to liver involvement by tumor.\n   4. Hemoglobin ≥ 9.0 g\u002FdL (last transfusion \\> 14 days prior to first dose of study drug).\n   5. Platelets ≥ 100 × 10\\^9 cells\u002FL (last platelet transfusion \\> 14 days prior to first dose of study drug).\n   6. Absolute neutrophil count ≥ 1.2 ×10\\^9 cells\u002FL (last dose of hematopoietic growth factors \\> 14 days from first dose of study drug).\n9. Females of childbearing potential must commit to sexual abstinence or to use two acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives) for the duration of the study and for four months following the last dose of study treatment. Females who are at least two years postmenopausal or premenopausal with documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or permanent infertility due to alternate medical causes other than above are not considered females of childbearing potential. Male patients must be sterile (biologically or surgically), commit to sexual abstinence or to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for four months following the last dose of study treatment.\n10. Females of childbearing potential must have a negative serum pregnancy test during Screening and a negative urine or serum test prior to receiving first dose of study drug. Females who are at least two years postmenopausal or premenopausal with documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or permanent infertility due to alternate medical causes other than above are not considered females of childbearing potential.\n11. Signed and dated IRB\u002FEC-approved ICF for potential patients ≥ 18 years of age. A signed and dated IRB\u002FEC-approved adolescent assent form may also be required for patients 12 to 17 years of age in addition to an ICF signed by a parent or legal guardian.\n\nExclusion Criteria:\n\nA patient who meets any of the following exclusion criteria will be ineligible to participate in this study.\n\n1. Treatment with any of the following:\n\n   1. Targeted therapy ≤ eight days or 5× the terminal phase elimination half-lives, whichever is shorter, prior to the first dose of study drug.\n   2. Systemic anticancer treatment (excluding targeted therapy as described above) ≤ 14 days prior to the first dose of study drug.\n   3. Radiotherapy ≤ 28 days and palliative radiation ≤ 14 days prior to the first dose of study drug. If irradiated, lesions must have demonstrated clear-cut progression prior to being eligible for evaluation as target lesions.\n   4. Immunotherapy ≤ 28 days prior to the first dose of study drug.\n   5. Major surgery ≤ 28 days prior to the first dose of study drug.\n2. Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Patients with chronic, but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor Medical Monitor.\n3. Have known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, treated with surgery and\u002For radiation, and has been stable without requiring escalating doses of corticosteroids or anti-convulsant medications for at least four weeks prior to the first dose of study drug.\n4. Prior therapy with CID-078.\n5. Known hypersensitivity to CID-078 or any drugs similar in structure or class.\n6. Past medical history of interstitial lung disease or any evidence of clinically active interstitial lung disease. Patients with sub-clinical pneumonitis who have received anti-cancer therapy (e.g., immunotherapy, ADC) previously can be included if their condition is stable without any medical intervention.\n7. Patient has a history of CHF Class III\u002FIV according to the NYHA Functional Classification Appendix 2) or serious cardiac arrhythmias requiring treatment.\n8. QTc interval (using Fridericia correction calculation) (QTcF) \\> 470 msec.\n9. Current treatment with medication known to prolong the QT\u002FQTcF interval or history of additional risk factors for Torsade de Pointes (e.g., heart failure, Grade ≥ 3 hypokalemia, family history of long QT syndrome). Patient who has adequately controlled condition or require use of medications from Table 28 may be allowed to enroll upon agreement by the Investigator and Sponsor Medical Monitor.\n10. Pregnant or lactating women.\n11. History of another primary malignancy ≤ two years prior to starting study drug, except for adequately treated cancer (e.g., basal or squamous cell carcinoma of the skin or cancer of the cervix in situ).\n12. Malabsorption syndrome or other conditions (e.g., refractory nausea and vomiting, external biliary diversion, or any significant small bowel resection) that may interfere with adequate absorption of investigational product.\n13. Uncontrolled intercurrent illness including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, active infection (including untreated HIV and active clinical tuberculosis), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n14. Current endocrinopathies, unless in the opinion of the Investigator, endocrine complications are stable and well controlled and study participation does not jeopardize patient's health and wellbeing. Patients with asymptomatic endocrine disease on endocrine replacement therapy are eligible.\n15. Active hepatitis B infection as defined by a positive HBsAg test and detectable HBV DNA. Patients ineligible due to detectable levels of HBV DNA at baseline may be rescreened for enrollment if their HBV DNA levels become undetectable after treatment with antiviral agents, and upon agreement between the Investigator and Sponsor Medical Monitor.\n16. Active hepatitis C infection as defined by a reactive HCV antibody test and detectable HCV RNA.\n17. For patients with a history of HIV or AIDS:\n\n    1. Must have a CD4+ T-cell count ≥ 350 cells\u002FμL.\n    2. Have not had an opportunistic infection within the previous 12 months.\n    3. To be on current ART regimen for a minimum of four weeks and have an HIV viral load \\\u003C 400 copies\u002FmL at the time of enrollment.\n    4. Patients who are using concurrent strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat) or strong CYP3A4 inducers are excluded from the study if their regimen cannot be altered. Otherwise, eligible study patients could be switched to an alternate effective ART regimen before study participation.\n18. Current treatment with a strong CYP3A4 inhibitor or inducer, Pgp inhibitor, or CYP3A4 sensitive substrate as specifically listed in Table 26 and Table 27 within 14 days or five terminal half-lives prior to the first dose of study drug, whichever is shorter.\n19. Active bleeding disorders.\n20. Prior solid organ transplantation.\n21. Is, in the Investigator's opinion, unable or unwilling to comply with the study procedures.\n22. Have any condition or illness that, in the opinion of the Investigator, might compromise patient safety or interfere with the evaluation of the safety of the study drug.","12 Years",{"count":55,"type":20},220,[23],"This is a first-in-human, multicenter, open-label, phase 1 study to evaluate safety, tolerability, and efficacy of CID-078, a Cyclin A\u002FB-RxL inhibitor, in patients with advanced solid tumors.",[59,60,27,61,62,63,64,65,66,67],"Advanced Solid Tumor","Metastatic Solid Tumor","Cancer","Lung Cancer","Triple Negative Breast Cancer","Breast Neoplasms","Neuroendocrine Tumors","Neuroendocrine Carcinoma","RB1 Gene Mutation",[69,70,71],"Phase 1","CID-078","Estrogen","2025-09-09",{"date":74,"type":37},"2025-09-15",{"date":76,"type":37},"2024-08-14",{"date":78,"type":20},"2027-03-14",{"name":80,"class":81},"Circle Pharma","INDUSTRY",10,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100544951","phase-1-clinical-evaluation-of-177lu-ab-3prgd2-in-various-solid-tumors-with-integrin-v3-positive-expression-100544951","NCT06375564","Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression","An Open-Label, Non-Randomized, Single-Center, Investigator-Initiated Trial to Determine the Effectiveness of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign a written informed consent document.\n2. Age 18 and older.\n3. Confirmed unresectable or metastatic refractory cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion \\> 1 cm or lymph node \\> 1.5 cm in short axis).\n4. Progressive disease after multiple-lines treatment.\n5. Eastern Cooperative Oncology Group Performance Status ≤ 3.\n6. Participant must have completed prior therapy at least 2 weeks (washout period) before 68Ga-RGD PET\u002FCT scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved below Grade 2 or baseline. Completion of entry into 68Ga-RGD study and completion of the scan.\n7. Hematologic parameters are defined as Absolute neutrophil count (ANC) ≥ 1000 cells\u002Fmm3 Platelet count ≥ 50,000\u002Fmm3 Hemoglobin ≥ 8 g\u002FdL.\n8. Blood chemistry levels defined as AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 3 times ULN Creatinine ≤ 3 times ULN Able to remain motionless for up to 30-60 minutes per scan.\n\nExclusion Criteria:\n\n1. Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA).\n2. Participants with Class 3 or 4 NYHA Congestive Heart Failure.\n3. Clinically significant bleeding within two weeks before trial entry (e.g. gastrointestinal bleeding, intracranial bleeding).\n4. Pregnant or lactating women.\n5. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days before study day 1 or anticipated surgery within the subsequent 6 weeks.\n6. Has an additional active malignancy requiring therapy within the past 2 years.\n7. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.\n8. Psychiatric illness\u002Fsocial situations that would interfere with compliance with study requirements\n9. Cannot undergo PET\u002FCT scanning because of weight limits (350 lbs).\n10. INR\\>1.2; PTT\\>5 seconds above UNL.","18 Years","90 Years",{"count":93,"type":20},20,[23],"This is an open-label, non-controlled, non-randomized study to assess the therapeutic efficacy of 177Lu-AB-3PRGD2 in patients with various solid tumors who will undergo radioligand therapy using 177Lu-AB-3PRGD.",[27],[27,98,99],"Radioligand therapy","177Lu-AB-3PRGD2","2025-08-05",{"date":102,"type":37},"2025-08-08",{"date":104,"type":37},"2024-06-12",{"date":106,"type":20},"2026-12-30",{"name":108,"class":44},"The First Affiliated Hospital of Xiamen University",1]