[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-solid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-solid-tumor":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,58,0,25,[9,44,76,156,178,207,238,279,299,320,339,368,400,427,453,478,499,533,557,585,614,640,667,697,719],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100652336","validation-of-the-g8-screening-tool-for-prognostic-assessment-of-frailty-and-early-mortality-in-elderly-individuals-with-cancer-prospective-cohort-study-in-brazil-100652336",false,"NCT07773285","Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil","Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil - CORALINE (LACOG 0625)","CORALINE","Inclusion Criteria:\n\n1. Aged 70 or above\n2. Diagnosis of cancer (solid tumors)\n3. Metastatic or recurrent cancer (treatment-naïve) regardless of the interval from prior localized disease\n4. Intention to start first systemic line of therapy\n5. Be able to understand and provide informed consent (ICF).\n\nExclusion Criteria:\n\n1\\. Nonmelanoma skin cancer","ALL","70 Years",{"count":21,"type":22},250,"ESTIMATED","OBSERVATIONAL","This is a prospective observational cohort study including 250 individuals aged 70 years or older newly diagnosed with solid tumors. In this non-interventional study, all patient contacts will be conducted via telephone or video call.\n\nAfter obtaining informed consent which will be conducted electronically, an initial telemedicine assessment will be performed. During this evaluation, sociodemographic and clinical data will be collected, and a Comprehensive Geriatric Assessment (CGA) will be conducted. The assessment will be performed by a trained professional using internationally recognized, validated instruments that are preferably culturally adapted to the Brazilian population. The G8 score will be calculated based on information collected at baseline. Additionally, medication use, the Charlson Comorbidity Index, Mini Nutritional Assessment, and self-rated health status will be recorded. The total G8 score ranges from 0 to 17, with higher scores indicating better health status (abnormal G8 score ≤14).",[26,27,28],"Solid Tumor","Metastatic Solid Tumor","Recurrent Solid Tumor",[30],"Metastatic or recurrent cancer","NOT_YET_RECRUITING","2026-08-12",{"date":34,"type":35},"2026-08-19","ACTUAL",{"date":37,"type":22},"2026-09",{"date":39,"type":22},"2030-09",{"name":41,"class":42},"Latin American Cooperative Oncology Group","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100506498","phase-1-first-in-human-study-of-ds-3939a-in-participants-with-advanced-solid-tumors-100506498","NCT05875168","First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors","Phase 1\u002F2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n* Sign and date the main Informed Consent Form (ICF).\n* Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment.\n* Has adequate organ function.\n* Measurable disease based on RECIST V1.1.\n* Eastern Cooperative Oncology Group performance status score of 0 or 1.\n\nAdditional inclusion criteria for Part 1\n\n* Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors.\n\nAdditional inclusion criteria for Part 2\n\n* Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria\n* Is able to provide either of the following baseline tumor samples:\n\n  1. Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Main Screening or Tissue Screening Period, or\n\n     * Fresh core needle biopsy sample\n     * Fresh biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy, or other procedures as long as the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual.\n  2. FFPE tumor tissue samples obtained by biopsy or surgery performed within 6 months before signing the main ICF. If samples were obtained prior to the start of the most recent anticancer therapy, the Sponsor Medical Monitor should be consulted regarding the adequacy of the sample.\n\nExclusion Criteria:\n\n* Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.\n* Has spinal cord compression or clinically active central nervous system metastases.\n* Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years.\n* Has any history of ILD\u002Fpneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids.\n* Has active or uncontrolled human immunodeficiency virus (HIV) infection.\n* Has evidence of active or uncontrolled hepatitis B virus or hepatitis C virus infection.\n* Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n* Has an active (ie, symptomatic and\u002For on-treatment), known, or suspected autoimmune disease.\n* Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.","18 Years",{"count":53,"type":22},590,"INTERVENTIONAL",[56,57],"PHASE1","PHASE2","This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.",[60,27],"Advanced Solid Tumor",[62,63,64],"DS-3939a","Advanced\u002Fmetastatic solid tumors","Antibody drug conjugate","RECRUITING","2026-08-11",{"date":32,"type":35},{"date":69,"type":35},"2023-08-18",{"date":71,"type":22},"2027-02-15",{"name":73,"class":74},"Daiichi Sankyo","INDUSTRY",36,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":54,"phases":86,"briefSummary":87,"conditions":88,"keywords":117,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},"100407463","the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":85,"type":22},300,[56,57],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[60,89,90,27,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116],"Advanced Malignant Neoplasm","Metastatic Cancer","Lung Cancer","Ovarian Cancer","Endometrial Cancer","Prostate Cancer","Colorectal Cancer","Breast Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt","2026-08-07",{"date":148,"type":35},"2026-08-10",{"date":150,"type":35},"2020-10-29",{"date":152,"type":22},"2027-12-31",{"name":154,"class":74},"PMV Pharmaceuticals, Inc",77,{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":54,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},"100645357","first-in-human-trial-of-ds1025a-in-participants-with-advanced-solid-tumors-100645357","NCT07681882","First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors","A Phase 1, Multicenter, Open-label, First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors","To be eligible to participate in this trial, an individual must meet all the following criteria:\n\n1. Sign and date the main ICF, prior to the start of any trial-specific procedures.\n2. Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old).\n3. Histologically documented, advanced, metastatic, or unresectable solid tumors.\n4. Relapsed or refractory disease, following at least 1 line of therapy, not amenable to standard therapy.\n5. Is willing to provide a newly obtained tumor tissue sample at screening, if not clinically contraindicated and at an acceptable risk as determined by the Investigator. If a fresh tumor biopsy is not clinically feasible or would pose unacceptable risk, an archival tumor tissue sample (obtained within 24 months of consent) must be submitted.\n6. Has measurable disease based on local CT\u002FMRI imaging as assessment by the Investigator using RECIST v1.1; radiographic tumor assessment must be performed within 28 days prior to initiation of trial intervention.\n7. ECOG PS of 0 or 1 assessed no more than 28 days prior to initiation of trial intervention.\n8. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention as defined in the protocol.\n9. A WOCBP is eligible to participate if the following conditions are met:\n\n   * Participant is not pregnant as confirmed by highly sensitive pregnancy test\n   * Participant does not plan to breastfeed during the Trial Intervention Period and for at least 8 months after last dose of trial intervention.\n   * Participant agrees to adhere to a contraceptive method that is highly effective with low user dependency only and agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore eggs during the Treatment Period and for at least the time needed to eliminate the trial intervention after the last dose.\n10. A male participant capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate the trial intervention:\n\n    * Avoid donating sperm.\n    * Adhere to approved contraception method as specified in the protocol.\n\nAn individual who meets any of the following criteria will be excluded from participation in this trial:\n\n1. Prior treatment with an anti-CD25 therapy.\n2. Treatment discontinuation history due to toxicity to a DXd-ADC agent and considered not able to tolerate DS1025a based on the discussion between the investigator and the Sponsor (for participants who have DXd-ADC treatment history).\n3. Inadequate washout period before initiation of trial intervention as specified in the protocol.\n4. Has spinal cord compression or clinically active central nervous system tumors, including metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n5. Uncontrolled or significant cardiovascular disease as specified in the protocol.\n6. Any of the following within the past 6 months prior to initiation of trial intervention: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n7. Participants with any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening.\n8. Lung-specific intercurrent clinically significant illnesses as specified in the protocol.\n9. Has clinically significant pulmonary compromise or requirement for supplemental oxygen.\n10. History of other active malignancy within 3 years prior to initiation of trial intervention, with the exception of those with a negligible risk of metastasis or death (eg, 5-year OS rate \\>90%) and treated with expected curative outcome\n11. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v 6.0, Grade ≤1 or baseline.\n12. History of hypersensitivity to any excipients in DS1025a or any known contraindication to treatment with, including hypersensitivity to, the trial intervention.\n13. Has a known history of HLH.\n14. Has a known active infection, or reactivation of latent following infections as specified in the protocol among participants who received treatment such as antivirals, antifungals, or IV antibiotics within 14 days prior to first dose of trial intervention.\n15. Has active or uncontrolled HBV infection.\n16. Has active or uncontrolled HCV infection.\n17. Has active or uncontrolled HIV infection.\n18. Has an active, known, or suspected autoimmune disease.\n19. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\>10 mg daily prednisone equivalents) or any other form of immunosuppressive therapy within 14 days prior to the trial intervention.",{"count":164,"type":22},45,[56],"This clinical trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy signals of DS1025a, given as a single agent to participants with advanced, metastatic, or unresectable solid tumors.",[60,27,168],"Unresectable Solid Tumor",[60,27,168,170],"DS1025a","2026-08-06",{"date":148,"type":35},{"date":171,"type":35},{"date":175,"type":22},"2029-01-21",{"name":73,"class":74},2,{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":54,"phases":187,"briefSummary":188,"conditions":189,"keywords":190,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100577852","a-study-of-bgb-b455-in-adults-with-advanced-or-metastatic-solid-tumors-100577852","NCT06803680","A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors","A Phase 1, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B455 in Patients With Selected Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced or metastatic, and unresectable solid tumors who have previously received standard systemic therapy for advanced or metastatic disease or for whom treatment is not available or not tolerated. Only participants with CLDN6+ high-grade OC (ie, ovarian cancer, fallopian tube cancer, or primary peritoneal cancer) will be enrolled in dose escalation cohorts, starting from Protocol Amendment 3.0.\n* Agreement for collection of formalin-fixed paraffin-embedded (FFPE) tumor tissue for central CLDN6 testing and other biomarker assessments.\n* Tumor CLDN6 expression (CDLN6+) by central immunohistochemistry testing is required for certain cohorts.\n* ≥ 1 measurable lesion as assessed by RECIST v1.1.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Prior systemic anticancer therapy, including chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin), targeted therapy, and antibody drug conjugates (ADCs) that are standard or investigational agents (including herbal medicine or Chinese \\[or other country\\] patent medicines, ≤ 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug(s).\n* Palliative radiation treatment or other locoregional therapies ≤ 14 days before the first dose of study drug(s).\n* Live vaccine ≤ 28 days before the first dose of study drug(s). Vaccines for COVID-19 are allowed except for any live vaccine that may become available. Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.\n* Any major surgical procedure ≤ 28 days before the first dose of study drug(s).\n* History of prior ≥ Grade 3 cytokine release syndrome (CRS).\n* Participants with toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized, except for adverse events not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":186,"type":22},90,[56],"The goal of this clinical trial is to learn if BGB-B455 can treat advanced or metastatic solid tumors expressing claudin 6 (CLDN6), a protein that is found on some tumors.\n\nThe main questions it aims to answer are:\n\n* What is the recommended dosing for BGB-B455?\n* What medical problems do participants have when taking BGB-B455?\n\nThe study has two parts:\n\n* Phase 1a: dose escalation and safety expansion\n* Phase 1b: dose expansion",[60,27],[191,192,193,194,195,196,197,198],"Claudin-6","CLDN6+","advanced or metastatic solid tumor","CD3","BsAb","bispecific antibody","CD3-BsAb","CLDN",{"date":148,"type":35},{"date":201,"type":35},"2025-03-18",{"date":203,"type":22},"2028-04-29",{"name":205,"class":74},"BeOne Medicines",12,{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":54,"phases":216,"briefSummary":217,"conditions":218,"keywords":221,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":237},"100559250","phase-1-a-study-of-ly4050784-in-participants-with-advanced-or-metastatic-solid-tumors-100559250","NCT06561685","A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors","An Open-label, Multicenter Study of LY4050784, a Selective SMARCA2\u002FBRM Inhibitor, in Advanced Solid Tumor Malignancies With SMARCA4\u002FBRG1 Alterations","Inclusion Criteria:\n\n* Have one of the following locally advanced or metastatic solid tumor malignancy with SMARCA4 (BRG1) alteration:\n\n  * Phase 1a dose escalation: Presence of any alteration in SMARCA4 (BRG1)\n  * Phase 1b expansion: Part A: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.\n  * Phase 1b expansion: Part B: Any tumor type (other than NSCLC) that has the presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.\n  * Phase 1b expansion: Part C: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.\n* Prior Systemic Therapy Criteria:\n\n  * Phase 1a dose escalation and Phase 1b (Part B): Participants who received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating Investigator; or the individual is refusing the remaining most appropriate standard of care treatment; or there is no standard therapy available for the disease.\n  * Phase 1b expansion (Part A): Participants must have received at least one line of therapy for advanced or metastatic disease.\n  * Phase 1b expansion (Part C): Participants may be treatment naïve or have received therapy for advanced or metastatic disease\n* Measurability of disease\n\n  * Phase 1a dose escalation (excluding backfill): measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)\n  * Phase 1a backfill and Phase 1b expansion: Measurable disease required as defined by RECIST v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n\nExclusion Criteria:\n\n* Participants with known or likely loss of function alteration of SMARCA2 (BRM) or malignancy with known association with SMARCA2 (BRM) alterations\n* Prior exposure to SMARCA2 (BRM) inhibitor(s) and\u002For degrader(s) (prior exposure may be permitted for dose escalation)\n* Participants with known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement\n* Participants with history of increased risk of prolonged QT or significant arrythmia\n* Significant cardiovascular disease\n* Participants with active and\u002For treated for an additional primary malignancy within 2 years prior to enrolment\n* Participants who are pregnant, breastfeeding or plan to breastfeed or expecting to conceive or father children during study or within 6 months after the last dose of study intervention\n* Participants with history of active autoimmune diseases, history of allogenic stem cell\u002Forgan transplant or compromised immune system within past 2 years (Part C only)",{"count":215,"type":22},340,[56],"The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants alone or in combination with other anticancer agents. In addition, with locally advanced or metastatic solid tumors with a BRG1 (Brahma-related gene 1, also known as SMARCA4) alteration who have previously received, do not qualify for, or are refusing standard of care treatments, or there is no standard therapy available for the disease. The study is conducted in two parts - phase Ia (dose-escalation) and phase Ib (dose-optimization, dose-expansion). The study will last up to approximately 4 years.",[27,60,219,220],"Non-small Cell Lung Cancer","SMARCA4-Deficient Tumor",[222,223,224,225,226,227,228,229],"SMARCA2","SMARCA4","Lung cancer","BRM","BRG1","Adenocarcinoma","Squamous cell carcinoma","Targeted therapy",{"date":146,"type":35},{"date":232,"type":35},"2024-09-19",{"date":234,"type":22},"2027-10",{"name":236,"class":74},"Eli Lilly and Company",33,{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":54,"phases":248,"briefSummary":249,"conditions":250,"keywords":258,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":278},"100551821","phase-1-a-study-of-ly4052031-in-participants-with-advanced-or-metastatic-urothelial-cancer-or-other-solid-tumors-100551821","NCT06465069","A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","A Phase 1a\u002F1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors","NEXUS-01","Inclusion Criteria:\n\n* Have one of the following solid tumor cancers:\n\n  * Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer\n  * Cohort A2\u002FB1\u002FB2: urothelial carcinoma\n  * Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer\n* Prior Systemic Therapy Criteria:\n\n  * Cohort A1\u002FC: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies\n  * Cohort A2\u002FB1\u002FB2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.\n* Prior enfortumab vedotin specific requirements:\n\n  * Cohorts A1\u002FA2\u002FC: prior treatment with enfortumab vedotin is allowed, but not required\n  * Cohort B1: individual must be enfortumab vedotin naive in the advanced\u002Fmetastatic setting\n  * Cohort B2: individual must have received enfortumab vedotin in the metastatic\u002Fadvanced setting.\n* Measurability of disease\n\n  * Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)\n  * Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations\n\nExclusion Criteria:\n\n* Individual with known or suspected uncontrolled CNS metastases\n* Individual with uncontrolled hypercalcemia\n* Individual with uncontrolled diabetes\n* Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Recent thromboembolic event and\u002For clinically significant bleeding disorder\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms\n* History of pneumonitis\u002Finterstitial lung disease\n* History of Grade ≥3 skin toxicity when receiving enfortumab vedotin\n* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention",{"count":247,"type":22},420,[56],"The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.",[27,28,60,251,108,219,252,253,92,254,255,94,256,257],"Urinary Bladder Neoplasm","Esophageal Cancer","Pancreatic Cancer","Cervical Cancer","Head and Neck Squamous Cell Carcinoma","Renal Pelvis Cancer","Bladder Cancer",[257,259,260,261,262,263,256,264,265,266,267,268,269],"Bladder Neoplasm","Bladder Urothelial Carcinoma","Urinary Bladder Cancer","Urinary Tract Cancer","Urothelial Neoplasms","Ureter Cancer","Nectin-4","Antibody Drug Conjugate (ADC)","Triple Negative Breast Cancer (TNBC)","Non-small Cell Lung Cancer (NSCLC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","2026-08-04",{"date":272,"type":35},"2026-08-05",{"date":274,"type":35},"2024-07-01",{"date":276,"type":22},"2027-05",{"name":236,"class":74},39,{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":54,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":4},"100650127","phase-1-a-first-in-human-study-investigating-bg-85738-alone-or-in-combination-with-other-antitumor-agents-in-patients-with-advanced-or-metastatic-solid-tumors-with-rat-sarcoma-virus-ras-mutations-100650127","NCT07746141","A First-in-Human Study Investigating BG-85738 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors With Rat Sarcoma Virus (RAS) Mutations","A Phase 1a\u002F1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-85738, Alone or in Combination With Other Antitumor Agents, in Patients With Advanced or Metastatic Solid Tumors With RAS Mutations","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if they meet all the following criteria:\n\n* Participants must sign the informed consent form and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* Participants must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place, whichever is older), at the time of signing the ICF.\n* Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors and meet study part and cohort-specific criteria\n* Participants must have evidence of a RAS mutation defined as a nonsynonymous mutation in Kirsten rat sarcoma viral oncogene homolog (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), or Harvey rat sarcoma viral oncogene homolog (HRAS) at codons 12, 13, or 61 (G12, G13, or Q61), based on testing of either tumor tissue or liquid biopsy (blood or plasma) as determined by the local laboratory\n\nExclusion Criteria:\n\nParticipants are excluded from the study if they meet any of the following criteria:\n\n* Participants who have prior RAS-targeted therapy, including, but not limited to, KRAS mutation-specific inhibitors (with the exception of participants with NSCLC and colorectal cancer who received a G12C inhibitor), pan-KRAS inhibitors, and pan-RAS inhibitors.\n* Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of study treatment.\n* Participants who are unable to comply with the requirements of the protocol.\n* Participants with active leptomeningeal disease or uncontrolled, untreated brain metastases\n* Participants with any malignancy ≤ 3 years before the first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).\n* Participants with active hepatitis C.\n* Participants with medical history of untreated Human Immunodeficiency Virus infection.\n\nNote: Other protocol defined criteria may apply.",{"count":287,"type":22},100,[56],"The purpose of this study is to test if the BG-85738 is safe and if it works in patients with advanced solid tumors with RAS mutations when it is given on its own and in combination.",[291,60,27],"RAS Mutation","2026-07-30",{"date":270,"type":35},{"date":295,"type":22},"2026-09-04",{"date":297,"type":22},"2028-09-30",{"name":205,"class":74},{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":54,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":319},"100609380","phase-1-a-study-to-assess-the-safety-tolerability-pharmacokinetics-pharmacodynamics-immunogenicity-and-anti-tumour-activity-of-ipn01203-in-adults-with-locally-advanced-or-metastatic-solid-tumours-exposed-to-immune-checkpoint-inhibitor-therapies-100609380","NCT07213830","A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies","An Open-label, Phase I\u002FII First in Human, Dose Escalation, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Participants With Locally Advanced or Metastatic Solid Tumours Who Have Progressed on or After Immune Checkpoint Inhibitor Therapies","Inclusion Criteria:\n\n* Participant must be ≥18 years of age, at the time of signing the informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Measurable disease per RECIST version 1.1 (at least one lesion that is measurable by RECIST 1.1. Tumour lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after radiation) and documented locally advanced or metastatic disease with CT and\u002For MRI.\n* All acute, clinically significant (CS) treatment-related AEs from a prior therapy resolved to Grade 1 or lower prior to study entry. Participants with chronic toxicities such as Grade ≤2 neuropathy or alopecia can be included.\n* Have a life expectancy for disease-related mortality, as evaluated by the investigator.\n* Male and female participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Adequate haematologic and end organ function\n* Participant is capable of giving signed informed consent as described in the protocol.\n\nExclusion Criteria:\n\n* Have untreated or active primary brain tumour, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression.\n* Experienced severe, life-threatening immune-mediated AEs, or infusion-related reactions such as those that lead to permanent discontinuation while on treatment with prior anticancer therapy such as immune checkpoint inhibitor therapy.\n* History of known autoimmune disease\n* History of stroke or significant cerebrovascular disease, encephalitis, meningitis, organic brain disease (e,g., Parkinson's disease) or uncontrolled seizures in the year prior to first dose of study drug.\n* History of CS cardiac disease within 6 months prior to the initiation of study intervention, including but not limited to unstable angina, acute myocardial infarction, endoscopic or open-heart cardiac surgery, or heart failure classified as New York Heart Association Grade 2 or higher. Additional exclusion criteria include:\n\n  1. Left ventricular ejection fraction \\\u003C45%\n  2. QT interval corrected by Fridericia (QTcF) \\>470 ms (for women) and \\>450 ms (for men) or CS arrhythmias.\n* History of CS respiratory disease within 6 months prior to the initiation of study intervention, including severe chronic obstructive pulmonary disease or asthma.\n* Prior organ transplantation.\n* Chronic or ongoing active infections within 4 weeks prior to Cycle1 Day1 (C1D1).\n* Presence of hepatitis B surface antigen (HBsAg) \\[or hepatitis B core antibody (HBcAb)\\] at screening or within 3 months prior to the first dose of study intervention.\n* Positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of study intervention.\n* Participants with known history of HIV infection are excluded from the study unless they meet the following criteria:\n\n  1. Stable Antiretroviral Therapy: Participants must be on a stable antiretroviral therapy regimen for at least 4 weeks prior to enrolment.\n  2. CD4+ T cell Count: Participants must have a CD4+ T cell count of at least 200 cells\u002FµL.\n  3. Viral Load: Participants must have an undetectable viral load (HIV RNA \\\u003C50 copies\u002FmL)\n  4. No Opportunistic Infections: Participants must not have had any opportunistic infections or other human immunodeficiency virus (HIV)-related illness within the past 6 months Note: HIV testing will be performed in any countries where it is mandatory per local requirements.\n* History of other malignancy within the last years.\n* Significant concurrent, uncontrolled medical condition that would put participants at unacceptable risk from study participation or preclude them from complying with study procedures per investigator including, but not limited to renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.\n* Treatment with \\>10 mg per day of prednisone (or equivalent) or other immune suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for participants who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.\n* Concurrent participation in another therapeutic treatment study.\n* Participants accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalised.\n* For French participants only: participants are under court protection, not affiliated to a social security system or protected adults.",{"count":307,"type":22},102,[56,57],"The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours.\n\nAdvanced solid tumours are cancers that can occur in various organs or tissues and have spread from their original site to nearby tissues or other parts of the body.\n\nThere will be two parts to this study:\n\n* Phase Ia: This part (called dose escalation) will find the dose range that shows activity against the tumour and can be tolerated by participants by testing different increasing doses of IPN01203.\n* Phase Ib: This part (called dose optimisation) will assess the ability of the drug to prevent, slow down, or stop the growth of tumours and how the body processes and responds to the drug when given in \"low dose\" or \"high dose.\" It will also further explore the safety and tolerability.\n\nAn additional part (phase II) may be added to the study based on the results of phase Ia and phase Ib.\n\nEach part will consist of the following periods:\n\n* A screening period (up to 28 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre.\n* A treatment period where all eligible participants will receive IPN01203. Requires approximately 15 visits for the first 2 months followed by 3 visits every month from month 3 until unacceptable toxicity, disease progression, death, upon participant's withdrawal of consent, investigator decision, or study termination by the sponsor, whichever occurs first.\n\nThere will also be one visit at the end of treatment (EoT), 30 days after the last administration of the study intervention or prior to the start of new anticancer treatment, whichever is earlier. Additionally, there will be one visit (the safety follow-up visit) 90 days after the last administration of study intervention or prior to the start of new anticancer treatment, whichever is earlier.\n\nIn both parts of the study, participants will undergo blood sampling, urine collection, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded.\n\nEach participant will be in this study until death or withdrawal from the study. IPN01203 will be provided to participants who tolerate it for as long as their disease does not progress. Participants may withdraw consent to participate at any time.",[60,27],"2026-07-29",{"date":292,"type":35},{"date":314,"type":35},"2026-02-06",{"date":316,"type":22},"2032-07-14",{"name":318,"class":74},"Ipsen",11,{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":54,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":206},"100609379","phase-1-a-study-to-assess-the-safety-tolerability-pharmacokinetic-pharmacodynamic-immunogenicity-and-antitumour-activity-of-ipn60300-in-adults-with-locally-advanced-or-metastatic-solid-tumours-100609379","NCT07213817","A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours","An Open-Label, Phase I\u002FII First-in-Human, Dose Escalation, Dose Optimisation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 as Single Agent in Adult Participants With Locally Advanced or Metastatic Solid Tumours.","Inclusion criteria:\n\n* Participant must be ≥18 years of age, at the time of signing the informed consent.\n* Participants with histologically or cytologically documented, locally advanced, or metastatic solid tumors, that relapsed or were refractory after being previously treated with standard of care therapy; or for which there is no available established therapy; or standard therapy is contraindicated or not deemed appropriate by the treating investigator.\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Male and female participants Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Adequate bone marrow function within 7 days before first dose of study intervention,\n* Adequate renal function within 7 days before first dose of study intervention,\n* Adequate hepatic function or laboratory abnormalities indicating hepatic injury within 7 days before first dose of study intervention,\n* Prothrombin time or international normalised ratio (INR) ≤1.5 × ULN.\n* At the time of screening, a tumour tissue specimen is required for enrolment into the dose escalation and dose optimisation portions of the study for retrospective central laboratory determination.\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).\n* Have a life expectancy of more than 3 months for disease-related mortality, as evaluated by the investigator.\n\nExclusion Criteria:\n\n* Known second malignancy either progressing or requiring active treatment within the last 2 years prior to first dose of study intervention.\n* Residual toxicity from prior anticancer therapy that are NCI CTCAE version 5.0 Grade 2 or higher. Stable chronic Grade 2 toxicities from previous treatments may be eligible per the judgement of investigator.\n* History of major surgery within 4 weeks prior to the first dose of study intervention.\n* Previous solid organ transplantation.\n* Pre-existing, acute or chronic severe corneal disorders, sequelae from severe corneal disorders, or a history of corneal transplantation.\n* Active brain metastases or leptomeningeal metastases with exception to asymptomatic and treated brain metastases (i.e. no neurological symptoms, no requirements for corticosteroids and lesions \\\u003C1.5 cm), which are stable and not expected to become symptomatic in the next 3 months in the opinion of the investigator.\n* History of stroke or significant cerebrovascular disease (ie, transient ischemic attack) within 6 months prior to initiation of study intervention.\n* History of clinically significant cardiac disease within 6 months prior to the initiation of study intervention, including but not limited to unstable angina, acute myocardial infarction, endoscopic or open-heart cardiac surgery, or heart failure classified as New York Heart Association Grade 2 or higher.\n* History of clinically significant respiratory disease within 6 months prior to the initiation of study intervention, including severe chronic obstructive pulmonary disease or asthma.\n* History of noninfectious interstitial lung disease (ILD)\u002Fpneumonitis\u002Fradiation pneumonitis that required steroids or has current ILD\u002Fpneumonitis.\n* Clinically significant gastrointestinal disorder including bleeding, occlusion, diarrhoea \\>Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease or partial bowel obstruction.\n* Any evidence of severe active infection or inflammatory condition.\n* Significant concurrent, uncontrolled medical condition that would put participants at unacceptable risk from study participation or preclude them from complying with study procedures as per investigator assessment, including, but not limited to renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.\n* Participants with uncontrolled human immunodeficiency virus (HIV). HIV infected participants are eligible if they meet criteria described in the protocol.\n* Known active infection with hepatitis B virus (HBV) OR hepatitis C virus (HCV). Participants are eligible if they meet criteria described in the protocol.\n* Ongoing immunosuppressive therapy, including systemic corticosteroids. NOTE: Physiologic replacement or use of topical or inhaled corticosteroids are allowed.\n* Concurrent participation in another therapeutic treatment trial, previous participation should respect the minimum of 5 half-lives or 4 weeks before the study intervention initiation (whichever is shorter).\n* Participants accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalised.\n* For French participants only: participants are under court protection, not affiliated to a social security system or protected adults.",{"count":328,"type":22},114,[56,57],"This study aims to find the right dosage and evaluate the safety and effectiveness of the drug IPN60300 in adults with advanced solid tumours, which are cancers that have spread to other parts of the body from their original location. All participants will receive the drug by injection.\n\nStudy Phases:\n\n* Phase Ia: Participants with certain types of tumours will be treated in cohorts of increasingly higher doses of the drug to determine the safe and effective dose range (a high and a low dose).\n* Phase Ib: Participants with a specific tumour type will receive one of the two doses identified in phase Ia. The dose level will be assigned randomly (by chance).\n\nStudy Periods:\n\nScreening: Up to 28 days before first IPN60300 injection to determine eligibility.\n\nTreatment: Starts with the first dose of IPN60300 and continues until it needs to be stopped due to harmful effects, the disease getting worse, or if the participant decides to stop taking part in the study, the investigator's decision to stop treatment, death or the study is terminated early by the sponsor.\n\nParticipants will undergo blood tests, urine collections, physical examinations, and clinical evaluations.",[332,27],"Locally Advanced Solid Tumor",{"date":292,"type":35},{"date":335,"type":35},"2025-12-05",{"date":337,"type":22},"2028-10-30",{"name":318,"class":74},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":54,"phases":348,"briefSummary":349,"conditions":350,"keywords":357,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":367},"100638760","phase-1-a-study-of-idp-001-in-advanced-or-metastatic-solid-tumors-100638760","NCT07602842","A Study of IDP-001 in Advanced or Metastatic Solid Tumors","A Phase 1\u002F2 Open-label Study of IDP-001 in Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options\n* Satisfy requirements for prior treatments per tumor type as outlined in the protocol\n* Measurable disease per RECIST v1.1\n* Participant willing to provide tumor biopsies\n* Adequate organ function\n* Agree to contraception requirements as outlined in the protocol\n* Life expectancy greater than 12 weeks\n\nExclusion Criteria:\n\n* Any clinically significant cardiac disease\n* Any clinically significant corneal disorder\n* Known, active, and uncontrolled hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV), or uncontrolled chronic or ongoing infectious requiring intravenous treatment.\n* Active significant neurologic disorders\n* Requires home oxygen\n* Active autoimmune disease\n* History or active skin disease requiring frequent treatment\n* History of major immunologic reaction to prior immunoglobulin G-containing agent\n* Clinically significant ascites or liver disease\n* Uncontrolled diabetes or diabetic neuropathy\n* Active bleeding disorders\n* Participation in a concurrent clinical study in the treatment period\n* Pregnant or lactating or planning to become pregnant\n* Known hypersensitivity to IDP-001 or any of its ingredients\n* Unresolved toxicities from previous anticancer therapy\n* Has had a seizure prior to Screening\n* Prior solid organ transplant or allogeneic stem cell transplant\n* Current endocrinopathy\n* History of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis\n* History or interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids\n* Stroke or transient ischemic attack prior to Screening\n* Participant has any other condition or illness that, in the opinion of the Investigator, may compromise participant safety, compliance, or interfere with the conduct and evaluation of the current study.\n\nNote: Other inclusion and exclusion criteria may apply.",{"count":347,"type":22},132,[56,57],"This clinical study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of IDP-001 in participants with advanced or metastatic squamous and non-squamous NSCLC and other squamous cell solid tumors (for example, head and neck, esophageal, cervical, cutaneous).",[60,27,255,351,352,353,354,355,356],"Cutaneous Squamous Cell Carcinoma","Squamous Cell Carcinoma of the Cervix","Non Squamous Non Small Cell Lung Cancer","Squamous Cell Carcinoma of the Esophagus","Squamous Cell Carcinoma of the Anus","Squamous Cell Carcinoma",[104,358],"Squamous NSCLC","2026-07-28",{"date":311,"type":35},{"date":362,"type":22},"2026-06",{"date":364,"type":22},"2028-12",{"name":366,"class":74},"InduPro, Inc.",4,{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":54,"phases":377,"briefSummary":378,"conditions":379,"keywords":381,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":392,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":399},"100633242","phase-1-a-first-in-human-study-of-ze94-0605-in-patients-with-advanced-solid-tumors-100633242","NCT07524140","A First-in-Human Study of ZE94-0605 in Patients With Advanced Solid Tumors","A Phase 1, First-in-Human Study of ZE94-0605 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\nPhase 1a Dose-Escalation Cohorts:\n\n1. Age 18 years or older with a pathologically confirmed, advanced, unresectable or metastatic solid tumor that is refractory to, or intolerant of, available existing therapy or therapies known to provide clinical benefit for the condition, if available, and with measurable disease.\n\n   Phase 1b Dose-Expansion Cohorts:\n2. Age 18 years or older with a pathologically confirmed, advanced, unresectable or metastatic solid tumor that is refractory to, or intolerant of, available existing therapy or therapies known to provide clinical benefit for the condition, if available, or who has declined such therapy; presence of CCNE1 amplification; and measurable disease.\n\n   Common Eligibility Criteria:\n3. Eastern Cooperative Oncology Group performance status of 0 or 1.\n4. Adequate end-organ function, defined as creatinine clearance greater than 60 mL\u002Fmin, aspartate aminotransferase and alanine aminotransferase less than 3 times the upper limit of normal, and total bilirubin less than 1.5 times the upper limit of normal, except for participants with Gilbert's disease.\n5. Absolute neutrophil count at least 1.5 × 10\\^9\u002FL and platelet count at least 100 × 10\\^9\u002FL.\n6. Female participants of childbearing potential must be willing to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from screening throughout study treatment and for 90 days after the last dose of ZE94-0605.\n7. Male participants of reproductive potential who have intercourse with females of childbearing potential must be willing to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from the start of study treatment throughout study treatment and for 90 days after the last dose of ZE94-0605. Male participants must also refrain from sperm donation during this period.\n8. Willingness to comply with scheduled visits, the drug-administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions.\n\nExclusion Criteria:\n\n1. History of another malignancy, except adequately treated local basal cell carcinoma or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease, or another cancer that has been in complete remission without treatment for at least 2 years before enrollment or has a life expectancy of 24 months and does not require therapy that would confound interpretation of this study. Such cases must be discussed with the Medical Monitor before screening.\n2. Known active hepatitis C, hepatitis B, or human immunodeficiency virus infection.\n3. Pregnancy or breastfeeding.\n4. Concurrent participation in an investigational-drug trial with therapeutic intent, defined as receipt of prior study therapy within 14 days before study treatment.\n5. Inability to tolerate oral medication, including symptomatic disease that significantly affects gastrointestinal function, such as inflammatory bowel disease or resection of the stomach or small bowel.\n6. Receipt of an investigational agent for any indication within 5 half-lives of the agent. If the half-life is unknown, the participant must wait 1 week before the first dose of study treatment. An investigational agent is one for which there is no approved indication from the U.S. Food and Drug Administration.\n7. Psychological, familial, social, or geographic factors; another significant medical condition; or a laboratory abnormality that precludes informed consent or protocol compliance, may hamper adherence to study treatment or follow-up, or would confound interpretation of study results.\n8. Uncontrolled intercurrent illness, including but not limited to symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, New York Heart Association Class III or IV heart failure, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction-system abnormalities. Participants with medical comorbidities that would preclude safety evaluation of ZE94-0605 must not be enrolled.\n9. QT interval corrected using Fridericia's formula (QTcF) greater than or equal to 470 milliseconds, unless the participant has a pacemaker. Participants with an incomplete or complete right or left bundle branch block may participate if cleared for enrollment by a cardiology evaluation.",{"count":376,"type":22},60,[56],"ZE94-0605 is an oral, selective cyclin-dependent kinase 2 (CDK2) inhibitor. This multicenter, open-label, first-in-human Phase 1 study will evaluate ZE94-0605 in adults with advanced, unresectable or metastatic solid tumors. Phase 1a will use sequential dose escalation to determine the maximally tolerated dose and biologically effective dose. Phase 1b will randomize participants with CCNE1 amplification, or another prospectively specified molecular feature, between two dose levels to select the recommended Phase 2 dose.",[380,27],"Advanced Solid Tumor Cancer",[382,383,384,385,386,387,388,389,390,391],"ZE94-0605","Selective CDK2 inhibitor","CCNE1 amplification","Cyclin E1","First-in-human","Dose escalation","Dose optimization","Recommended Phase 2 dose","Project Optimus","Brain-penetrant CDK2 inhibitor",{"date":311,"type":35},{"date":394,"type":35},"2026-06-25",{"date":396,"type":22},"2028-05",{"name":398,"class":74},"Eilean Therapeutics",3,{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":54,"phases":408,"briefSummary":409,"conditions":410,"keywords":414,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":424,"locationsCount":426},"100590952","phase-1-study-of-orally-administered-moma-341-in-participants-with-advanced-or-metastatic-solid-tumors-100590952","NCT06974110","Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors","A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Participants have unresectable advanced or metastatic solid tumors with MSI-H or dMMR alterations and histologically confirmed disease. Participants must have previously received and progressed on an anti-PD-(L)1-based regimen, unless ineligible or in a region without access to anti-PD-(L)1 therapies\n3. Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and\u002For PCWG-3\n4. ECOG PS ≤ 2\n5. Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and\u002For surgery \\*\\*hormonal therapy allowed. Palliative radiotherapy allowed\n6. Adequate organ function per local labs\n7. Comply with contraception requirements\n8. Written informed consent must be obtained according to local guidelines\n\nExclusion Criteria:\n\n1. Known Werner Syndrome\n2. Active prior or concurrent advanced-stage malignancy (some exceptions allowed including early-stage cancers)\n3. Clinically relevant cardiovascular disease\n4. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)\n5. Known active uncontrolled infection\n6. Known allergy, hypersensitivity, and\u002For intolerance to MOMA-341\n7. Impaired GI function that may impact absorption\n8. Patient is pregnant or breastfeeding\n9. Known to be HIV positive, unless all of the following criteria are met:\n\n   1. Undetectable viral load or CD4+ count ≥300 cells\u002FμL\n   2. Receiving highly active antiretroviral therapy\n   3. No AIDS-related illness within the past 12 months\n10. Active liver disease (some exceptions are allowed)\n11. Prior or ongoing condition, therapy, or laboratory abnormality that, in the investigator's opinion, may affect safety of the patient, confound the results of the study, and\u002For interfere with the patients participation in the study",{"count":347,"type":22},[56],"This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-341 administered orally as a single agent or combination therapy in patients with microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors.",[60,27,93,411,95,412,413],"MSI-H Cancer","Gastric Cancer","dMMR Cancer",[121,415,416,417,60,27,412,95,93,411,413],"MOMA-341","Werner helicase","WRN","2026-07-22",{"date":420,"type":35},"2026-07-23",{"date":422,"type":35},"2025-07-16",{"date":396,"type":22},{"name":425,"class":74},"MOMA Therapeutics",15,{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":54,"phases":436,"briefSummary":437,"conditions":438,"keywords":441,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":452},"100558040","phase-1-study-of-orally-administered-moma-313-in-participants-with-advanced-or-metastatic-solid-tumors-100558040","NCT06545942","Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors","A Phase 1 Study of MOMA-313 Given as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Have histologically confirmed disease for each treatment arm as follows:\n\n   1. Treatment Arm 1 (MOMA-313 Monotherapy)\n\n      \\- Advanced (including locally), relapsed or metastatic solid tumors that are not eligible for curative therapy, with any HR-deficient alteration.\n   2. Treatment Arm 2 (MOMA-313 in Combination with Olaparib):\n\n      * Dose escalation: Advanced (including locally), relapsed or metastatic solid tumors that are not eligible for curative therapy, for which a PARP inhibitor is indicated, with select HR-deficient mutations. Patients may be PARP inhibitor naive or exposed.\n      * Dose optimization: Advanced (including locally), relapsed or metastatic CRPC or pancreatic ductal adenocarcinoma (PDAC) with select HR-deficient mutations. Patients must be PARP inhibitor naive.\n3. Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and\u002For PCWG-3\n4. ECOG PS ≤ 2\n5. Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and\u002For surgery \\*\\*hormonal therapy allowed. Palliative radiotherapy allowed.\n6. Adequate organ function per local labs\n7. Comply with contraception requirements\n8. Written informed consent must be obtained according to local guidelines\n\nKey Exclusion Criteria:\n\n1. Active prior or concurrent malignancy (some exceptions allowed)\n2. Clinically relevant cardiovascular disease\n3. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)\n4. Known active infection\n5. Prior polymerase theta inhibitor exposure\n6. Known allergy, hypersensitivity, and\u002For intolerance to MOMA-313\n7. Olaparib exposed patients with known hypersensitivity to PARP inhibitors (for patients considered for olaparib only)\n8. Impaired GI function that may impact absorption.\n9. Patient is pregnant or breastfeeding.\n10. Known to be HIV positive, unless all of the following criteria are met:\n\n    1. Undetectable viral load or CD4+ count ≥300 cells\u002FμL\n    2. Receiving highly active antiretroviral therapy\n    3. No AIDS-related illness within the past 12 months\n11. Active liver disease (some exceptions are allowed)\n12. Prior or ongoing condition, therapy, or laboratory abnormality that, in the investigator's opinion, may affect safety of the patient, confound the results of the study, and\u002For interfere with the patients participation in the study",{"count":435,"type":22},220,[56],"This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-313 administered orally as a single agent or combination therapy in patients with homologous recombinant deficient solid tumors.",[60,27,94,439,96,92,440],"Pancreas Cancer","Homologous Recombination Deficiency",[121,442,443,425,60,27,94,439,96,92,440,444,445],"MOMA-313","Polymerase theta","HRD Mutation","Advanced (including locally)",{"date":420,"type":35},{"date":448,"type":35},"2024-08-13",{"date":450,"type":22},"2027-11-30",{"name":425,"class":74},18,{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":54,"phases":462,"briefSummary":463,"conditions":464,"keywords":466,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":4},"100571729","phase-1-study-of-ism5939-in-patients-with-advanced-andor-metastatic-solid-tumors-100571729","NCT06724042","Study of ISM5939 in Patients With Advanced and\u002For Metastatic Solid Tumors","First-in-human Phase 1a\u002Fb, Open-Label, Multicenter, Dose Escalation, Optimization and Expansion Study of ISM5939 in Patients With Advanced and\u002For Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Patients aged ≥18 years.\n2. Patients with histologically or cytologically confirmed diagnosis of advanced\u002Fmetastatic solid tumor that is either locally advanced and not amenable to curative therapy or stage 4 disease.\n3. Patients must have tumor relapse\u002Frecurrence and be refractory to available SOC treatment, be intolerant to or ineligible for available SOC treatment, or have no SOC treatment available.\n4. Patients enrolled in Part 3 (combination cohorts) must be acceptable and eligible for treatment with cisplatin, docetaxel, or pembrolizumab.\n5. Measurable disease per RECIST version 1.1 or PCWG3 criteria for patients with metastatic castration-resistant prostate cancer.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.\n7. Patients must have recovered to Grade 1 or baseline levels from toxicity or AEs related to prior treatment for their cancer, excluding: Grade ≤2 neuropathy; alopecia of any grade, or skin pigmentation; Grade ≤2 hypothyroidism stable on hormone replacement therapy, Grade ≤2 anorexia or fatigue.\n8. Patients must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.\n9. Patient must be capable of oral administration of ISM5939 and not have any clinically significant gastrointestinal abnormalities that may alter absorption.\n10. Adequate bone marrow and organ function.\n11. If receiving corticosteroids, patient must be maintained on a stable or decreasing dose for at least 7 days prior to Day 1.\n12. Life expectancy ≥3 months in the opinion of the investigator.\n\nExclusion Criteria:\n\n1. Patient has had prior systemic anti-cancer therapy within 3 weeks or at least 5 half-lives (whichever is shorter, but no less than 2 weeks) prior to Day 1.\n2. Prior radiation therapy at the target lesion, unless there is evidence of disease progression and the prior radiation therapy is to have been completed at least 7 days before study drug.\n3. Treatment with any investigational agent administered within 30 days or 5 half-lives, whichever is shorter, before the first dose of ISM5939.\n4. Prior therapy with an ENPP1 inhibitor.\n5. Currently receiving any of the CYP3A4\u002F5 inhibitors\u002Finducers, or CYP2C9 inhibitors, or inhibitors\u002Finducers of MDR1, or medications known to prolong the QT interval that cannot be discontinued 14 days or 5 half-lives prior to Day 1.\n6. Major surgery within 21 days prior to Day 1.\n7. Patients with active (uncontrolled, metastatic) second malignancies or requiring therapy, or who have undergone potentially curative therapy with no evidence of the disease recurrence for at least 3 years prior to the first dose of study treatment.\n8. Patients with a primary CNS tumor.\n9. Patient has uncontrolled hypertension, or heart disease and\u002For cardiac repolarization abnormality, or uncontrolled systemic infection.\n10. Other medical illness that, in the opinion of the investigator, may impact the safety of the patient or the objectives of the study.\n\nOther protocol inclusion and exclusion criteria may apply.",{"count":461,"type":22},159,[56],"This is a first-in-human Phase 1a\u002Fb, open-label, multicenter, dose escalation, optimization and expansion study of ISM5939 to evaluate the safety, tolerability, PK, PD, and preliminary antitumor activity of ISM5939 in patients with advanced or metastatic solid tumors.\n\nThe study will be conducted in 3 parts sequentially: Part 1 dose escalation ISM5939 monotherapy, Part 2 dose optimization to determine RP2D of ISM5939 monotherapy, and Part 3 dose expansion in 3 cohorts after initial safety run-in of ISM5939 combination therapy.",[60,27,465],"Advanced and\u002For Metastatic Solid Tumors",[467,468,469,26],"ISM5939","Ectonucleotide pyrophosphatase\u002Fphosphodiesterase 1 (ENPP1)","ENPP1 inhibitor","2026-07-21",{"date":420,"type":35},{"date":473,"type":22},"2026-12-30",{"date":475,"type":22},"2030-12-30",{"name":477,"class":74},"InSilico Medicine Hong Kong Limited",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":54,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":43},"100491038","phase-2-a-phase-ii-study-of-tucatinib-and-ado-trastuzumab-emtansine-t-dm1-in-patients-with-her2-positive-metastatic-solid-tumors-and-metastases-to-brain-tucatemeb-100491038","NCT05673928","A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)","Inclusion Criteria:\n\n1. Histologically confirmed HER2-positive metastatic solid tumor. HER2 positivity defined as HER2 overexpression by immunohistochemistry (IHC) 3+ or 2+ and fluorescence in situ hybridization (FISH) positive and\u002For HER2 amplification by in situ hybridization (ISH) or next generation sequencing (NGS) and\u002For activating ERBB2 mutation(s) (verified by MDACC Precision Oncology Decision Support).\n2. Patients must have one of the following on the screening brain MRI:\n\n   * Untreated brain metastases not requiring immediate local CNS therapy\n   * Previously treated brain metastases with progression of previous lesions or new lesions, but not requiring immediate local CNS therapy\n   * At least one measurable untreated brain lesion ≥0.5 cm and \\\u003C3.0 cm in the longest axis\n   * Prior SRS radiosurgery (must be completed within 7 days of study treatment initiation) is allowed as long as the previous treatment volume does not overlap with the current targets.\n3. Measurable (per the RECIST v1.1) or evaluable extracranial disease.\n4. Prior treatment with HER2-targeted treatments such as trastuzumab, pertuzumab, T-DM1, neratinib, lapatinib, or tucatinib is allowed, but not required. Patients with breast and gastric cancer must have received at least 1 line of HER2 targeted treatment.\n5. Age ≥18 years at the time of consent.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Appendix B).\n7. Life expectancy ≥3 months, in the opinion of the investigator.\n8. Adequate hematological and end-organ function, defined by the following laboratory test results, obtained within 28 days prior to study treatment initiation:\n\n   * Absolute neutrophil count ≥1,200\u002FμL\n   * Platelet count ≥100,000\u002FμL\n   * Hemoglobin ≥9g\u002FdL\n   * Total bilirubin ≤1.5 × upper limit of normal (ULN), except for patients with known Gilbert's disease, who may enroll if conjugated bilirubin is ≤1.5 × ULN\n   * Transaminases (AST\u002FALT) ≤1.5 × ULN (≤5 × ULN if liver metastases are present)\n   * Creatinine level \\\u003C1.5 x ULN or estimated glomerular filtration rate (GFR) ≥50 mL\u002Fmin\u002F1.73 m2 using the Modification of Diet in Renal Disease (MDRD) study equation as applicable.\n9. International normalized ratio (INR) and partial thromboplastin time (PTT)\u002Factivated partial thromboplastin time (aPTT) ≤1.5 × ULN, unless on medication known to alter INR and PTT\u002FaPTT. Proprietary Information of MD Anderson Protocol 2021-0899 v.5.0,04\u002F24\u002F2023 28\n10. LVEF ≥50% as assessed by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan documented within 3weeks prior to study treatment initiation.\n11. For patients of childbearing potential, as defined in Section 4.3, the following stipulations apply:\n\n    * Must have a negative serum or urine pregnancy test (minimum sensitivity of 25 mIU\u002FmL or equivalent units of beta-human chorionic gonadotropin \\[β-hCG\\]) result within 3 days prior to study treatment initiation. A patient with a false positive result and documented verification that the patient is not pregnant will be eligible.\n    * Must agree not to try to become pregnant during the study and for at least 7 months after the final dose of study treatment\n    * Must agree not to breastfeed or donate ova starting at the time of informed consent and continuing through the study and for 7 months after the final dose of study treatment\n    * If sexually active in a way that could lead to pregnancy, must consistently use highly effective methods of birth control (i.e., methods that achieve a failure rate of \\\u003C1% per year when used consistently and correctly) starting at the time of informed consent and continuing throughout the study and for at least 7 months after the final dose of study treatment.\n\n    Highly effective methods of birth control include:\n\n    i. Intrauterine device ii. Bilateral tubal occlusion\u002Fligation iii. Vasectomized partner iv. Sexual abstinence when it is the preferred and usual lifestyle choice of the patient.\n12. For patients who can father children, the following stipulations apply:\n\n    * Must agree not to donate sperm starting at the time of informed consent and continuing throughout the study and for at least 7 months after the final dose of study treatment\n    * If sexually active with a person of childbearing potential in a way that could lead to pregnancy, must consistently use a barrier method of birth control starting at the time of informed consent and continuing throughout the study and for at least 7 months after the final dose of study treatment\n    * If sexually active with a person who is pregnant or breastfeeding, must consistently use a barrier method of birth control starting at the time of informed consent and continuing throughout the study and for at least 7 months after the final dose of study treatment.\n13. The patient must provide written informed consent.\n14. Must be willing to undergo biopsy as required by the study, if clinically considered safe and feasible by the investigator.\n\nExclusion Criteria:\n\n1. Patients must not have any of the following on the screening brain MRI:\n\n   * Any untreated brain lesions \\>3.0 cm in size\n   * Any brain lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to the patient (e.g., brainstem lesions). Patients who undergo local treatment for such lesions may still be eligible for the study based on inclusion criteria #2.\n2. Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \\>4 mg of dexamethasone (or equivalent).\n3. Poorly controlled (\\>1\u002Fweek) generalized or complex partial seizures, or manifestation of neurologic progression due to brain metastases notwithstanding CNS-directed therapy.\n4. History of allergic reactions to trastuzumab or compounds chemically or biologically similar to tucatinib, except for Grade 1 or 2 IRRs to trastuzumab that were successfully managed, or known allergy to any of the excipients in the study drugs.\n5. Treatment with any systemic anticancer therapy or investigational agent within 5 half-lives (of the drug) or within 21 days (whichever is shorter ) prior to study treatment initiation.\n6. Any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the following exceptions:\n\n   * Alopecia;\n   * Neuropathy, which must have resolved to ≤ Grade 2;\n   * Congestive heart failure (CHF), which must have been ≤ Grade 1 in severity at the time of occurrence and must have resolved completely.\n7. Clinically significant cardiopulmonary disease such as:\n\n   * Ventricular arrhythmia requiring therapy\n   * Symptomatic hypertension or uncontrolled asymptomatic hypertension as determined by the investigator\n   * Any history of symptomatic CHF, left ventricular systolic dysfunction, or decrease in LVEF\n   * Severe dyspnea at rest (National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\] ≥ Grade 3) due to complications of advanced malignancy or hypoxia requiring supplementary oxygen therapy\n   * Grade 2 or greater corrected QT interval (QTc) prolongation on screening electrocardiogram (ECG).\n8. Known myocardial infarction or unstable angina within 6 months prior to study treatment initiation.\n9. Unable for any reason to undergo contrast MRI of the brain.\n10. Have used a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the inhibitor, or a strong CYP3A4 or CYP2C8 inducer within 5 days prior to study treatment initiation. Concomitant use of strong CYP3A4 inducers or CYP2C8 inducers or inhibitors is also prohibited during study treatment and for 2 weeks after discontinuation of study treatment. Use Proprietary Information of MD Anderson of sensitive CYP3A substrates should be avoided 2 weeks prior to study treatment initiation and during study treatment.\n11. Known carrier of hepatitis B or hepatitis C virus or has other known chronic liver disease.\n12. Known positive human immunodeficiency virus status.\n13. Patients who are pregnant, breastfeeding, or planning to become pregnant from the time of informed consent until 7 months after the last dose of study treatment.\n14. Unable to swallow pills or has significant GI disease that would preclude adequate oral absorption of medication.\n15. Other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact patient safety or compliance with study procedures.\n16. Evidence within 1 year of the start of study treatment of another malignancy that required systemic treatment.\n17. Patients who are eligible for the HER2CLIMB-02 study (NCT03975647) and they can be enrolled in that study.",{"count":485,"type":22},30,[57],"To learn if the study drugs, tucatinib and adotrastuzumab emtansine (T-DM1), can help to control solid tumors that have spread to the brain.",[27,489],"Brain Metastases","2026-07-15",{"date":492,"type":35},"2026-07-16",{"date":494,"type":35},"2023-05-16",{"date":496,"type":22},"2029-03-01",{"name":498,"class":42},"M.D. Anderson Cancer Center",{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":54,"phases":508,"briefSummary":509,"conditions":510,"keywords":511,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":485},"100566589","phase-1-a-study-of-chs-114-tagmokitug-in-combination-with-toripalimab-andor-other-treatments-in-participants-with-advanced-solid-tumors-100566589","NCT06657144","A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and\u002For Other Treatments in Participants With Advanced Solid Tumors","A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants With Advanced or Metastatic Solid Tumors (TREGCHECK 102)","Key Inclusion Criteria:\n\n* At least 1 measurable lesion based on RECIST v1.1 as determined by the Investigator.\n* Resolved acute effects of any prior therapy to baseline severity or Grade 1 in accordance with National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except for adverse events (AEs) not constituting a safety risk per Investigator judgement.\n\nCohort A (2L Gastric, Gastro-esophageal-junction \\[GEJ\\], Esophageal Adenocarcinoma \\[EAC\\]) Specific Inclusion Criteria:\n\n* Histologically or cytologically documented unresectable, locally advanced or metastatic gastric, GEJ, or esophageal adenocarcinoma that is human epidermal growth factor receptor 2 (HER2) - negative and microsatellite stable (MSS)\u002Fproficient mismatch repair (pMMR).\n* Progressed during or after first line systemic therapy that includes a platinum and fluoropyrimidine doublet with or without anti-programmed death receptor 1 (PD-1)\u002Fprogrammed death ligand 1 (PD-L1)-directed therapy (that is, in the second line setting).\n* Consent to provide tumor tissue samples (baseline and on-treatment) is required for enrollment.\n\nCohort B (2L Esophageal Squamous Cell Carcinoma \\[ESCC\\]) - Specific Inclusion Criteria:\n\n* Histologically or cytologically documented unresectable, locally advanced or metastatic ESCC.\n* Progressed during or after first line systemic therapy including a doublet of platinum and fluoropyrimidine or paclitaxel with or without anti-PD-1\u002FPD-L1-directed therapy or anti-CTLA-4 and anti-PD-1\u002FPD-L1-directed combination therapy.\n* Consent to provide results from prior PD-L1 IHC assay score by FDA-approved or equivalent PD-L1 IHC diagnostic tests.\n* Consent to provide archival tumor tissue sample (baseline) is required for enrolment.\n\nCohort C (1L Esophageal Squamous Cell Carcinoma \\[ESCC\\]) - Specific Inclusion Criteria:\n\n* Histologically or cytologically documented unresectable, locally advanced or metastatic ESCC.\n* Consent to provide baseline tumor tissue is required.\n* Consent to provide results from prior PD-L1 IHC assay score by FDA-approved or equivalent PD-L1 IHC diagnostic tests.\n* Calculated creatinine clearance ≥60 mL\u002Fmin.\n\nCohort D, Arms D1 and D2 (4L+ Colorectal Carcinoma \\[CRC\\]) - Specific Inclusion Criteria:\n\n* Histologically and\u002For cytologically documented unresectable advanced or metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability\u002Fmismatch repair status for each participant must be documented, according to country level guidelines.\n* Participants who have no available therapies with a proven clinical benefit available in the participant's country per investigator. These therapies include the following: fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapy, anti-VEGF biological therapy (eg, bevacizumab, aflibercept, ramucirumab), an anti-EGFR therapy (eg, cetuximab, panitumumab) if RAS wildtype unless right-sided, either trifluridine\u002Ftipiracil, fruqintinib or regorafenib, and a BRAF inhibitor (ie, encorafenib) in BRAF V600E mutant).\n* Participants who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxalipatin-based therapy in the metastatic setting.\n* Consent to provide baseline tumor tissue sample is required for enrolment.\n\nKey Exclusion Criteria:\n\n* History of prior malignancy other than the cancer under study that is progressing or has required active treatment within the past 3 years.\n* Symptomatic or untreated central nervous system metastases, including leptomeningeal metastases, requiring concurrent treatment, including but not limited to surgery, radiation, and\u002For corticosteroids.\n* Major surgery requiring general anesthesia within 28 days prior to the first dose of study treatment, still recovering from prior surgery, or with surgery scheduled during the study.\n* Prior exposure to anti-C-C motif chemokine receptor 8 (CCR8) antibody.\n* History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody (mAb) therapy or any excipient in the study treatment.\n* Active uncontrolled bacterial, fungal, or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.\n* Any condition that, in the opinion of the Investigator or Sponsor, would interfere with the interpretation of study results.\n\nCohort A (2L Gastric, Gastro-esophageal-junction \\[GEJ\\], Esophageal Adenocarcinoma \\[EAC\\]) Specific Exclusion Criteria:\n\n* Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.\n* Participants at high risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula or T4 classification assessed by endoscopic ultrasound (EUS).\n\nCohort B (2L Esophageal Squamous Cell Carcinoma \\[ESCC\\]) - Specific Exclusion Criteria:\n\n* Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.\n* Participants at high risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula or T4 classification assessed by endoscopic ultrasound (EUS).\n\nCohort C (1L Esophageal Squamous Cell Carcinoma \\[ESCC\\]) - Specific Exclusion Criteria:\n\n* Received ≥ 1 prior systemic anticancer therapies for advanced or metastatic disease.\n* Participants who progressed during or within 6 months following the last dose of neoadjuvant, or perioperative therapy with curative intent.\n* Participants at high risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula or T4 classification assessed by endoscopic ultrasound (EUS).\n* Known dihydropyrimidine dehydrogenase deficiency or thymidine synthase gene polymorphism predisposing the participant to 5-FU toxicity.\n* Known allergies to 5-FU or cisplatin.\n\nNote: Other protocol-specified inclusion\u002Fexclusion criteria apply.",{"count":507,"type":22},154,[56],"The main purpose of this study is to evaluate the safety and preliminary efficacy of CHS-114 in combination with toripalimab and\u002For other standard of care (SOC) compound(s) in participants with advanced or metastatic solid tumors.",[27,60],[512,513,27,514,515,516,517,133,518,519,520,521,522,523,524],"Solid Tumors","Advanced Solid Tumors","Cancer","Oncology","Tumor","CCR8","Gastric cancer","Gastro-esophageal-junction (GEJ) cancer","Esophageal Adenocarcinoma (EAC)","Esophageal Squamous Cell Carcinoma","Cisplatin","5 Fluorouracil (5-FU)","Colorectal Carcinoma (CRC)","2026-07-14",{"date":490,"type":35},{"date":528,"type":35},"2025-04-01",{"date":530,"type":22},"2028-01",{"name":532,"class":74},"Coherus Oncology, Inc.",{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":18,"minAge":540,"maxAge":541,"enrollmentInfo":542,"targetDuration":4,"studyType":54,"phases":544,"briefSummary":545,"conditions":546,"keywords":547,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":43},"100561217","phase-1-intramuscular-acm-cpg-monotherapy-in-patients-with-advancedmetastatic-solid-tumors-with-prior-response-to-immunotherapy-alone-or-in-combination-with-chemotherapy-100561217","NCT06587295","Intramuscular ACM-CpG Monotherapy in Patients With Advanced\u002FMetastatic Solid Tumors With Prior Response to Immunotherapy Alone or in Combination With Chemotherapy","A Phase 1, Open-Label, Dose Escalation and Expansion Study of Intramuscular ACM-CpG Monotherapy in Patients With Advanced\u002FMetastatic Solid Tumors With Prior Response to Immunotherapy Alone or in Combination With Chemotherapy","Inclusion Criteria:\n\n1. ≥ 21 years of age at the time of informed consent.\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no functional deterioration over the previous 2 weeks.\n3. Estimated life expectancy of more than 12 weeks.\n4. Patients with terminal, Stage 4, advanced or metastatic solid tumors, confirmed histologically or pathologically documented, and who have previously received and clinically responded to ICI alone or in combination chemotherapy with best response by RECIST 1.1 being complete response (CR), partial response (PR) or stable disease (SD) who now have progression of disease and have previously received existing standard of care treatment.\n5. Adequate hematologic function, defined by the following:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 ×10\\*\\*9\u002FL, without the use of granulocyte colony stimulating factor such as filgrastim within 2 weeks prior to study treatment.\n   2. Platelet count ≥ 100 × 10\\*\\*9\u002FL without transfusion within 2 weeks (≤ 14 days) prior to study treatment.\n   3. Hemoglobin ≥ 9 g\u002FdL without transfusion or erythropoietin within 2 weeks (≤ 14 days) prior to study treatment.\n6. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), and total bilirubin ≤ 5 × ULN. Exception: Patients who have serum bilirubin increases due to documented underlying Gilbert's Syndrome or familial benign unconjugated hyperbilirubinemia. Known Hepatitis B and Hepatitis C carriers are eligible if their liver function falls within specifications stipulated here and for Hepatitis B carriers (HBsAg positive) have low HBV DNA, and for Hepatitis C carriers are HCV RNA negative, as well as having adequate disease control on antiviral therapy as required having commenced at least 1 month prior to enrolment.\n7. Adequate renal function defined by either a creatinine clearance ≥ 30 mL\u002Fmin (by Cockcroft- Gault formula) or serum creatinine (SCr) \\\u003C 1.5 × ULN\n8. Coagulation tests, defined by the following:\n\n   1. Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.\n   2. International normalized ratio (INR) ≤ 1.5 × ULN. Exception: INR 2 to ≤ 3 × ULN is acceptable for patients on Warfarin anticoagulation.\n9. Previous antitumor therapy (including endocrine, chemoradiotherapy\u002F radiotherapy, targeted therapy, or immunotherapy) stopped at least 4 weeks\u002F5 half lives (whichever is shorter) prior to administration of ACM-CpG. Focal radiation therapy for symptom relief must have been completed at least 2 weeks prior to the first dose of ACM-CpG.\n10. Previous AEs including irAE, have been improved to baseline or Grade ≤ 1 NCI CTCAE v5.0 (except for patients with alopecia, neuropathy, now or other AEs deemed to be G2 but clinically well managed), and specifically prior immune-related adverse events (irAEs) controlled and improved back to baseline or to Grade ≤ 2 NCI CTCAE v5.0, for example ICI related hypothyroidism requiring repletion with thyroid hormone.\n11. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test positive is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 26 weeks after the last dose of the study medication.\n12. Male subjects should agree to use adequate method of contraception starting with the first dose of study therapy through 26 weeks after the last dose of the study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n\nExclusion Criteria:\n\n1. Patients receiving granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), erythropoietin, or blood (red blood cell \\[RBC\\] or platelet) transfusion within 14 days prior to the first dose of the study drug.\n2. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled diabetes as evidenced by screening (baseline) Hb1Ac ≥7.5, asthma, chronic obstructive pulmonary disease (COPD).\n3. Known positive test result for human immunodeficiency virus (HIV) (except the disease is clinically controlled) or acquired immune deficiency syndrome (AIDS).\n4. Patients with any type of primary immunodeficiency or autoimmune disorder requiring treatment.\n5. Major surgery within 4 weeks prior to the first dose of the study drug.\n6. Pregnant or nursing\n7. Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)\u002Fbone marrow (BM) transplantation.\n8. Clinically significant cardiac conditions, including myocardial infarction within the last 6 months, uncontrolled angina, viral myocarditis, pericarditis, cerebrovascular accident, or other acute uncontrolled heart disease \\\u003C 3 months prior to the first dose of the study drug.\n9. Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.\n10. Live viral vaccine therapies within 4 weeks prior to the first dose of study drug.\n11. Any known, documented, or suspected history of illicit substance abuse.\n12. Any other disease or clinically significant abnormality in laboratory parameters, including serious medical or psychiatric illness\u002Fcondition, which in the judgment of the Investigator might compromise the safety of the patient or integrity of the study, interfere with the patient participation in the trial or compromise the trial objectives.\n13. Patients with systemic disease requiring systemic pharmacologic doses of corticosteroids greater than 10 mg daily prednisolone (or equivalent) are excluded\n\n    * Subjects who are currently receiving steroids at a dose of \\\u003C= 10 mg daily do not need to discontinue steroids prior to enrollment.\n    * Subjects that require topical, ophthalmological, and inhalational steroids would not be excluded from the study.\n    * Subjects who require active immunosuppression of greater than the steroid dose discussed above for any reason are excluded.","21 Years","99 Years",{"count":543,"type":22},40,[56],"ACM-CpG is a CpG-B TLR9 agonist, which in animal models has led to shrinkage and complete disappearance of injected tumors, durable antitumor memory, and growth inhibitory effects on non-injected tumors while intramuscular administration led to durable control of tumors. This Phase I trial will assess the safety and early signs of efficacy of intramuscular injection of ACM-CpG in patients with advanced malignant solid tumors.\n\nThe overall objectives of this trial are to establish the safety ACM-CpG.",[60,27],[548],"ACM-CpG","2026-07-13",{"date":490,"type":35},{"date":552,"type":35},"2025-01-15",{"date":554,"type":22},"2026-12",{"name":556,"class":42},"National Cancer Centre, Singapore",{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":54,"phases":566,"briefSummary":567,"conditions":568,"keywords":570,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":583,"locationsCount":319},"100589253","phase-1-a-study-of-xb628-alone-and-in-combination-with-zanzalintinib-in-participants-with-recurrent-advanced-or-metastatic-solid-tumors-100589253","NCT06952010","A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors","A Phase 1 Dose Escalation and Expansion Study of XB628 as a Single Agent and in Combination With Zanzalintinib in Participants With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Minimum life expectancy of ≥ 12 weeks.\n* Have a recurrent advanced or metastatic solid tumor that is histologically or cytologically confirmed.\n* Adequate organ and marrow function.\n* Not amenable to curative treatment with surgery or radiation.\n* Received at least 1 line of prior systemic anticancer therapy in the recurrent or metastatic setting.\n* Acceptable alternative therapy was received, refused, intolerable, or no longer effective.\n* Capable of understanding and complying with the protocol requirements and provide signed informed consent according to the protocol and local requirements.\n\nKey Exclusion Criteria\n\n* Primary brain tumors or known active brain metastases.\n* Major surgery (eg, gastrointestinal surgery, removal or biopsy of brain metastasis) within 4 weeks before the first dose of study treatment.\n* Received radiation therapy within 1 week before the first dose of study treatment or clinically relevant ongoing complications from prior radiation therapy.\n* Received prior therapy targeting NK cells (eg, monalizumab).\n* A woman of childbearing potential has a positive serum pregnancy test within 7 days prior to study treatment.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":565,"type":22},303,[56],"This study consists of a Dose-Escalation stage and a Dose Expansion stage. The primary purpose of the dose escalation stage is to determine the maximum tolerated dose (MTD) and\u002For recommended dosage(s) for expansion (RDE\\[s\\]); and the dose expansion stage is to evaluate the preliminary antitumor activity of XB628 as a single agent and in combination with zanzalintinib.",[26,60,27,569],"Immune Sensitive Tumor",[571,572,573,574,575,134,576],"XB628","Solid tumor","Advanced solid tumor","Metastatic solid tumor","Immune sensitive tumor","Zanzalintinib","2026-06-19",{"date":579,"type":35},"2026-06-24",{"date":581,"type":35},"2025-05-01",{"date":450,"type":22},{"name":584,"class":74},"Exelixis",{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":54,"phases":594,"briefSummary":595,"conditions":596,"keywords":601,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":43},"100492635","phase-1-combination-therapy-in-cancers-with-mutations-in-dna-repair-genes-100492635","NCT05694715","Combination Therapy in Cancers With Mutations in DNA Repair Genes","Combination Therapy of Niraparib and Irinotecan in Cancers With Mutations in DNA Repair Genes","Inclusion Criteria:\n\n1. Individuals 18 years of age or older.\n2. Ability to understand and willingness to voluntarily sign a written informed consent document prior to any study-related assessments or procedures are conducted; and willing and able to adhere to the study visit schedule and other protocol requirements.\n3. Solid tumors where topoisomerase I inhibitors have shown efficacy, including gastrointestinal tumors (e.g., colon, pancreatic, gastric cancer and cholangiocarcinoma), breast cancer, and ovarian cancer (prostate cancer is excluded), with one or more of the following DNA repair defects:\n\n   a. BRCA1, BRCA2, ATM, and\u002For PALB2 (based upon archival tumor tissue or germ line testing from any Clinical Laboratory Improvement Amendments (CLIA) approved lab). This testing must occur prior to study enrollment.\n4. Presence of at least one lesion with measurable disease as defined by RECIST 1.1 criteria for response assessment\n5. Advanced solid tumor malignancy without curative options\n6. At least 5 half-lives or 3 weeks (whichever is shorter) must have passed since last anticancer therapy\n7. The washout period for investigational agents without published half-lives should be 3 weeks since last therapy, and all treatment related toxicities must have recovered to less than grade 2.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status of \\\u003C=1 (Karnofsky \\> 60%; Appendix 1).\n9. Adequate organ function:\n\n   1. Absolute neutrophil count (ANC) \\>= 1.5 X 109\u002FL (no growth factors allowed within 14 days of enrollment)\n   2. Hemoglobin (Hgb) ≥10 g\u002FdL (no transfusion allowed within 7 days of enrollment)\n   3. Platelets (plt) \\>= 100 x 109\u002FL\n   4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C=2.5 x Upper Limit Normal (ULN), or AST and ALT \\\u003C5 x ULN in patients with known liver metastases or known primary liver tumor(s)\n   5. Serum total bilirubin \\\u003C= 1.5 x ULN\n   6. Creatinine \\\u003C1.5 x ULN, or Estimated Glomerular filtration rate (GFR) \\>= 50ml\u002Fmin by Cockcroft-Gault (http:\u002F\u002Fwww.mdcalc.com\u002Fcreatinine-clearance-cockcroft-gault-equation\u002F)\n10. Must have recovered to less than Grade 2 (CTCAE v5.0) in terms of toxicity from prior treatments (excluding neuropathy which can be ≤ Grade 2, alopecia, nail changes\u002Fnail loss or other chronic minor grade 2 AEs).\n11. Must be able to take oral medications.\n12. Based on its mechanism of action and pre-clinical findings, irinotecan can cause fetal harm when administered to a pregnant woman. Additionally, the effects of niraparib on the developing fetus are unknown. Therefore:\n\n    a. Females of childbearing potential and their male partners are advised to practice a highly effective method of contraception during treatment with niraparib and\u002For irinotecan and for 180 days following the last dose for females and 90 days following the last dose for males. A woman is considered to be of childbearing potential unless one of the following applies:\n\n    i. Is considered to be permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n\n    ii. Is postmenopausal, defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level consistently in the postmenopausal range (30 milli-international units per millilitre (mIU\u002FmL) or higher) may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to confirm a postmenopausal state.\n\n    b. A male participant of reproductive potential is eligible to participate if he agrees to the following starting with the first dose of study treatment through at least 90 days (a spermatogenesis cycle) after the last dose of study treatment:\n\n    i. refrain from donating sperm.\n\n    ii. Must agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak).\n\n    c. Highly effective contraception is considered to be a method with a \\\u003C 1% per year failure rate. Recommendations for highly effective contraception while taking niraparib include:\n\n    i. Ongoing use of injectable or implantable progesterone.\n\n    ii. Placement of an intrauterine device or intrauterine system.\n\n    iii. Bilateral tubal occlusion.\n\n    iv. Complete (as opposed to periodic) abstinence\n\n    . v. Male sterilization, with appropriate post-vasectomy documentation of absence of sperm in ejaculate.\n13. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n14. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n15. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\nExclusion Criteria:\n\n1. Any significant medical condition, laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study at clinician's discretion and not otherwise stated below.\n2. Prior allergic reaction to PARP inhibitor or irinotecan or their excipients. Prior PARP inhibitor or irinotecan (or topoisomerase 1 inhibitors) use is allowed.\n3. Individuals with known toxicity to irinotecan (e.g., grade 3 or 4 neutropenia) or suspected sensitivity.\n4. Individuals with homozygous or compound heterozygous UGT1A1 polymorphisms (e.g., alleles \\*28\u002F\\*28, \\*6\u002F\\*6, or \\*6\u002F\\*28) predicted to be associated with medium-to-high risk of irinotecan-related toxicity\n5. Individuals receiving any other investigational agents concurrently with the study drugs within 3 weeks or 5 half-lives, whichever is shorter, of the first dose of therapy preceding the study.\n6. Participants with unstable brain metastases are excluded. Patients with a history of brain metastases (\\>1cm) are permitted to enroll if they have been treated and have been stable for a minimum of one month on imaging. Patients may not currently receive steroids for their brain metastases. Patients with small, asymptomatic brain metastases (\\\u003C1cm) may enroll.\n7. Individuals with a second primary malignancy\n8. Individuals with a prior history of posterior reversible encephalopathy syndrome (PRES)\n9. Individuals with systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg that has not been adequately treated or controlled\n10. History of a malabsorption syndrome or uncontrolled nausea, vomiting, or diarrhea that may interfere with the absorption of oral study medication in the opinion of the investigator.\n11. Known or suspected diagnosis of Myelodysplastic syndromes (MDS) or Acute myeloid leukemia (AML).\n12. Known Gilbert's disease\n13. Individuals who are pregnant and\u002For breast feeding, or expecting to conceive children while receiving study treatment and\u002For for up to 180 days after the last dose of study treatment.\n14. Inability to comply with study procedures or unwilling to use adequate highly effective contraception",{"count":593,"type":22},24,[56],"The purpose of this phase 1 clinical trials is to determine whether niraparib (a Poly (ADP-ribose) polymerase inhibitor (PARPi)) can be safely combined with irinotecan with manageable toxicity and reasonable efficacy. Emerging evidence suggest that PARPi is an effective therapeutic strategy in a wider subset of solid tumors that may have defective homologous recombination (HR) or DNA repair gene mutations. BReast CAncer gene (BRCA), partner and localizer of BRCA2 (PALB2), and various other DNA repair germline mutations predispose carriers to cancers of the breast, ovaries, pancreas, prostate and melanoma. A number of preclinical studies have demonstrated that PARP inhibitors can work as chemopotentiators. There is significant interest in this combination, and the recommended phase II dose will be used in the upcoming NCI ComboMatch trial.",[27,597,598,599,600],"BRCA1 Mutation","BRCA2 Mutation","ATM Gene Mutation","PALB2 Gene Mutation",[602,603,604],"DNA Repair Gene Mutations","Small Molecule Inhibitor","Poly (ADP-ribose) polymerase inhibitor therapy (PARPi)","2026-06-16",{"date":607,"type":35},"2026-06-18",{"date":609,"type":35},"2023-05-23",{"date":611,"type":22},"2028-01-31",{"name":613,"class":42},"University of California, San Francisco",{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":54,"phases":623,"briefSummary":624,"conditions":625,"keywords":627,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":639},"100642168","phase-1-fortras-a-study-of-msk-tcr5-in-people-with-solid-tumor-cancers-100642168","NCT07638371","FORTRAS: A Study of MSK-TCR5 in People With Solid Tumor Cancers","FORTRAS: Phase I, Investigator Initiated, Dose-escalation Clinical Trial Evaluating a CD8 Alpha\u002FBeta Armored RAS G12D\u002FHLA-A*11:01-specific T-cell Receptor Therapy (MSK-TCR5) in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\nPart A: Prior to cell collection all of the following inclusion criteria must be met:\n\n* Age ≥18 years.\n* Histologically confirmed advanced or metastatic, unresectable solid tumor\n* Positive for RAS G12D mutation and HLA-A\\*11:01 allele\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease after at least 1 line of systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options. Subjects with stable disease (SD), or that present lack of clinical benefit from previous therapy (including treatment suspension due to toxicity) may be considered eligible for enrollment. :\n\n  1. For CRC: Patients harboring genomic aberrations such as BRAFV600E mutations, HER2 amplifications, or VEGF expression for which FDA-approved targeted therapies are available must have received prior treatment with applicable FDA-approved targeted therapies, including multi-kinase inhibitors. Patients whose tumors have deficient mismatch repair (dMMR)\u002Fhigh microsatellite instability (MSI-H) must have received an immune checkpoint inhibitor prior to enrolling in this study.\n  2. For NSCLC: Patients harboring genomic aberrations such as non-resistant EGFR mutations, ALK rearrangement, ROS rearrangement, and BRAF V600E mutation for which FDA-approved targeted therapies are available must have received prior treatment with the applicable FDA-approved targeted therapies. Patients with the appropriate PD-L1 expression score must have received treatment with an FDA-approved checkpoint inhibitor with or without chemotherapy consistent with the FDA-approved label.\n  3. Any other solid tumors, including PDAC: Patients harboring genomic aberrations for which FDA-approved targeted therapies are available must have received prior treatment with the applicable FDA-approved targeted therapies. Patients whose tumors have dMMR\u002FMSI-H must have received an immune checkpoint inhibitor prior to enrolling in this study.\n\nPart B: Prior to treatment with MSK-TCR5 all of the following inclusion criteria must be met:\n\n* Measurable disease per RECIST version 1.1. Note: a previously irradiated or locoregionally treated lesion can be considered a target lesion if it progressed post-treatment.\n* ECOG performance status of 0 or 1\n* Adequate organ and bone marrow function based on the following laboratory values:\n\n  1. ANC ≥1000\u002Fmm3 without granulocyte colony-stimulating factor support (filgrastim within 7 days or peg-filgrastim within 14 days of screening)\n  2. Platelets ≥75,000\u002Fmm3 without transfusion within the preceding 7 days of screening.\n  3. Hemoglobin ≥8.0 g\u002FdL (≥80 g\u002FL); blood transfusion permitted within 7 days of screening.\n  4. AST, ALT, and ALP ≤ 3x ULN, or ≤ 5x ULN if liver or bone metastases present.\n  5. Total bilirubin ≤ 1.5x ULN or ≤ 3x ULN in the presence of documented Gilbert's Syndrome\n  6. CrCl ≥50 mL\u002Fmin by Cockcroft-Gualt equation\n\nExclusion Criteria:\n\nPart A: Participant Exclusion Criteria prior to cell collection\n\n* Previous allogeneic stem cell transplantation or prior organ transplantation\n* History of primary immunodeficiency, autoimmune, or inflammatory disease including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, or Grave's disease that in the past year has required systemic treatment with corticosteroids \\> 10mg\u002Fday of prednisone or equivalent doses of other corticosteroids or immunosuppressive drugs. Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal\u002Fpituitary insufficiency is not considered a form of systemic treatment and allowed)\n* Primary brain tumor\n* Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression. Patients previously treated for CNS metastases that are radiographically and neurologically stable and off steroids for at least 2 weeks prior to enrollment are eligible.\n* Surgery or catheter-based interventions such as transarterial chemoembolization or percutaneous coronary intervention within 2 weeks.\n* Uncontrolled significant intercurrent or recent illness including, but not limited to the following conditions:\n\n  a. Significant cardiovascular abnormalities as defined by any one of the following: uncontrolled congestive heart failure or hypertension, clinically significant hypotension, symptomatic coronary artery disease, or a documented ejection fraction (EF) of \\\u003C 50% as assessed by echocardiogram or multigated acquisition scan (MUGA).\n* Uncontrolled active bacterial, viral, fungal, or mycobacterial infection not responding to antibiotics, antimycotics, or antifungal agents, as well as long-term oral treatment with any of these agents.\n* Subject has had radiotherapy or systemic anti-cancer therapy within at least 2 weeks or 3 half-lives, whichever is shorter.\n* Pregnant or lactating women; women of childbearing age, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while receiving study treatment and for at least 12 months after all treatment is finished. Sexually active males, unless they are willing to use a condom during intercourse while receiving study treatment and for at least 12 months after all treatment is finished.\n* Previously identified allergy, hypersensitivity, or known contraindication to cyclophosphamide, fludarabine, or any other agent associated with LDC or MSK-TCR5.\n* Positive serologic test results for HIV.\n* Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.\n* Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR\n* Patient\u002Fparent\u002FLAR unable to give informed consent\n\nPart B: Participant Exclusion Criteria prior to MSK-TCR5 infusion\n\n* Any exclusion criterion listed in Part A.",{"count":622,"type":22},16,[56],"The purpose of this study is to test the safety of MSK-TCR5 in participants with advance solid tumor cancer that has a KRAS, HRAS, or NRAS G12D mutation.",[26,626,60,168,27],"Solid Carcinoma",[26,626,60,168,27,628,629,630],"MSK-TCR5","Memorial Sloan Kettering Cancer Center","26-083","2026-06-11",{"date":633,"type":35},"2026-06-15",{"date":635,"type":35},"2026-06-09",{"date":637,"type":22},"2030-06-09",{"name":629,"class":42},7,{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":4,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":54,"phases":649,"briefSummary":650,"conditions":651,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":664,"locationsCount":666},"100614791","phase-1-first-in-human-study-of-plx-61639-in-locally-advanced-or-metastatic-solid-tumors-100614791","NCT07284186","First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors","A Phase 1, First-in-Human Study of the SMARCA2 Degrader, PLX-61639, in Patients With SMARCA4-Mutated Locally Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Participants with locally advanced or metastatic, relapsed\u002Frefractory, solid tumors harboring a SMARCA4 loss-of-function mutation that have progressed on, are intolerant of, or not otherwise candidates for available approved therapies\n* Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function\n* Measurable disease per RECIST 1.1\n* ECOG PS of 0 or 1\n\nKey Exclusion Criteria:\n\n* Germline SMARCA4 mutations\n* Known SMARCA2 mutation or loss of expression\n* Symptomatic CNS disease\n* Prior treatment with another SMARCA2-directed therapy\n* History of other malignancies\n* Clinically significant heart disease\n* Uncontrolled hypertension\n* Prolongation of QT interval",{"count":648,"type":22},155,[56],"A multicenter, single-arm, first-in-human study to investigate the safety, pharmacokinetics, and preliminary antitumor activity of PLX-61639 in participants with locally advanced or metastatic, relapsed\u002Frefractory, SMARCA4-deficient solid tumors who are intolerant of or have failed available, approved therapies.\n\nThe study will be conducted in 3 parts: dose escalation (Part 1), dose optimization (Part 2), and cohort expansion (Part 3). Each part of the study will consist of a Screening Phase lasting up to 28 days during which participants will be assessed for eligibility, a Treatment Phase beginning on Cycle 1 Day 1 and consisting of consecutive 28-day cycles, an End of Treatment Visit, and a Post-Treatment Follow-Up Phase.\n\nParticipants will receive their assigned dose of PLX-61639 administered orally, once daily until progression\u002Frelapse, intolerance, death, or withdrawal from study treatment by the Investigator or participant.",[521,652,653,654,27,107,655,656,657,60],"Gastric Adenocarcinoma","Gastric Squamous Cell Carcinoma","Gastroesophageal Junction (GEJ) Adenocarcinoma","Esophageal Adenocarcinoma","SMARCA4 Mutation","Gastroesophageal Junction Squamous Cell Carcinoma","2026-06-10",{"date":660,"type":35},"2026-06-12",{"date":662,"type":35},"2025-12-01",{"date":39,"type":22},{"name":665,"class":74},"Plexium, Inc.",10,{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":672,"acronym":4,"eligibilityCriteria":673,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":674,"targetDuration":4,"studyType":54,"phases":676,"briefSummary":677,"conditions":678,"keywords":680,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":690,"startDateStruct":691,"completionDateStruct":693,"leadSponsor":695,"locationsCount":367},"100591052","phase-1-clinical-trial-of-yh32364-in-patients-with-locally-advanced-or-metastatic-egfr-overexpressing-solid-tumors-100591052","NCT06975410","Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors","A Phase 1\u002F2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32364 in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Must sign an informed consent form (ICF) prior to any study specific procedures\n* ECOG performance status 0 or 1\n* Estimated life expectancy of at least 3 months\n* A woman must not be breastfeeding\n* Have at least one measurable lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline ≥10 mm in the longest diameter (except lymph nodes which must have a short axis of ≥15 mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), are suitable for accurate repeated measurements.\n\n\\[Dose Escalation Only\\] Locally advanced or metastatic EGFR overexpressing solid tumor\\* that is refractory or intolerable on all available standard therapy and that is considered uncurable by local therapy\n\n\\* One of the following pathologically confirmed EGFR overexpressing (IHC3+ or IHC2+) tumors.\n\n* Head and neck squamous cell carcinoma (HNSCC)\n* Non-small cell lung cancer (NSCLC): squamous cell carcinoma (SqCC)\n* Esophageal squamous cell carcinoma (ESCC)\n* Biliary tract cancer (BTC)\n* Uterine cervical cancer\n* Vulvar cancer\n* Urothelial cancer\n* Squamous cell carcinoma of other origin of tumor (e.g., skin squamous cell tumor)\n\n\\[Dose Expansion Only\\] Cohort 1: Pathologically confirmed EGFR overexpressing (IHC3+ or IHC2+), locally advanced or metastatic HNSCC other than nasopharyngeal carcinoma (NPC)\\* that is refractory or intolerable on all available standard therapy and that is considered uncurable by local therapy.\n\nExclusion Criteria:\n\n* Known uncontrolled central nervous system (CNS) metastases, spinal cord compression, and\u002For carcinomatous meningitis\n* Have history of a second primary cancer with the exception of\n\n  * curatively treated non-melanomatous skin cancer\n  * curatively treated cervical or breast carcinoma in situ, or\n  * other malignancy with no known active disease present and no treatment administered during the last 2 years\n* Have history of or current Class II, III or IV heart failure as defined by the New York Heart Association (NYHA)\n* Have history of acute coronary syndromes, including myocardial infarction, coronary artery bypass graft, unstable angina, coronary angioplasty or stenting within past 24 weeks\n* Have history of (non-infectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or any evidence of current ILD or pneumonitis\n* Have autoimmune disease that has required systemic treatment\n* Infection with human immunodeficiency virus (HIV)\n* Active chronic hepatitis B or chronic hepatitis C\n\n\\[Prior\u002FConcomitant Therapy\\]\n\n* Have received systemic steroid therapy\n* Previous treatment with a 4-1BB\u002FCD137-modulating agent\n* Have used a live vaccine within 4 weeks\n* Have received treatment with immunotherapy, biological therapies, targeted small molecules, or hormonal therapies\n* Have received radiation therapy\n* Have received cytotoxic chemotherapy",{"count":675,"type":22},80,[56,57],"This is a study for people with locally advanced or metastatic cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with Epidermal Growth Factor Receptor (EGFR) overexpressing can join the study. The purpose of this study is to find out whether a medicine called YH32364 helps people with locally advanced or metastatic cancers with EGFR overexpression.",[679,332,27],"EGFR Overexpression",[681,682,572,683,684,685,686,687,688,689],"YH32364","EGFR\u002F4-1BB bispecific antibody","Head and neck squamous cell carcinoma (HNSCC)","Non-small cell lung cancer (NSCLC)","Esophageal squamous cell carcinoma (ESCC)","Biliary tract cancer (BTC)","Uterine cervical cancer","Vulvar cancer","Urothelial cancer",{"date":658,"type":35},{"date":692,"type":35},"2025-06-12",{"date":694,"type":22},"2029-12",{"name":696,"class":74},"Yuhan Corporation",{"id":698,"slug":699,"hasResults":12,"nctId":700,"briefTitle":701,"officialTitle":702,"acronym":4,"eligibilityCriteria":703,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":541,"enrollmentInfo":704,"targetDuration":4,"studyType":54,"phases":706,"briefSummary":707,"conditions":708,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":710,"lastUpdatePostDateStruct":711,"startDateStruct":713,"completionDateStruct":715,"leadSponsor":717,"locationsCount":43},"100457116","phase-1-determine-safety--recommended-phase-2-dosing-of-zeaxanthin-alone-or-in-combination-wpembrolizumab-in-patients-with-metastatic-cancer-100457116","NCT05232409","Determine Safety & Recommended Phase 2 Dosing of Zeaxanthin Alone or in Combination w\u002FPembrolizumab in Patients With Metastatic Cancer","A Phase I Study to Determine the Safety and Recommended Phase 2 Dosing of Zeaxanthin Alone or in Combination With Pembrolizumab in Patients With Metastatic Solid Tumors","Inclusion Criteria for Dose escalation zeaxanthin monotherapy\n\n1. Stage IV or unresectable stage 3 histologically confirmed solid tumor malignancy refractory to all standard therapies known to provide clinical benefit (unless the therapy is contraindicated or intolerable) in the opinion of the treating investigator for his\u002Fher tumor type. Subjects are not required to have received systemic therapies that have response rates under 20% with no associated survival benefit (for example DTIC chemotherapy and high dose Interleukin-2 in melanoma patients).\n2. Age ≥ 18 years.\n3. Performance status ECOG 0, 1 or 2\n4. Adequate organ and marrow function as describe below:\n\n   * Absolute neutrophil count ≥ 1,500\u002FmcL\n   * Platelets ≥ 100,000\u002Fmcl\n   * Total bilirubin \\\u003C 1.5 x the normal institutional limits excluding patients with confirmed Gilbert's syndrome\n   * AST (SGOT)\u002FALT (SPGT) ≤ 3 x the institutional upper limit of normal (ULN)\n   * Creatinine ≤ 1.5 x the institutional upper limit of normal\n5. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\n   Recommended methods of birth control are:\n   1. The consistent use of an approved hormonal contraception (birth control pill\u002Fpatches, rings), An intrauterine device (IUD), Contraceptive injection (Depo-Provera), Double barrier methods (Diaphragm with spermicidal gel or condoms with contraceptive foam), Sexual abstinence (no sexual intercourse) or Sterilization.\n   2. Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after completion of therapy\n\n   A Female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets at least one of the following criteria:\n   1. Has not undergone a hysterectomy or bilateral oophorectomy\n   2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n6. Ability to understand and the willingness to sign a written informed consent.\n7. Measurable disease is not required but evaluable disease is required.\n8. Life expectancy of at least 3 months\n\nExclusion Criteria for Dose escalation zeoxanthin monotherapy\n\n1. Patients who have had chemotherapy or radiotherapy within 21 days prior to initiating study treatment or those who have not recovered to grade 1 or less from adverse events due to agents administered more than 21 days earlier excluding alopecia, gd 2 fatigue, gd 2 hearing loss from platinum agent, and endocrinopathies on stable replacement therapy.\n\n   (Patients may not be receiving any other investigational agents or concomitant chemotherapy or radiation therapy. Hormonal therapy is not exclusionary.)\n2. Patients with active brain metastases requiring palliation with steroids and not stable for at least 4 weeks post radiation therapy or surgery.\n3. Leptomeningeal carcinomatosis\n4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to zeaxanthin.\n5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n6. Patients with another primary malignancy not in remission for at least 3 years. Exceptions include nonmelanoma skin cancer, curatively treated localized prostate cancer with normal prostate specific antigen, low risk prostate cancer followed expectantly, stage I colorectal cancer resected, resected stage 1 breast cancer cervical carcinoma in situ on biopsy, melanoma in situ resected, or squamous intraepithelial lesion on PAP smear.\n7. Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. Women of child bearing potential must have a negative serum or urine pregnancy test prior to the first dose of study treatment\n8. Inability to swallow pills.\n\nInclusion Criteria for dose escalation zeoxanthin plus pembrolizumab\n\n1. Stage IV or unresectable stage 3 histologically confirmed solid tumor malignancy for which pembrolizumab is FDA approved and progressed on prior PD-1 or PD-L1 therapy and if indicated for cancer type refractory to all standard therapies known to provide clinical benefit (unless the therapy is contraindicated or intolerable) in the opinion of the treating investigator for his\u002Fher tumor type. Subjects are not required to have received systemic therapies that have response rates under 20% with no associated survival benefit (for example DTIC chemotherapy and high dose Interleukin-2 in melanoma patients).\n2. Patients must have had symptomatic or radiographic progression during or following treatment with a PD-1 or PD-L1 inhibitor. This is defined as imaging obtained subsequent to initiation of PD-1 or PD-L1 inhibitor demonstrating a new lesion that is consistent with metastasis or growth of a preexisting metastasis which the treating physician felt reflected tumor progression and therefore discontinued the immunotherapy. . Symptomatic progression refers to development of worsening bone pain related to bone metastasis that cannot be accurately measured on imaging and for which the treating physician had discontinued the immunotherapy.\n3. Age ≥ 18 years.\n4. Performance status ECOG 0, 1or 2.\n5. Adequate organ and marrow function as describe below:\n\n   * Absolute neutrophil count ≥ 1,500\u002FmcL\n   * Platelets ≥ 100,000\u002Fmcl\n   * Total bilirubin) ≤ 1.5 x normal institutional limits excluding patients with confirmed Gilbert's syndrome\n   * AST (SGOT)\u002FALT (SPGT) ≤ 3 x institutional upper limit of normal\n   * Creatinine ≤ 1.5 x the institutional upper limit of normal\n6. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\n   Recommended methods of birth control are:\n   1. The consistent use of an approved hormonal contraception (birth control pill\u002Fpatches, rings), An intrauterine device (IUD), Contraceptive injection (Depo-Provera), Double barrier methods (Diaphragm with spermicidal gel or condoms with contraceptive foam), Sexual abstinence (no sexual intercourse) or Sterilization.\n   2. Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after completion of therapy\n\n   A Female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets at least one of the following criteria:\n   1. Has not undergone a hysterectomy or bilateral oophorectomy\n   2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n7. Ability to understand and the willingness to sign a written informed consent.\n8. Measurable disease is not required but evaluable disease is required\n9. Life expectancy of at least 3 months\n\nExclusion Criteria for zeoxanthin plus pembrolizumab\n\n1. Patients who have had immunotherapy, chemotherapy or radiotherapy within 21 days prior to entering the study or those who have not recovered to grade1 or lower from adverse events due to agents administered more than 21 days earlier excluding alopecia, gd 2 fatigue, gd 2 hearing loss from platinum agent, and endocrinopathies on stable replacement therapy.\n2. Prior grade 3 or greater immune mediated toxicity related to PD-1 or PD-L1 inhibitor. Prior grade 2 or higher colitis, diarrhea, hepatitis, neurologic, cardiac, immune mediated toxicity related to PD-1 or PD-L1 inhibitor. Exceptions include vitiligo and controlled endocrinopathies.\n3. Patients may not be receiving any other investigational agents or concomitant chemotherapy or radiation therapy.\n4. Patients taking oral steroids at or greater than the equivalent of 10 milligrams of oral prednisone daily.\n5. Inability to swallow pills.\n6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to zeaxanthin.\n7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n8. Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. Women of child bearing potential must have a negative serum or urine pregnancy test prior to the first dose of study treatment\n9. Patients with active brain metastases requiring palliation with steroids not stable for at least 4 weeks post radiation therapy or surgery\n10. Leptomeningeal carcinomatosis\n11. Patients with another primary malignancy not in remission for at least 3 years. Exceptions include non-melanoma skin cancer, curatively treated localized prostate cancer with normal prostate specific antigen, low risk prostate cancer followed expectantly, resected stage 1 colon cancer, resected stage 1 breast cancer, cervical carcinoma in situ on biopsy, melanoma in situ resected, or squamous intraepithelial lesion on PAP smear.",{"count":705,"type":22},72,[56],"The purpose of the research is to determine the highest dose of an oral compound called zeaxanthin that can be safely taken each day in patients with advanced cancer, the toxicity profile of zeaxanthin, and the dose of zeaxanthin to use in future cancer clinical trials.",[709,27],"Cancer Metastatic","2026-06-03",{"date":712,"type":35},"2026-06-05",{"date":714,"type":35},"2022-04-17",{"date":716,"type":22},"2028-03",{"name":718,"class":42},"Valley Health System",{"id":720,"slug":721,"hasResults":12,"nctId":722,"briefTitle":723,"officialTitle":724,"acronym":4,"eligibilityCriteria":725,"healthyVolunteers":12,"sex":18,"minAge":726,"maxAge":727,"enrollmentInfo":728,"targetDuration":4,"studyType":54,"phases":729,"briefSummary":730,"conditions":731,"keywords":733,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":736,"lastUpdatePostDateStruct":737,"startDateStruct":739,"completionDateStruct":741,"leadSponsor":743,"locationsCount":43},"100439578","phase-1-a-study-of-repotrectinib-in-combination-with-chemotherapy-in-children-and-young-adults-with-solid-tumor-cancer-100439578","NCT05004116","A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer","Phase 1\u002F2 Study of TPX-0005 (Repotrectinib) in Combination With Chemotherapy in Pediatric and Young Adult Subjects With Advanced or Metastatic Solid Tumors and Primary Central Nervous System Tumors","Inclusion Criteria (ALL Patients) :\n\n* Prior Therapy: Patients must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy prior to study enrollment. Patients must not have received the therapies indicated below for the specified time period prior to the first day of administration of protocol therapy on this study:\n\n  * Myelosuppressive chemotherapy: Last dose was given at least 21 days before the start date for protocol therapy.\n  * Biologic (anti-neoplastic agent including retinoids): Last dose given at least 7 days prior to the start date for protocol therapy.\n  * Monoclonal antibodies: Last dose of any monoclonal antibodies must have received at least 7 days or 3 half-lives, whichever is longer, prior to the start date for protocol therapy.\n  * Other immunotherapy (ex: tumor vaccine): Patient is eligible after 42 days of completion. Steroids are excluded from inclusion in immunotherapy.\n  * Radiation Therapy: Patients must not have received radiation for a minimum of two weeks prior to first dose of the drug for small port. If extensive bone marrow radiation, at least 42 days must have elapsed.\n  * Palliative radiotherapy on study is permitted for the treatment of painful bony lesions providing the lesions were known at the time of study entry and the Investigator clearly indicates that the need for palliative radiotherapy is not indicative of disease progression. In view of the current lack of data about the interaction of repotrectinib with radiotherapy, repotrectinib treatment should be interrupted during palliative radiotherapy, stopping 1 day before palliative radiotherapy and resuming treatment 1 day after completion of palliative radiotherapy and recovery from any acute radiation toxicities to baseline.\n  * Hematopoietic Stem Cell Transplant (HSCT): Patients are eligible 12 weeks after date of autologous hematopoietic stem cell infusion following myeloablative therapy (timed from first day of this protocol therapy). Patients who have received an autologous hematopoietic stem cell infusion to support non- myeloablative therapy (such as \\^131 I-MIBG) are eligible at any time as long as they meet the other criteria for eligibility.\n  * \\^131 I-MIBG therapy: A minimum of 6 weeks must have elapsed after \\^131 I-MIBG therapy prior to start of protocol therapy.\n  * Growth factors: Patients are eligible 14 days after last dose of long-acting growth factor (ex: peg-GCSF) or 7 days after short acting growth factor.\n  * Any investigational agent or anticancer therapy other than chemotherapy and not otherwise noted: Not within 2 weeks prior to planned start of TPX-0005 (Repotrectinib) or 5 half-lives, whichever is shorter. Full recovery of clinically significant toxicities from that therapy must be evident.\n  * Any prior treatment with a tyrosine kinase inhibitor (TKI) of ALK\u002FROS\u002FNTRK does NOT exclude patient from study (Patients are eligible for study at least 7 days or 5 half-lives, whichever is shorter, after last dose)\n* Disease Status\n\n  * Patients must have relapsed or refractory disease despite standard therapy.\n  * Phase 1: Patients must have evaluable or measurable disease\n  * Phase 2: All patients must have measurable disease (per Appendices 1-3) at time of enrollment\n  * Exception: Patients with DIPG must have recurrent and\u002For progressive disease after upfront radiation therapy. Any number of prior recurrences is permitted.\n* Biopsy Requirement\n\n  °Archived tissue must be available for analysis, but no fresh biopsy is required (exception: patients with DIPG do not require archived tissue). If no archival tissue is available, waiver may be permitted by study PI (phase 1 only).\n* Patients with Primary CNS Tumors:\n\n  * Patients with primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 14 days prior to enrollment\n  * Archived tissue and histologic verification requirement are waived for patients with diffuse intrinsic pontine glioma (DIPG)\n* Performance Score: Patients must have a Lansky (\\< 16 years age) or Karnofsky (≥ 16 years age) score of at least 50. Patients who are unable to walk because of paralysis or tumor pain, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* No bone marrow involvement\n\n  * Absolute Neutrophil Count ≥1000\u002Fmm\\^3 (1 x 10\\^9\u002FL)\n  * Platelet Count ≥100,000\u002Fmm \\^3 (100 x 10\\^9\u002FL); transfusions allowed\n  * Hemoglobin ≥ 8.0 g\u002FdL, transfusions are allowed\n* Known bone marrow involvement (applicable for phase 2 only)\n\n  * Absolute Neutrophil Count ≥750\u002Fmm 3 (0.75 x 10\\^9\u002FL)\n  * Platelet Count ≥50,000\u002Fmm\\^3 (100 x 10\\^9\u002FL), transfusions allowed\n  * Hemoglobin ≥ 8.0 g\u002FdL, transfusions are allowed\n* Serum Creatinine or Creatinine Clearance\\*Creatinine within normal limits for age\u002Fgender (see table below) or creatinine clearance or nuclear GFR ≥ 60 mL\u002Fmin\u002F1.73m\\^2\n* Total Serum Bilirubin \\<2.5 x ULN for age\u002Fgender\n* Liver Transaminases (AST\u002FALT) \\<2.5 x ULN for age\u002Fgender; \\< 5 x ULN for age\u002Fgender if liver metastasis is present\n* Serum calcium, magnesium and potassium Normal for age\u002Fgender or ≤ CTCAE Grade 1 with or without supplementation.\n* Cardiac Function Echocardiogram with left ventricular shortening fraction \\>25% and QTc Friderica (QTcF) \\<\u002F= 470ms on screening electrocardiogram\n* AST\u002FALT = aspartate aminotransferase\u002Falanine aminotransferase, ULN = upper limit of normal\n* Adequate Renal Function using the Schwartz formula for estimating GFR Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC.\n* Females of Childbearing potential: Must have negative serum pregnancy test during screening and be neither breastfeeding nor intending to become pregnant during study participation. Females of childbearing potential must agree to avoid pregnancy during the study and agree to the use of 2 effective contraceptive methods (hormonal and barrier method of birth control) prior to study entry, for the duration of study participation, and in the following 1 month after discontinuation of study treatment. Men with partner(s) of childbearing potential must take appropriate precautions to avoid fathering a child from screening until 6 months after discontinuation of study treatment and to use appropriate barrier contraception or abstinence.\n* Ability to comply with outpatient visits, laboratory testing, and study procedures during study participation\n* The patient, parent or guardian must voluntarily sign and date an informed consent approved (in addition to pediatric assent, if required) by an Independent Ethics Committee (IEC)\u002FInstitutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.\n* Age:\n\n  * Phase 1 (Part A): ≤ 30 years old (age at C1D1)\n  * Phase 1 (Part B): \\< 12 years old (age at C1D1)\n  * Phase 2: ≤ 30 years old (age at C1D1)\n* Disease:\n\n  * Phase 1: Pediatric patients with relapsed\u002Frefractory solid tumors (including primary CNS tumors). Patients with ALK, ROS1, or NTRK1\u002F2\u002F3 fusions are permitted to enroll in this cohort if progressed on prior targeted therapy or are not eligible for a higher priority study of single agent inhibition (ex: repotrectinib monotherapy IRB#20-077). Patients with tumors not characterized by any ALK\u002FROS\u002FNTRK aberration are also permitted to enroll in this cohort.\n  * Phase 2\n* Cohort 1: Patients with molecularly defined desmoplastic small round cell tumor (DSRCT)\n* Cohort 2: Exploratory cohort of patients with relapsed or refractory solid tumors including CNS tumors (no requirement of ALK, ROS1, NTRK1-3 aberrations). Patients with ALK, ROS1, or NTRK1\u002F2\u002F3 fusions are permitted to enroll in this cohort if progressed on prior targeted therapy or are not eligible for a higher priority study of single agent inhibition (ex: repotrectinib monotherapy IRB# 20-077). Note: Refractory disease is defined as the presence of persistent abnormality on conventional MRI imaging that is further distinguished by histology (biopsy or sample of lesion) or advanced imaging, OR as determined by the treating physician and discussed with the primary investigator prior to enrollment.\n* Cohort 3: Patients with recurrent or progressive DIPG. Patients with typical DIPG, defined as tumors with a pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons on at least 1 axial T2-weighted image, are eligible. No histologic confirmation is required. Patients with pontine tumors that do not meet radiographic criteria for typical DIPG (e.g., focal tumors or those involving less than 2\u002F3 of the pontine cross sectional area with or without extrapontine extension) are eligible if the tumors are biopsied and proven to be high-grade gliomas (such as anaplastic astrocytoma, glioblastoma, high-grade glioma NOS, and\u002For H3 K27M-mutant by immunohistochemistry or next generation sequencing CLIA certified) by institutional diagnosis.\n* Patients treated in Phase 1 at RP2D will be evaluable in the Phase 2 cohort if they meet all other inclusion criteria for the specified cohort. Patients receiving oral capsule OR oral suspension can be included in Phase 2 cohort. Enrollment of patients of at least 12 years old can begin treatment in Phase 2 once TPX-0005 (Repotrectinib) combination therapy RP2D is defined in Phase 1A (even if Phase 1B is not yet completed) Exception: DIPG patients may be enrolled on phase 2 cohort 3 prior to the completion of Phase 1 including the Phase 1 part B (PK expansion) since they will receive TPX-0005 (Repotrectinib) monotherapy at the pediatric RP2D.\n* Tissue Analysis\n\n  * Phase 1: All patients must have archived tissue available for analysis (exception: DIPG patients), but ALK\u002FROS\u002FNTRK status verification is not required prior to enrollment. If no archival tissue is available, waiver may be permitted by study PI (phase 1 only).\n  * Phase 2: Prior to enrollment, all patients must have ALK\u002FROS\u002FNTRK status evaluated in CLIA lab or equivalent by any nucleic acid-based diagnostic testing method (e.g., next-generation sequencing \\[NGS\\], Sanger sequencing, reverse transcription-polymerase chain reaction). Exception: Patients with molecularly defined DSRCT do not require ALK\u002FROS\u002FNTRK status confirmed prior to enrollment. Exception: Patients enrolling on cohort 3 (recurrent\u002Fprogressive DIPG)\n\nExclusion Criteria:\n\n* Phase 1- patients with known bone marrow disease\n* Concurrent participation in another therapeutic clinical trial\n* Major surgery within 14 days (2 weeks) prior to C1D1. Central venous access (Broviac, MediPort) placement does not meet criteria for major surgery.\n* Pregnancy or lactation\n* Known active systemic infections requiring ongoing treatment (bacterial, fungal, viral including human immunodeficiency virus positivity). Skin or other superficial infections requiring topical treatment only are not an exclusion.\n* Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.\n* Peripheral neuropathy CTCAE grade ≥ 3.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study, or could compromise protocol objectives in the opinion of the Investigator and\u002For Turning Point Therapeutics.\n* Current use or anticipated need for drugs that are known to be strong CYP3A4 inhibitors or inducers\n* Disease progression while on treatment with irinotecan\u002Ftemozolomide.\n* Gilbert Syndrome or Crigler-Najjar\n* Prolonged QTc: 450m\u002Fs for male patients and 470ms for female patients.","1 Year","25 Years",{"count":155,"type":22},[56,57],"This study will test the safety of the study drug, repotrectinib, in combination with chemotherapy (irinotecan and temozolomide) in children and young adults who have advanced or metastatic solid tumors. We researchers will try to find the highest dose of the study drug that causes few or mild side effects in study participants. When the researchers find this dose, we will evaluate it in a different group of participants to find out whether repotrectinib in combination with chemotherapy is an effective treatment for children and young adults who have advanced\u002Fmetastatic solid tumors. Another purpose of the study is to look at the way the body absorbs, distributes, and gets rid of repotrectinib.",[732,27],"Advanced Cancer",[734,735],"Repotrectinib","21-156","2026-06-02",{"date":738,"type":35},"2026-06-04",{"date":740,"type":35},"2021-08-09",{"date":742,"type":22},"2028-08",{"name":629,"class":42}]