[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumours\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumours":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,52,74,96,116,142,154,191,217,239,265,310,331],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100053964","phase-1-a-phase-i-dose-escalation-and-dose-expansion-study-to-investigate-the-pharmacokinetics-and-safety-of-subcutaneous-durvalumab-100053964",false,"NCT07391670","A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab","A Phase I, Multicentre, Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab in Adult Participants With Solid Tumours","IMFINZI-subQ","Inclusion Criteria:\n\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy of ≥ 12 weeks at enrolment.\n* Adequate organ and marrow function.\n* Minimum body weight \\> 30 kg.\n\nPart 1 only:\n\nLocally Advanced Unresectable (Stage III) NSCLC Participants -\n\n* Histological or cytological documented evidence of NSCLC (locally advanced, unresectable, Stage III).\n* Must have received at least 2 cycles of platinum-based chemotherapy concurrent with definitive radiation therapy.\n* Have not progressed following definitive concurrent chemoradiation.\n\nLS-SCLC Participants -\n\n* Histologically or cytologically documented LS-SCLC (Stage I-III).\n* Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to enrolment.\n* Have not progressed following definitive concurrent chemoradiation.\n\nPart 1 and 2:\n\nUnresectable HCC Participants -\n\n* Unresectable HCC based on histopathological confirmation.\n* No prior systemic therapy for unresectable HCC.\n* Must not be eligible for locoregional therapy for unresectable HCC.\n* Child-Pugh Score class A.\n* Measurable disease as defined by RECIST v1.1.\n\nExclusion Criteria:\n\n* Active or prior documented autoimmune disease requiring systemic treatment.\n* Uncontrolled infection (including human immunodeficiency virus \\[HIV\\], hepatitis B or C).\n* Prior exposure to immune checkpoint inhibitors.\n\nPart 1 only:\n\nLocally Advanced Unresectable (Stage III) NSCLC Participants -\n\n* Mixed SCLC and NSCLC histology.\n* Active pneumonitis or interstitial lung disease requiring systemic therapy.\n\nLS SCLC Participants -\n\n* Mixed SCLC and NSCLC histology.\n* Extensive-stage disease.\n* History of Grade ≥ 2 pneumonitis.\n\nPart 1 and 2:\n\nUnresectable HCC Participants -\n\n* Hepatic encephalopathy.\n* Uncontrolled ascites.\n* Active gastrointestinal (GI) bleeding.","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of the study is to determine a subcutaneous (SC: under the skin) durvalumab + recombinant human hyaluronidase (rHu) dose that yields systemic drug exposure similar to intravenous (IV: into the veins) durvalumab administration and to evaluate the pharmacokinetics and safety of SC durvalumab + rHu injection in participants with different types of solid tumours (cancers).",[27],"Solid Tumours",[29,30,31,32,33,34,35,36,37,38],"Pharmacokinetics","Non-small cell lung cancer (Stage III, unresectable)","Small cell lung cancer (Limited stage)","Hepatocellular carcinoma (Unresectable)","Subcutaneous","Human hyaluronidase","Monoclonal antibody","Programmed cell death ligand 1 (PD-L1)","Programmed cell death protein 1","Anticancer therapy","RECRUITING","2026-07-10",{"date":42,"type":43},"2026-07-13","ACTUAL",{"date":45,"type":43},"2026-03-31",{"date":47,"type":21},"2027-08-30",{"name":49,"class":50},"AstraZeneca","INDUSTRY",19,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":51},"100605300","phase-1-a-phase-12a-first-in-human-study-of-bms-986517-in-participants-with-advanced-solid-tumors-100605300","NCT07160725","A Phase 1\u002F2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors","A Phase 1\u002F2a, First-in-human, Open-label Study of BMS-986517 as Monotherapy in Adult Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants must have an ECOG performance status of 0 to 1.\n* Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator).\n* Participants must have documented histologically or cytologically confirmed advanced, unresectable\u002Fmetastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+\u002FHER2- breast cancer.\n\nExclusion Criteria:\n\n* Participants must not have untreated CNS metastases. Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).\n* Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.\n* Participants must not have history of serious recurrent infections.\n* Participants must not have impaired cardiac function or history of severe heart disease.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":60,"type":21},315,[24,62],"PHASE2","A phase 1\u002F2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors",[27],"2026-06-24",{"date":67,"type":43},"2026-06-25",{"date":69,"type":43},"2025-10-15",{"date":71,"type":21},"2028-08-01",{"name":73,"class":50},"Bristol-Myers Squibb",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100610195","phase-1-a-study-of-bi-3810944-in-patients-with-advanced-cancer-100610195","NCT07224425","A Study of BI 3810944 in Patients With Advanced Cancer","A First-in-human, Phase I, Open-label, Non-randomized, Multicentre Dose Escalation and Expansion Trial of BI 3810944 in Patients With Solid Tumours and Melanoma","Inclusion Criteria:\n\n1. Trial participant population specifically to Part A and B:\n\n   * Part A only: participants with any histologically or cytologically confirmed diagnosis of solid tumour who failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Participant must have exhausted available treatment options known to prolong survival for their disease.\n   * Part B only: participants with histologically or cytologically confirmed diagnosis of who has progressed on, or is intolerant to available standard therapies, or for whom no standard therapy with proven benefit exists according to the local and institutional guidelines. Participants should not have received \\>3 previous lines of treatment (excluding prior systemic regimens received at adjuvant or neoadjuvant setting and excluding treatment with tumour-infiltrating lymphocytes at any timepoint). B-raf protein kinase (BRAF) mutation status must be known prior to screening\n2. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n3. Presence of at least one measurable lesion outside of central nervous system (CNS) as defined per response evaluation criteria in solid tumours (RECIST v 1.1)\n4. Age ≥18 years\n5. Adequate organ function\n6. Life expectancy of ≥3 months at the start of the trial treatment in the opinion of the investigator\n7. All toxicities related to previous anticancer therapies have resolved to common terminology criteria for adverse events (CTCAE) Grade ≤1 prior to trial treatment administration (except for alopecia and peripheral neuropathy which must be CTCAE Grade ≤2 and amenorrhea\u002Fmenstrual disorders which can be any Grade) Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Active primary central nervous system (CNS) malignancy, active untreated CNS metastases and\u002For carcinomatous meningitis\n\n   * Participants with asymptomatic (i.e. no clinical neurological symptoms) brain lesions are eligible provided they meet the following criteria:\n\n     * Radiotherapy or surgery for brain metastases was completed ≥2 weeks before the first administration of BI 3810944\n     * Patient is off steroids for ≥7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for ≥7 days or on stable doses of anti-epileptic drugs for malignant CNS disease\n2. A diagnosis of immunodeficiency; receiving chronic systemic therapy exceeding prednisone 10 mg daily or equivalent or any other form of immunosuppressive therapy within 7 days before the first dose of BI 3810944\n3. Prior anticancer therapy:\n\n   * Participants who have been treated with any other anticancer drug(s), within 28 days or within 5 half-life periods (whichever is shorter) prior to the first administration of BI 3810944\n   * Participants who have been treated with extensive field radiotherapy including whole brain irradiation, within 2 weeks prior to first administration of BI 3810944\n4. Prior treatment with organ transplant or hematopoietic stem-cell transplant\n5. Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy)\n6. Women who are pregnant, breastfeeding or who plan to become pregnant or breastfeeding during the trial or within 4 months after the last dose of BI 3810944 Further exclusion criteria apply.",{"count":82,"type":21},69,[24],"This study is open to adults with advanced cancer (solid tumours) for whom previous treatment was not successful, or no treatment exists. The study tests different doses of BI 3810944 to find out which doses they can tolerate. Another purpose is to identify the most suitable dose of BI 3810944 and to find out whether it helps people with advanced cancer. BI 3810944 may help fight cancer.\n\nParticipants get BI 3810944 usually once every 3 weeks. At treatment start, it is given once a week for a short time. Participants may continue to get BI 3810944 as long as they benefit from treatment but no longer than 2 years. During this time, they regularly visit the study site. The first study visits include overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects.\n\nThe doctors also regularly check the size of the tumour with imaging methods.",[27,86],"Melanoma","2026-06-23",{"date":65,"type":43},{"date":90,"type":43},"2026-02-24",{"date":92,"type":21},"2029-10-05",{"name":94,"class":50},"Boehringer Ingelheim",7,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100560767","phase-2-beamion-pantumor-1-a-study-to-test-whether-zongertinib-helps-people-with-advanced-cancers-with-her2-alterations-100560767","NCT06581432","Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations","Beamion PANTUMOR-1: A Phase II, Multicentre, Multicohort, Open-label Trial to Evaluate the Efficacy and Safety of Oral Zongertinib (BI 1810631) for the Treatment of Selected HER2-mutated or Overexpressed\u002FAmplified Solid Tumours","inclusion criteria:\n\n* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.\n* Patients ≥18 years old or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the Informed consent form (ICF).\n* Documented (previously established by local testing) Human epidermal growth factor receptor 2 (HER2) status of:\n\n  * HER2 amplification\n  * Known activating HER2 mutations\n* Availability and willingness to provide a sample of archival formalin-fixed paraffin embedded (FFPE) tumour tissue material\n* Patient with histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumour who has had at least one prior line of therapy for metastatic disease. In the opinion of the Investigator, patients must be unlikely to tolerate or derive clinically meaningful benefit from further standard of care therapy known to prolong survival.\n\nFurther inclusion criteria apply.\n\nexclusion criteria:\n\n* Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC)\n* Previous or concomitant malignancies other than the 1 treated in this trial within the previous 3 years except:\n\n  * effectively treated non-melanoma skin cancers\n  * effectively treated carcinoma in situ of the cervix\n  * effectively treated ductal carcinoma in situ of the breast\n  * localised prostate cancer on watchful waiting or active surveillance\n  * other effectively treated malignancy that is considered cured by local treatment.\n* Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial\n* Not completely recovered from major surgery (major according to the investigator's assessment) performed prior to screening or planned within 6 months after screening, e.g. hip replacement Further exclusion criteria apply.",{"count":104,"type":21},430,[62],"This is a study for people with advanced cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study. The purpose of this study is to find out whether a medicine called zongertinib helps people with advanced cancers with HER2 alterations. HER2 alterations can cause cancer. Zongertinib inhibits HER2.\n\nParticipants are put into groups based on the type of advanced cancer they have, the type of HER2 alterations they have, and the dose of zongertinib they receive. Depending on the group they are in, participants take 1 of 2 different doses of zongertinib each day. Participants can continue the treatment as long as they benefit from it and can tolerate it.\n\nParticipants visit the study site regularly. During many of the visits, the doctors check the size of the tumour and whether it has spread to other parts of the body. During all the visits, the doctors check participants' health and take note of any unwanted effects.",[27],"2026-06-22",{"date":87,"type":43},{"date":111,"type":43},"2024-10-11",{"date":113,"type":21},"2028-12-29",{"name":94,"class":50},88,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":130,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":51},"100627301","phase-1-study-of-azd4956-as-monotherapy-and-in-combination-with-anti-cancer-agents-in-participants-with-advancedmetastatic-homologous-recombination-deficient-solid-tumours-100627301","NCT07446855","Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced\u002FMetastatic Homologous Recombination Deficient Solid Tumours","A Modular Open-label, Phase I\u002FIIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Ascending Doses of AZD4956 as Monotherapy, and in Combination With Anti-Cancer Agents in Participants With Advanced\u002FMetastatic Homologous Recombination Repair Defective Solid Tumours","PARTHENON","Core Inclusion Criteria:\n\n* Documented locally advanced or metastatic solid tumour malignancy.\n* Eastern cooperative oncology group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to screening and first day of dosing.\n* Minimum life expectancy ≥ 12 weeks.\n* Adequate organ and marrow function.\n* Female participants must not breastfeed and must not donate or retrieve ova for their own use from screening to approximately 6 months after the last dose of study intervention.\n\nModule 1 Inclusion Criteria:\n\n* Demonstrated evidence of disease progression.\n* Participants must have advanced or metastatic solid tumours.\n* Participants may have received up to one prior line of therapy with a poly (adenosine diphosphate-ribose) polymerase inhibitor (PARPi)-based regimen (either as a treatment or as maintenance).\n\nModule 2 Inclusion Criteria:\n\nPart A (AZD4956 in Combination with Saruparib Dose Escalation) and Part A-PD (PD Backfill Cohorts):\n\n* Participants must have one of the following conditions-\n\n  1. Histologically or cytologically confirmed carcinoma of the breast with recurrent locally advanced or metastatic disease and evidence of a predicted loss of function germline or somatic mutation.\n  2. Histologically or cytologically confirmed advanced ovarian, fallopian tube, or primary peritoneal cancer.\n  3. Histologically or cytologically confirmed adenocarcinoma of the prostate and advanced\u002Fmetastatic castrate resistant prostate cancer (CRPC).\n  4. Histologically or cytologically confirmed advanced\u002Fmetastatic pancreatic cancer.\n* Participants must have evaluable disease.\n* Participants in PD backfill cohorts must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).\n\nPart A (PD Backfill Cohorts) - Participants Undergoing Paired Biopsies:\n\n\\- Participants must have a tumour suitable for biopsy.\n\nPart A-Non-PD (Non-PD Backfill Cohorts) and Part B (Dose Expansion Cohorts):\n\n* Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate and advanced\u002Fmetastatic CRPC.\n* Participants must have documented metastatic disease by clear evidence of ≥ 1 bone lesion (defined as one lesion with positive uptake on bone scan) and\u002For ≥ 1 soft tissue lesion (measurable or non-measurable).\n* Participants must have received the prior approved systemic therapies for metastatic prostate cancer.\n* Participants must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).\n\nCore Exclusion Criteria:\n\n* Any significant laboratory finding or any severe and uncontrolled medical condition.\n* Participants with any known predisposition to bleeding.\n* Spinal cord compression or symptomatic and unstable brain metastases or leptomeningeal disease.\n* Allogenic organ transplantation.\n* Known to have active infection, including hepatitis B virus (HBV) or hepatitis C virus (HCV).\n* Known history of infection with human immunodeficiency virus (HIV).\n* Active gastrointestinal disease or other condition that will interfere significantly with the swallowing, absorption, distribution, metabolism or excretion of oral therapy.\n* Participants with history of myelodysplastic syndrome (MDS)\u002Facute myeloid leukaemia (AML) or with features suggestive of MDS\u002FAML.\n* Participants with a known hypersensitivity to the investigational product(s) or any of the excipients of the product(s).\n* Previous dosing with AZD4956.","130 Years",{"count":126,"type":21},180,[24,62],"The purpose of this modular, first trial in human study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of ascending dose levels (DLs) of AZD4956 monotherapy and in combination with other anti-cancer agents in participants with advanced\u002Fmetastatic solid tumours with homologous recombination repair (HRR) deficiencies.",[27],[131,132,29,133],"Advanced\u002Fmetastatic homologous recombination repair defective solid tumours","Poly (adenosine diphosphate-ribose) polymerase inhibitor (PARPi)","Pharmacodynamics","2026-06-16",{"date":136,"type":43},"2026-06-17",{"date":138,"type":43},"2026-03-17",{"date":140,"type":21},"2030-03-29",{"name":49,"class":50},{"id":143,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":25,"conditions":146,"keywords":147,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":152,"leadSponsor":153,"locationsCount":51},"100623056",{"count":20,"type":21},[24],[27],[29,30,31,32,33,34,35,36,37,38],"2026-06-12",{"date":150,"type":43},"2026-06-15",{"date":45,"type":43},{"date":47,"type":21},{"name":49,"class":50},{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100576736","phase-1-a-phase-1-first-in-human-study-of-okn4395-and-pembrolizumab-in-patients-with-solid-tumors-100576736","NCT06789172","A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors","A Phase 1, Open-label, Multicenter, Dose-escalation and Cohort Expansion Study of OKN4395, a Triple Antagonist of EP2, EP4, and DP1 Prostanoid Receptors, as Monotherapy and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors","INVOKE","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed disease, locally advanced or metastatic:\n\n   For Phase 1a:\n\n   Solid tumor with a COX2-associated immunosuppressive pathway, for which standard treatment options are not available, no longer effective, refused or not tolerated.\n\n   For Phase 1b:\n\n   For all cohorts, in the opinion of the investigator, all appropriate authorized treatment options should be exhausted\n   * Cohort 1: Sarcoma (fibrous sarcoma \\[myxofibrosarcoma or solitary fibrous tumor\\], dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma or pleomorphic sarcoma, or leiomyosarcoma), that is either refractory to or progressing on standard of care, with no more than 3 prior lines of systemic therapy. Patients with a solitary fibrous tumor can be included in the study without prior treatment if, in the investigator's opinion, it is in the participant's best interest and no established standard of care exists or is available.\n   * Cohort 2: NSCLC (squamous or adenomatous without EGFR\u002FALK mutations), with disease progression on a PD-(L)1 CPI regimen, and no more than 3 prior lines of systemic therapy. When known, PD-L1 status should be provided.\n   * Cohort 3: CRC (Microsatellite stable or Microsatellite instability - low), and no more than 4 prior lines of systemic therapy.\n   * Cohort 4: GC (gastric and gastro-esophageal junction adenocarcinoma), HER2-negative, planned to or currently receiving CPI monotherapy as maintenance of a first-line CPI + chemotherapy regimen, after chemotherapy cessation.\n2. ECOG performance status of 0 or 1.\n3. Recovery from any medically relevant AE\u002FirAE from previous treatment regimen (defined as recovery to Grade ≤1 level per CTCAE v 5.0 before Screening, or chronic, stable, Grade 2 AEs \\[not worsened to Grade \\>2 for \\>3 months prior to screening\\]).\n4. One or more new or growing tumor lesions amenable to a safe biopsy (at baseline, a suitable archival specimen obtained when not undergoing treatment and within 1 year \\[Phase 1a\\], or within 90 days and after the last administration of the previous systemic therapy \\[Phase 1b\\] is suitable). In addition (where applicable) an archival tumor biopsy collected before the start of the first-line treatment in the metastatic setting is requested (but optional).\n5. At least one target lesion measurable by RECIST 1.1 as noted by local investigators\u002Fradiologists.\n6. The ability to swallow and retain OKN4395 as an oral medication without significant gastrointestinal abnormalities that might alter absorption.\n7. The willingness and ability to comply with the evaluation, randomizations and requirements of the protocol. For Substudy 1, the ability to comply with the evaluation requirements includes the absence of any condition known to affect upper gastrointestinal motility, absorption, and pH.\n8. Adequate hematologic, renal, and hepatic function (based on local laboratory assessments):\n\n   1. Hematological variables: absolute neutrophil counts ≥1.5 × 109 \u002FL, platelet counts ≥75 × 109 \u002FL, and hemoglobin ≥8 g\u002FdL\n   2. Renal variables: creatinine clearance ≥ 60 mL\u002Fmin1 by Du Bois \\& Du Bois formula\n   3. Hepatic variables: total serum bilirubin ≤1.5 × ULN, AST and ALT ≤3 × ULN, and ALP ≤2.5 × ULN; except for hyperbilirubinemia of Gilbert's syndrome (participants with Gilbert's syndrome can be included if total serum bilirubin ≤5× ULN and direct bilirubin ≤1.5 x ULN)\n   4. Serum albumin ≥30 g\u002FL\n\nExclusion Criteria:\n\n1. Except for the current regimen in Cohort 4, ongoing or recent anticancer therapy within the following timeframe prior to first dose of study drug:\n\n   1. Chemotherapy, ADCs, or other antibodies \\\u003C 21 days\n   2. Immunotherapy or cellular therapy \\\u003C 28 days\n   3. Radiation therapy (palliative radiation for bone pain \\\u003C48 hours; stereotactic or small field brain irradiation \\\u003C7 days; all other radiation therapy \\\u003C14 days)\n   4. TKI or any other anticancer therapy \\\u003C 5 half-lives or \\\u003C 7 days, whichever is longer\n2. Central nervous system metastasis (radiologically progressive, or clinically symptomatic, or requiring immunosuppressive therapies \\[including low dose steroids\\]).\n3. Any active infection (bacterial, viral, fungal) requiring IV systemic therapy.\n4. Unstable COPD defined as frequent or severe exacerbations per investigator discretion.\n5. Known history of or active HBV (HBsAg reactive and\u002For HBV DNA detected) or HCV (HCV RNA detected) infection.\n6. HIV infection with CD4 lymphocyte count \\\u003C350 cells\u002FμL at time of Screening, or failure to achieve and maintain virologic suppression defined as confirmed HIV RNA level \\\u003C 50 or lower limit of detection by the local available assay at time of Screening and for at least 12 weeks prior to Screening.\n7. Known history of bleeding disorders, INR ≥1.5 × ULN at screening (or INR and\u002For aPTT within therapeutic range if on anticoagulation therapy), or a history of gastrointestinal bleeding (inflammatory, ulcerative, or diverticular) within the last 2 years.\n8. Known H. pylori infection without proof of eradication at least 2 months prior to screening.\n9. Systemic treatment with any drug known to impact gastrointestinal pH within 7 days (PPIs) or 12 hours (H2 antagonists) of first dose of OKN4395 (unless adapted after Substudy 1). Where said treatments have been used for more than 2 weeks prior to discontinuation, discontinuation should occur at least 21 days before first dose of OKN4395.\n10. Acute treatment with any systemic steroid therapy (\\>10 mg prednisone equivalent), or any corticosteroid medication within 14 days of first dose of OKN4395 for any condition.\n11. For participants planned to receive combination therapy: Ongoing and history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Any replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. Participants with hyperthyroidism or hypothyroidism but that are stable on hormone replacement are also allowed.\n12. Systemic treatment with NSAIDs, COX2 inhibitors, or synthetic prostaglandins within 5 half-lives prior to the first dose of OKN4395 (acetylsalicylic acid ≤ 160 mg\u002Fday, or 325 mg ≤ 3 times\u002Fweek is permitted).\n13. Systemic treatment with strong inhibitors\u002Finducers of CYP and UGT enzymes within 14 days of first dose of OKN4395.\n14. QTcF interval of \\> 450 ms based on mean of the central triplicate readings.\n15. Known hypersensitivity to any excipients of the OKN4395 formulation or pembrolizumab (for combination cohorts).\n16. Pregnant or lactating women. Women of childbearing potential must have a negative serum pregnancy test at screening and have a negative a urine dipstick pregnancy test prior to the initiation of study treatment (can be done on C1-D1 visit).\n17. Evidence of any other active malignancy requiring systemic therapy within the 2 years prior to Screening. (Exceptions: non-melanoma skin cancer, in situ melanoma, in situ cervical cancer, ductal carcinoma in situ of the breast, or localized and presumed cured prostate cancer; participants on long-term anti-hormonal therapy for a prior malignancy are allowed if the malignancy has not been active within the prior 2 years).\n18. History or current evidence of any condition, surgical or medical therapy, or laboratory abnormalities that might confound the results of the study, make study drug administration hazardous, interfere with the participant's involvement for the full duration of the study, or make it difficult to monitor AEs such that, in the opinion of the treating physician, it is not in the best interest of the participant to participate",{"count":163,"type":21},146,[24],"The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab.\n\nThe overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab.\n\nThis study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395 either alone (monotherapy) or with pembrolizumab (combination therapy) administered on day 1 of each 21-day cycle in patients with solid tumors until the participant has disease progression or discontinues for any reason. The dose of OKN4395 will be increased, after each group of 3 or more participants completes their first 3 weeks of treatment and their data is evaluated for safety, with a planned dose range from 10 mg twice a day to 450 mg twice a day through 13 dose levels. Part 1a also includes a parallel substudy (Substudy 1) consisting of at least 12 participants, aiming to test the effect of food and stomach acid on the levels of OKN4395 in the blood as well as its tolerability.\n\nPart 1b will evaluate OKN4395 alone and in combination with pembrolizumab administered on day 1 of each 21-day cycle in patients with selected cancer types. Part 1b will comprise 4 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 in non-small cell lung cancer (NSCLC), Cohort 3 in colorectal cancer, and Cohort 4 in gastric cancer (GC), with cohorts 2 to 4 in combination with pembrolizumab.\n\nThe overall study will enrol approximately 146 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 80 participants in Part 1b split: 20 on monotherapy and 60 on combination therapy.\n\nThe study will be conducted in the US, Australia, UK and in the EU.",[27,167,168,169,170,171,172,173,174,175,176,177,178,179,180],"Sarcoma","HNSCC","Non Small Cell Lung Cancer","NSCLC","Colorectal Cancer (CRC)","Myxofibrosarcoma (MFS)","Solitary Fibrous Tumors","Dedifferentiated Liposarcoma","Undifferentiated Pleomorphic Sarcoma (UPS)","Leiomyosarcoma","Leiomyosarcoma (LMS)","Gastric Cancer (GC)","Gastric Cancer Adenocarcinoma Metastatic","Gastric \u002F Gastroesophageal Junction Adenocarcinoma","2026-06-09",{"date":183,"type":43},"2026-06-11",{"date":185,"type":43},"2025-01-23",{"date":187,"type":21},"2028-09",{"name":189,"class":50},"Epkin",10,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":216},"100578767","phase-1-a-safety-and-pharmacokinetics-study-of-rc220-combined-with-doxorubicin-in-adult-participants-with-solid-tumours-100578767","NCT06815575","A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.","A Two-part Phase 1 Open-label Safety and Pharmacokinetic Study of Intravenous RC220 in Combination With Doxorubicin in Adult Patients With Solid Tumours.","Inclusion Criteria (For Part 1 and Part 2):\n\n1. Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures.\n2. Aged between 18 years to ≤ 80 years at the time of informed consent. Note: In Korea, only participants aged ≥19 years at the time of informed consent will be enrolled\n3. Life expectancy ≥ 3 months.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n5. Have measurable or evaluable disease per RECIST v1.1. The target lesions must not have prior radiation or other locally treated area unless imaging-based progression has been clearly documented following radiation or other local therapy.\n6. Adequate haematological, liver, and kidney function as follows:\n\n   a. Bone marrow reserve:\n\n   • Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL without growth factor support in the 2 weeks prior to study entry.\n   * Haemoglobin ≥ 90 g\u002FL without transfusion and\u002For without growth factor support in 2 weeks prior to study entry.\n   * Platelet count ≥ 100 × 109\u002FL without transfusion in 2 weeks prior to study entry.\n\n     b. Hepatic function:\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \\\u003C 3 × upper limit of normal (ULN) (≤5 × ULN if liver metastases or hepatic cell carcinoma (HCC)).\n\n     c. Renal function:\n   * Serum creatinine \\\u003C 1.5 × ULN or Serum creatinine clearance (CrCL) \\> 50 mL\u002Fmin, as per the Cockcroft-Gault Equation Glomerular Filtration Rate: \\[(140-age in years) × weight in kg\\] \u002F (7.2 × serum creatinine in mg\u002FdL) (× 0.85 for females).\n7. International normalised ratio (INR) \u002Fprothrombin time (PT) \\\u003C 2 x ULN, activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.\n8. Practice adequate contraceptive measures as per below:\n\n   Female patients must:\n\n   • Be of nonchildbearing potential i.e., surgically sterilised or postmenopausal, or;\n\n   • If of childbearing potential, must have a negative serum pregnancy test at Screening and a negative urine pregnancy test before the first study treatment administration and on Day 1 of each Cycle. They must agree not to attempt to become pregnant, must not donate ova, and must agree to use 2 forms of highly effective contraceptive method between signing consent, during the study, and at least 180 days after the last dose of study drug, OR use 1 form of highly effective contraceptive method, plus an additional barrier method of contraception between signing consent, during the study, and at least 180 days after the last dose of study drug.\n\n   • Women of childbearing potential with same sex partners (abstinence from penile vaginal intercourse) are eligible when this is their preferred and usual lifestyle.\n\n   Male patients must:\n\n   • be willing not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, a willingness to use a condom in addition to having the female partner use a highly effective contraceptive method between signing consent, during the study, and at least 90 days after the last dose of the study treatment.\n\n   PART 1 only - Dose Escalation Specific Inclusion Criteria\n9. Histologically\u002Fcytologically confirmed, locally advanced unresectable or metastatic solid tumours for whom prior treatments have failed, and where an anthracycline may be considered as a treatment option or is indicated.\n10. Adequate Hepatic function as per below:\n\n    * Serum Total bilirubin (TBIL) as per below:\n\n      1. Patients with documented Gilbert's syndrome - baseline TBIL \\\u003C 3 × ULN,\n      2. Patient with either HCC or liver metastases - baseline TBIL \\\u003C 2 × ULN\n      3. All other patients baseline TBIL \\\u003C 2 × ULN.\n\nPART 2 only - Exploratory Dose Expansion Specific Inclusion Criteria 8. Histologically\u002Fcytologically confirmed solid tumours of any stage for which the patient has not received prior treatment with an anthracycline and for whom treatment with doxorubicin is indicated.\n\n9\\. Adequate Hepatic function as per below:\n\n• Serum TBIL as per below:\n\n1. Patients with documented Gilbert's syndrome - baseline TBIL \\\u003C 3 × ULN,\n2. Patient with either HCC or liver metastases - baseline TBIL \\\u003C 3 × ULN\n3. All other patients baseline TBIL \\\u003C 2 × ULN.\n\nExclusion Criteria (for Part 1 and Part 2):\n\n1. Females who are pregnant or nursing.\n2. Received cancer-directed therapy within the following timeframes:\n\n   1. Antitumour therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy or investigational agent) within 28 days prior to the first dose of study treatment (or 5 times the half-life if shorter than 28 days, there can be exceptions on a case-by-case as approved by Study Medical Monitor based on pharmacology). Note: concurrent use of hormone deprivation therapy for hormone-refractory prostate cancer, bisphosphonate or denosumab for skeletal related events per institution guideline is permitted.\n   2. Wide-field radiation therapy within 28 days (or palliative radiation therapy within 7 days) prior to the first dose of study treatment or has not recovered from the side effects of radiation therapy in the opinion of the Investigator.\n   3. Any other concurrent investigational device(s) or conventional agent(s) within 28 days (unless 5 times the half-life is shorter than 28 days) prior to the first dose of study treatment.\n   4. Therapeutic radiopharmaceuticals must be stopped 8 weeks prior to the first dose of the study treatment.\n3. Persisting Grade 2 or higher severity AEs from prior antitumour treatment as per CTCAE v5.0. Patients with pre-existing non-treatable Grade 2 toxicities may be eligible per discretion of the Investigator and with approval from Study Medical Monitor (e.g., Grade 2 chemotherapy induced neuropathy).\n4. Patients with primary central nervous system (CNS) malignancy, symptomatic CNS metastases, meningeal metastases or leptomeningeal disease are not allowed.\n\n   Note: Patients with asymptomatic CNS metastases are eligible if clinically controlled, which is defined as 1) ≥ 4 weeks of stable neurologic function following CNS-directed therapy prior to the first dose of study treatment 2) no evidence of CNS disease progression as determined by radiographic imaging ≥ 4 weeks prior to the first dose of study treatment, 3) ≥ 2 weeks from discontinuation of anti-seizure and steroid therapies (receiving prednisone ≤ 10 mg or equivalent steroid therapies is allowed) prior to the first dose of study treatment.\n5. Had major surgery within 28-days of the Screening Visit. Note: Patients who have undergone a non-major surgical procedure within 28-days prior to Screening must have recovered adequately from the surgery before the administration of the first dose of study treatment. Exception: no waiting period applies following central venous catheter placement.\n6. History of tissue or organ transplantation.\n7. Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study treatment. Exceptions: Daily prednisone equivalent ≤10 mg\u002Fday; topical, inhaled, or intranasal corticosteroids.\n8. History of severe infection deemed clinically significant by the Investigator or designee within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose of study treatment.\n9. Active hepatitis B or C. Note: Hepatitis B virus (HBV) carriers without active disease (HBV DNA titer \\\u003C 1000 copies\u002FmL or 200 IU\u002FmL) or cured hepatitis C (negative HCV RNA test) with confirmed viral clearance that are not receiving ongoing treatment and without residual chronic liver disease may be enrolled.\n10. Confirmed human immunodeficiency virus (HIV) infection and receiving anti-retroviral therapy (ART). Patients with well controlled HIV infection (i.e., CD4+ count \\>350 cells\u002FμL and viral copies less than 400\u002FmL after at least 4 weeks of ART) may be eligible per discretion of the Investigator and with approval from Study Medical Monitor.\n11. Patients with any inherited predisposition to bleeding or to thrombosis (von Willebrand disease, haemophilia, etc.). Patients with a history of nontraumatic haemorrhage (i.e., end stage liver disease, any haemorrhage requiring medical intervention), thromboembolic event or any condition which may increase bleeding risk including clotting disorders, thrombocytopenia during the last 3 months prior to the first dose of study treatment administration.\n12. Receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the Investigator, increase the risk of serious neutropenic complications.\n13. Any other disease or clinically significant abnormality in laboratory parameters, including serious medical or psychiatric illness\u002Fcondition, which in the judgement of the Investigator might compromise the safety of the patient or integrity of the study, interfere with the patient's participation in the trial or compromise the trial objectives.\n14. Known allergies, hypersensitivity, or intolerance to the study drug or its excipients.\n15. Any known, documented, or suspected history of illicit substance abuse that would preclude patient from participation, unless clinically justified (i.e., will not interfere with study participation and\u002For will not compromise trial objectives) per judgement of the Investigator and with approval of Study Medical Monitor. Exception: Physician-prescribed medicinal opioids or cannabinoids are allowed for pain management.\n16. Vaccinated with any live vaccine within 4 weeks prior to the first dose of study treatment.\n17. Judgement by the Investigator that the patient is unlikely to comply with study procedures, restrictions and requirements.\n18. Use of prescription or non-prescription medications, including complementary medicines, within 14 days or 5 half-lives (whichever is longer) if the medication is a potential inhibitor of cytochrome P450 (CYP) isoform 3A4 or 2D6, and\u002For P-glycoprotein (P-gp), or if the medication is an inducer of CYP3A4 or P-gp, prior to dosing and throughout study participation.\n\n    PART 1 only - Dose Escalation Specific Criteria\n19. A ≥ 20% decrease in serum albumin from baseline, sustained over two consecutive measurements taken more than 14 days apart during screening prior to the first administration of study treatment.\n20. Severe or uncontrolled cardiac disease requiring treatment, CHF (New York Heart Association) NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the 6 months prior to screening, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).\n21. Treatment with prior anthracyclines exceeding the maximum equivalent cumulative lifetime dose.\n\nPART 2 only -Dose Expansion Specific Criteria 19. Uncontrolled or severe cardiac disease that in the opinion of the Investigator would prevent treatment with doxorubicin.","80 Years",{"count":200,"type":21},53,[24],"This is a multi-centre, two-part, open-label, phase 1, first in human study of multiple ascending doses of RC220 bisantrene formulation alone and in combination with fixed dose doxorubicin to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) in adult patients with locally advanced unresectable or metastatic solid tumours where doxorubicin may be considered as a treatment option \u002F or is indicated.\n\nThe study will consist of two parts: Part 1 - This part involves a fixed-dose doxorubicin (60 mg\u002Fm2) tolerability lead-in period, followed by dose-escalating doses of IV RC220 alone, and in combination, with fixed dose doxorubicin, to determine the maximum tolerated combined dose (MTCD) of RC220 with doxorubicin to be evaluated in Part 2. This dose-expansion cohort will enrol patients with solid tumours that are anthracycline treatment naïve and for whom treatment with doxorubicin is indicated. The objective of Part 2 will be to confirm the safety and tolerability and evaluate the preliminary cardioprotective and anti-tumour efficacy of the maximum tolerated combined dose (MTCD) of RC220 with doxorubicin.",[27,204],"Advanced Solid Tumours",[27,204,206],"Phase 1","2026-05-30",{"date":209,"type":43},"2026-06-02",{"date":211,"type":43},"2025-04-02",{"date":213,"type":21},"2029-01-31",{"name":215,"class":50},"Racura Oncology Ltd",9,{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":226,"conditions":227,"keywords":228,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":238},"100571861","phase-1-a-phase-12-first-in-human-study-on-odm-212-in-subjects-with-selected-advanced-solid-tumours-100571861","NCT06725758","A Phase 1\u002F2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours","TEADES","Inclusion Criteria:\n\n1. Male or female subjects ≥18 years old\n2. Subjects must have histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumour of the kind listed below that is not amenable for treatment with curative intent, e.g.:\n\n   Part 1:\n   * mesothelioma\n   * epithelioid hemangioendothelioma (EHE)\n   * cholangiocarcinoma (CCA)\n   * head and neck squamous cell carcinoma (HNSCC)\n   * non-small cell lung carcinoma (NSCLC)\n   * colorectal cancer (CRC)\n   * hepatocellular cancer (HCC)\n   * castration-resistant prostate cancer (CRPC)\n   * meningioma\n   * any other solid tumours with available local data for loss-of-function genetic alterations (truncating mutations or gene deletion) in neurofibrin 2 (NF2)\u002Flarge tumour suppressor kinase (LATS1\u002FLATS2), or Yes-associated protein\u002F Transiptional coactivator with PDZ-binding motif (YAP\u002FTAZ) fusions\n   * any other solid tumour based on emerging scientific data as per sponsor's decision.\n\n   Part 2: Any solid tumour type harbouring a Hippo pathway alteration and other tumour types potentially responsive to transcriptional enhanced associate domain (TEAD) inhibition based on data from Part 1 or other existing or emerging scientific data.\n3. Subjects must be in need of systemic treatment for their cancer and to either be refractory to or have progressed on, are intolerant to, or are not otherwise a candidate, in the opinion of the investigator, for any of the currently available established therapies (reasons of unsuitability of standard of care treatments to be recorded).\n4. Part 2 only: Subjects must have measurable disease by response evaluation criteria in solid tumours (response evaluation criteria in solid tumors - RECIST) v. 1.1 (modified RECIST for malignant pleural mesothelioma - MPM).\n5. Part 2 only: A fresh or recent (taken up to 1 year ago) primary tumour tissue sample from a diagnostic biopsy\u002Fsurgery or a tumour biopsy taken from a metastasis must be available; exemptions possible by the sponsor's decision.\n6. Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.\n7. Life expectancy of \\>12 weeks.\n8. Willing and able to comply with all aspects of the protocol.\n9. Provide written informed consent (IC; or witness consent) prior to any study-specific screening procedures.\n\nExclusion Criteria:\n\n1. Other malignancy active within the previous 2 years except for basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast, for which the subject has completed curative therapy.\n2. Prior chemotherapy, immunotherapy (tumour vaccine, cytokine or growth factor given to control the cancer) or other anti-cancer therapy within less than 2 weeks before study drug administration, or any persistent unresolved toxicity from previous anti-cancer therapies of common terminology criteria for adverse events (CTCAE) Grade ≥ 2 (except for peripheral neuropathy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities). Especially, care should be exercised to exclude subjects with potential carry-over nephrotoxic effects from previous therapies (e.g., cisplatin). Luteinizing hormone releasing hormone (LHRH) agonists or antagonists are allowed as concomitant treatment.\n3. Prior definitive radiation therapy within less than 4 weeks and prior palliative radiotherapy within less than 2 weeks before study drug administration. Radiopharmaceuticals (strontium, samarium) within less than 8 weeks before study drug administration.\n4. Subjects with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and do not require treatment or have been adequately treated with local therapy.\n5. Known human immunodeficiency virus (HIV) infection.\n6. Active infection requiring therapy, including known positive tests for Hepatitis B surface antigen and hepatitis C virus (HCV) Ribonucleic acid (RNA). Pre-study testing for these pathogens is not required.\n7. Major surgery within 4 weeks before the first dose of study drug or minor surgery within 1 week (subject must also have recovered from any surgery-related toxicities to less than CTCAE Grade 2).\n8. Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses \\>10 mg\u002Fday prednisone or equivalent) within 2 weeks before study drug administration.\n9. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g. nausea, diarrhoea, or vomiting) that might impair the bioavailability of ODM-212.\n10. Use of other investigational medicinal products within 2 weeks or at least5 half-lives (whichever is longer) before study drug administration, or any persistent unresolved toxicity from such treatment that, according to the judgement of the investigator, may pose a health risk for the subject, if taking part in the study. For drugs such as investigational monoclonal antibodies with half-lives \\>10 days, at least 8 weeks is required. In addition, all visits (apart from survival follow-up) related to the use of another IMP must be completed before dosing with ODM-212 may commence.\n11. Use of any live or live-attenuated vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines) within 28 days prior to the first dose of study drug.\n12. Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG; e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\>250 ms, a prolonged QTc interval (QTcF\u002FB \\>470 ms) as demonstrated by 2 out of 3 repeated ECG at screening, performed according to local practice. A history of risk factors for torsade de pointes (e.g. heart failure, hypokalaemia, family history of long QT Syndrome) or the use of concomitant medications that prolong the QTc interval.\n13. Significant cardiovascular impairment: history of congestive heart failure of New York Heart Association (NYHA) Class III-IV, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke, left ventricular ejection fraction (LVEF) \\\u003C50%, cardiac arrhythmia requiring medical treatment (including oral anticoagulation) within 6 months prior to the first dose of study drug.\n14. Female subjects who are breastfeeding or pregnant at screening or baseline.\n15. A separate baseline assessment for pregnancy is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.\n16. Female subjects of childbearing potential who meet any of the following criteria:\n\n    Had unprotected sexual intercourse within 30 days before study entry or who do not agree to use a highly effective method of contraception (e.g., true abstinence if it is their preferred and usual lifestyle \\[defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment\\], an intrauterine device, a contraceptive implant, an oral contraceptive combined with a double barrier method \\[e.g. combination of male condom with either cap, diaphragm or sponge with spermicide\\], or have a vasectomized partner with confirmed azoospermia) throughout the entire treatment period and for 28 days after treatment discontinuation.\n\n    Are neither using a highly effective method of contraception (as listed above) nor currently abstinent, or do not agree to refrain from sexual activity during the treatment period and for 28 days after treatment discontinuation.\n\n    Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study and for 28 days after treatment discontinuation.\n17. Male subjects who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the treatment period and for 28 days after treatment discontinuation).\n18. Urine albumin\u002Fcreatinine ratio ≥3 mg\u002Fmmol (category A2 urine albumin\u002Fcreatinine ratio \\[UACR\\] or higher) in laboratory testing at screening, end-stage renal disease (subjects with eGFR \\\u003C15 ml\u002Fmin\u002F1.73 m2, subjects on dialysis and kidney transplant recipients), moderately or severely impaired kidney function (eGFR 15-60 ml\u002Fmin\u002F1.73 m2), or any pre-existing condition associated with kidney impairment (e.g. subjects with type 1 or type 2 diabetes mellitus and confirmed nephropathy).\n19. Hepatic impairment defined as having any of the following laboratory values at screening: total bilirubin ≥1.5xupper limit of normal (ULN) (or \\>3xULN for subjects with Gilbert's syndrome), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3xULN (or ≥5xULN for subjects with liver metastasis), or albumin ≤30 g\u002FL.\n20. Abnormalities in coagulation values defined as International Normalised ratio (INR) \\>1.5xULN at screening (unless subject is receiving anticoagulant therapy, as long as subject's laboratory values are within therapeutic range of intended use of anticoagulants).\n21. Haemoglobin \\\u003C10 g\u002FdL (in absence of blood transfusion within 7 days of value obtained), absolute neutrophil count \\\u003C1500\u002Fµl (1.5 x 109\u002Fl), platelet count \\\u003C100 000\u002Fµl (100 x 109\u002Fl).\n22. Any other major illness, any history of a medical condition or a concomitant medical condition that, in the investigator's judgment, will substantially increase the risk associated with, or compromise the subject's participation in this study.\n23. History of treatment with other TEAD inhibitors.",{"count":60,"type":21},[24,62],"Multi-site, open-label, first-in-human study with 2 parts (dose escalation and dose expansion) in subjects with selected advanced solid tumours",[27],[27],"2026-05-07",{"date":231,"type":43},"2026-05-08",{"date":233,"type":43},"2023-10-26",{"date":235,"type":21},"2027-12-31",{"name":237,"class":50},"Orion Corporation, Orion Pharma",20,{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":22,"phases":248,"briefSummary":249,"conditions":250,"keywords":251,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":264},"100605634","phase-1-a-study-of-ap601-in-patients-with-locally-unresectable-advanced-or-metastatic-solid-tumors-100605634","NCT07165067","A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors","A Phase 1, Open-label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP601 in Patients With Solid Tumors.","Inclusion Criteria: 1. Patients with histologically or cytologically proven locally unresectable advanced or metastatic solid tumors. Patients must be relapsed or refractory to at least one standard-of-care therapy, and\u002For have refused standard-of-care therapy.\n\n2\\. Eastern Cooperative Oncology Group performance status of 0 to 1 at Screening, with an estimated life expectancy of at least 3 months.\n\n3\\. Disease must have at least 1 assessable (long diameter ≥1 cm) lesion for evaluation of response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n\n4\\. Patients with adequate organ and bone marrow function, in the absence of growth factors, including the specific laboratory findings of Absolute neutophil count, platelet count, Haemoglobin, AST, ALT, Serum total Bilirubin, Alkaline phosphatase, prothrombin time, INR or activated partial thromboplastin time, creatinine and albumin.\n\n5\\. Female Volunteers must be of nonchild bearing potential i.e, surgically sterilised at least 6 weeks before Screening Visit or postmenopausal.\n\n6\\. Females of childbearing potential must have a negative pregnancy test, agree not to attempt to become pregnant or donate Ova and agree to use contraception from one month prior to Screening until at least 90 days after last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle.\n\nMale Vonuteers:\n\n* Must agree not to donate sperm from signing the ICF until at aleast 90 days after the last dose of the study drug.\n* If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception.\n* Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n\nExclusion Criteria:\n\n1. Has received concurrent antitumor treatment or IPs within 28 days of C1D1. The antitumor treatments include chemotherapy, radiotherapy, immunotherapy, targeted therapy, hormonal therapy, or cytokine therapy.\n2. Has received prior CD73-targeted and\u002For CD137-targeted therapeutics.\n3. Has had major surgery within 28 days prior to C1D1 (excluding prior diagnostic biopsy).\n4. Any unresolved toxicity (except alopecia) from prior therapy of ≥CTCAE Grade 1, prior to the day of the first dose of IP. Participants with Grade 2 toxicity that is not CS (e.g., alopecia, vitiligo), or that is deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.\n5. History of any other malignancy, which has been active or treated within the past 2 years, with the exception of thyroid cancer, cervical intraepithelial neoplasia, basal cell carcinoma and squamous cell carcinoma.\n6. Prior history of an irAE with immunotherapy-related toxicities that resulted in discontinuation of prior immunotherapy.\n7. Current symptomatic leptomeningeal disease or uncontrolled, untreated brain metastasis.\n8. Has received any organ transplantation including allogeneic stem cell transplantation.\n9. Has received blood transfusions or growth factor support ≤ 14 days prior to screening.\n10. Has any significant acute or chronic infections including:\n\n    1. Infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before first dose of AP601.\n    2. Known active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.\n11. Current active, or history of, any autoimmune disease that may relapse or immunodeficiencies.\n12. Any condition that required systemic treatment with either corticosteroids (\\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of AP601.\n13. Known severe hypersensitivity reactions to monoclonal antibodies.\n14. Breastfeeding (or planning to breastfeed) at any time during the study, and for 90 days following study completion.\n15. Participants with a current or recent (within the past 12 months) diagnosis of alcohol or non-prescribed drug abuse, as defined by local guidelines.\n16. Evidence of cardiac dysfunction (defined as myocardial infarction within the last 6 months, New York Heart Association Class II\u002FIII\u002FIV heart failure, unstable angina, unstable cardiac arrhythmias, or known left ventricular ejection fraction \\[LVEF\\] \\\u003C55%) or other CS cardiac pathology likely to impair the participants ability to participate in the study.\n17. Uncontrolled intercurrent illness including, but not limited to, uncontrolled hypertension, uncontrolled diabetes, uncontrolled endocrinopathy, severe active peptic ulcer disease or gastritis.\n18. Has received a live (or live attenuated) vaccination within 28 days of the first dose of AP601 and during the study period.\n19. Any other condition or prior therapy that in the opinion of the PI (or delegate) would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.",{"count":247,"type":21},36,[24],"A Phase 1, Open-Label Study of the Safety, Tolerability,Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP601 in Patients with Solid Tumours.The study is designed to find the highest dose of AP601 that can be given safely. Participants will be assigned to one of six cohorts. Each cohort will receive a different dose of the study medication, AP601, based on the body weight. Each cohort will initially enrol 1-3 participants. If no serious side effects are seen in the first participant(s), the next cohort will receive the next dose level.",[27],[252,253,254],"solid tumours","advanced or metastatic solid tumours","open label","2025-12-22",{"date":257,"type":43},"2025-12-29",{"date":259,"type":21},"2026-01-21",{"date":261,"type":21},"2028-01-30",{"name":263,"class":50},"AP Biosciences Inc.",3,{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":277,"conditions":278,"keywords":287,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":309},"100498426","phase-2-determine-trial-treatment-arm-02-atezolizumab-in-adult-paediatric-and-teenageyoung-adult-patients-with-cancers-with-high-tumour-mutational-burden-tmb-or-microsatellite-instability-high-msi-high-or-proven-constitutional-mismatch-repair-deficiency-cmmrd-disposition-100498426","NCT05770102","DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With High TMB or MSI-high or Proven CMMRD Disposition.","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 02 (ATEZOLIZUMAB) OUTLINED BELOW\\*\n\n\\*When atezolizumab-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the atezolizumab-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of a malignancy that is high TMB (defined as ≥10 mut\u002FMb), MSI-high or of proven (previously diagnosed) CMMRD disposition using an analytically validated next-generation sequencing method. Patient cases with TMB between 10-15 mut\u002FMb may be discussed in an MTB meeting. TMB ≥19 mut\u002FMb will be fast-tracked for an MTB recommendation, unless there are any patient-specific individualities (such as multiple gene amplifications) that require MTB discussion.\n\nB. Women of childbearing potential are eligible provide they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment and;\n* Agree to use one form of effective birth control method such as:\n\nI. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (\\[oral, intravaginal or transdermal\\]);\n\nII. progestogen-only hormonal contraception associated with or without inhibition of ovulation (oral, injectable or implantable);\n\nIII. intrauterine device (IUD),\n\nIV. intrauterine hormone-releasing system (IUS),\n\nV. bilateral tubal occlusion,\n\nVI. vasectomised partner,\n\nVII. sexual abstinence,\n\nVIII. male or female condom with or without spermicide;\n\nIX. cap, diaphragm or sponge with spermicide.\n\nEffective from the first administration of atezolizumab, throughout the trial and for five months after the last administration of atezolizumab.\n\nC. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of atezolizumab, throughout the trial until the last administration of atezolizumab:\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses an effective method of contraception.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nD. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nE. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nF. PAEDIATRIC PATIENTS (\\\u003C18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nG. Patients must have stable thyroid function tests. Patients on stable doses of thyroxine replacement are permitted.\n\nExclusion Criteria:\n\nA. Diagnosis of urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, hepatocellular carcinoma or triple negative breast cancer.\n\nB. Patients with rapidly progressing or symptomatically deteriorating brain metastases and\u002For leptomeningeal disease. Patients with previously treated brain metastases are eligible, provided the patient has not experienced a seizure or had a clinically significant change in neurological status within 14 days (for adult patients) or 7 days (for paediatric patients) prior to the start of IMP administration. Such patients must be non-dependent on steroids or on a stable or reducing dose of steroid treatment for at least 14 days (or 7 days for paediatric patients) prior to the start of IMP administration. Primary brain or central nervous system (CNS) malignancies are allowed providing the patient is clinically stable (if requiring corticosteroids must be at stable or decreasing doses for at least 14 days for adults and 7 days for paediatric patients prior to the start of IMP administration). Patients who have received brain irradiation must have completed whole-brain radiotherapy and\u002For stereotactic radiosurgery at least 14 days prior to the start of IMP administration.\n\n• Paediatric patients with either primary brain tumours or extracranial solid tumours with intracranial metastases with one or more intracranial lesions should only be considered for inclusion if largest intracranial lesion is ≤6 cm in longest axis. Consideration should also be given to the intracranial location of the tumour and potential risk should swelling occur. This is because of the class risk of immune checkpoint inhibitors such as atezolizumab causing immune-mediated inflammatory response and 'tumour flare' which may result in acute neurological deterioration.\n\nC. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within five months following their last dose of atezolizumab.\n\nD. History or clinical evidence of current inflammatory lung disease:\n\n* History of idiopathic pulmonary fibrosis, organising pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.\n* Evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n\nE. Active autoimmune disease that requires the use of systemic immunomodulatory therapy (i.e. with disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy for hypothyroidism and adrenal or pituitary insufficiency is acceptable.\n\nF. Ongoing lung pathologies which, in the opinion of the Investigator present a compromise to safety (e.g. active tuberculosis).\n\nG. Systemic immunomodulatory agents within 14 days prior to trial entry (immunostimulatory agents within four weeks). Exceptions to this are:\n\n* Patients who received acute, low dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g. 48 hours of corticosteroids for a contrast allergy) are eligible for the trial.\n* Patients who received corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma equivalent to ≤10 mg prednisolone a day or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the trial.\n* Patients with primary CNS disease can be receiving concurrent treatment with corticosteroids. Patients must be receiving a stable or decreasing dose for ≥14 days for adults and ≥7 days for paediatric patients prior to the screening magnetic resonance imaging (MRI) scan and at the time of drug initiation.\n* Patients who receive physiological doses of steroid replacement (e.g. hydrocortisone) are permitted.\n\nH. Known to be serologically positive (as detected by polymerase chain reaction) for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n\nI. History of severe allergic anaphylactic reactions to chimeric, human or humanised antibodies, or fusion proteins including other immune checkpoint inhibitors.\n\nJ. Known hypersensitivity to Chinese hamster ovary cell products.\n\nK. Known hypersensitivity to atezolizumab or any of the excipients.\n\nL. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during atezolizumab treatment or within six months after the final dose of atezolizumab.\n\nM. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or NYHA class III or IV congestive heart failure.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attacks \\[TIA\\]) or cardiovascular event (including acute myocardial infarction \\[MI\\]) within three months before the first dose of atezolizumab.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of atezolizumab, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nPatients with a prior history of pericardial disorders, including pericarditis, pericardial effusion and cardiac tamponade.\n\nN. Prior allogeneic stem cell or solid organ transplantation on immunosuppression.\n\nO. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to atezolizumab.\n\nP. Uncontrolled diabetes.\n\nQ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.\n\nR. Severe infection within four weeks prior to the first IMP administration or the administration of antibiotics within two weeks prior to the first IMP administration, with the exemption of patients requiring prophylaxis.",{"count":274,"type":21},30,[62,276],"PHASE3","This clinical trial is looking at a drug called atezolizumab. Atezolizumab is approved as standard of care treatment for adult patients with urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, hepatocellular carcinoma and triple negative breast cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nAtezolizumab works in patients with these types of cancers which have certain changes in the cancer cells called high tumour mutational burden (TMB) or high microsatellite instability (MSI) or proven (previously diagnosed) constitutional mismatch repair deficiency (CMMRD).\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which are also TMB\u002FMSH-high or show CMMRD. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[279,280,281,282,283,284,285,286,86,27],"Malignancy","Malignant Neoplasm","Lymphoproliferative Disorders","Neoplasms by Histologic Type","Neoplasms by Site","Cancer","Colorectal Neoplasms","Endometrial Neoplasms",[288,289,290,284,291,279,292,293,282,283,294,295,296,297,298],"Adult","Antineoplastic Agents","Atezolizumab","Child","Malignant Neoplasms","Molecular Targeted Therapy","Paediatric","Precision Medicine","Rare","Tumour-agnostic","Young adult","2025-11-19",{"date":301,"type":43},"2025-11-24",{"date":303,"type":43},"2023-10-25",{"date":305,"type":21},"2029-10",{"name":307,"class":308},"Cancer Research UK","OTHER",27,{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":318,"phases":4,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":330},"100329666","tissue-collection-framework-to-improve-outcomes-in-solid-tumours-100329666","NCT03572192","Tissue Collection Framework To Improve Outcomes In Solid Tumours","Inclusion Criteria:\n\n1. Male and female patients over the age of 18 years who have been diagnosed with a solid tumour and who are seen at the Barts Health NHS Trust for clinical management of their tumour.\n2. Male or female more than 18 years of age\n3. Able to participate in the study.\n4. Able to give informed consent.\n5. Patients enrolled into other clinical trials may be included into this study\n\nExclusion Criteria\n\n1. Any co-existing medical condition that in the Investigator's judgement will substantially increase the risk associated with the patient's participation in the study\n2. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and\u002For completion of the necessary studies\n3. Physical or mental health issues that preclude them from participation",{"count":317,"type":21},3000,"OBSERVATIONAL","Background:\n\nCancer therapies have significantly improved over the last decades, allowing cancer specialists to keep cancer under control for longer than ever before. However, metastatic cancer still develops in a large number of patients and drug resistance occurs in the majority of them after an initial period of response and leads to cancer progression and death.\n\nAims:\n\nTo date, the mechanisms which allow cancer cells to spread through the body to form metastases and to become resistant even to the most powerful treatments are poorly understood. Our aim is to collect cancer specimens and normal tissue specimens such as blood from patients with solid tumours and to analyse these samples with some of the latest molecular profiling technologies in the research laboratory. This comprehensive analysis should reveal what molecular defects fuel the growth of cancer cells adn what allows them to spread through the body and then develop resistance to cancer therapies. Such insights could subsequently lead to the development of better more improved treatments which prevent drug resistance, to novel molecular tests which can also predict which treatment is most likely to be effective and tolerable in individual patients.\n\nMethods:\n\nTo achieve this, we aim to collect multiple samples from consenting patients starting from the diagnosis of a tumour to the time drug resistance develops more. Importantly, this study will collect tissues from interventional procedures which are performed as part of routine patient management of patients seen at Barts Health NHS trust. We will then apply molecular tests such as proteomics and DNA sequencing to these samples. Tissues which are left over after these tests have been applied will be stored in a licensed tissue bank to allow future research with novel technologies.",[27],"2025-11-17",{"date":323,"type":43},"2025-11-18",{"date":325,"type":4},"2013-09",{"date":327,"type":21},"2043-08",{"name":329,"class":308},"Queen Mary University of London",1,{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":344,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":4},"100595286","phase-1-a-study-to-evaluate-the-safety-and-tolerability-of-ep0089-100595286","NCT07030478","A Study to Evaluate the Safety and Tolerability of EP0089","A Phase I\u002FIIa Study to Evaluate the Safety and Tolerability of Monoclonal Antibody EP0089 in Patients With Advanced Solid Tumours","Inclusion Criteria:\n\nApplicable to all patients:\n\n1. Must be ≥18 years of age (≥19 in South Korea) with documented recurrent, metastatic or unresectable solid tumours for whom no standard therapy exists or standard therapy has failed\n2. ECOG performance status of 0 or 1 and life expectancy \\>3 months at screening\n3. Ability to understand and provide written informed consent\n4. Must be willing to comply with necessary contraceptive methods as required\n5. Willing and able to comply with the scheduled study treatment plan, laboratory tests, and other study procedures.\n6. Adequate hepatic, haematological and renal function as assessed by protocol-defined criteria.\n7. Additional cohort\u002Fdisease specific criteria apply\n8. Measurable disease per RECIST v1.1\n\nExclusion Criteria:\n\n1. Known active CNS metastases and\u002For leptomeningeal disease and\u002For carcinomatous meningitis.\n2. Recent major surgery\n3. Recent live or live-attenuated vaccine ≤ 30 days prior to the first dose\n4. Current active, or history of, autoimmune disease that requires or required systemic treatment (ie, with disease modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to starting study treatment.\n5. Prior severe hypersensitivity reaction to mAbs\n6. Previous \\> Grade 2 peripheral neuropathy.\n7. Significant neurological condition eg stroke, transient ischaemic attack (in the last 12 months), epilepsy, head trauma, brain surgery or prior history of any significant psychiatric disorder\n\n9\\. Current active, or history of, autoimmune disease that requires or required continuous treatment within 2 years prior to starting study treatment\n\n10\\. Receiving chronic systemic steroid therapy (\\> 10 mg \u002Fday of prednisone or equivalent) or any other form of immunosuppressive therapy ≤ 7 days prior the first dose of study drug. Topical or inhaled steroids are permitted.\n\n11\\. Any prior immune-mediated or immune-related adverse events related to treatment with immune-modulatory agents that caused permanent discontinuation of the agent, that were ≥ Grade 3 in severity or in the opinion of the Investigator would otherwise jeopardise patient safety in this study.\n\n12\\. One or more clinically significant (ie, active) cardiovascular diseases, myocardial infarction, or unstable angina (≤ 6 months prior to first administration of study drug)",{"count":339,"type":21},190,[24,62],"This is a first-in-human (FIH), first-in-class, Phase I\u002FIIa, open-label study designed to evaluate the safety and tolerability of EP0089 (study drug). Study drug will initially be given via intravenous (IV) infusion once every 2 weeks (Q2W), with one treatment cycle defined as 14 days. The study will enroll patients with advanced solid tumours for whom no standard therapy exists or for whom standard therapy has failed. An independent Safety Monitoring Committee (SMC) will review safety data at regular intervals to ensure participant safety and support dose escalation decisions.",[343,27],"Solid Cancers","NOT_YET_RECRUITING","2025-06-12",{"date":347,"type":43},"2025-06-22",{"date":349,"type":21},"2025-09",{"date":351,"type":21},"2029-06",{"name":353,"class":50},"Ellipses Pharma"]