[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,102,0,25,[9,44,68,86,128,150,188,221,250,280,303,335,360,387,405,431,455,481,509,541,561,580,601,625,644],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100625755","phase-1-an-open-label-study-to-evaluate-pf-07994525-in-participants-with-advanced-cancers-100625755",false,"NCT07426757","An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers","AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-07994525 IN PARTICIPANTS WITH ADVANCED MALIGNANCIES","Inclusion Criteria:\n\n* Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at the time of informed consent.\n* Prior diagnosis of MM as defined according to IMWG criteria (Rajkumar et al. 2014)\n\nMeasurable disease based on IMWG criteria as defined by at least 1 of the following:\n\n1. Serum M-protein \\>0.5 g\u002FdL by serum protein electrophoresis (SPEP)\n2. Urinary M-protein excretion \\>200 mg\u002F24 hours by urine protein electrophoresis (UPEP)\n3. Serum immunoglobulin Free Light Chain (FLC) ≥10 mg\u002FdL (≥100 mg\u002FL) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\\\u003C0.26 or \\>1.65)\n\n   * Participants must be refractory to, or intolerant to, all established therapies known to provide clinical benefit in multiple myeloma that are an appropriate therapeutic option, in the judgement of the investigator. A minimum of 3 prior lines of therapy are required.\n   * Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n\nExclusion Criteria:\n\n* Active plasma cell leukemia, Smoldering MM, Waldenströms macroglobulinemia, Amyloidosis, POEMS Syndrome.\n* Autologous stem cell transplant within 12 weeks prior to enrollment or active Graft-versus-host disease (GVHD).\n* Active or suspected cerebral\u002Fmeningeal disease related to the underlying malignancy.\n* Any active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), known HIV or AIDS related illness, unless deemed not clinically significant by the investigator (eg, onychomycosis).","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is an open-label, dose escalation and dose expansion study evaluating the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and antitumor activity of PF-07994525 in participants with R\u002FR MM.\n\nThe study will consist of 2 parts: Part 1 (Dose Escalation) will consist of PF-07994525 dose escalation to assess the safety, tolerability, and preliminary antitumor activity in participants with R\u002FR MM. In Part 2 (Dose expansion), PF-07994525 may be evaluated in additional participants with R\u002FR MM to further assess safety, PK, PD, and preliminary anti-tumor activity.",[27,28],"Advanced Malignancies","Advanced Cancer",[27,30,28],"Advanced Cancers","RECRUITING","2026-08-14",{"date":34,"type":35},"2026-08-17","ACTUAL",{"date":37,"type":35},"2026-07-01",{"date":39,"type":21},"2030-07-10",{"name":41,"class":42},"Pfizer","INDUSTRY",19,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100622355","phase-1-phase-1b-trial-of-bms-986504-in-combination-with-olaparib-in-patients-with-mtap-loss-100622355","NCT07382544","Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss","Phase 1b Trial of Combined PRMT5 Inhibition With BMS-986504 and PARP Inhibition With Olaparib in Patients With Advanced Cancer With MTAP Loss","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. All patients must have a histologically confirmed advanced or metastatic solid tumor that has been refractory to standard therapy or are not eligible for standard therapy and have no alternative curative-intent treatment options at the time of patient enrollment. For the dose escalation, any solid tumor is eligible, but enrollment will be enriched for CCA and pancreatic cancer. For the pharmacodynamic expansion, patients must have histologically confirmed advanced or metastatic CCA or pancreatic cancer.\n3. Homozygous deletion of MTAP as detected by Clinical Laboratory Improvement Amendmentscertified next-generation sequencing test or absence of MTAP protein as detected by CLIAcertified immunohistochemistry test.\n4. Patients in Part A must have archived tumor tissue available for retrospective analysis or agree to pre-treatment biopsy.\n5. Ability to understand and the willingness to sign a written informed consent document.\n6. Ability to comply with the study protocol, in the investigator's judgment.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 1).\n8. Life expectancy ≥3 months.\n9. Patients in the pharmacodynamic expansion must have measurable and biopsiable disease per the RECIST v1.1 (Appendix 2). Patients in the dose escalation can have evaluable or measurable disease.\n10. Patients must have adequate washout from prior therapy at the time of study treatment initiation: 3 weeks from any treatment specifically for systemic tumor control: 5 half-lives from small molecule targeted agents and ≥ 2 weeks from radiotherapy (except for patients with brain metastasis treatment with Gamma Knife; in these cases, \\> 1 week is required). Palliative radiotherapy is permitted for a preexisting lesion, provided it does not interfere with the assessment of tumor target lesions (e.g., the lesion to be irradiated must not be a site of measurable disease).\n11. Patients must have recovered from toxicities of prior anticancer therapy (Grade ≤ 1 toxicity) except for alopecia and peripheral neuropathy.\n12. Adequate organ and marrow function as defined below within 28 days prior to study treatment initiation:\n\n    * Hemoglobin ≥ 9.0 g\u002FdL\n    * Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3\n    * Platelets ≥ 100,000\u002Fmm3\n    * Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL\u002Fmin\u002F1.73 m2 by the Chronic Disease Epidemiology Collaboration equation; estimated creatinine clearance ≥50 mL\u002Fmin (calculated using institutional standard method).\n    * Adequate hepatic function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Patients with Gilbert's syndrome with total bilirubin ≤ 2.0 × ULN and direct bilirubin within normal limits are permitted; Aspartate aminotransferase\u002FALT ≤ 3 × institutional ULN or ≤ 5 × ULN for patients with liver metastases.\n    * For patients not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time ≤1.5 × ULN. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen.\n13. Patients must be able to take PO medications.\n14. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result within 72 hours prior to study treatment initiation.\n\nWOCBP must agree to use adequate contraception as described below from the screening visit through at least 6 months after the last dose of study treatment. (Refer to Pregnancy Assessment Policy MD Anderson Cancer Center \\[MDACC\\] Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n* Postmenopausal (no menses in ≥ 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range and have received whole pelvic radiation therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n\nWOCBP must agree to use a combination of a hormonal and a non-hormonal contraceptive method or a non-hormonal method alone that is highly effective (with a failure rate of \\\u003C 1% per year: copper intrauterine device) during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for individual chemotherapy agents, whichever is longer.\n\nWOCBP are not permitted to use hormonal contraceptive methods alone as a highly effective method of contraception and must use an additional non-hormonal highly effective method of contraception.\n\nWOCBP must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period. Participants should be advised to seek advice about egg donation and cryopreservation of germ cells before treatment.\n\nExclusion Criteria:\n\n1. Part B only: Prior treatment with a PRMT5 or methionine adenosyltransferase 2A inhibitor.\n2. Patients who have a known additional malignancy that is progressing or requires active treatment at time of study treatment initiation. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer.\n3. Patients with meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases. Note: Patients with stable brain metastases (defined as asymptomatic or no requirement for high-dose or increasing dose of systemic corticosteroids and without imminent need of radiation therapy) are eligible (including those with untreated brain metastases). If applicable, patients must have completed brain radiation therapy and recovered adequately from any associated toxicity and\u002For complications prior to eligibility assessment.\n4. Concomitant use of strong cytochrome P450 (CYP)3A inhibitors or inducers are prohibited within 14 days or 5 half-lives, whichever is longer, prior to study treatment initiation and during the study treatment period. For a comprehensive list of CYP3A inhibitors\u002Finducers, refer to: https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactionstable-substrates-inhibitors-and-inducers.\n5. Any clinically significant comorbidities such as uncontrolled pulmonary disease, known impaired cardiac function or clinically significant cardiac disease (including but not limited to known left ventricular ejection fraction \\\u003C 50%, congenital long QT syndrome, corrected QT interval using Fridericia's formula ≥ 480 msec on screening electrocardiogram \\[ECG\\], unstable angina pectoris ≤ 3 months prior to study treatment initiation, and acute myocardial infarction ≤ 3 months prior to study treatment initiation), or any other condition that could compromise the patient's participation in the study.\n6. Treatment with a live, attenuated vaccine within 4 weeks prior to study treatment initiation.\n\n   Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, Bacille Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Non-live COVID vaccines will be allowed on study, but it is recommended to avoid their use during the first treatment cycle (from 3 days prior to Cycle 1 Day 1 through Cycle 2 Day 3).\n7. Concomitant use of medications known to be sensitive substrates of breast cancer resistance protein (including, but not limited to, rosuvastatin and sulfasalazine) or P-glycoprotein (P-gp; including, but not limited to, dabigatran etexilate, digoxin, fexofenadine).\n8. Patients who are pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 7 months after the last dose of study treatment.\n9. Any known psychiatric, substance abuse, or other disorder that would interfere with cooperation with the requirements of the study, in the opinion of the investigator.\n10. Patients who are receiving any other investigational agents.\n11. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.\n12. Patients who have an active infection requiring intravenous (IV) antibiotics.\n13. Patients with any gastrointestinal disorder that would significantly alter the absorption of the study drugs (e.g., active ulcerative diseases, uncontrolled nausea, uncontrolled vomiting, uncontrolled diarrhea, malabsorption syndrome).",{"count":52,"type":21},36,[24],"The goal of this clinical research study is to learn about the safety and effects of BMS-986504 in combination with olaparib in patients with advanced solid tumors with MTAP loss.",[28,56],"Solid Tumor","2026-08-10",{"date":59,"type":35},"2026-08-12",{"date":61,"type":35},"2026-02-12",{"date":63,"type":21},"2032-01-31",{"name":65,"class":66},"M.D. Anderson Cancer Center","OTHER",1,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":67},"100593703","development-of-an-educational-patient-decision-aid-treatments-in-advanced-cancer---decision-aid-ta-da-to-promote-shared-decision-making-for-third-line-or-beyond-palliative-systemic-therapy-100593703","NCT07009886","Development of an Educational Patient Decision Aid (Treatments in Advanced Cancer - Decision Aid, TA-DA) to Promote Shared Decision Making for Third-line or Beyond Palliative Systemic Therapy","Inclusion Criteria:\n\n1. Clinicians (Part I\u002FII\u002FIII):\n\n   MD Anderson medical oncologists and APPs who provide care to patients with advanced cancer\n2. Patients (Part I\u002FII\u002FIII):\n\n   Age 18 or over\n   * Diagnosis of advanced cancer (i.e., metastatic, relapsed, and\u002For incurable disease as defined by the treating oncologist) who has received at least 2 lines of palliative systemic therapy\\*\n   * Patient-rated ECOG performance status of 1-3 for Part I\u002FII and 2-3 for Part III\n   * Able to make treatment decisions based on the clinical judgement of the oncology team\n   * English speaking\n\n     * patient has started, is receiving, and\u002For has completed second-line palliative systemic therapy or beyond\n3. Caregivers (Part I\u002FII\u002FIII):\n\n   * Age 18 or older\n   * Currently a primary caregiver to a patient who satisfies the patient eligibility criteria listed above\n   * For the study purposes, a primary caregiver is defined as:\n\n     * someone who provides physical, emotional, decisional and\u002For logistical assistance to the patient regularly (e.g. daily, weekly);\n     * can be a family member, friend, or other individual in a close relationship with the patient;\n     * must be identified by the patient and self-identify as the primary person providing caregiving support to the patient\n   * Able to provide informed consent and participate in the study\n   * English speaking\n\nExclusion Criteria:\n\nAny patient who meets any of the following criteria will be excluded from participation in this study:\n\n* (Part I\u002FII\u002FIII): Diagnosis of cognitive impairment or dementia requiring a surrogate decision maker as determined by the clinical team\n* (Part III only): Participants in Part I and II",{"count":75,"type":21},155,[77],"NA","To develop an educational patient decision aid for advanced cancer patients to prepare them to have conversations with their clinicians about treatment options (Treatments in Advanced cancer - Decision Aid, TA-DA).",[28],{"date":59,"type":35},{"date":82,"type":35},"2025-07-10",{"date":84,"type":21},"2030-07-31",{"name":65,"class":66},{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100534718","phase-1-a-study-of-mgc026-in-participants-with-advanced-solid-tumors-100534718","NCT06242470","A Study of MGC026 in Participants With Advanced Solid Tumors","A Phase 1\u002F1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years old, able to provide informed consent\n* Adequate performance and laboratory parameters\n* Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible\n* Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.\n* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.\n* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.\n* Not pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \\\u003C 6), or carcinoma in situ.\n* Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.\n* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.\n* Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.\n* Prior autologous or allogeneic stem cell or solid organ transplant.\n* Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.\n* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.\n* Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.\n* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.\n* History of primary immunodeficiency.\n* Major trauma or major surgery within 4 weeks of first study drug administration.\n* Known hypersensitivity to recombinant proteins.",{"count":94,"type":21},250,[24],"The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.\n\nParticipants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.",[98,28,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118],"Advanced Solid Tumor","Metastatic Cancer","Squamous Cell Carcinoma of Head and Neck","Non Small Cell Lung Cancer","Small-cell Lung Cancer","Bladder Cancer","Sarcoma","Endometrial Cancer","Melanoma","Castration Resistant Prostatic Cancer","Cervical Cancer","Colorectal Cancer","Gastric Cancer","Gastro-esophageal Cancer","Pancreas Cancer","Clear Cell Renal Cell Carcinoma","Hepatocellular Carcinoma","Platinum-resistant Ovarian Cancer","Breast Cancer","Ovarian Cancer","Esophageal Squamous Cell Cancer (SCC)",{"date":120,"type":35},"2026-08-11",{"date":122,"type":35},"2024-03-06",{"date":124,"type":21},"2028-10",{"name":126,"class":42},"MacroGenics",12,{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":135,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":67},"100531465","phase-2-psilocybin-assisted-psychotherapy-in-patients-with-advanced-cancer-on-maintenance-therapy-100531465","NCT06200155","Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy","TRIP - TReatment to Improve Depression and\u002For Anxiety Using Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy","Inclusion Criteria:\n\n1. Participants must have one of the following histology documented tumor types: non-small cell lung carcinoma, renal cell carcinoma, urothelial carcinoma, prostate cancer, head and neck squamous cell carcinoma, ovarian cancer, breast cancer, gastric\u002FGEJ cancer, cervical, anal, or MSI-high\n2. Documentation of locally advanced, recurrent, or metastatic incurable malignancy that has partially responded or progressed after at least 1 available standard therapy and disease is stable (no progression of disease for 3 months or more on current treatment regimen)\n3. No prior grade 3 AEs on current standard of care cancer treatment regimen;\n4. Age ≥ 25 years; as by the age of 25 brain is fully developed.\n5. Have a DSM-V psychiatric diagnosis, as determined by the SCID (Structured Clinical Interview for DSM, by a board certified psychiatrist), of one or more of the following Axis I psychiatric disorders that is judged to have been precipitated by the psychological stress of the cancer diagnosis: Generalized Anxiety Disorder; Acute Stress Disorder; Posttraumatic Stress Disorder; Major Depressive Disorder; Dysthymic Disorder; Adjustment Disorder with Anxiety; Adjustment Disorder with Depressed Mood; Adjustment Disorder with Mixed Anxiety and Depressed Mood; Adjustment Disorder with Disturbance of Conduct; Adjustment Disorder with Disturbance of Emotions and Conduct. Psychiatric diagnosis are determined by a MD Anderson board certified psychiatrist.\n6. At least 6 months life expectancy as per primary medical oncologist.\n7. Have an ECOG performance status of 0, 1, or 2.\n8. Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental exam).\n9. Must demonstrate willingness to travel to MD Anderson Cancer center for all treatment and follow-up sessions, as well as consent to complete all evaluation instruments and assessments.\n10. Agree to abstain from any nicotine products for at least 12 hours prior to psilocybin administration until approximately 12 hours after (or when all post-session questionnaires have been completed) as well as on days of salivary sample collection.\n11. Refrain from any psychoactive drugs (including alcohol) for 48 hours prior to psilocybin sessions (except as described above for nicotine and caffeine) and must refrain from psychoactive drugs 12 hours after psilocybin sessions. Must consent to urine drug screen (UDS) which will be given before receiving psilocybin. Participants with positive drug test will be retested (UDS) after 6 weeks and included if the repeated UDS is negative. Participant tested positive for a prescribed substance are eligible. Participant failing on the 2nd test (UDS) will be excluded.\n12. Must be free from any regularly scheduled psychotropic (antidepressant\u002Fanxiolytic class) medications and those with primary MOA on serotonergic neurons (e.g., ondansetron) for a minimum of 2 weeks prior to study or 4 weeks for SSRI. Intermittent or PRN use of short-acting anxiolytics may be permitted as defined below in exclusionary criteria).\n13. Inhibitors of monoamine oxidase, UGT1A9, 1A10, and aldehyde or alcohol dehydrogenase should be discontinued 5 half-lives prior to active dose of psilocybin.\n14. Eligible participants will have a responsible individual that will provide transportation home after the psilocybin session is complete.\n15. Fluent in English\n\nExclusion Criteria:\n\n1. History of depression prior to cancer diagnosis.\n2. Clinically significant suicidality or high risk of completed suicide defined as:\n\n   i. Answer 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline ii. Report having had any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts iii. Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior\n3. History of bipolar disorder, psychosis (of any nature), and seizures.\n4. Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total .glossectomy.\n5. ECG with QTc \\> 450.\n6. Patients with metal implants.\n7. Asymptomatic ALT or AST elevations \\>\u002F= 5X upper limit of normal, symptomatic ALT or AST elevations \\>\u002F= 2X upper limit of normal, or total bilirubin \\>\u002F= 2X upper limit of normal.\n8. The effects of psilocybin on the developing human fetus are unknown. For this reason, pregnant women will be excluded (Urine test for screening), women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n   Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n\n   History of bilateral tubal ligation or another surgical sterilization procedure.\n\n   Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n9. persons with first- or second-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder.\n10. Actively progressing disease as defined by the primary oncologist.\n11. Vulnerable populations, including children and cognitively impaired patients, will not be enrolled in this study.\n12. Participants with brain metastases.\n13. Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (prior to dosing) Blood Pressure \\>140\u002F90 mmHg and HR\\> 90 bpm.\n14. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:\n\n    i. Uncompensated congestive heart failure ii. Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., QTC interval \\> 450) iii. Recent acute myocardial infarction or evidence of ischemia iv. Malignant hypertension v. Congenital long QT syndrome vi. Acute renal failure vii. Severe hepatic impairment viii. Respiratory failure\n15. Significant central nervous system (CNS) pathology. Some examples include:\n\n    i. Primary or secondary cerebral neoplasm ii. Epilepsy iii. History of stroke iv. Cerebral aneurysm v. Dementia vi. Delirium\n16. a. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation. Examples include: i. Agitation ii. Violent behavior b. Active substance use disorders (SUDs) defined as: DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year c. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as: i. Any use in the last 12 months ii. \\>25 lifetime uses d. History of hallucinogen persisting perception disorder (HPPD) e. Concurrent Medications i. Antidepressants ii. Centrally-acting serotonergic agents (e.g., MAO inhibitors) iii. Antipsychotics (e.g., first and second generation) iv. Mood stabilizers (e.g., lithium, valproic acid) v. Aldehyde dehydrogenase inhibitors (e.g., disulfiram) vi. Significant inhibitors of UGT 1A0 or UGT 1A10 vii. Niacin. Note: If taking any supplement containing niacin, agrees to suspend use for at least five days prior to dosing and for the duration of the study f. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC).\n\n    i. Note: Prescribed opiate medications (e.g., cancer-related pain) will be allowed to continue through the study period for participants who have been on a stable dose of such medicine for at least 1 month prior to Screening, as determined during review of concomitant medications.\n\n    ii. Note: Prescribed benzodiazepine medications and nonbenzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications.\n\n    iii. Note: Participants using cannabis, including legal cannabis, for any purposes must agree to refrain from use beginning at Screening, as confirmed with a negative Baseline drug test, and through to the end of the study.\n\n    iv. Note: Participants using prescribed psychostimulants (amphetamines and Ritalin), must agree to refrain from use two weeks prior to baseline visit, as confirmed with a negative Baseline drug test, and through to the end of the study.\n\n    g. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin h. Have any psychological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.\n\n    i. Have an allergy or intolerance to any of the materials contained in either drug product j. Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and\u002For existential distress (e.g., pharmacologic or psychotherapeutic interventions)\n17. Participants who have any of the below niacin contraindications:\n\n    1. Active liver disease or unexplained persistent elevations in hepatic transaminases\n    2. active peptic ulcer disease\n    3. arterial bleeding\n    4. Hypersensitivity to niacin or any component of this medication\n18. BP\\> 200\u002F110 (or malignant hypertension defined as 200\u002F120) would prevent a patient from receiving psilocybin dosing and would prompt calling a physician during blood pressure monitoring for cardiac risk evaluation.","25 Years",{"count":137,"type":21},30,[139],"PHASE2","To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and\u002For anxiety in participants who are being treated for advanced cancer.",[142,143,28],"Depression, Anxiety","Psilocybin-Assisted Psychotherapy",{"date":59,"type":35},{"date":146,"type":35},"2024-04-16",{"date":148,"type":21},"2026-12-31",{"name":65,"class":66},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":177,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},"100505262","phase-1-a-study-of-mq710-with-and-without-pembrolizumab-in-people-with-solid-tumor-cancer-100505262","NCT05859074","A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer","A First-In-Human Phase I, Open Label, Safety and Tolerability Study of Escalating Multiple Doses of Intratumoral MQ710, a Multi-Transgene Expressing Modified Vaccinia Virus Ankara-Based Virotherapy, Alone and in Combination With the Systemic Checkpoint Inhibitor Pembrolizumab in Solid Tumors","Inclusion Criteria:\n\n* Age 18 or over\n* Histologically or cytologically documented advanced or metastatic cancer that has relapsed from or is refractory to standard treatment in two lines of prior therapy in the advanced setting unless there are fewer than two FDA approved lines of therapy for the particular disease, or for which no standard treatment is available\n* At least 2 tumors suitable for direct or ultrasound-guided injection defined as at least one cutaneous, subcutaneous, or nodal lesion or aggregate of lesions, ≥0.5 cm for any single lesion and cumulative lesion dimensions. One lesion must meet criteria for RECIST measurable disease if in Part 2. Note: One lesion will be biopsied (if possible)\n* Mandatory initial screening biopsy\n\n  a. For patients undergoing surgical excision\u002Fresection: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to biopsy and surgical procedure iii. Patient able to undergo surgical procedure and appropriate anesthesia b. For patients not undergoing surgical excision\u002Fresection to obtain mandatory screening biopsy: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to initial tumor biopsy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Patients with no curative treatment options available including surgery and\u002For definitive radiation or patients in which these modalities are associated with significant morbidity\n* Patients with advanced disease who have received and progressed on standard therapy or have disease for which there is no standard therapy or have contraindications to standard therapy\n\nPart 1a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. Any malignancy with superficial cutaneous or subcutaneous lesions or palpable lymph nodes may be eligible based on the discretion of the investigator.\n\n* Part 2a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. BCC will also be included, given that pembrolizumab has not been approved for this condition, although cemiplimab is approved.\n* Parts 1b and 2b: Patients must have cSCC, Merkel cell carcinoma, melanoma, or head and neck squamous cell carcinoma. These patients should be refractory to anti-PD-1 therapy, with the exception of patients with HNSCC with PD-L1 expression \\\u003C1.\n* Parts 1a, 2a and 2b: Patients with BRAF-mutated melanoma should have received BRAF-targeted therapy.\n* Predicted life expectancy of 3 months or more (in both Part 1 and Part 2)\n* Participant or their legally authorized representative (LAR able to provide written informed consent to participate\n* Ability to comply with study procedures in the Investigator's opinion\n* Adequate renal function as defined by Cr \\\u003C2 mg\u002FdL\n* Adequate hepatic function\n\n  1. Serum bilirubin ≤1.5 x ULN\n  2. AST and ALT ≤2.5 ULN (no liver mets)\n  3. AST and ALT ≤5.0 ULN (for patients with liver mets)\n* Adequate bone marrow and hematologic function\n\n  1. Coagulation function adequate (PT and aPTT within x1.5 ULN)\n  2. Platelets ≥ 75,000\u002Fmm\\^2\n  3. ANC ≥ 1000\u002FuL\n* Females of child-bearing potential must have a negative pregnancy test within 14 days prior to enrollment and on day of treatment. All patients must agree to use adequate contraception prior to study entry, for the duration of study participation, and up to 90 days after the last dose of MQ710\n* Part 2 only: at least one measurable site of disease according to RECIST criteria\n* Prior non-immunotherapy, anti-tumor treatment including endocrine, chemical\u002Fradiotherapy, targeted therapy, or major surgery (but not anti-PD1\u002F- L1 therapies) was discontinued for more than 4 weeks prior to enrollment\n* Patients who have failed prior anti-PD1\u002F-PDL1 may be included. Washout of anti-PD1\u002F-PDL1 at least 3 weeks prior to initiation of therapy in Part 1a and 2a. No washout period is required for Part 1b and 2b.\n\nExclusion Criteria:\n\n* Splenectomy\n* Active infections requiring antibiotics, physician monitoring or recurrent fevers (\\>38.0 ℃) associated with a clinical diagnosis of active infection\n* Acute or chronic active viral disease or positive test for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) with CD4 count \\\u003C100mg\u002Fm3, or received treatment with antivirals or nucleoside analogs such as those used in the treatment of hepatitis B (e.g. lamivudine, adefovir, tenofovir, telbivudine, entecavir), ribavirin, cidofovir, diaminopurine analogs, methyladenosine analogs, or interferon alpha within 4 weeks of initiation of study treatment .a. Patients with HIV are allowed on study if CD4 count is \\>100 cells\u002Fmm3.\n* Incomplete recovery from surgery, incomplete healing of an incision site\n* Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding\u002Fhaemorrhage (unless due to resected tumour), treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thrombo-embolic event, history or evidence of haemoptysis or menorrhagia\n* History of myocardial infarction, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classsification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia,or significant cardiovascular or cerebrovascular event in the 6 months before the first dose of study treatment\n* Uncontrolled infection within 6 months prior to study entry.\n* History of significant bleeding requiring hospitalization in the 12 months before the first dose of study treatment\n* Treatment with PD-1\u002Fprogrammed death ligand (PD-L1), cytotoxic T-lymphocyte associated protein 4 (CTLA-4), or any other (including experimental) immune checkpoint inhibitor or immune-stimulatory treatment in the 3 weeks before the first dose of study treatment\n* Prior chemotherapy, radiotherapy, biological cancer therapy (not including anti-PD1\u002F-L1 immunotherapies), targeted therapy, investigational drug, or major surgery 28 days prior to enrollment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment with the exception of grade 2 or better for alopecia and neuropathy.\n* Has known active CNS metastases and\u002For carcinomatous meningitis\n* Received live vaccine within 28 days prior to enrollment\n* Patient is pregnant or breast-feeding, or expecting to conceive or father children within the duration of the trial\n* Patients with tumor that directly contacts, encases or penetrates a major blood vessel, pericardium, gastrointestinal tract, or other hollow organs that may lead to perforation due to tumor necrosis\n* Patients at risk of airway compromise in the event of post-injection tumor swelling\u002Finflammation based on investigator judgement\n* History or evidence of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)\n* History of chronic liver disease or evidence of hepatic cirrhosis\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, active interstitial lung disease (ILD) requiring treatment with systemic steroids\n* Baseline pulse oximetry less than 92% on room air\n* History of re-irradiation to a field which includes the carotid arteries\n* History of leukemia: ALL and CLL (patients with a history of aggressive lymphomas in remission or patients with a history of allogeneic stem cell transplants are eligible if no longer on immunosuppressive therapy and without evidence of GvHD)\n* Current use of steroids such as prednisone 10 mg\u002Fdaily or greater (or its equivalent) or immunosupressants within 2 weeks of initiation of study treatment\n* Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results\n* Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent\n* Known allergy to MQ710 transgene products or formulation.\n* Patient requires anticoagulation therapy, such as warfarin.",{"count":158,"type":21},56,[24],"Participants of this study will have a diagnosis of a solid tumor cancer that has come back to its original location or spread beyond its original location (advanced), came back (relapsed) or worsened (refractory) after standard treatments, or no standard treatments are available for the participants' cancer. The purpose of this study if to find the highest dose of MQ710 that causes few or mild side effects in participants with a solid tumor cancer diagnosis.",[162,163,164,165,166,106,167,168,169,170,171,172,173,174,175,28,99,176,56],"Cutaneous Squamous Cell Carcinoma","SCC - Squamous Cell Carcinoma","Basal Cell Carcinoma","BCC","BCC - Basal Cell Carcinoma","Merkel Cell Carcinoma","Sebaceous Carcinoma","Extramammary Paget Disease","Kaposi Sarcoma","Head and Neck Squamous Cell Carcinoma","HNSCC","Adnexal Carcinoma","Angiosarcoma","Cutaneous Neoplasm","Refractory Cancer",[162,163,164,165,106,167,168,169,170,171,172,173,174,175,28,99,176,178,179,180,56],"MQ710","Memorial Sloan Kettering Cancer Center","22-278",{"date":59,"type":35},{"date":183,"type":35},"2023-05-04",{"date":185,"type":21},"2028-05-04",{"name":179,"class":66},7,{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":201,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":67},"100651534","the-familystrong-pilot-randomized-trial-100651534","NCT07761988","The FamilyStrong Pilot Randomized Trial","Brief Distress Support for Family Caregivers of Persons With Advanced Cancer: The FamilyStrong Pilot Randomized Trial","Inclusion Criteria:\n\n* CAREGIVERS:\n\n  1\\) ≥18 years of age; 2) self-endorsing or identified by the patient as \"a relative, friend, or partner that has a close relationship with you and who assists with your health and medical care and who may or may not live in the same residence as you and who is not paid for their help\"; 3) caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below) who is not enrolled in hospice; 4) caregivers will NOT need to have a patient willing to participate; and 5) able to speak and read English and complete baseline measures.\n* PATIENTS:\n\n  1. ≥18 years of age; 2) screened within 60 days of an oncology visit where the patient had documentation of a new diagnosis of an advanced stage cancer, defined as metastatic and\u002For recurrent\u002Fprogressive stage III\u002FIV cancer, including brain, lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, melanoma; and hematologic malignancies; and 3) able to speak and read English and complete baseline measures.\n\nExclusion Criteria:\n\n* CAREGIVERS:\n\n  1\\) Self-reported active, untreated mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse.\n* PATIENTS:\n\n  1. Receiving hospice per EHR; 2) Per EHR, active, untreated mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, suicidal ideation, uncorrected hearing loss, or substance abuse.",{"count":20,"type":21},[77],"When someone is diagnosed with advanced cancer, their family members and close friends often take on the role of caregiver, providing emotional support and complex medical care for their loved one, often for up to eight hours a day. This responsibility can take a significant toll, leaving family caregivers overwhelmed, highly stressed, and without access to the support they need. Research shows that when caregivers are struggling, both they and the patients they care for suffer. Caregiver distress has been linked to poor quality of life for patients and greater emotional strain on families. Despite the well-documented emotional and physical burdens on family caregivers, most cancer centers do not include structured support services to help them cope and navigate challenges. Many caregivers do not even realize help is available, leading to feelings of isolation and burnout. Yet, despite the critical role caregivers play in cancer care, there are very few programs designed to support them in ways that are both effective and widely accessible. To address this urgent need, our team has developed FamilyStrong, a novel intervention specifically designed to fill this gap and support family caregivers in real-world cancer care settings. FamilyStrong is a brief and easy-to-use program that helps family caregivers recognize and manage distress while connecting them to the right support. Unlike many caregiver support programs that require extensive time and highly trained specialists, FamilyStrong is led by lay navigators, who are trained individuals who can guide caregivers through challenges and connect them with appropriate resources. The program uses a simple distress screening tool to quickly assess how caregivers are coping and then tailors support to their specific needs. We will test FamilyStrong in a small pilot study with 60 caregivers of patients newly diagnosed with advanced cancer. Over a period of 24 weeks, we will evaluate how well the program works, whether caregivers find it helpful, and whether it improves caregiver and patient well-being compared to usual care. Specifically, we will measure whether caregivers experience lower stress, improved quality of life, and fewer unmet needs when they participate in the FamilyStrong program. After this study, we will use these results and our experiences to inform a larger clinical trial to confirm FamilyStrong's benefits and eventually expand the program nationwide. By providing caregivers with practical, effective support, FamilyStrong has the potential to improve the quality of life for both caregivers and cancer patients, ensuring that families facing cancer receive the help they need when they need it most.",[199,200,28],"Family Caregivers","Distress in Caregivers of Cancer Patients",[202,203,204,205,206,207,208,209,210],"family caregiver","cancer caregiving","caregiver support","distress screening","lay navigation","supportive care","psychosocial support","telehealth","unmet supportive care needs","NOT_YET_RECRUITING","2026-08-06",{"date":214,"type":35},"2026-08-13",{"date":216,"type":21},"2027-01-01",{"date":218,"type":21},"2028-09-30",{"name":220,"class":66},"University of Alabama at Birmingham",{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":237,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":249},"100602773","phase-1-a-study-of-phn-012-in-patients-with-advanced-solid-tumors-100602773","NCT07127874","A Study of PHN-012 in Patients With Advanced Solid Tumors","First-in-Human, Phase 1 Study of PHN-012, an Antibody Drug Conjugate, in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Has histologically confirmed, advanced\u002Fmetastatic:\n\n  1. Colorectal adenocarcinoma (CRC), or\n  2. Non-small cell lung cancer (NSCLC), or\n  3. Pancreatic ductal adenocarcinoma (PDAC).\n* Has received at least one prior systemic therapy and radiologically or clinically determined progressive disease during or after the most recent line of therapy, and for whom no further standard therapy is available or who is intolerant to standard therapy.\n* Has measurable disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Has adequate organ function.\n* Has available tumor tissue sample at screening (either an archival specimen or fresh biopsy material).\n\nExclusion Criteria:\n\n* Had prior treatment with any ADC containing topoisomerase-1 inhibiting payload.\n* Has unstable central nervous system metastasis.\n* Has persistent toxicities from previous systemic anti-cancer treatments of Grade \\>1.\n* Has received systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the study drug.\n* Has received wide-field radiotherapy (\\> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of the study drug, or no recovery from side effects of such intervention.\n* Had major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to first dose of the study drug, or no recovery from side effects of such intervention.\n* Has a history of non-infectious pneumonitis (NIP) \u002F interstitial lung disease (ILD) requiring systemic steroids within 6 months prior to first dose of the study drug, active NIP \u002F ILD or suspected NIP \u002F ILD which cannot be ruled out by imaging for Screening.",{"count":229,"type":21},165,[24],"This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-012, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.",[233,234,235,28,236],"Colon Cancer","Pancreatic Cancer","Lung Cancer (NSCLC)","Advanced Solid Tumors",[238,239,240,56],"Antibody Drug Conjugate","Carcinoma","Cancer","2026-08-05",{"date":212,"type":35},{"date":244,"type":35},"2025-09-23",{"date":246,"type":21},"2028-05",{"name":248,"class":42},"Pheon Therapeutics",26,{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":17,"minAge":258,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":261,"phases":4,"briefSummary":262,"conditions":263,"keywords":266,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100582999","practical-geriatric-assessment-pga-implementation-strategies-and-correlative-evaluations-pace-70-100582999","NCT06870617","Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations (PACE-70)","Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations for Older Adults With Cancer (PACE-70): A Hybrid Implementation-effectiveness Study","PACE-70","For PGA Implementation Cohort, patients must meet the following criteria:\n\n1. Age greater than or equal to 70 years.\n2. Diagnosis of advanced or metastatic solid malignancy\n3. Initiating a new line of palliative-intent systemic therapy with a prevalence of grade 3 toxicity exceeding 50%.\n\nFor Correlative Analysis Cohort, patients must additionally meet the following criteria:\n\n1. Must read and speak English and be able to fill out surveys\n2. Ability to walk independently or with the use of an assistive device (e.g., walker, cane)\n3. Consents to participate in correlative analysis cohort with Fitbit monitoring, body composition analysis, and self-report surveys\n4. Have a smartphone able to operate with the Fitbit\n\nFor PGA Implementation Cohort, there are no specific exclusion criteria other than not meeting inclusion criteria.\n\nFor Correlative Analysis Cohort, patients will be excluded if meeting any of the following criteria:\n\n1. Unable to effectively read and speak English\n2. Reliance on a wheelchair, ECOG of 3 or above, clinically bedbound, or unable to walk without assistance every day for the past 7 days (ECOG 3 is confined to bed or chair for more than 50% of waking hours)\n3. Concurrent enrollment in a therapeutic clinical trial (as clinical trials often have a substantial symptom-reporting structure). Non-therapeutic clinical trial enrollment is permitted\n4. Lack of clinician consent to approach patient","70 Years",{"count":260,"type":21},150,"OBSERVATIONAL","The use of a geriatric assessment to inform oncologic care for older persons with cancer is an evidence-based practice that improves patient-clinician communication, reduces treatment-related toxicity, and is recommended by national guidelines. However, the implementation of a geriatric assessment can be time-consuming and burdensome, leading to suboptimal use in clinical practice. Developed and endorsed by the American Society for Clinical Oncology (ASCO), the Practical Geriatric Assessment (PGA) is designed to improve clinical usability and adoption, but its implementation in real-world settings has not been evaluated. The PACE-70 study aims to evaluate PGA implementation and resultant chemotherapy dose modification among older adults with advanced cancer treated in a community setting. An exploratory aim will evaluate how the PGA, body composition (via abdominal computed tomography scan) and step count monitoring (via FitBit) correlate with chemotherapy toxicity and other clinical outcomes.",[264,28,265],"Geriatric Assessment","Toxicity",[256,267,268,269,270],"Practical geriatric assessment","body composition in cancer","step count in cancer","Start low go slow","2026-08-04",{"date":212,"type":35},{"date":274,"type":35},"2025-07-01",{"date":276,"type":21},"2026-10-01",{"name":278,"class":66},"Abramson Cancer Center at Penn Medicine",3,{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":22,"phases":289,"briefSummary":290,"conditions":291,"keywords":295,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":301,"locationsCount":67},"100516225","phase-2-psilocybin-in-cancer-pain-study-100516225","NCT06001749","Psilocybin in Cancer Pain Study","Feasibility Phase 2 Study of Psilocybin-Assisted Therapy for Opioid-Refractory Pain in Patients With Advanced Cancer","Inclusion Criteria:\n\n* Participants must be 18 year old or older;\n* Participants must have advanced cancer, defined as a cancer that is unlikely to be cured or controlled with treatment;\n* Participants must have progressed on or be intolerant to approved therapies with a known clinical benefit (unless it is documented that they have refused such treatments);\n* Participants must evaluate their average pain on BPI Severity Scale ≥ 4\u002F10 over the past week;\n* Participants must receive chronic opioid pharmacotherapy for pain with an Oral Morphine Equivalent (OME) ≥ 200mg\u002Fday;\n* Participants must have been seen by a palliative care clinician either at DFCI, MGH or associated satellites in the last three months;\n* Participants must have an ECOG Performance Status ≤ 2\n* Participants must meet the following organ and marrow function on their last available bloodwork as defined below:\n\n  * Platelets ≥ 50,000\u002FmcL\n  * AST(SGOT)\u002FALT(SGPT) ≤ 5 × institutional ULN\n* Participants must be able to understand and willing to sign a written informed consent document\n* Participants must be able to swallow pills.\n* Participants must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.\n* Participants must agree to inform the investigators within 48 hours of any new medical conditions and procedures.\n* Participants must agree to the following lifestyle modifications (described in more detail in Section 3.4 Lifestyle Modifications):\n\n  * Comply with requirements for diet,\n  * Refrain from certain medications prior to Experimental Sessions,\n  * Be driven home after each Experimental Session,\n  * Commit to medication dosing, therapy, and study procedures.\n\nExclusion Criteria:\n\n* Participants who receive concurrent (less than four weeks or planned within 6 weeks) cytotoxic chemotherapy or radiation therapy that may impair general level of physical functioning or affect study outcomes;\n* Participants with a condition impairing oral intake or digestive absorption;\n* Participants who are not able to give adequate informed consent;\n* Participants who have a significant suicide risk as defined by suicidal ideation with intent and with or without a plan as endorsed on items 4 and\u002For 5 on the C-SSRS within the past 6 months or at V0\n* Participants who have a history of, or a current diagnostic of primary psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1 or history of or current dissociative identity disorder; and participants who have an ongoing substance use disorder (defined as active in the past year). Participants with first-degree relatives with schizophrenia or bipolar disorder may be eligible depending on their age and personal and family psychiatric history. The decision will be made by the principal investigator and study psychiatrist based on risk assessment.\n* Participants for whom there is a potential for adverse drug-drug interactions. Concomitant medications with significant potential to interact with study medications will be exclusionary if they cannot be tapered. These include the following:\n\n  * Serotoninergic antidepressants\n  * Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs)\n  * Tricyclic Antidepressants (TCAs)\n  * Efavirenz\n  * serotonin-acting dietary supplements (i.e. 5-hydroxy-tryptophan or St. John's wort)\n  * Centrally-acting serotonergic agents (e.g. MAO inhibitors)\n  * Antipsychotics (e.g. first and second generation)\n  * Mood stabilizers (e.g. lithium, valproic acid)\n  * Aldehyde dehydrogenase inhibitors (e.g. disulfiram)\n  * Significant inhibitors of UGT 1A0 or UGT 1A10 Any psychiatric medication will be tapered if possible in an appropriate fashion to avoid withdrawal effects. They will be discontinued long enough before the psilocybin Session to avoid the possibility of any drug-drug interaction (the interval will be at least five times the particular drug and active metabolites' half-life + one week for stabilization). See section 5.3 of the protocol for concomitant medications and tapering instructions.\n* Participants who have evidence or history of significant (controlled or uncontrolled) hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of psilocybin administration (participants with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).\n* Participants with brain tumors or brain metastases that haven't been successfully treated\n* Participants with lab abnormalities that may contribute to somnolence, confusion or delayed metabolism of psilocybin and\u002For with severe lab abnormalities (grade 3 or more per CTCAE scale).\n* Participants with a diagnosis of cirrhosis or liver failure\n* Participants who have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140\u002F90 milligrams of Mercury \\[mmHg\\] or higher assessed on three separate occasions)\n* Participants who have a heart rate \\> 100 bpm on three separate occasions\n* Participants who have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.\n* Participants who have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.\n* Participants who have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening. Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled if they have been successfully treated.\n* Participants who have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)\n* Participants who have a history of myocardial infarction, coronary artery disease or heart failure\n* Participants who have a marked Baseline prolongation of QT\u002FQTc interval. For purposes of eligibility, this is defined as repeated demonstration of a QT interval corrected on the triplicate ECGs performed at screening, using Fridericia's formula \\[QTcF\\] \\> 450 milliseconds \\[ms\\] in males and \\> 460 ms in females.\n* For transgender or non binary participants, QTc interval will be evaluated based on sex assigned at birth, unless the participant has been on hormonal treatment for five or more years.\n* Women who are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control. Acceptable methods of contraception are the following: intrauterine device, injected\u002F implanted\u002F intravaginal\u002F transdermal hormonal method, oral hormones plus a barrier contraception, abstinence, vasectomized sole partner, or double barrier contraception.\n* Participants who have hypersensitivity to any ingredient of the IMP (Investigational Medicinal Product).",{"count":288,"type":21},15,[139],"The overall objective of this study is to assess the feasibility, safety and preliminary efficacy of psilocybin-assisted therapy to alleviate opioid-refractory pain in patients with advanced-cancer.\n\nThe name of the study intervention used in this research study is:\n\nPsilocybin (a tryptamine derivative)",[292,293,294,28,30],"Opioid-Related Disorders","Pain Management","Pain Management and Care",[292,293,294,28,30],"2026-08-03",{"date":241,"type":35},{"date":299,"type":35},"2024-09-23",{"date":148,"type":21},{"name":302,"class":66},"Yvan Beaussant, MD, MSci",{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":319,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":330,"leadSponsor":332,"locationsCount":334},"100649602","primary-palliative-care---a-feasibility-cluster-trial-100649602","NCT07737899","Primary Palliative Care - a Feasibility Cluster Trial","PrimPal","Inclusion Criteria:\n\n* Aged 18 years or older.\n* Enrolled as a patient on the list of a recruited General Practitioner in one of the participating Family Health Units.\n* Diagnosed with one or more of the following advanced chronic conditions:\n* Advanced-stage neoplasm (metastatic\u002Fstage IV cancer);\n* Chronic Obstructive Pulmonary Disease (COPD) - GOLD classification III or IV;\n* Congestive Heart Failure (CHF) - New York Heart Association (NYHA) functional classification III or IV;\n* Chronic Kidney Disease (CKD) - stage IV or V.\n\nExclusion Criteria:\n\n* Refusal to provide informed consent or to participate in the study at any point.\n* Disease severity requiring urgent medical intervention (acute crisis\u002Femergency care need at time of recruitment).",{"count":137,"type":21},[77],"This feasibility cluster-controlled randomized trial (RCT) evaluates a complex intervention for the delivery of primary palliative care in Family Health Units (FHUs). The intervention consists of training General Practitioners (GPs) in palliative care through a 30 hour e-learning program and implementing a structured consultation model (4 consultations over 12 weeks) for adult patients with advanced chronic illness. One FHU will receive the intervention and one FHU will follow usual care. The primary goal is to assess feasibility metrics (GP adherence, patient recruitment rate, and patient retention rate), which will inform the design of a subsequent full-scale cluster RCT.",[314,315,28,316,317,318],"Palliative Care","Primary Palliative Care","Chronic Obstructive Pulmonary Disease (COPD)","Congestive Heart Failure Chronic","Chronic Kidney Disease (Stages 4 and 5)",[320,315,321,322,323,324,325,326],"Palliative care","General practice","Family medicine","Feasibility study","Cluster randomized controlled trial","Complex intervention","Chronic disease","2026-07-31",{"date":296,"type":35},{"date":276,"type":21},{"date":331,"type":21},"2027-08-31",{"name":333,"class":66},"University of Coimbra",2,{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":22,"phases":345,"briefSummary":346,"conditions":347,"keywords":348,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":67},"100643024","simulation-free-celiac-plexus-pain-ablation-using-stereotactic-body-radiotherapy-in-patients-with-cancer-related-celiac-pain-100643024","NCT07636382","Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain","A Prospective Pilot Clinical Trial of Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain","Celiac SRS","Inclusion Criteria:\n\n* Subjects must have histologically or cytologically confirmed cancer that is metastatic or unresectable, and considered appropriate per the treating physician to receive celiac plexus SBRT.\n* Age \\>18 years. Because no data are currently available on the use of celiac axis SBRT in subjects ≤18 years of age, children are excluded from this study.\n* Performance status: ECOG Performance status ≤ 3\n* Severe retroperitoneal pain syndrome (radiates from the lower back to the upper abdomen, belt- like distribution), intensity of at least 5 on 11-point Brief Pain Inventory (BPI, average pain) scale.\n* Subjects must have anatomical involvement of the celiac plexus on the diagnostic CT, PET\u002FCT, or MRI. This includes: Any pancreatic cancer, any other cancer that on imaging demonstrates either gross involvement of the celiac blood vessels or celiac plexus on imaging OR haziness around the celiac blood vessels that typically implies tumor engulfment.\n* Prior chemotherapy or biological treatment is allowed, but any active oncological treatment should be stopped at least 1 week prior to radiation therapy and renewed at least 1 week following radiation therapy.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n* Subjects must have a diagnostic CT of the abdomen and pelvis, with or without contrast, acquired \\\u003C 28 days prior to the study consent.\n\nExclusion Criteria:\n\n* In ability to tolerate lying supine and still for at least 45 minutes.\n* Performance status: ECOG Performance status of 4.\n* Previous radiotherapy to the upper abdomen overlapping with the projected site of treatment.\n* Pregnant or breastfeeding women are excluded from this study.\n* Subjects with conditions associated with increased risk of side effects from radiation such as inflammatory bowel disease and scleroderma.\n* Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol principal investigator, documentation of this exception is sufficient in lieu of a pregnancy test.",{"count":344,"type":21},5,[77],"This is a prospective, single-arm, pilot feasibility clinical trial designed to evaluate the feasibility and safety of a simulation-free adaptive radiotherapy workflow to enable single-session celiac plexus SBRT planning and delivery. In this trial, the treatment itself is non-investigational (standard-of-care celiac plexus SBRT) but the treatment workflow (simulation-free, using adaptive radiotherapy to compress treatment planning and delivery into a single session) is novel. Investigators hypothesize the successful completion of the simulation-free ART workflow through treatment delivery in the first on-table treatment attempt for at least 80% of patients.",[28,234],[349,350,234],"SBRT","Celiac","2026-07-29",{"date":353,"type":35},"2026-07-30",{"date":355,"type":35},"2026-06-04",{"date":357,"type":21},"2027-06-01",{"name":359,"class":66},"University Health Network, Toronto",{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":22,"phases":369,"briefSummary":370,"conditions":371,"keywords":377,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":386},"100412938","phase-1-a-study-of-art0380-for-the-treatment-of-advanced-or-metastatic-solid-tumors-100412938","NCT04657068","A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors","A Phase I\u002FIIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors","General Inclusion Criteria:\n\n* Signed informed consent\n* Discontinued all previous treatments for cancer for at least 21 days or 5 half-lives, whichever is shorter, and recovered from the acute effects of therapy to CTCAE Grade ≤1. Palliative radiotherapy must have completed 1 week prior to start of study treatment.\n* If patients have a known germline BRCA mutation or a cancer with a somatic BRCA mutations or which is HRD positive and for which there is an approved PARP inhibitor, participants should have received such treatment before participating in the study unless contra-indicated\n* At least 1 radiologically evaluable lesion (measurable and\u002For non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation by RECIST v1.1 or Prostate Cancer Working Group-3 Guidelines (PCWG-3)\n* Acceptable hematologic, renal, hepatic, and coagulation functions independent of transfusions and granulocyte colony-stimulating factor\n* Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis.\n* Female patients of childbearing potential and male patients with female partners of childbearing potential are required to use highly effective contraception plus one barrier method during their participation in the study and for 7 months and 5 months respectively following the last dose. For male and female patients given gemcitabine or irinotecan, highly effective contraception plus one barrier method must be used from study entry until 6 months after the last dose of study treatment. Male patients are required to refrain from donating sperm and female patients are required to refrain from donating eggs, during their participation in the study and for 6 months following last dose.\n* Estimated life expectancy of ≥12 weeks\n* Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n* Performance status of 0-1 on the ECOG Scale\n\nAdditional inclusion criteria for participants in dose escalation (Part A1):\n\n* Advanced or metastatic cancer which is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study\n* Performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale\n\nAdditional inclusion criteria for participants in dose escalation (Part A2):\n\n•Advanced or metastatic cancer for which gemcitabine is an appropriate treatment. Prior treatment with gemcitabine is permitted.\n\nAdditional inclusion criteria for participants in dose escalation (Part A3):\n\n* Advanced or metastatic cancer for which irinotecan is an appropriate treatment. Prior treatment with irinotecan is permitted.\n* For food effect cohort only: Patients must be able to eat a high-fat meal within a 30 minute period, as provided by the study site.\n\nAdditional inclusion criteria for participants in dose expansion (Part B1):\n\n* Patients with advanced or metastatic solid tumors with alterations to the ATM gene likely to predict for loss of ATM protein\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1\n* For France only ART0380 Monotherapy; Patient that is not eligible for curative treatment, for whom all standard of care therapies have failed and no therapies known to provide clinical benefit are available.\n* Combination arms; Patients for which irinotecan is an appropriate treatment. Prior treatment with irinotecan is permitted.\n* For Spain only ART0380 Combination therapy, Patient that is not eligible for curative treatment, for whom standard of care therapies have failed.\n\nAdditional inclusion criteria for participants in dose expansion (Part B2):\n\n* Patients with a known germline BRCA mutation, or a cancer with a known somatic BRCA mutation, or which is known to be HRD positive, and for which there is an approved PARP inhibitor should have received such treatment before participating in the study, unless contra-indicated.\n* Females with histologically-confirmed diagnosis of high grade serous carcinoma of the ovary, fallopian tube or primary peritoneum that is not amenable to curative therapy\n* Platinum-resistant disease. Patients must not have had primary platinum-refractory disease (disease that progressed during first-line platinum-based therapy).\n* No more than one prior regimen in the platinum-resistant setting. Hormonal therapies and antiangiogenic therapies (as single agents) and PARP inhibitors used as maintenance therapy are not considered as separate lines of therapy. Patients should have previously received bevacizumab and chemotherapy unless contra-indicated.\n* Have not received prior treatment with gemcitabine unless administered in combination with a platinum with no disease progression within 12 months after completion of that regimen\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1\n\nInclusion criteria specific to Part B3\n\n* Persistent or recurrent endometrial cancer with biological selection.:\n* Patients should have received taxane\u002Fplatinum chemotherapy, unless contraindicated.\n* Measurable disease.\n\nInclusion criteria specific to Part B4\n\n* Advanced or metastatic solid cancers of any histology with biological selection\n* If a PD-1\u002FPDL-1 inhibitor (eg, pembrolizumab) is approved and available for the patient's cancer, the patient should have received such treatment before participating in this study.\n* Radiologically evaluable disease\n* Performance status of 0-1 on the ECOG scale\n\nInclusion criteria specific to Part B5\n\n* Metastatic CRC with alterations to the ATM gene\n* Participants should have previously received appropriate prior lines of therapy in this setting.\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1.\n* Patients have received a maximum of 2 prior chemotherapy regimens for the treatment of CRC.\n* Serum albumin ≥3g\u002FdL within 7 days prior to first dose.\n* ECOG Performance Status must be stable for at least 2 weeks prior to enrollment.\n* Must have the clinical capacity to complete at least one 21-day treatment cycle without, in the investigator's judgment, a foreseeable need for prolonged hospitalization related to their underlying disease\n\nInclusion criteria specific to Part B6:\n\n* Metastatic or locally advanced PDAC or acinar cell carcinoma with alterations to the ATM gene\n* Participants must have received at least 1 prior chemotherapy regimen for the treatment of the advanced disease OR have received neoadjuvant\u002Fadjuvant therapy with recurring occurring \\\u003C6 months following completion of this treatment.\n* Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1. Previously irradiated lesions may not be considered target lesions.\n* Serum albumin ≥3g\u002FdL within 7 days prior to first dose.\n* ECOG Performance Status must be stable for at least 2 weeks prior to enrollment.\n* Must have the clinical capacity to complete at least one 21-day treatment cycle without, in the investigator's judgment, a foreseeable need for prolonged hospitalization related to their underlying disease.\n\nGeneral Exclusion Criteria:\n\n* Women who are pregnant, breast feeding, or who plan to become pregnant while in the study or within 7 months after the last administration of study treatment\n* Men who plan to father a child while in the study or within5 months after the last administration of study treatment\n* Serious concomitant systemic disorder that would compromise the participants ability to adhere to the protocol including: one or more opportunistic HIV\u002FAIDs-related infections within the past 12 months, a known hepatitis B virus, or known hepatitis C virus; documented active or chronic tuberculosis infection; malignancy prior to the one currently being treated that is not in remission\n* Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).\n* Moderate or severe cardiovascular disease\n* Valvulopathy that is severe, moderate, or deemed clinically significant\n* Documented major electrocardiogram (ECG) abnormalities which are clinically significant\n* Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment\n* Received a live vaccine within 30 days before the first dose of study treatment\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate\n* Recent major surgery within 4 weeks prior to entry into the study or minor surgery within 1 week of entry into the study\n* Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks before the first dose of study treatment.\n* A significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment\n* Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study\n\nAdditional exclusion criteria for participants in dose escalation (Part A3, B1, B5, and B6 in combination with irinotecan):\n\n* Patients who have symptoms or signs of clinically unacceptable deterioration of the primary disease at the time of screening.\n* Patients who are known to be homozygous for both UGT1A1 \\*6 and \\*28 (UGT1A1 7\u002F7 genotype), or simultaneously heterozygous for both UGT1A1 \\*6 and \\*28.\n* Patients receiving strong inhibitors of UGT1A1 within 2 weeks before the first dose of study treatment\n* Part A3 Fed-fasted cohort only: Patients receiving acid reducing agents within 1 week before the first dose of study treatment will be excluded\n* Part B6: Neuroendocrine (carcinoid, islet cell) or adenosquamous carcinoma pancreatic cancer\n* Parts B5 and B6: Initiation of opioids in the previous 2 weeks.\n* Parts B5 and B6: Weight loss \\>10% in the previous 8 weeks.\n* Parts B5 and B6: Active intestinal obstruction, ileus, or significant malabsorption.",{"count":368,"type":21},542,[24,139],"This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to:\n\n* Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan\n* Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan\n* Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan",[28,99,117,372,373,105,374,375,376],"Primary Peritoneal Cancer","Fallopian Tube Cancer","Metastatic Colorectal Cancer","Pancreatic Ductal Adenocarcinoma","Acinar Cell Carcinoma",[378],"Loss of Ataxia Telangiectasia Mutated (ATM) protein",{"date":353,"type":35},{"date":381,"type":35},"2021-01-27",{"date":383,"type":21},"2028-06",{"name":385,"class":42},"Artios Pharma Ltd",82,{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":22,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":67},"100490252","phase-1-phase-1b2-study-of-combination-177lu-girentuximab-plus-cabozantinib-and-nivolumab-in-treatment-nave-patients-with-advanced-clear-cell-rcc-100490252","NCT05663710","Phase 1b\u002F2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC","Inclusion Criteria:\n\n1. Has the ability to understand and willingness to sign a written ICF before the performance of any study-specific procedures on this protocol and 2022-0515\n2. Age ≥ 18 years\n3. Has locally advanced or metastatic RCC with predominantly clear cell subtype\n4. Has at least one measurable lesion as defined by RECIST version 1.1\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1\n6. Has adequate organ function defined as follows:\n\n   a. Absolute neutrophil count ≥ 1,500\u002FµL, Hgb level ≥ 9 g\u002FdL and platelet count (Plt) i. ≥ 100,000\u002FµL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening; b. Creatinine clearance ≥ 40 mL\u002Fmin\u002F1.73m2 c. Transaminase levels (AST\u002FALT) ≤ 3.0 × upper limit of normal (ULN); total bilirubin i. (TBILI) ≤ 1.5 mg\u002FdL in the absence of Gilbert's disease\n7. Women of child beariring potential must have a negative serum preganancy test within 7 days before first study drug administration\n8. Female patients of child bearing potential, or a male patients with a female partner of child-bearing potential (defined as all women physiologically capable of becoming pregnant), must agree to use a highly effective method of contraception during screening, during the period of drug administration and for 120 days after stopping study drug administration. Highly effective contraception methods include the following:\n\n   1. Total abstinence (defined as refraining from heterosexual intercourse during the entire period outlined above),\n   2. Male or female sterilization, or\n\n   Use of at least one of the following:\n\n   Use of oral, injectable, transdermal, intravaginal, or implantable hormonal methods of contraception i. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation ii. Progestogen-only hormonal contraception associated with inhibition of ovulation c. Placement of an intrauterine device or intrauterine system\n9. Able to swallow oral medications\n10. Able to provide tumor tissue sample (archival or recent acquisition)\n11. Patients with brain metastases are eligible providing other measurable disease exists and brain lesions are controlled for one month (requiring no therapy) and are not life threatening.\n\nExclusion Criteria:\n\n1. Has received treatment with any frontline systemic therapy for metastatic RCC\n2. Has a history of leptomeningeal disease or spinal cord compression\n3. Has a history of autoimmune disease requiring active therapy\n4. Has a history of brain metastases except:\n\n   1. Patients may be enrolled if they have treated brain metastases with no evidence of progression or hemorrhage after therapy for brain metastases (e.g. radiation therapy, surgery, radiosurgery) AND\n   2. Patients may be enrolled if they do not require ongoing treatment with dexamethasone or anti-epileptic drugs\n5. Has had radiation therapy for bone metastases within 2 weeks, or any other external radiation therapy (5 days or longer) to sites other than bone, within 4 weeks before administration of the first dose of study treatment. Patients with clinically relevant ongoing major complications from prior radiation therapy are not eligible.\n6. Has uncontrolled or poorly controlled hypertension, as defined by a sustained blood pressure (BP) \\> 140\u002F90 with or without antihypertensive treatment\n7. Has had any major cardiovascular event within 6 months prior to study drug administration including but not limited to myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, clinically significant ventricular arrhythmias (e.g. sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or New York Heart Association Class III or IV heart failure\n8. Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor\n9. Has an active infection requiring systemic treatment\n10. Is participating in another therapeutic clinical trial\n11. Is receiving chronic concomitant treatment with strong CYP3A4 inducers or CYP3A4 inhibitors\n12. Has manifestations of malabsorption due to prior gastrointestinal (GI) surgery or GI disease\n13. Has GI disorders including those associated with a high risk of perforation or fistula formation:\n\n    1. Tumors invading the GI-tract, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction\n    2. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before administration of the first dose of study treatment. Note: complete healing of an intra-abdominal abscess must be confirmed before administration of the first dose of study treatment\n14. Has tumor invading or encasing any major blood vessels\n15. Has other clinically significant disorders such as:\n\n    1. Serious non-healing wound\u002Fulcer\u002Fbone fracture\n    2. Moderate to severe hepatic impairment (Child-Pugh B or C).\n    3. Requirement for hemodialysis or peritoneal dialysis\n    4. History of solid organ transplantation\n16. Has had major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 2 months before the first study drug administration. Complete wound healing from major surgery must have occurred 1 month before the first study drug administration and from minor surgery (e.g., simple excision, tooth extraction) at least 10 days before the first study drug administration. Patients with clinically relevant ongoing complications from prior surgery are not eligible\n17. Has a prior or concomitant invasive malignancy other than RCC with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or any other malignancy from which the patient has remained disease free for more than 2 years.",{"count":394,"type":21},100,[24,139],"To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).",[28,113],"2026-07-28",{"date":353,"type":35},{"date":401,"type":35},"2023-06-30",{"date":403,"type":21},"2027-10-30",{"name":65,"class":66},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":17,"minAge":412,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":67},"100593112","phase-1-personalized-neoantigen-peptide-vaccines-for-solid-tumors-100593112","NCT07002203","Personalized Neoantigen Peptide Vaccines for Solid Tumors","A Phase Ib Clinical Study of Personalized Neoantigen Peptide Vaccines for Solid Tumors","Inclusion Criteria:\n\n1. Age: 20 years or older.\n2. Language proficiency: Able to read and understand Thai clearly.\n3. Consent: Willing to provide informed consent and sign a participation agreement.\n4. Life expectancy: Estimated to be at least 6 months from the date of consent.\n5. Eligibility from prior research: Must have participated in the SQK01-002A research project and have tumor tissue confirmed as suitable for neoantigen peptide vaccine production.\n6. Performance status: ECOG performance status of 0-2 with stable organ function, no rapid disease progression, or impending organ failure.\n7. Cancer diagnosis: Clinically and pathologically confirmed cancer diagnosis, with supporting radiological evidence.\n8. Cancer stage-specific criteria:\n\n   i. Advanced cancer: Suitable for immune checkpoint inhibitors (ICIs) and shows resistance to prior therapies, with measurable lesions based on mRECIST1.1 criteria.\n\n   ii. Early-stage cancer: High recurrence risk despite prior surgery and\u002For radiotherapy, with no current adjuvant treatment standard.\n9. Laboratory parameters:\n\n   i. Lymphocyte count ≥ 800 cells\u002FμL. ii. Neutrophil count ≥ 1,500 cells\u002FμL. iii. Platelet count ≥ 75,000 cells\u002FμL. iv. AST ≤ 2.5 times the upper limit of normal (ULN). v. ALT ≤ 2.5 times ULN. vi. Total bilirubin ≤ 1.5 times ULN. vii. Serum creatinine ≤ 1.5 times ULN.\n10. Consent to Avoid Pregnancy or Causing Pregnancy Under the Following Criteria i. Female participants not of reproductive age, defined as having undergone a hysterectomy and\u002For bilateral oophorectomy, experiencing continuous menopause for more than 12 months, or being over 60 years of age.\n\nii. Female participants of reproductive age must undergo a pregnancy test and have a confirmed negative result during the preparation phase and before the first day of vaccination. They must also consent to using contraception with an efficacy rate greater than 99%, as recommended by the principal investigator, throughout the study duration, including the preparation phase and follow-up, and up to 120 days after the final treatment.\n\niii. Male participants must consent to using contraception with an efficacy rate greater than 99%, as recommended by the principal investigator, throughout the study duration, including the preparation phase and up to 120 days after the final treatment.\n\nExclusion Criteria:\n\n1. History of hypersensitivity to peptide vaccines or related substances.\n2. Autoimmune disease history.\n3. Previous treatments that significantly suppress or impair immune function.\n4. Refusal of current standard-of-care treatment.\n5. Active brain or central nervous system metastases unless well-controlled with steroids ≤ 10 mg\u002Fday prednisolone.\n6. Presence of more than one active cancer type.\n7. Uncontrolled cardiac conditions, such as unstable angina or advanced heart failure (NYHA Class III\u002FIV).\n\n   i. Participants with pacemakers may be eligible if stabilized for at least 1 month before vaccination.\n8. Receipt of any other vaccines within 28 days before the first neoantigen peptide vaccine.\n9. Participation in another clinical trial.\n10. Use of immunosuppressive drugs or steroids \\> 10 mg\u002Fday prednisolone (except inhaled\u002Fintranasal corticosteroids).\n11. Pre-existing conditions that could compromise the efficacy or safety of the peptide vaccine.\n12. Pregnancy or breastfeeding.","20 Years",{"count":414,"type":21},10,[24,139],"This clinical trial is studying the safety and efficacy of a personalized cancer vaccine called a neoantigen peptide vaccine in patients with solid tumors. These vaccines are custom-made for each patient using specific mutations (neoantigens) found in their own tumor. The goal is to help the patient's immune system recognize and attack their cancer.\n\nThe study will enroll adult patients (20 years or older) who have solid tumors that meet specific stage-related criteria. These include advanced cancers that are resistant to prior treatments and early-stage cancers at high risk of recurrence, where there are no standard adjuvant therapies available.\n\nParticipants will receive:\n\n* A personalized neoantigen peptide vaccine designed from the mutations in their tumor tissue.\n* Poly-ICLC (Hiltonol), a substance that stimulates the immune system.\n* An anti-PD-1 immune checkpoint inhibitor, a drug that helps the immune system stay active against cancer.\n\nThe vaccine and drugs will be given through multiple injections over several months. Blood samples and imaging will be used to monitor the immune response and how the cancer responds to treatment. Participants will be followed for up to 12 months.\n\nThis study does not include a placebo group. Every participant will receive the personalized vaccine along with the other therapies.\n\nThe primary objectives of this study are:\n\n1. To assess whether the treatment is safe and tolerable.\n2. To evaluate whether this approach helps control the cancer and can be combined with other standard treatments in the future.",[418,28,419,420,421],"Solid Tumors","Recurrent Cancer","Neoantigen-Specific Immunotherapy","Personalized Cancer Vaccine","2026-07-23",{"date":424,"type":35},"2026-07-24",{"date":426,"type":35},"2024-03-01",{"date":428,"type":21},"2027-08",{"name":430,"class":42},"Seqker Biosciences, Inc.",{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":17,"minAge":438,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":443,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":414},"100575356","phase-1-slv-154-treatment-of-advanced-cancers-100575356","NCT06771219","SLV-154 Treatment of Advanced Cancers","A Phase 1 Dose-Escalation\u002FExpansion Study of SLV-154 in Subjects With Advanced Cancers","Inclusion Criteria:\n\n1. Men or women (as appropriate for cancer type) of age ≥12 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n3. Histologically or cytologically confirmed diagnosis of advanced cancer as documented in medical records.\n4. Presence of metastatic or recurrent locally advanced cancer.\n5. Presence of radiographically measurable disease.\n6. Prior receipt of one or more commercially available therapies that are indicated within product labelling or recommended under current guidelines as appropriate treatment for the subject's cancer (unless evolving data support application of SLV-154 in previously untreated subjects with high unmet medical need and inadequate and\u002For poorly tolerated treatment options).\n7. Availability of tumor tissue from a fresh tumor biopsy obtained by a core needle, excisional, or incisional biopsy; or punch biopsy (for cutaneous disease); or archival tumor sample from a previous biopsy.\n8. Availability of computed tomography (CT) or magnetic resonance imaging (MRI) of chest, abdomen, and pelvis, and\u002For fluorodeoxyglucose (FDG) positron emission tomography (PET)\u002FCT (if appropriate for tumor type) (with PET from base of the skull to mid-thigh, if performed) within 35 days before study drug administration.\n9. Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week before the start of study drug administration.\n10. Adequate hematological profile.\n11. Adequate coagulation profile.\n12. Adequate hepatic profile.\n13. Adequate renal function.\n14. Negative viral serology or adequate therapy for human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection.\n15. For female subjects of childbearing potential, a negative serum pregnancy test.\n16. For female subjects of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of the screening period until ≥6 months after the final dose of study therapy.\n17. For male subjects who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use a protocol-recommended method of contraception from the start of study therapy until ≥6 months after the final dose of study therapy and to refrain from sperm donation from the start of study therapy until ≥12 months after administration of the final dose of study therapy.\n18. Willingness and ability of the subject to comply with scheduled visits, the drug administration plan, protocol-specified laboratory tests, other study procedures (including required tumor biopsy\u002Faspirations and\u002For radiographic studies), and study restrictions.\n19. Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\n1. Unstable malignancy involving the central nervous system.\n2. Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.\n3. Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of start of study therapy.\n4. Significant cardiovascular event or comorbidity.\n5. Significant screening ECG abnormalities.\n6. Pregnancy or breastfeeding.\n7. Major surgery within 3 weeks before the start of study therapy.\n8. Use of a strong inhibitor or inducer of CYP3A4 or CYP1A2.\n9. Concurrent participation in another therapeutic or imaging clinical trial.\n10. Other conditions likely to interfere with a subject's ability to participate in the study.","12 Years",{"count":94,"type":21},[24],"This is a Phase 1 study comprising a Phase 1a dose-escalation portion and a Phase 1b expansion portion evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with advanced solid tumors.",[28,98,99],[444,445,446],"metastatic solid tumors","metastatic cancer","solid tumor","2026-07-22",{"date":424,"type":35},{"date":450,"type":35},"2025-05-14",{"date":452,"type":21},"2027-11",{"name":454,"class":42},"Solve Therapeutics",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":462,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":22,"phases":465,"briefSummary":466,"conditions":467,"keywords":469,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":67},"100525128","integrated-smartphone-technology-to-alleviate-malignant-pain-i-stamp-testing-100525128","NCT06117709","Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP) Testing","Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP): Development, Usability, and Acceptability Testing","Inclusion Criteria for Participants (Activities 1a, 2a, 3a):\n\n* Age ≥ 21 years\n* Current or previous diagnosis of advanced cancer\n* Current or previous experience with cancer pain\n\nExclusion Criteria for Participants (Activities 1a, 2a, 3a):\n\n* Inability to understand, speak, or read English\n* Any condition that would impede the patient's ability to complete study procedures such as visual impairment or significant cognitive impairment as determined by the participant's treating provider.","21 Years",{"count":464,"type":21},73,[77],"The purpose of the study is to evaluate if the smartphone app, I-STAMP (Integrated Smartphone Technology to Alleviate Malignant Pain), helps participants with cancer pain manage symptoms and keep track of medications.",[28,468],"Pain",[28,470,471],"Pain management","Opioid pain management","2026-07-15",{"date":474,"type":35},"2026-07-16",{"date":476,"type":21},"2026-08",{"date":478,"type":21},"2026-11-30",{"name":480,"class":66},"Dana-Farber Cancer Institute",{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":17,"minAge":489,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":492,"briefSummary":493,"conditions":494,"keywords":497,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":67},"100623199","a-pilot-randomized-controlled-trial-of-a-social-network-intervention-100623199","NCT07393529","A Pilot Randomized Controlled Trial of a Social Network Intervention","A Pilot Randomized Controlled Trial of a Social Network Intervention for Older Patients With Cancer","SONATA 2","Patients\n\nInclusion criteria:\n\n* Age ≥65 years\n* A diagnosis of advanced or likely incurable cancer, as determined by the primary oncologist\n* Able to speak English\n* Able to provide informed consent\n\nExclusion criteria:\n\n* Any psychiatric or cognitive impairments interfering with participation as determined by the oncology team\n* Unwilling to complete study procedures\n\nSocial Network Members (if available, for intervention arm only)\n\nInclusion criteria:\n\n* Age ≥18 years\n* Identified as an SN member by the patient in the intervention arm\n* Able to speak English\n* Able to provide informed consent\n\nExclusion criteria:\n\n• Unwilling to complete study procedures","65 Years",{"count":491,"type":21},70,[77],"This is a pilot randomized controlled trial to assess the feasibility, acceptability, appropriateness, and structure of the SONATA intervention. In addition, it will assess the preliminary efficacy of SONATA compared to enhanced usual care among 70 older adults with advanced cancer.",[28,495,496],"Older Adults (65 Years and Older)","Social Networks",[498,499],"geriatric oncology","social networks","2026-07-02",{"date":502,"type":35},"2026-07-07",{"date":504,"type":35},"2026-04-10",{"date":506,"type":21},"2029-03-31",{"name":508,"class":66},"University of Rochester",{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":261,"phases":4,"briefSummary":519,"conditions":520,"keywords":523,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":534,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":67},"100393716","routine-evaluation-of-people-living-with-cancer-100393716","NCT04406662","Routine Evaluation of People Living With Cancer","Routine Evaluation of People Living With Cancer - Body Composition, Physical Function, Systemic Inflammatory Response, Quality of Life and Symptoms","REVOLUTION","Inclusion Criteria:\n\n* Patients with incurable cancer (metastatic cancer (Clinical, histological, cytological or radiological evidence) or receiving anti-cancer therapy with palliative intent).\n* Aged 18-years and over\n* Written informed consent\n\nExclusion Criteria:\n\n* Any concomitant medical or psychiatric problems which, in the opinion of the investigator, would increase the risk of complication for the participant and\u002For investigator.\n* Participants will not be able to take part in bio-impedance analysis if they have a pacemaker or implantable cardiac defibrillator.",{"count":518,"type":21},600,"People with incurable cancer often have complex individual needs, however there are several common themes encountered when considering this group.\n\nAs cancer progresses there are series of interactions between the tumour and the patient, producing both local and systemic effects. This altered state of illness can have multiple ill effects including weight loss, fatigue, increased symptom burden and reduction in physical function which all contribute to a reduced quality of life.\n\nThese areas are often studied in isolation, giving an incomplete picture. A detailed, holistic characterisation of this group of people does not exist.\n\nA robust characterisation of people with incurable cancer will allow identification and prioritisation of future research and has the potential to inform new therapeutics and provide justification for treatments.\n\nThis study aims to collect information about symptoms and quality of life, weight loss and body composition, physical activity and the body's immune response to cancer.\n\nParticipants with incurable cancer will be recruited to the study from oncology and palliative medicine services in the UK. Participants will answer questionnaires about quality of life and symptoms, have bloods taken for inflammatory marker and cytokine analysis and have their body composition measured by a variety of methods.",[521,28,522],"Cachexia; Cancer","Quality of Life",[524,525,526,527,528,529,530,531,532,533],"cancer","advanced cancer","incurable cancer","body composition","physical function","symptoms","cachexia","quality of life","systemic inflammatory response","palliative medicine",{"date":502,"type":35},{"date":536,"type":35},"2020-07-15",{"date":538,"type":21},"2029-08-08",{"name":540,"class":66},"University of Edinburgh",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":22,"phases":550,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":67},"100454946","phase-1-actinium-225-labeled-anti-cea-antibody-ac225-dota-m5a-for-the-treatment-of-cea-producing-advanced-or-metastatic-cancers-100454946","NCT05204147","Actinium 225 Labeled Anti-CEA Antibody (Ac225-DOTA-M5A) for the Treatment of CEA Producing Advanced or Metastatic Cancers","A Phase I Study of Actinium-225 Labeled Humanized Anti-CEA M5A Antibody in Patients With CEA Producing Advanced or Metastatic Cancers","Inclusion Criteria:\n\n* Patients must have a histologic diagnosis of a malignancy that expresses CEA. If biopsies were performed at an outside facility, the histology must be reviewed and confirmed by the Department of Pathology at the City of Hope\n* Patients must have tumors that produce CEA as documented by either an elevated serum CEA above the institutional limit of normal or by immunohistochemical methods. Positive CEA immunohistochemical staining, for the purposes of this protocol, is graded 0-3 and the percentage of tumor cells positive is estimated. A positive CEA stain is determined if more than 30% of the tumor cells have an intensity of 2+ or greater\n* Patients must have an advanced disease for which no standard or effective treatment is available. Patients who refuse a standard but non-curative treatment is available may also be considered\n* Karnofsky performance status \\>= 60% and an estimated survival of at least 3 months\n* Patients must be \\>= 18 years old as phase I data for the antibody is not available for younger patients.\n* The effects of Ac-225-DOTA-M5A on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately\n* Adequate bone marrow function as evidenced by white blood count (WBC) \\>= 4000\u002Ful, absolute neutrophil count \\>= 1500\u002Ful, platelet count \\>= 125,000\u002Ful are required\n* Adequate renal function as evidenced by a creatinine =\\\u003C 1.5 mg\u002Fdl and\u002For a calculated creatinine clearance \\>= 60 cc\u002Fmin\n* Adequate liver function as evidenced by bilirubin =\\\u003C 1.5 mg\u002Fdl and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no greater than 2 times the upper limit of normal. Less than 1\u002F3 of the liver must be estimated to be involved with tumor\n* Presence of measurable disease is required for study entry\n* All patients must be seen in consultation by City of Hope Radiation Oncology and City of Hope Medical Oncology prior to entry onto this trial\n* All subjects must have the ability to understand and the willingness to sign a written informed consent\n* Prior radiotherapy, immunotherapy, or chemotherapy must have been completed at least 4 weeks prior to patient entry on this study (6 weeks if treated with mitomycin-c or nitrosoureas) and patients must have recovered from any expected side effects of prior therapy\n\nExclusion Criteria:\n\n* Patients should not have any uncontrolled illness including ongoing or uncontrolled active infection\n* Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy\n* Pregnant women are excluded from this study because Ac225-DOTA-M5A are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Ac225-DOTA-M5A, breastfeeding should be discontinued if the mother is treated with Ac225-DOTA-M5A\n* Patients with recurrent or progressive brain or leptomeningeal involvement with cancer. Patients that have had previous therapies for brain metastasis or leptomeningeal disease with demonstrated response or stable disease at least four weeks after therapy will be eligible for the trial\n* Patients who have received previous radiation to \\> 50% of their bone marrow\n* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study",{"count":549,"type":21},20,[24],"This phase I study tests the safety, side effects, and best dose of Ac225-DOTA-M5A in treating patients with CEA positive colorectal cancer that has spread to other places in the body (advanced). Ac225-DOTA-M5A is a humanized monoclonal anti-CEA antibody, linked to a radioactive agent called actinium 225. M5A attaches to CEA positive cancer cells in a targeted way and delivers actinium 225 to kill them.",[28,99],{"date":554,"type":35},"2026-07-06",{"date":556,"type":35},"2022-06-02",{"date":558,"type":21},"2026-07-21",{"name":560,"class":66},"City of Hope Medical Center",{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":22,"phases":569,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":67},"100641626","virtual-group-resilient-living-program-for-patients-living-with-advanced-cancer-100641626","NCT07659158","Virtual Group Resilient Living Program For Patients Living With Advanced Cancer","Inclusion Criteria:\n\n* English fluency\n* Diagnosis of advanced (stage III\u002FIV) malignancy\n* Baseline distress score ≥ 4\u002F10. Patients can answer questions orally rather than complete worksheet, if applicable\n* Life expectancy of ≥ 6 months\n* Provide informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Has a reliable internet connection\n* Has the ability to utilize technology to watch online modules, \\& participate in virtual sessions\n\nExclusion Criteria:\n\n* As determined through self-report, those diagnosed with a history of a psychotic episode ≤ 5 years\n* All psychological co-morbidities such as a history of untreated schizophrenia, \\& bipolar disease\n* A diagnosis of severe cognitive impairment",{"count":568,"type":21},42,[77],"This study is a prospective, minimal risk, non-randomized, single-arm study to determine feasibility and assess effectiveness of a Virtual Group Resilient Living Program (RLP) on anxiety, stress, quality of life (QOL), coping, and fatigue among patients with advanced cancer. The group RLP is a psychosocial intervention that consists of a total of 7 weekly sessions in which the interventionalist teaches the patients techniques on stress management and building resilience (mindfulness, uplifting emotions, reframe experiences through principles of gratitude, compassion, acceptance, meaning, and forgiveness). The group setting allows for support and connection amongst the patients, providing further support and motivation to practice the principles of the program.",[28],"2026-06-30",{"date":500,"type":35},{"date":575,"type":35},"2026-06-19",{"date":577,"type":21},"2027-06-30",{"name":579,"class":66},"Mayo Clinic",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":22,"phases":589,"briefSummary":590,"conditions":591,"keywords":592,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":598,"leadSponsor":600,"locationsCount":67},"100642719","contrast-enhanced-cbct-with-c-arm-hypersight-technology-100642719","NCT07648160","Contrast-enhanced CBCT With C-arm HyperSight Technology","Contrast-enhanced CBCT With C-arm HyperSight Technology: A Feasibility Study","IV-CBCT","Inclusion Criteria:\n\n* Primary biopsy-proven cancer\n* Planning to undergo spatially fractionated radiation therapy\n* Able to provide informed consent\n* Willingness to participate in follow-up\n* ECOG less than or equal to 3\n* Normal creatinine (below 109mmol\u002FL), normal eGF\n\nExclusion Criteria:\n\n* Unable to understand\u002Fprovide consent\n* History of allergic reaction to iodinated IV contrast dye (allergy to MR contrast is not an exclusion criteria)\n* Known renal disease\n* Single kidney\n* Kidney transplant\n* Dialysis\n* Contraindication to MRI",{"count":549,"type":21},[77],"This is a single-arm prospective, feasibility study evaluating the intravenous contrast-enhanced cone beam computed tomography (IV CBCT) for image guidance during radiotherapy. Patients treated with SFRT will receive IV-contrast enhanced CT and fMRI before treatment for simulation purposes. Additionally, patients will receive mpMRI just before and IV-contrast enhanced CBCT during their second and last fraction of RT, in addition to the standard of care CBCT that is acquired for daily image-guided patient positioning. Patients will undergo both IV-contrast enhanced CBCT and treatment on the TrueBeam with HyperSight imaging capability. We hypothesize IV contrast enhanced CBCT is feasible, well-tolerated by patients and improves the visibility of the target.",[28],[593],"IV-contrast-enhanced CT","2026-06-24",{"date":596,"type":35},"2026-06-26",{"date":594,"type":35},{"date":599,"type":21},"2027-07-01",{"name":359,"class":66},{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":22,"phases":611,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":187},"100542694","phase-3-combination-of-immune-checkpoint-in-locally-advanced-or-metastatic-msidmmr-esogastric-adenocarcinomas-100542694","NCT06346197","Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI\u002FdMMR Esogastric Adenocarcinomas","A Multicenter, Randomised, Comparative, Open-label Phase III Aiming to Compare the Survival of Patients With Locally Advanced or Metastatic MSI\u002FdMMR Esogastric Adenocarcinomas Treated by a Combination of Immune Checkpoint Inhibitors (Botensilimab + Balstilimab) Versus the Standard of Care (FOLFOX\u002FXELOX + Nivolumab)","CIME","Inclusion Criteria:\n\n* Male or female patient ≥18 years of age at time of informed consent form signature.\n* Patient with MSI-H\u002FdMMR, HER2 negativeadvanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5. Note :The claudin 18.2 status must be known and documented before inclusion.\n* Patient to be treated with a first line therapy for locally advanced\u002Fmetastatic disease.\n* No prior treatment with chemotherapy for locally advanced\u002Fmetastatic disease.\n\n  o Note - adjuvant or neoadjuvant chemotherapy is allowed providing that 6 months have relapsed between completion of adjuvant chemotherapy and recurrence.\n* Measurable disease (outside any previous irradiated field within the past 6 months) defined as at least one unidimensional lesion that can be accurately measured as ≥ 10 mm with CT scan according to RECIST V1.1 (Appendix 01).\n\n  * Note: Lesions intended to be biopsied should not be defined as target lesions.\n  * Note: previously irradiated lesions can be selected as target lesion only if recurrence\u002FPD is documented after RT.\n* Patient with PS ECOG 0 or 1 (Appendix 02).\n* Adequate hematologic and end-organ function, defined by the following laboratory test results:\n\nAbsolute neutrophil count ≥ 1.5 109\u002FL (without growth factor support within 14 d) Platelets ≥ 100 109\u002FL (without transfusion for platelets within 7 d) Hemoglobin ≥ 9 g\u002FdL (without transfusion within 7 d) Creatinine clearance according to CKD-EPI ≥ 30 mL\u002Fmin\u002F1.73 m2 Serum total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert disease for whom a total serum bilirubin ≤ 3 x ULN is acceptable) ASAT and ALAT ≤ 3 x ULN (or up to 5 x ULN in case of liver metastasis or hepatic infiltration)\n\n* Availability of a representative formalin-fixed paraffin-embedded (FFPE) sample of the primary or metastatic tumor tissue (resection or biopsy) with an associated pathology report must be available. This tumor sample must meet the following quality\u002Fquantity control criteria: ≥30 % of tumor cells and a tumor surface area ≥ 5mm2 or biopsiable disease (see next inclusion criteria).\n* Tumor lesion visible by medical imaging and accessible to repeatable percutaneous or endoscopic sampling that permits core needle biopsy without unacceptable risk of a significant procedural complications, and suitable for retrieval of a minimum of 4 cores with a needle minimum diameter :16-gauge.\n\n  * Note 1: Fine needle aspirates, bone biopsies do not satisfy the requirement for tumor tissue.\n  * Note 2: Tumor lesions used for biopsy should not be lesions used as RECIST 1.1 target lesions unless there are no other lesions suitable for biopsy. If a RECIST target lesion is used for biopsy, the lesion must be ≥ 2 cm in longest diameter.\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at the Screening Visit (within 72 hours of first dose of study drugs) and must agree to use highly effective contraceptive measures starting with the Screening Visit through\n\n  * 9 months after the end of the treatment with oxaliplatin\n  * 6 months after the end of the treatment with fluorouracil\n  * 5 months after the end of the treatment with nivolumab or botensilimab or Balstilimab\n  * 6 months for capecitabine\n\n    * Highly effective contraception is defined in Appendix 03.\n\nNote Non-childbearing potential is defined as:\n\n1. ≥ 50 years of age and has not had menses for greater than 1 year.\n2. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation.\n3. Status is post-hysterectomy, bilateral oophorectomy, or tubal ligation.\n\n   * Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 6 months after the end of the treatment with oxaliplatine or 3 months after the last dose for other study treatments is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.\n   * Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed and should be able and willing to comply with study visits and procedures as per protocol.\n   * Patients must be covered by a medical insurance.\n\nExclusion Criteria:\n\n* Oesogastric cancer eligible to treatment with curative intent\n* Patients previously treated by anti-PD-1, anti-PD-L1, or anti-CTLA-4 or any other immunotherapy\n* Patients with surgery or radiotherapy within less than 4 weeks before C1D1\n* Patients with persistent AE Grade \\>1 related to previous anti-cancer treatment, except alopecia (all grades), laboratory value according to criteria I7.\n* Patients with: hypokalemia, hypomagnesemia, hypocalcemia less than normal\n* Patients with known prolongation QT\u002FQTc interval i.e. QT\u002FQTc interval longer than 450 msec for men and longer than 470 msec for women according to the inclusion ECG.\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.\n\nNote: Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:\n\n* Measurable disease, per RECIST v1.1, must be present outside the CNS.\n* The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.\n* Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).\n* There is no evidence of interim progression between completion of CNS-directed therapy and initiation of study treatment.\n* The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, neurosurgical resection within 21 days prior to initiation of study treatment.\n* The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted. A minimal wash-out period of 10days for corticosteroids is required.\n\n  * Patients with other malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints (basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer), or with no evidence of disease for ≥ 2 years.\n  * Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n  * of ILD or non-infectious pneumonitis requiring glucocorticoids.\n  * History of allogeneic organ transplant.\n  * Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n  * Patient with peripheral sensory neuropathy with functional impairment.\n  * Patients with clinically significant active heart disease or myocardial infarction within 6 months, history of uncontrolled or symptomatic cardiac disease.\n  * Patient with recent (within 7d before C1D1) or concomitant treatment with brivudine.\n  * Patient with complete absence of dihydropyrimidine dehydrogenase (DPD) activity (blood uracil level ≥ 150 ng\u002FmL) or partial deficit in DPD (i.e. blood uracil level between ≥ 16 ng\u002Fml and \\\u003C 150 ng\u002FmL)\n  * Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.\n  * Patient with Live vaccines injection within 4 weeks before C1D1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed.\n  * Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).\n  * History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n  * Patients with documented:\n* Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) unless their HBV is stably controlled on nucleoside analogs (eg entecavir or tenofovir) which will be continued for the duration of the study. Note: Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. HBV DNA test must be performed in these patients prior to C1D1.\n* Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA, or\n* HIV infection\n\n  * Prior organ or bone marrow transplant.\n  * Pregnant or lactating women.",{"count":610,"type":21},132,[612],"PHASE3","CIME is a multicenter, randomised, comparative, open-label phase III study aiming to compare the survival of patients suffering from MSI-H\u002FdMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy (experimental arm) versus standard current treatment (FOLFOX\u002FXELOX + nivolumab : standard arm).",[110,615,99,28],"MSI-H","2026-06-23",{"date":618,"type":35},"2026-06-25",{"date":620,"type":35},"2025-12-08",{"date":622,"type":21},"2028-05-15",{"name":624,"class":66},"Centre Leon Berard",{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":22,"phases":633,"briefSummary":634,"conditions":635,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":638,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":67},"100578575","phase-2-using-tumor-models-to-determine-treatments-100578575","NCT06813079","Using Tumor Models to Determine Treatments","ADOPT: Adaptive Organoid-Based Precision Therapy Study in Pancreatic Cancer - A Prospective Single-Arm Phase II Trial","Inclusion Criteria:\n\n1. Age 18 years or over\n2. Ability to understand and willing to sign a written informed consent form in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to screening to document their willingness to participate.\n3. Advanced inoperable malignant epithelial pancreatic ductal carcinomas (i.e. primary diagnosis of ductal adenocarcinoma or acinar cell adenocarcinoma, inclusive of all subtypes)\n4. Treatment history meeting one of either:\n\n   1. Stable disease or partial response to FOLFIRINOX (leucovorin calcium\u002Ffolinic acid, fluorouracil, irinotecan hydrochloride, and oxaliplatin) after at least eight cycles of treatment (Cohort B)\n   2. Progression of disease after receiving standard of care chemotherapies (Cohort A).\n\n   i. There is no maximum number of prior lines\n\n   ii. Patients with recurrence within six months of adjuvant-intent chemotherapy will be eligible\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n6. Life Expectancy of greater than 12 weeks\n7. Patients must have acceptable organ function\n8. Patients must have baseline hepatitis B screening. If they have a positive surface antigen the case will discussed with the hepatologist to determine if therapy is indicated. This does not exclude them from study.\n9. Patients must agree to use effective contraceptive methods for the period required by the study.\n10. Patients must have measurable disease\n11. Patient-derived organoid is sensitive to a drug listed for this study, defined by\n\n    1. Consensus agreement in molecular tumor boards, considering the totality of the genomic and organoid data, and the safety profile of the drug, and the clinical situation\n    2. Sensitivity to a drug chosen for the study, based on\n\n    i. IC50 \\\u003C Cmax (maximum plasma concentration) ii. Area under the curve (AUC) \\\u003C 30th percentile of cohort iii. Individual assay fulfills quality control metrics c. Matched clinical scenario (maintenance versus treatment) as outlined in this protocol.\n12. Able to swallow and tolerate oral medication (as applicable)\n\nExclusion Criteria:\n\n1. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n2. Patient received last dose of chemotherapy within 21 days prior to Cycle 1 Day 1.\n3. Patients with ongoing toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2, other than peripheral neuropathy, related to prior anti-tumour treatment.\n4. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.\n5. Patients concurrently receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g. megestrol acetate, bisphosphonates). These medications must have been started ≥ one month prior to enrolment in this study.\n6. Patients with a history of a severe allergic reaction attributed to compounds of similar or biologic composition to the PDO matched drug may be excluded if assessed by the investigator and determined to be unsafe to proceed.\n7. Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific ineligibility criteria.\n8. Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within one month prior to screening. All patients with previously treated brain metastases must be stable (clinically and radiologically) for at least one month after completion of treatment and either off steroid treatment or only taking physiological doses of steroids prior to the screening step.\n9. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure.\n10. Patients with known left ventricular ejection fraction (LVEF) \\\u003C 40 % as determined by a multigated acquisition (MUGA) scan or echocardiogram.\n11. Patients with stroke (including TIA) or acute myocardial infarction within three months prior to the screening step.\n12. Patients with acute gastrointestinal bleeding within one month prior to the screening step.\n13. Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness\u002Fsocial situations.\n14. Lactating and nursing women.\n15. Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician.",{"count":7,"type":21},[139],"The purpose of this study is to see if using Patient Derived Organoids (PDO) to choose a drug for the treatment of pancreatic cancer individually for each patient is useful. The study will look at the number of participants who have a response to their assigned drug.",[636,28,637],"Pancreatic Ductal Carcinoma","Epithelial Tumor",{"date":616,"type":35},{"date":640,"type":35},"2025-04-07",{"date":642,"type":21},"2028-02-17",{"name":359,"class":66},{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":650,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":652,"targetDuration":4,"studyType":22,"phases":653,"briefSummary":654,"conditions":655,"keywords":658,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":334},"100588091","bolster-learning-new-skills-to-thrive-100588091","NCT06936878","BOLSTER: Learning New Skills to Thrive","BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers","BOLSTER","Participant Inclusion Criteria:\n\n* Age ≥18 years\n* Currently hospitalized with skilled care need or have acquired a new skilled care need as an outpatient\n* Diagnosed with advanced gastrointestinal cancer (esophageal, gastric, pancreatic, hepatobiliary, colorectal, unknown GI primary, anal) or advanced gynecologic cancer (ovarian, endometrial, cervical, vaginal, vulvar)\n* Has a complex care need (e.g., ostomy, ileostomy, urostomy, nephrostomy, biliary drain, venting gastric tube, feeding tube, intraabdominal or pleural catheter, wound VAC)\n* Plans to receive ongoing cancer treatment\n* Has a family caregiver or friend (hereafter designated family caregiver) willing to participate\n* Able to speak and read English or Spanish (self-report)\n* Are willing to be audio-recorded\n* Have the cognitive\u002Fphysical ability to participate in a 60-minute interview\n\nFamily or Caregiver Inclusion Criteria:\n\n* Age ≥ 18 years\n* Identified by a patient (as defined above) as a family or friend who is involved in their care.\n* Willing to participate in study visits\n* Willing to be audio recorded\n\nParticipant Exclusion Criteria:\n\n* Has cognitive impairments (as determined by the patient's oncologist)\n* Planning to enroll in hospice\n* Unable to complete baseline survey\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n\nFamily or Caregiver Exclusion Criteria:\n\n* Unable to complete baseline survey\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners",{"count":518,"type":21},[77],"This research study is evaluating a new program called Building Out Lifelines for Safety, Trust, Empowerment, and Renewal or (BOLSTER), which was designed to support participants with a gynecological or gastrointestinal cancer and new and complex care needs.",[656,657,28],"Gastrointestinal Cancer","Gynecologic Cancer",[656,657,28,659,660],"Advanced Gastrointestinal Cancer","Advanced Gynecologic Cancer","2026-06-16",{"date":663,"type":35},"2026-06-18",{"date":665,"type":35},"2025-05-12",{"date":667,"type":21},"2028-07-31",{"name":480,"class":66}]