[{"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":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,100,0,25,[9,40,63,90,114,133,161,185,211,242,265,288,313,340,366,389,409,432,456,479,503,527,546,570,594],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100641626","virtual-group-resilient-living-program-for-patients-living-with-advanced-cancer-100641626",false,"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","ALL","18 Years",{"count":19,"type":20},42,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.",[26],"Advanced Cancer","RECRUITING","2026-06-30",{"date":30,"type":31},"2026-07-02","ACTUAL",{"date":33,"type":31},"2026-06-19",{"date":35,"type":20},"2027-06-30",{"name":37,"class":38},"Mayo Clinic","OTHER",1,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":53,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":59,"leadSponsor":61,"locationsCount":39},"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":49,"type":20},20,[23],"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.",[26],[54],"IV-contrast-enhanced CT","2026-06-24",{"date":57,"type":31},"2026-06-26",{"date":55,"type":31},{"date":60,"type":20},"2027-07-01",{"name":62,"class":38},"University Health Network, Toronto",{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"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":72,"type":20},132,[74],"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).",[77,78,79,26],"Gastric Cancer","MSI-H","Metastatic Cancer","2026-06-23",{"date":82,"type":31},"2026-06-25",{"date":84,"type":31},"2025-12-08",{"date":86,"type":20},"2028-05-15",{"name":88,"class":38},"Centre Leon Berard",7,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":16,"minAge":97,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":39},"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":99,"type":20},30,[101],"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.",[104,105,26],"Depression, Anxiety","Psilocybin-Assisted Psychotherapy","2026-06-22",{"date":55,"type":31},{"date":109,"type":31},"2024-04-16",{"date":111,"type":20},"2026-12-31",{"name":113,"class":38},"M.D. Anderson Cancer Center",{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":39},"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":20},[101],"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.",[125,26,126],"Pancreatic Ductal Carcinoma","Epithelial Tumor",{"date":80,"type":31},{"date":129,"type":31},"2025-04-07",{"date":131,"type":20},"2028-02-17",{"name":62,"class":38},{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"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":142,"type":20},600,[23],"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.",[146,147,26],"Gastrointestinal Cancer","Gynecologic Cancer",[146,147,26,149,150],"Advanced Gastrointestinal Cancer","Advanced Gynecologic Cancer","2026-06-16",{"date":153,"type":31},"2026-06-18",{"date":155,"type":31},"2025-05-12",{"date":157,"type":20},"2028-07-31",{"name":159,"class":38},"Dana-Farber Cancer Institute",2,{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":171,"phases":4,"briefSummary":172,"conditions":173,"keywords":174,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":39},"100522353","evaluating-disparities-in-precision-oncology-100522353","NCT06081517","Evaluating Disparities in Precision Oncology","Evaluating Disparities in Precision Oncology: An Observational Trial in the Context of a Real-World Academic Practice Model","EDPO","Inclusion Criteria:\n\n1. Ability to provide written informed consent and HIPAA authorization\n2. Patients must be ≥ 18 years old at the time of consent\n3. Patients who have or are planning to undergo molecular testing as part of their routine cancer care\n\nExclusion Criteria:\n\nN\u002FA",{"count":170,"type":20},10600,"OBSERVATIONAL","This is a non-randomized observational trial designed to collect detailed clinical, social determinant, and genomic data from patients enrolled in molecular oncology tumor boards across four comprehensive cancer centers.",[79,26],[175,176],"Precision Medicine","Disparities","2026-06-12",{"date":151,"type":31},{"date":180,"type":31},"2024-01-26",{"date":182,"type":20},"2028-12",{"name":184,"class":38},"Indiana University",{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":200,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":39},"100642496","electroacupuncture-for-preventing-chemotherapy-induced-peripheral-neuropathy-in-patients-with-advanced-cancer-100642496","NCT07644533","Electroacupuncture for Preventing Chemotherapy-Induced Peripheral Neuropathy in Patients With Advanced Cancer","Electroacupuncture for Preventing Chemotherapy-Induced Peripheral Neuropathy in Patients With Advanced Cancer: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Pathological and imaging examinations confirmed the diagnosis of advanced cancer(IV stage), including: breast cancer, gastric cancer, intestinal cancer, non-small cell lung cancer or ovarian cancer;\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Scheduled to receive chemotherapy containing a taxane, utidelone, or oxaliplatin, with no significant pre-existing neurological symptoms prior to chemotherapy. Specific regimens include: Colorectal cancer: Oxaliplatin-containing regimen. Gastric cancer: Oxaliplatin-containing or taxane-containing regimen. Breast cancer: Taxane-containing or utidelone-containing regimen. NSCLC or Ovarian cancer: Taxane-containing regimen.\n* No history of acupuncture treatment within one month prior to study initiation.\n* Adequate major organ function, meeting the following laboratory criteria: Hematology: Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL; Platelet count ≥ 100 × 10\\^9\u002FL; White blood cell count 3.5 - 9.5 × 10\\^9\u002FL; Hemoglobin ≥ 100 g\u002FL. Hepatic Function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Aspartate aminotransferase and alanine aminotransferase ≤ 3 × ULN; Serum bilirubin concentration \\\u003C 1.5 mg\u002FdL; Serum albumin \\> 2.5 g\u002FdL. Renal Function: Serum creatinine ≤ 1.5 × ULN, OR calculated creatinine clearance ≥ 50 mL\u002Fmin (using the Cockcroft-Gault formula). Coagulation: International normalized ratio ≤ 1.5, AND activated partial thromboplastin time ≤ 1.5 × ULN.\n* Willing to receive acupuncture intervention and undergo subsequent follow-up assessments.\n* Voluntarily agree to participate in the study and sign an informed consent form.\n\nExclusion Criteria:\n\n* Patients with early-stage cancer.\n* Pre-existing peripheral neuropathy prior to the initiation of chemotherapy.\n* Severe impairment of major organ function, rendering the patient unable to tolerate standard-dose chemotherapy.\n* Presence of active skin infection or other conditions unsuitable for acupuncture treatment.\n* Coexisting underlying diseases associated with peripheral neuropathy, such as diabetes mellitus, Guillain-Barré syndrome, or chronic inflammatory demyelinating polyradiculoneuropathy.\n* Current use of medications for neuropathic pain (e.g., gabapentin, pregabalin).\n* Pregnant or lactating patients.\n* Presence of dermatological conditions, as assessed by the clinician, that may interfere with the study procedures or outcomes.\n* Patients with active brain metastases.\n* Patients with a history of implanted cardiac pacemakers or defibrillators, or a history of epilepsy.",{"count":193,"type":20},264,[23],"This randomized controlled clinical trial aims to clarify the clinical efficacy and safety of electroacupuncture combined with thumbtack needle for the prevention of chemotherapy-induced peripheral neuropathy(CIPN), and to provide high-level evidence-based medicine for the prevention of CIPN in patients with advanced cancer. At the same time, the effects of electroacupuncture on the median nerve, tibial nerve, sural nerve sensory conduction velocity and sensory nerve action potential, as well as on the median nerve and tibial nerve motor conduction velocity will be analyzed.",[197,198,26,199],"Electroacupuncture","Chemotherapy","Peripheral Neuropathy",[198,26,201,197],"Peripheral neuropathy","NOT_YET_RECRUITING","2026-06-10",{"date":177,"type":31},{"date":206,"type":20},"2026-05-25",{"date":208,"type":20},"2029-07-31",{"name":210,"class":38},"Affiliated Hospital of Qinghai University",{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":21,"phases":220,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":160},"100445155","phase-1-mem-288-oncolytic-virus-alone-and-in-combination-with-standard-of-care-therapy-in-advanced-solid-tumors-100445155","NCT05076760","MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors","Phase I Study Evaluating MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors","Inclusion Criteria:\n\n1. Ability to understand and provide informed consent.\n2. Willingness and ability to comply with scheduled study visits and procedures.\n3. Adult men or women age ≥ 18 years.\n4. ECOG performance status of 0 or 1.\n5. Part 1A monotherapy: Advanced\u002Fmetastatic NSCLC, cSCC, Merkel cell, melanoma, TNBC, pancreatic cancer, or head and neck cancer.\n6. Parts 1B and 1C combination: Advanced\u002Fmetastatic NSCLC which has progressed following front-line anti-PD-1\u002FPD-L1 with or without concurrent chemotherapy.\n7. Per each tumor type shown below, the specific initial standard of care therapies after which the subjects with specific histologies must have progressed have been included. Subjects will have been treated with at least one or more than one line of therapy prior to enrollment in the study.\n\n   1. Non-small cell lung cancer (NSCLC)\n\n      Part 1A monotherapy\n      * Must have progressed on standard therapy, including platinum-based chemotherapy and checkpoint inhibitor therapy (combined or sequential).\n      * Patients with tumors that have known actionable molecular alteration such in EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS must have progressed on standard directed molecular therapy, and platinum-based chemotherapy.\n\n      Part 1B MEM-288 plus nivolumab combination\n      * Must have first progression more than (\\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or PD-L1 checkpoint inhibitor therapy with or without concurrent chemotherapy\n\n      Part 1C MEM-288 plus docetaxel combination must have either:\n      * first progression with anti-PD-1 or PD-L1 checkpoint inhibitor therapy with or without concurrent chemotherapy, or\n      * progressed following initial first line anti-PD-1 or PD-L1 monotherapy followed by 2nd line platinum chemotherapy (with or without continuation of their first line anti-PD-1 or PD-L1 therapy).\n   2. Cutaneous squamous-cell carcinoma (cSCC)\n\n      * Must have progressed on standard therapy, including platinum-based chemotherapy and\u002For checkpoint inhibitor therapy.\n   3. Merkel cell Carcinoma\n\n      * Must have progressed on standard checkpoint inhibitor therapy.\n   4. Melanoma\n\n      * Subjects must have received a BRAF inhibitor as monotherapy or in combination with other targeted agents for BRAF V600E mutant melanoma.\n      * Subjects must have received an anti-PD-1\u002F PD-L1inhibitor as monotherapy or combination with anti-CTLA-4 inhibitor or other therapies.\n   5. Pancreatic cancer\n\n      * Progression after systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU)-based regimen (including capecitabine).\n   6. Triple negative breast cancer (TNBC)\n\n      * Prior treatment (for advanced, metastatic or (neo)adjuvant) must have included a taxane and\u002For anthracycline-based therapy.\n   7. Head and Neck Cancer\n\n      * Prior treatment requirement in the metastatic or unresectable locally advanced setting include:\n      * Subjects must have received a platinum containing chemotherapy regimen for treatment of primary tumor in locally advanced, or metastatic settings\n      * Subjects must have received an anti-PD-1\u002F PD-L1 as monotherapy or in combination with chemotherapy.\n8. Progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status), except for patients with pancreatic cancer.\n\n   a) Prior progression on a PD-1 or PD-L1 checkpoint inhibitor should be unequivocal; progression that occurs within the first 8 weeks of treatment on these agents should be confirmed with a second CT at least 4 weeks apart (to exclude pseudo-progression).\n9. Patients with activating EGFR mutation or ALK rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, must have been previously treated with an applicable tyrosine kinase inhibitor.\n10. Tumor lesion which is deemed feasible for biopsy and injection under CT or ultrasound guidance (based on size, location, and visibility) by an interventional radiologist, and patient willing and able to provide tissue from biopsy of this lesion. Injected tumor should be \\> 1 cm3 in volume and should not encase or be inseparable from vital structures such as major nerves or blood vessels.\n\n    a) For Part 1 monotherapy patients treated at the first dose level, the tumor for injection must be an accessible cutaneous, subcutaneous, or superficial lymph node lesion that is palpable.\n11. Measurable disease, as defined per RECIST version 1.1.\n12. Prior history of brain metastases are eligible, provided:\n\n    1. Brain metastases have been treated\n    2. Asymptomatic from the brain metastases\n    3. Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days before registration to study\n    4. Brain metastases are stable on pre-registration imaging\n    5. No evidence of leptomeningeal disease\n13. Life expectancy \\> 3 months.\n14. Adequate organ and marrow function as defined below:\n\n    1. Absolute neutrophil count (ANC) ≥1.5 x 10\\^9\u002FL\n    2. Hemoglobin ≥90 g\u002FL (or ≥9 g\u002FdL)\n    3. Platelets ≥100 x 10\\^9\u002FL\n    4. Calculated creatinine clearance of \\>50 mL\u002Fmin using Cockcroft Gault equation\n    5. Total bilirubin ≤ 1.5 x institutional upper limit of normal\n    6. AST (SGOT) and ALT (SGPT) ≤2.5 x institutional upper limit of normal\n    7. If Alkaline Phosphatase ≥ 2.5 x institutional upper limit of normal, then AST and ALT must be ≤ 1.5 x institutional upper limit of normal\n15. Patients of childbearing age must not be pregnant and must use established contraceptive strategies:\n\n    1. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n    2. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n    3. Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n\nExclusion Criteria:\n\n1. Pregnant or breast feeding.\n2. Serious uncontrolled medical disorder, psychiatric condition or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.\n3. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic), or significant traumatic injury, within 4 weeks prior to starting study treatment or has not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy are exceptions and patients can receive study treatment ≥1 week after these procedures.\n4. History of clinically significant noninfectious interstitial pneumonitis (i.e., limiting activities of daily living or requiring therapeutic intervention), including clinically significant radiation pneumonitis.\n5. Residual toxicity from prior anticancer therapy of grade 3 or greater (CTCAE v5.0), with the exception of alopecia.\n6. Concurrent use of other anticancer approved or investigational agents.\n7. Clinically significant, uncontrolled heart disease and\u002For recent cardiac event (within 6 months), such as:\n\n   1. unstable angina within 6 months prior to screening\n   2. myocardial infarction within 6 months prior to screening\n   3. history of documented congestive heart failure (New York Heart Association functional classification III-IV)\n   4. cardiac arrhythmias not controlled with medication\n8. Active autoimmune disease requiring disease modifying therapy (except vitiligo, Grave's, or psoriasis not requiring systemic treatment).\n9. Any form of active primary or secondary immunodeficiency.\n10. Receiving ≥10 mg daily prednisone (or equivalent).\n11. Prior malignancy (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical\u002Fdysplasia endometrial, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period.\n12. Active systemic infections requiring intravenous antibiotics.\n13. Prior therapy with anti-tumor vaccines or other immune-stimulatory antitumor agents (other than FDA approved and National Comprehensive Cancer Network \\[NCCN\\] recommended systemic therapies).\n14. Prisoners or subjects who are involuntarily incarcerated, or who are compulsorily detained for treatment of either a psychiatric or physical illness.\n15. Any unresolved grade 2 irAE (except adequately treated endocrine irAE).\n16. Any toxicity that led to permanent discontinuation of prior anti-PD-1\u002FPD-L1 immunotherapy.",{"count":219,"type":20},40,[221],"PHASE1","This is a multipart, open-label, multi-center dose escalation, dose expansion phase I clinical trial designed to evaluate the safety, tolerability, maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and preliminary efficacy of MEM-288 in patients with advanced solid tumors. Eligible subjects must have a tumor lesion(s) which is accessible for injection.\n\nThe dose escalation phase (Part 1A - advanced solid tumors) has completed and is closed to enrollment. This phase evaluated multiple doses of MEM-288 dosed via intratumoral injection once every 3 weeks to assess safety, tolerability, preliminary efficacy, and to determine the MTD.\n\nThe dose expansion phase has multiple parts for advanced NSCLC. Part 1B has completed after evaluation of MEM-288 dosed via intratumoral injection in combination with standard of care nivolumab dosed via intravenous injection.\n\nIn a separate dose expansion arm (Part 1C) that is open for enrollment, patients with advanced NSCLC will be randomized to receive either an initial priming dose of MEM-288 injected into an accessible lesion (s) alone (Day 1) followed by MEM-288 in combination with standard of care docetaxel every 3 weeks up to 6 doses or MEM-288 injected into an accessible lesion(s) in combination with standard of care docetaxel therapy Day 1 and every 3 weeks up to 6 doses.\n\nThe study rationale is that the oncolytic effect of MEM-288 combined with the presence of CD40L and type 1 IFN in injected tumors will provide a strong signal for DC-mediated T cell activation leading to generation of systemic anti-tumor T cell responses with broad specificity akin to what is observed in the abscopal effect.",[224,26,79,225,226,227,228,229,230,231],"Solid Tumor","Non Small Cell Lung Cancer","Cutaneous Squamous Cell Carcinoma","Merkel Cell Carcinoma","Melanoma","Pancreatic Cancer","Triple Negative Breast Cancer","Head and Neck Cancer","2026-06-09",{"date":234,"type":31},"2026-06-11",{"date":236,"type":31},"2022-04-21",{"date":238,"type":20},"2031-12",{"name":240,"class":241},"Memgen, Inc.","INDUSTRY",{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":171,"phases":4,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":39},"100096334","psychophysical-studies-of-cancer-therapy-pain-100096334","NCT00515060","Psychophysical Studies of Cancer Therapy Pain","Psychophysical Studies of Cancer Therapy-Induced Pain: A Feasibility Study","Inclusion Criteria:\n\n1. Since moderate pain, albeit brief, will be induced, this feasibility project will be limited to consenting adults, 18 years old or older, in which there is also a well established QST database.\n2. The subjects must be able to understand the nature of the study and have signed consent.\n3. The patients must either: a) have pain that has developed as a consequence of cancer therapy with either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds or ionizing irradiation. OR b) have no pain that has developed as a consequence of cancer therapy, and are just entering chemotherapy with taxanes, vinka alkaloids, bortezomib, thalidomide, or platinum-based compounds\n4. (For Healthy Controls) Willing to participate and have signed an informed consent.\n\nExclusion Criteria:\n\n1. Patients who refuse to participate or who are determined incapable of completing the research.\n2. (For Healthy Controls) Receiving anti-coagulants, immunosuppressed or diabetic.",{"count":250,"type":20},450,"The Aim of this Study is to examine the feasibility of using quantitative sensory testing procedures, widely applied to the experimental study of sensory processing in humans both with and without various pain syndromes, to now characterize the psychophysical properties of neuropathic pain that has developed as a consequence of cancer therapy. Skin punch biopsies will be performed in patients with chemotherapy-induced pain to determine whether the impairment of nerve function is due to actual retraction or loss of innervation to the skin in areas affected by sensory disturbance.",[26,253],"Pain",[26,255,256,257,258,253],"Therapy-Induced Pain","Pain Threshold","Sensory Tests","Stimuli",{"date":203,"type":31},{"date":261,"type":31},"2001-01-23",{"date":263,"type":20},"2028-04-30",{"name":113,"class":38},{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":21,"phases":275,"briefSummary":276,"conditions":277,"keywords":278,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":39},"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":274,"type":20},5,[23],"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.",[26,229],[279,280,229],"SBRT","Celiac","2026-06-08",{"date":203,"type":31},{"date":284,"type":20},"2026-06-01",{"date":286,"type":20},"2027-06-01",{"name":62,"class":38},{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":311,"locationsCount":39},"100625872","resilience-building-for-advance-care-planning-100625872","NCT07428278","Resilience-Building for Advance Care Planning","Facilitating Advance Care Planning Discussions Between Patients With Advanced Cancer and Their Family Caregivers Using a Resilience-Building Intervention: A Randomized Controlled Trial.","ROCKS","Inclusion Criteria:\n\n* Eligible patients will (1) be ≥ 18 years of age; (2) be diagnosed with stage 3 or 4 cancer; and (3) have a family caregiver who is willing to participate.\n* Eligible family caregivers will be ≥ 18 years of age. All participants must be able to read, write, and speak English with minimal assistance from others and have access to the internet on a smartphone, laptop, or computer.\n\nExclusion Criteria:\n\n* Patient participants will be ineligible if they have (1) a Short Portable Mental Status Questionnaire (SPMSQ) score \\\u003C 8; or (2) have completed any form of advance directive.","80 Years",{"count":298,"type":20},152,[23],"The aims of this study are to (1) assess the feasibility, acceptability, and usability of the ROCKS intervention among patients with advanced cancer and their family caregivers through a randomized controlled trial in a cancer center setting; (2) evaluate the preliminary efficacy of ROCKS, as compared to usual care, on changes in completion of advance directives; and (3) explore the dyadic effects of resilience on self-efficacy, optimism, dyadic communication and coping, anxiety, and depression using an actor-partner interdependence model.",[26,302],"End of Life",[304,305],"Resilience","Advance Care Planning","2026-06-05",{"date":232,"type":31},{"date":309,"type":31},"2026-05-28",{"date":157,"type":20},{"name":312,"class":38},"University of Illinois at Chicago",{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":21,"phases":322,"briefSummary":323,"conditions":324,"keywords":328,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":49},"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":321,"type":20},165,[221],"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.",[325,229,326,26,327],"Colon Cancer","Lung Cancer (NSCLC)","Advanced Solid Tumors",[329,330,331,224],"Antibody Drug Conjugate","Carcinoma","Cancer","2026-06-03",{"date":306,"type":31},{"date":335,"type":31},"2025-09-23",{"date":337,"type":20},"2028-05",{"name":339,"class":241},"Pheon Therapeutics",{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":16,"minAge":347,"maxAge":97,"enrollmentInfo":348,"targetDuration":4,"studyType":21,"phases":350,"briefSummary":351,"conditions":352,"keywords":354,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":39},"100439578","phase-1-a-study-of-repotrectinib-in-combination-with-chemotherapy-in-children-and-young-adults-with-solid-tumor-cancer-100439578","NCT05004116","A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer","Phase 1\u002F2 Study of TPX-0005 (Repotrectinib) in Combination With Chemotherapy in Pediatric and Young Adult Subjects With Advanced or Metastatic Solid Tumors and Primary Central Nervous System Tumors","Inclusion Criteria (ALL Patients) :\n\n* Prior Therapy: Patients must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy prior to study enrollment. Patients must not have received the therapies indicated below for the specified time period prior to the first day of administration of protocol therapy on this study:\n\n  * Myelosuppressive chemotherapy: Last dose was given at least 21 days before the start date for protocol therapy.\n  * Biologic (anti-neoplastic agent including retinoids): Last dose given at least 7 days prior to the start date for protocol therapy.\n  * Monoclonal antibodies: Last dose of any monoclonal antibodies must have received at least 7 days or 3 half-lives, whichever is longer, prior to the start date for protocol therapy.\n  * Other immunotherapy (ex: tumor vaccine): Patient is eligible after 42 days of completion. Steroids are excluded from inclusion in immunotherapy.\n  * Radiation Therapy: Patients must not have received radiation for a minimum of two weeks prior to first dose of the drug for small port. If extensive bone marrow radiation, at least 42 days must have elapsed.\n  * Palliative radiotherapy on study is permitted for the treatment of painful bony lesions providing the lesions were known at the time of study entry and the Investigator clearly indicates that the need for palliative radiotherapy is not indicative of disease progression. In view of the current lack of data about the interaction of repotrectinib with radiotherapy, repotrectinib treatment should be interrupted during palliative radiotherapy, stopping 1 day before palliative radiotherapy and resuming treatment 1 day after completion of palliative radiotherapy and recovery from any acute radiation toxicities to baseline.\n  * Hematopoietic Stem Cell Transplant (HSCT): Patients are eligible 12 weeks after date of autologous hematopoietic stem cell infusion following myeloablative therapy (timed from first day of this protocol therapy). Patients who have received an autologous hematopoietic stem cell infusion to support non- myeloablative therapy (such as \\^131 I-MIBG) are eligible at any time as long as they meet the other criteria for eligibility.\n  * \\^131 I-MIBG therapy: A minimum of 6 weeks must have elapsed after \\^131 I-MIBG therapy prior to start of protocol therapy.\n  * Growth factors: Patients are eligible 14 days after last dose of long-acting growth factor (ex: peg-GCSF) or 7 days after short acting growth factor.\n  * Any investigational agent or anticancer therapy other than chemotherapy and not otherwise noted: Not within 2 weeks prior to planned start of TPX-0005 (Repotrectinib) or 5 half-lives, whichever is shorter. Full recovery of clinically significant toxicities from that therapy must be evident.\n  * Any prior treatment with a tyrosine kinase inhibitor (TKI) of ALK\u002FROS\u002FNTRK does NOT exclude patient from study (Patients are eligible for study at least 7 days or 5 half-lives, whichever is shorter, after last dose)\n* Disease Status\n\n  * Patients must have relapsed or refractory disease despite standard therapy.\n  * Phase 1: Patients must have evaluable or measurable disease\n  * Phase 2: All patients must have measurable disease (per Appendices 1-3) at time of enrollment\n  * Exception: Patients with DIPG must have recurrent and\u002For progressive disease after upfront radiation therapy. Any number of prior recurrences is permitted.\n* Biopsy Requirement\n\n  °Archived tissue must be available for analysis, but no fresh biopsy is required (exception: patients with DIPG do not require archived tissue). If no archival tissue is available, waiver may be permitted by study PI (phase 1 only).\n* Patients with Primary CNS Tumors:\n\n  * Patients with primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 14 days prior to enrollment\n  * Archived tissue and histologic verification requirement are waived for patients with diffuse intrinsic pontine glioma (DIPG)\n* Performance Score: Patients must have a Lansky (\\< 16 years age) or Karnofsky (≥ 16 years age) score of at least 50. Patients who are unable to walk because of paralysis or tumor pain, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* No bone marrow involvement\n\n  * Absolute Neutrophil Count ≥1000\u002Fmm\\^3 (1 x 10\\^9\u002FL)\n  * Platelet Count ≥100,000\u002Fmm \\^3 (100 x 10\\^9\u002FL); transfusions allowed\n  * Hemoglobin ≥ 8.0 g\u002FdL, transfusions are allowed\n* Known bone marrow involvement (applicable for phase 2 only)\n\n  * Absolute Neutrophil Count ≥750\u002Fmm 3 (0.75 x 10\\^9\u002FL)\n  * Platelet Count ≥50,000\u002Fmm\\^3 (100 x 10\\^9\u002FL), transfusions allowed\n  * Hemoglobin ≥ 8.0 g\u002FdL, transfusions are allowed\n* Serum Creatinine or Creatinine Clearance\\*Creatinine within normal limits for age\u002Fgender (see table below) or creatinine clearance or nuclear GFR ≥ 60 mL\u002Fmin\u002F1.73m\\^2\n* Total Serum Bilirubin \\<2.5 x ULN for age\u002Fgender\n* Liver Transaminases (AST\u002FALT) \\<2.5 x ULN for age\u002Fgender; \\< 5 x ULN for age\u002Fgender if liver metastasis is present\n* Serum calcium, magnesium and potassium Normal for age\u002Fgender or ≤ CTCAE Grade 1 with or without supplementation.\n* Cardiac Function Echocardiogram with left ventricular shortening fraction \\>25% and QTc Friderica (QTcF) \\<\u002F= 470ms on screening electrocardiogram\n* AST\u002FALT = aspartate aminotransferase\u002Falanine aminotransferase, ULN = upper limit of normal\n* Adequate Renal Function using the Schwartz formula for estimating GFR Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC.\n* Females of Childbearing potential: Must have negative serum pregnancy test during screening and be neither breastfeeding nor intending to become pregnant during study participation. Females of childbearing potential must agree to avoid pregnancy during the study and agree to the use of 2 effective contraceptive methods (hormonal and barrier method of birth control) prior to study entry, for the duration of study participation, and in the following 1 month after discontinuation of study treatment. Men with partner(s) of childbearing potential must take appropriate precautions to avoid fathering a child from screening until 6 months after discontinuation of study treatment and to use appropriate barrier contraception or abstinence.\n* Ability to comply with outpatient visits, laboratory testing, and study procedures during study participation\n* The patient, parent or guardian must voluntarily sign and date an informed consent approved (in addition to pediatric assent, if required) by an Independent Ethics Committee (IEC)\u002FInstitutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.\n* Age:\n\n  * Phase 1 (Part A): ≤ 30 years old (age at C1D1)\n  * Phase 1 (Part B): \\< 12 years old (age at C1D1)\n  * Phase 2: ≤ 30 years old (age at C1D1)\n* Disease:\n\n  * Phase 1: Pediatric patients with relapsed\u002Frefractory solid tumors (including primary CNS tumors). Patients with ALK, ROS1, or NTRK1\u002F2\u002F3 fusions are permitted to enroll in this cohort if progressed on prior targeted therapy or are not eligible for a higher priority study of single agent inhibition (ex: repotrectinib monotherapy IRB#20-077). Patients with tumors not characterized by any ALK\u002FROS\u002FNTRK aberration are also permitted to enroll in this cohort.\n  * Phase 2\n* Cohort 1: Patients with molecularly defined desmoplastic small round cell tumor (DSRCT)\n* Cohort 2: Exploratory cohort of patients with relapsed or refractory solid tumors including CNS tumors (no requirement of ALK, ROS1, NTRK1-3 aberrations). Patients with ALK, ROS1, or NTRK1\u002F2\u002F3 fusions are permitted to enroll in this cohort if progressed on prior targeted therapy or are not eligible for a higher priority study of single agent inhibition (ex: repotrectinib monotherapy IRB# 20-077). Note: Refractory disease is defined as the presence of persistent abnormality on conventional MRI imaging that is further distinguished by histology (biopsy or sample of lesion) or advanced imaging, OR as determined by the treating physician and discussed with the primary investigator prior to enrollment.\n* Cohort 3: Patients with recurrent or progressive DIPG. Patients with typical DIPG, defined as tumors with a pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons on at least 1 axial T2-weighted image, are eligible. No histologic confirmation is required. Patients with pontine tumors that do not meet radiographic criteria for typical DIPG (e.g., focal tumors or those involving less than 2\u002F3 of the pontine cross sectional area with or without extrapontine extension) are eligible if the tumors are biopsied and proven to be high-grade gliomas (such as anaplastic astrocytoma, glioblastoma, high-grade glioma NOS, and\u002For H3 K27M-mutant by immunohistochemistry or next generation sequencing CLIA certified) by institutional diagnosis.\n* Patients treated in Phase 1 at RP2D will be evaluable in the Phase 2 cohort if they meet all other inclusion criteria for the specified cohort. Patients receiving oral capsule OR oral suspension can be included in Phase 2 cohort. Enrollment of patients of at least 12 years old can begin treatment in Phase 2 once TPX-0005 (Repotrectinib) combination therapy RP2D is defined in Phase 1A (even if Phase 1B is not yet completed) Exception: DIPG patients may be enrolled on phase 2 cohort 3 prior to the completion of Phase 1 including the Phase 1 part B (PK expansion) since they will receive TPX-0005 (Repotrectinib) monotherapy at the pediatric RP2D.\n* Tissue Analysis\n\n  * Phase 1: All patients must have archived tissue available for analysis (exception: DIPG patients), but ALK\u002FROS\u002FNTRK status verification is not required prior to enrollment. If no archival tissue is available, waiver may be permitted by study PI (phase 1 only).\n  * Phase 2: Prior to enrollment, all patients must have ALK\u002FROS\u002FNTRK status evaluated in CLIA lab or equivalent by any nucleic acid-based diagnostic testing method (e.g., next-generation sequencing \\[NGS\\], Sanger sequencing, reverse transcription-polymerase chain reaction). Exception: Patients with molecularly defined DSRCT do not require ALK\u002FROS\u002FNTRK status confirmed prior to enrollment. Exception: Patients enrolling on cohort 3 (recurrent\u002Fprogressive DIPG)\n\nExclusion Criteria:\n\n* Phase 1- patients with known bone marrow disease\n* Concurrent participation in another therapeutic clinical trial\n* Major surgery within 14 days (2 weeks) prior to C1D1. Central venous access (Broviac, MediPort) placement does not meet criteria for major surgery.\n* Pregnancy or lactation\n* Known active systemic infections requiring ongoing treatment (bacterial, fungal, viral including human immunodeficiency virus positivity). Skin or other superficial infections requiring topical treatment only are not an exclusion.\n* Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.\n* Peripheral neuropathy CTCAE grade ≥ 3.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study, or could compromise protocol objectives in the opinion of the Investigator and\u002For Turning Point Therapeutics.\n* Current use or anticipated need for drugs that are known to be strong CYP3A4 inhibitors or inducers\n* Disease progression while on treatment with irinotecan\u002Ftemozolomide.\n* Gilbert Syndrome or Crigler-Najjar\n* Prolonged QTc: 450m\u002Fs for male patients and 470ms for female patients.","1 Year",{"count":349,"type":20},77,[221,101],"This study will test the safety of the study drug, repotrectinib, in combination with chemotherapy (irinotecan and temozolomide) in children and young adults who have advanced or metastatic solid tumors. We researchers will try to find the highest dose of the study drug that causes few or mild side effects in study participants. When the researchers find this dose, we will evaluate it in a different group of participants to find out whether repotrectinib in combination with chemotherapy is an effective treatment for children and young adults who have advanced\u002Fmetastatic solid tumors. Another purpose of the study is to look at the way the body absorbs, distributes, and gets rid of repotrectinib.",[26,353],"Metastatic Solid Tumor",[355,356],"Repotrectinib","21-156","2026-06-02",{"date":359,"type":31},"2026-06-04",{"date":361,"type":31},"2021-08-09",{"date":363,"type":20},"2028-08",{"name":365,"class":38},"Memorial Sloan Kettering Cancer Center",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":21,"phases":375,"briefSummary":376,"conditions":377,"keywords":378,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":388},"100639508","phase-1-phase-12-study-of-ui-102-in-selected-advanced-cancers-100639508","NCT07605962","Phase 1\u002F2 Study of UI-102 in Selected Advanced Cancers","A Phase I\u002FII Open-Label, Dose Escalation, Dose Optimization, and Cohort Expansion Trial to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of UI-102, a Novel Cholesteryl Pullulan (CHP) Nanoparticle-formulated TLR7\u002F8 Agonist in Patients With Selected Locally Advanced and\u002For Metastatic Solid Tumors","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1,\n* 18 Years and Older (adult, older adult),\n* Histologically confirmed advanced cancer,\n* Archived or fresh tumor tissue sample that must be confirmed as adequate,\n* Evaluable\u002FMeasurable disease per RECIST 1.1,\n* Previously received applicable standard treatments,\n* Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control\n\nExclusion Criteria:\n\n* central nervous system metastasis,\n* Ongoing or uncontrolled ascites or pleural effusion,\n* Significant ongoing toxicity from prior anticancer treatment,\n* Out-of-range laboratory values,\n* Clinically significant lung, heart, or autoimmune disease,\n* Ongoing requirement for immunosuppressive treatment,\n* Significant secondary malignancy,\n* Hypersensitivity to study drug or excipients,\n* Pregnant or lactating,\n* Ongoing active infection",{"count":374,"type":20},140,[221,101],"This phase 1\u002F2 first-in-human study is designed to assess the safety and efficacy of UI-102, a TLR7\u002F8 agonist encapsulated in a Cholesteryl Pullulan Nanoparticle.",[26],[379,380],"metastatic solid tumors","advanced solid tumors",{"date":332,"type":31},{"date":383,"type":31},"2026-05-20",{"date":385,"type":20},"2031-03-31",{"name":387,"class":241},"United Immunity, co., Ltd.",3,{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":21,"phases":397,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":388},"100624336","trial-of-spiritual-care-interventions-for-patients-with-cancer-100624336","NCT07408310","Trial of Spiritual Care Interventions for Patients With Cancer","1. Diagnosed with an advanced cancer.\n2. Member of a religious faith community organization.\n3. Fluent in English.\n\nExclusion Criteria:\n\n1. Received spiritual care from a healthcare chaplain within the past 2 months.\n2. Too weak or cognitively impaired to engage in study activities.",{"count":396,"type":20},288,[23],"This study aims to determine the effects of 2 spiritual care interventions. Spiritual wellness and healthcare service utilization will be measured from a sample of advanced cancer patients recruited from outpatient settings.",[26],[26,401],"Spiritual Care",{"date":357,"type":31},{"date":404,"type":31},"2026-03-24",{"date":406,"type":20},"2029-06",{"name":408,"class":38},"Weill Medical College of Cornell University",{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":21,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":431},"100625755","phase-1-an-open-label-study-to-evaluate-pf-07994525-in-participants-with-advanced-cancers-100625755","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).",{"count":417,"type":20},120,[221],"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.",[421,26],"Advanced Malignancies",[421,423,26],"Advanced Cancers",{"date":284,"type":31},{"date":426,"type":20},"2026-05-15",{"date":428,"type":20},"2030-07-10",{"name":430,"class":241},"Pfizer",4,{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":439,"enrollmentInfo":440,"targetDuration":4,"studyType":21,"phases":442,"briefSummary":443,"conditions":444,"keywords":445,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":455},"100566531","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-pk-and-antitumor-activity-of-alk201-in-participants-with-advanced-solid-tumors-100566531","NCT06656390","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors","A First-in-Human, Open-Label, Multi-Center Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK201 for Injection in Adult Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Men and women ≥18 and ≤75 years old on the day of signing the ICF\n* At least 1 measurable lesion per RECIST v1.1\n* Expected survival ≥3 months\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1\n* Adequate organ function\n* Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods from the date of signing the ICF until at least 6 months after the last dose of the IP, and during this period, male participants are not allowed to donate sperms\n\nExclusion Criteria:\n\n* Active or pre-existing autoimmune diseases that may relapse\n* Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage\n* Allergies to any component of ALK201 or other monoclonal antibodies\n* Primary central nervous system malignancies, or active metastases to central nervous system and\u002For metastases to meninges\n* Combined with ≥ Grade 2 stomatitis and\u002For nose bleeding at screening\n* Vaccinated with live vaccines within 4 weeks prior to the first dose\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply","75 Years",{"count":441,"type":20},202,[221,101],"This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK201.",[26,327],[446],"First-in-human",{"date":448,"type":31},"2026-05-22",{"date":450,"type":31},"2024-10-24",{"date":452,"type":20},"2028-04-22",{"name":454,"class":241},"Shanghai Allink Biotherapeutics Co., Ltd.",38,{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":439,"enrollmentInfo":462,"targetDuration":4,"studyType":21,"phases":464,"briefSummary":466,"conditions":467,"keywords":469,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":39},"100572669","early-phase-1-a-phase-i-study-on-evaluating-the-safety-tolerability-pharmacokinetic-characteristics-and-preliminary-efficacy-of-sxrn-plasmid-dna-technique-in-patients-with-advanced-solid-tumors-100572669","NCT06736275","A Phase I Study on Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SXRN Plasmid DNA Technique in Patients With Advanced Solid Tumors","For Dose-Escalation Phase:\n\n* Inclusion Criteria:\n* male or female, aged 18\\~75 at the time of signing the ICF;\n* patient with advanced solid tumors who have failed\u002Fcannot tolerate previous standard therapies or lack conventional effective therapies;\n* at least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1);\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* expected survival time ≥12 weeks;\n* lab results and organ function tested within 7 days before the initial infusion meet the criteria below:\n* Blood routine: 1)Absolute Neutrophil Count (ANC) ≥1.5×10\\^9\u002FL;2)Platlets (PLT) Count≥90×10\\^9\u002FL; 3)Hemoglobins (Hb) ≥90 g\u002FL.\n\nNote: the criteria above shall still be maintained within 14 days before the initial infusion, either without the need of blood transfusion, or using supportive treatment including granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), interleukin-11 (IL-11), and erythropoietin (EPO), and etc.\n\n* Blood biochemistry: 1)Total bilirubin (TBIL) ≤3.0 × upper limit of normal (ULN); 2)Serum creatinine (SCr) ≤1.5 × ULN or creatinine clearance (CrCl) by Cockroft Gault formula ≥50 mL\u002Fmin; 3)Aspartate Amino Transferase (AST), Alanine Aminotransferase (ALT) ≤2.5×ULN; for participants with liver metastasis, AST, ALT≤5.0×ULN, and ALP≤6.0×ULN; d)Albumin (ALB) ≥30g\u002FL.\n* Urine protein ≤2+ (if \\>2+, urine protein shall be collected for 24 hours; total protein ≤1g is acceptable for inclusion).\n* International Normalized Ratio (INR), Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN.\n\nNote: for subjects receiving precautious anti-coagulation treatment, the investigator shall determine whether INR and APTT remains in a safe and effective range for treatment.\n\n* Left Ventricular Ejection Fraction (LVEF) ≥50%.\n* can understand and voluntarily sign the Informed Consent Form (ICF); must be voluntary and able to finish the study program and follow-up tests.\n\nExclusion Criteria:\n\n* Subjects who meet any of the criteria below must not be included:\n* has received any of the anti-tumor treatments below:a) received cytotoxic chemotherapy, tumor immunotherapy, anti-tumor biologics or other trail agents within 4 weeks or 5 half-times (whichever is shorter) before the initial infusion.b)received an oral small-molecule targeted anti-tumor agent within 2 weeks before the first infusion or for five half-lives(whichever was shorter).c) received anti-tumor Chinese patent medicine approved by NMPA within 2 weeks before the initial infusion.d) received more than 30% bone marrow radiotherapy or large area radiotherapy within 2 weeks before initial infusion (palliative radiotherapy at the bone or superficial lesions is acceptable).\n* participated in and received an investigational drug or device clinical trial within 4 weeks before initial infusion.\n* Patients who had undergone or planned to undergo major surgery or interventional therapy (excluding tumor biopsy, puncture, etc.) within 4 weeks before initial infusion.\n* unrecovered from the toxic reaction caused by previous anti-tumor treatment (not recovered to ≤ grade 1 or baseline; not including toxic reactions with no safety risk as determined by the investigator, such as alopecia, asymptomatic hypothyroidism caused by immune checkpoint inhibitors that can be treated with only thyroid hormone and remains stable, and etc.).\n* with clinically uncontrollable serous effusion (pleural effusion, ascites and pericardio effusion). Conditions may include: moderate or above sized effusion, received within 2 weeks before the selection or plans to receive local treatments (including drainage, peritoneal shunt, and cell-free concentrated ascites reinfusion, and etc.), or effusion obviously increased within 2 weeks after the local treatment and thus needs long-term catherterization. Candidates who meet any of the conditions above, or determined by the investigator as unsuitable, shall not be included.\n* with central nervous system metastasis and show relating symptoms.\n* with a history of other malignant tumors, except for those that have received radical surgery and not relapsed 5 years thereafter, such as carcinoma in situ of cervix, skin basal cell carcinoma, and etc.\n* with a history of immune deficiency diseases, including acquired or congenital immunodeficiency disorders; or a history of organ transplantation, heterogeneous bone marrow transplantation, or autologous hematopoietic stem cell transplantation.\n* had (non-infectious) lung inflammation \u002F interstitial lung disease that required steroid treatment within 4 weeks before the initial infusion.\n* with a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n  1. severe abnormalty in cardiac rhythm or conduction, such as ventricular arrhythmia requiring clinical intervention, atrioventricular block of II\\~III grade, and etc.;\n  2. cardiac insufficiency of III\\~IV grade as defined by New York Heart Association(NYHA);\n  3. acute coronary syndrome, congestive cardiac failure, aortic dissection, cerebral stroke or other grade 3 or above cardio-cerebral vascular events within 6 months before the initial infusion.\n* with uncontrollable high blood pressure (systolic pressure ≥160 mmHg and\u002For diastolic pressure ≥100 mmHg) after treatment with anti-hypertensive drugs of stable doses.\n* with active chronic hepatitis B (such as, HbsAg or HbcAb positive and HBV DNA ≥ lower limit of detection, active hepatisis C (such as, HCV antibody positive and HCV RNA≥ lower limit of detection), or HIV infection.\n* with active infections within 2 weeks before the initial infusion that require systematic treatment.\n* with a history of active tuberculosis infection within 1 year before the initial infusion.\n* had or has uncontrollable or serious diseases that may interfere with the participation or evaluation in the study, as considered by the investigator;\n* known to be allergic or taking drugs contradictionary to the study drug (Suplussirna) or its excipients.\n* premenopause female candidates (postmenopausal female patients can only be considered infertilewhen they have been postmenopausal for at least 12 months) with positive results in serum pregnancy test; candidates of reproductive age (also including female spouse of reproductive age of male candidates), during the study or within 6 months after the last infusion, who will probably bear children, breastfeed, or are unwilling to cake effective contraceptives, as considered by the investigator.\n* other conditions that are determined by the investigator as unsitable for entering this trial.\n\nFor Expansion Cohort(Randomized, Double-blind, Placebo-controlled Part):\n\n* Inclusion Criteria:\n* Male or female, aged 18 to 75 years at time of signing ICF.\n* Histologically or cytologically confirmed solid tumor.\n* Patients who have failed standard therapy, lack standard therapy, or are in a treatment holiday period (4 weeks) without need for anti-tumor therapy.\n* Diagnosis of cancer anorexia-cachexia according to 2025 CSCO guideline, meeting either (①+②) or (①+③):\n\n  * Involuntary weight loss \\>5% in 6 months; OR weight loss \\>2% with BMI \\\u003C18.5 kg\u002Fm²; OR weight loss \\>2% with reduced muscle mass.\n\n    * Anorexia (VAS ≤70 or FAACT-A\u002FCS-12 score ≤37).\n\n      * CRP \\>5 mg\u002FL.\n* ECOG performance status 0-2.\n* Life expectancy ≥12 weeks.\n* Adequate organ function and laboratory parameters within 7 days prior to first study drug, meeting the same criteria as listed above for the dose-escalation phase (i.e., ANC, platelets, hemoglobin, liver\u002Fkidney function, coagulation, LVEF, etc.).\n* Same informed consent requirement as the dose-escalation phase: able to understand and voluntarily sign the ICF, and willing\u002Fable to complete study procedures and follow-up.\n\nExclusion Criteria:\n\nThe exclusion criteria are the same as those for the dose-escalation phase above, with the following additional or modified criteria:\n\n* Reversible causes of reduced food intake determined by investigator (e.g., mechanical obstruction preventing eating).\n* Use of any medication or therapy for cachexia, anorexia, or weight loss (excluding enteral nutrition support) within 28 days or 5 half-lives (whichever shorter) prior to first study drug, including but not limited to progestins (megestrol acetate, medroxyprogesterone acetate), corticosteroids, anamorelin, cannabinoids, androgens, NSAIDs.\n* Currently receiving tube feeding or parenteral nutrition.\n* Cachexia clearly due to other causes (e.g., severe COPD, AIDS).\n* Hormone therapy judged by investigator to improve cachexia.\n* Central nervous system metastases requiring intervention (instead of \"symptomatic CNS metastases\").\n* Known allergy or contraindication to SXRN or its process impurities (e.g., spectinomycin).\n* Note: For the expansion cohort, the washout period for other investigational drugs is \"4 weeks or 5 half-lives\" (same as dose-escalation phase), and all other exclusion criteria (prior anti-tumor treatments, unresolved toxicity, serous effusion, cardiovascular disease, infections, etc.) apply identically as listed above.",{"count":463,"type":20},28,[465],"EARLY_PHASE1","The purpose of this clinical trial is to evaluate the safety and tolerability of SXRN Plasmid DNA Technique in patients with advanced solid tumors.",[26,468],"Cachexia",[470],"micoRNA","2026-05-13",{"date":426,"type":31},{"date":474,"type":31},"2024-09-02",{"date":476,"type":20},"2027-12-09",{"name":478,"class":241},"Jiangsu Nutai Biologics Co., Ltd",{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":21,"phases":488,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":502},"100626181","phase-2-givastomig-combined-with-nivolumab-and-chemotherapy-in-adults-with-cldn182-positive-metastatic-gastric-cancer-giva-2-100626181","NCT07432295","Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)","A Randomized, Multicenter, Open-Label, Phase 2 Study of Givastomig (TJ033721) in Combination With Nivolumab and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated CLDN18.2 Positive and PD-1L Positive Locally Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Histologically confirmed unresectable, locally advanced, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC).\n* Treatment-naïve for advanced\u002Fmetastatic disease (prior adjuvant\u002Fneoadjuvant therapy allowed if ≥6 months since last dose).\n* CLDN18.2 positive (membrane intensity score ≥1+ on ≥1% of tumor cells).\n* PD-L1 positive (CPS ≥1).\n* At least 1 measurable lesion per RECIST v1.1.\n* ECOG performance status 0 or 1.\n* Adequate organ function, including:\n\n  * Hematologic: WBC ≥2,000\u002FμL; ANC ≥1,500\u002FμL; platelets ≥100,000\u002FμL; hemoglobin ≥9 g\u002FdL\n  * Hepatic: AST\u002FALT ≤3×ULN (≤5×ULN if liver metastases); bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's)\n  * Renal: Creatinine ≤1.5×ULN or eGFR ≥50 mL\u002Fmin\u002F1.73 m²\n* Life expectancy ≥90 days.\n* Women of childbearing potential (WOCBP) and men must use effective contraception during the study and for a defined period after treatment.\n* Willing and able to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* HER2-positive tumors.\n* Second malignancy within 3 years, except certain skin or cervical cancers.\n* Active or unstable gastrointestinal ulcer or bleeding within 6 weeks.\n* Active autoimmune disease requiring systemic therapy within past 2 years or ongoing immunosuppressive therapy.\n* Active pneumonitis or history requiring steroids\u002Fimmunosuppressive therapy within 3 years.\n* Participation in another therapeutic clinical trial.\n* Major surgery or significant injury within 4 weeks prior to first dose, or planned major surgery within 6 months.\n* Radiotherapy within protocol-specified timeframes without adequate recovery.\n* Active CNS metastases or carcinomatous meningitis (previously treated brain metastases allowed if stable).\n* Significant cardiovascular disease (NYHA Class 3-4 CHF, recent MI, unstable angina, TIA\u002Fstroke, or major cardiac procedures within 6 months).\n* Active or uncontrolled HIV, hepatitis B, or hepatitis C infection, or immunodeficiency (controlled infection allowed).\n* Receipt of live vaccine within 30 days or other vaccines within 7 days of first dose.\n* Active infection requiring parenteral therapy.\n* Known hypersensitivity to study drug components (e.g., DPD deficiency).\n* Any other condition or laboratory abnormality that, in the investigator's judgment, increases risk or interferes with study participation.",{"count":487,"type":20},180,[101],"The goal of this clinical trial is to learn if givastomig in combination with standard therapy works to treat adults with cancer in the stomach and\u002For esophagus (GEA adenocarcinoma). It will also help the researchers to learn more about the safety of givastomig. The main questions it aims to answer are:\n\n* Does the addition of givastomig to standard therapy increase the amount of time that participants survive without progression of their cancer?\n* What toxicities do participants experience when taking givastomig?\n\nParticipants may be able to take part in the study if they have unresectable or metastatic GEA and if their cancer cells express certain proteins called Claudin 18.2 (CLDN18.2) and PD-L1. Participants whose cancer cells express a protein called HER2 cannot take part.\n\nUp to 180 participants will be randomly assigned to received givastomig at one of two doses in combination with an immunotherapy medicine called nivolumab and chemotherapy OR to receive nivolumab and chemotherapy alone. These therapies will be given primarily via intravenous (into a vein) infusion every 2 or 3 weeks.\n\nParticipants will:\n\n* Visit the study treatment center for infusions and\u002For check-ups and tests every 1-3 weeks\n* Report any changes in their symptoms to their study doctors\n* Have scans to check for any changes in their cancer every 8-12 weeks",[224,26,79,77,491,492],"Gastroesophageal Junction Carcinoma","Esophageal Adenocarcinoma","2026-05-11",{"date":495,"type":31},"2026-05-14",{"date":497,"type":31},"2026-02-11",{"date":499,"type":20},"2030-08",{"name":501,"class":241},"I-Mab Biopharma US Limited",6,{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":16,"minAge":510,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":21,"phases":513,"briefSummary":514,"conditions":515,"keywords":516,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":89},"100590154","longitudinal-screening-for-financial-hardship-to-improve-outcomes-in-patients-with-advanced-cancer-100590154","NCT06963723","Longitudinal Screening for Financial Hardship to Improve Outcomes in Patients With Advanced Cancer","PROOF","Inclusion Criteria:\n\n1. Minimum age of 21\n2. Understands English and\u002For Spanish\n3. Has a diagnosis of advanced\u002Fmetastatic cancer\n4. Currently undergoing systemic therapy (enteral or parenteral) with non-curative intent\n5. Has been receiving treatment for at least 2 months\n6. Life expectancy of at least 6 months, in the opinion of the treating oncologist\n7. Cognitively able to give informed consent\n\nExclusion Criteria:\n\n1. Under the age of 21\n2. Does not understand English or Spanish\n3. Has cognitive deficits that would preclude understanding of consent form and\u002For questionnaires\n4. Undergoing treatment with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer, primary curative therapy for testis cancer or lymphoma)\n5. Not undergoing systemic therapy (enteral or parenteral) with non-curative intent\n6. Receiving treatment for fewer than 2 months\n7. Life expectancy is less than 6 months, in the opinion of the treating oncologist","21 Years",{"count":512,"type":20},1000,[23],"The study aims to determine whether monthly remote digital financial hardship screening among adults with advanced\u002Fmetastatic cancer, undergoing outpatient systemic therapy with non-curative intent, improves patient-centered outcomes, including financial worry, health-related quality of life (HRQoL), symptom burden, patient-reported cancer treatment adherence, and exploratory outcomes of overall survival, patient-reported economic burden, patient-reported support received, patient-reported financial coping strategies, and health insurance literacy.",[26,79],[517],"Financial Toxicity","2026-05-08",{"date":520,"type":31},"2026-05-12",{"date":522,"type":31},"2025-07-01",{"date":524,"type":20},"2029-04-01",{"name":526,"class":38},"Alliance Foundation Trials, LLC.",{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":21,"phases":534,"briefSummary":535,"conditions":536,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":39},"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":5,"type":20},[221,101],"To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).",[26,537],"Clear Cell Renal Cell Carcinoma","2026-04-30",{"date":540,"type":31},"2026-05-05",{"date":542,"type":31},"2023-06-30",{"date":544,"type":20},"2027-10-30",{"name":113,"class":38},{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":554,"enrollmentInfo":555,"targetDuration":4,"studyType":21,"phases":556,"briefSummary":557,"conditions":558,"keywords":559,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":39},"100563448","align-for-older-adults-with-cancer-in-snfs-100563448","NCT06616298","ALIGN for Older Adults With Cancer in SNFs","Improving Person-Centered Outcomes for Older Adults With Cancer Discharged to Skilled Nursing Facilities and Their Family Caregivers","ALIGN","Patients\n\nInclusion Criteria:\n\n1. Adults between 18-98 years\n2. Stage I-IV solid tumors\n3. Discharging from an acute care hospital to a SNF in Colorado\n4. English speaking\n5. Receiving or establishing care at the University of Colorado Cancer Center\n6. If a patient lacks capacity, a legal surrogate decision-maker will be approached to provide proxy consent.\n7. Must have access to the technology needed to complete consenting visit and subsequent intervention visits. This includes internet access through a computer, tablet, or smartphone OR cellular service with adequate allowance of cellular minutes to allow virtual visits.\n8. Must have an email address or caregiver with an email address to facilitate communication during the trial\n\nExclusion Criteria:\n\n1. Discharging with hospice care\n2. Age less than 18\n3. Lacking capacity without a legal surrogate decision maker or proxy.\n4. Limited English proficiency\n5. Hospitalized for a planned admission or procedure\n6. Have any pschological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgement of the PI or relevant clinical study staff that would make a participant unsuitable for the study\n\nCaregivers\n\nInclusion Criteria:\n\n1. Patient-selected\n2. Age ≥ 18\n3. English speaking\n4. Able to complete baseline measures.\n\nExclusion Criteria:\n\n1. Discharging with hospice care\n2. Age ≤ 18\n3. Caregivers with limited English proficiency will be excluded as ALIGN intervention content and documents have only been validated in an English-speaking population.\n4. Have any pschological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgement of the PI or relevant clinical study staff that would make a participant unsuitable for the study\n\nSNF Staff\n\nInclusion Criteria:\n\n1\\. Working at a SNF that cared for a patient who received the ALIGN intervention\n\nExclusion Criteria:\n\n1\\. Not employed by a community SNF where patients were discharged to during the pilot trial\n\nPCSW\n\nInclusion Criteria:\n\n1\\. PCSWs who conducted the ALIGN intervention and consent to an interview","98 Years",{"count":417,"type":20},[23],"The goal of this clinical trial is to learn if it is possible to deliver a palliative care intervention called ALIGN (Assessing and Listening to Individual Goals and Needs) to hospitalized older adults with advanced cancer who are discharged to a skilled nursing facility and their caregivers. The main questions it aims to answer are:\n\n* Can the investigator successfully deliver the ALIGN intervention in different skilled community nursing facilities?\n* Can the investigator successfully collect information from participants throughout the study?\n* How can the investigator best prepare caregivers to make medical decisions for loved ones that become unable to do so themselves?\n\nResearchers will compare ALIGN to care as it is usually delivered.\n\nParticipants will:\n\n* Visit virtually with an ALIGN palliative care social worker every 1-2 weeks during their skilled nursing facility stay and up to 45 days after discharge from the facility or will see a palliative care clinician if recommended by their oncologist or other involved clinician.\n* Participants will provide information about how they are doing 1 month, 3 months, and 6 months after enrolling in the study.",[26],[560,561],"Skilled Nursing Facility","Caregiver","2026-04-29",{"date":540,"type":31},{"date":565,"type":31},"2025-02-24",{"date":567,"type":20},"2028-08-01",{"name":569,"class":38},"University of Colorado, Denver",{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":21,"phases":579,"briefSummary":580,"conditions":581,"keywords":582,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":593},"100482055","phase-1-a-study-of-jzp815-oral-capsules-in-adult-participants-with-advanced-or-metastatic-solid-tumors-harboring-mitogen-activated-protein-kinase-mapk-pathway-alterations-to-investigate-the-safety-dosing-and-antitumor-activity-of-jzp815-100482055","NCT05557045","A Study of JZP815 Oral Capsules in Adult Participants With Advanced or Metastatic Solid Tumors Harboring Mitogen Activated Protein Kinase (MAPK) Pathway Alterations to Investigate the Safety, Dosing, and Antitumor Activity of JZP815","Phase 1, FIH, Open-label, Nonrandomized, Multicenter Study of JZP815 in Participants With Advanced or Metastatic Solid Tumors Harboring Alterations in the MAPK Pathway","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age, at the time of signing the informed consent\n* Participants who have histological or cytological diagnosis of an advanced or metastatic solid tumor carrying a documented, clinically significant, MAPK pathway alteration\n* Participants must have exhausted all available standard of care therapies, or in the opinion of the investigator would be unlikely to tolerate or derive clinically meaningful benefit from available standard of care therapy\n* Performance status (ECOG) of 0 or 1, measured within 72 hours before start of treatment. For Arm 7 (NRAS Q61 mutated anaplastic thyroid cancer) in Part B (Expansion), ECOG of 0 to 2, measured within 72 hours before the start of treatment.\n* Must have measurable disease by RECIST v1.1\n* Tumor must be safely amenable to core needle or excisional biopsy (applies only to participants enrolled in Pre-Expansion cohorts)\n* Adequate organ function\n* Expected life expectancy of at least 12 weeks\n* For each arm in Part B (Expansion), participants must be diagnosed with the tumor type(s) carrying the mutation(s) specified and meet protocol specified requirements for prior therapy\n* Male participants must agree to refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or must agree to use contraception\n* Female participants are eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: is a women of nonchildbearing potential (WONCBP) or is a women of childbearing potential (WOCBP) and using a contraceptive method that is highly effective during the study intervention period and for at least 3 months after the last dose of study intervention and agrees not to donate eggs\n* A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 3 days before the first dose of study intervention\n* Capable of giving signed informed consent\n\nExclusion Criteria:\n\n* Known uncontrolled brain metastases. Stable brain metastases either treated or being treated with a stable dose of steroids\u002Fanticonvulsants, with no dose change in the previous 4 weeks, are permitted\n* Active fungal, bacterial and\u002For known viral infection including HIV or Hepatitis A, B, C\n* Concomitant malignancies or previous malignancies with less than 2 years disease-free interval at the time of enrollment, with the exception of non-metastatic, non-melanomatous skin cancers, carcinoma in-situ, melanoma in-situ, prostate cancer with undetectable PSA, indolent thyroid cancer that are adequately treated\n* Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (\\> New York Heart Association Classification Class II), QTc ≥ 470 msec, or serious cardiac arrhythmia requiring medication\n* Uncontrolled or severe intercurrent medical condition\n* Gastrointestinal condition that could impair absorption of study intervention or inability to ingest study intervention\n* In the judgement of the investigator, any important medical illness or abnormal laboratory finding that would increase the risk of participating in this study\n* Received any cancer directed therapy (chemotherapy, hormonal therapy, biologic, etc.) within 28 days or 5 half-lives (whichever is shorter) of starting study intervention. For Arm 7 (NRAS Q61 mutated anaplastic thyroid cancer) in Part B (Expansion), participants who have received radio-sensitizing chemotherapy (low-dose chemotherapy) are permitted a wash-out period of 7 days or 5 half-lives, whichever is shorter (a discussion with the sponsor is required). Participants who have received radiotherapy must have recovered from acute toxicities associated with treatment.\n* Use of any products or medicines known to be strong or moderate inducers or inhibitors of CYP3A4, which cannot be discontinued at least 4 weeks or 5 half-lives (whichever is shorter) before starting study intervention, or planned use at any time during the study\n* Use of proton pump inhibitors (eg, omeprazole) and histamine-2 receptor antagonists (eg, famotidine), which cannot be discontinued at least 2 weeks before first dose, or planned use at any time during the study\n* Concurrent therapy with any other investigational agent",{"count":578,"type":20},332,[221],"This phase 1 study will investigate the safety, dosing, and initial antitumor activity of JZP815 in participants with advanced or metastatic solid tumors harboring alterations in the MAPK pathway.",[26,79,224],[26,79,224,583],"JZP815","2026-04-22",{"date":586,"type":31},"2026-04-23",{"date":588,"type":31},"2022-10-10",{"date":590,"type":20},"2028-04-01",{"name":592,"class":241},"Jazz Pharmaceuticals",15,{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":16,"minAge":601,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":21,"phases":604,"briefSummary":605,"conditions":606,"keywords":607,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":388},"100460490","phase-1-a-study-of-imc-002-in-patients-with-advanced-cancer-failed-to-standard-therapy-100460490","NCT05276310","A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy","An Open-Label, Dose-Escalation and Expansion, Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy","Inclusion Criteria:\n\n1. Signed ICF\n2. Adult (19 years or older)\n3. Diagnosis and prior therapies\n\n   3-1. Part 1: Histologically or cytologically proven metastatic or locally advanced solid tumors\n\n   3-2. Part 2, HCC Cohort:\n   1. Histologically or cytologically proven metastatic or locally advanced of hepatocellular carcinoma (excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors)\n   2. Received ≥1 prior systemic therapy; lenvatinib-naive and eligible for lenvatinib.\n   3. Child Pugh classification A\n\n   3-3. Part 2, TNBC Cohort:\n   1. Histologically or cytologically proven metastatic or locally advanced of triple negative breast cancer: negative of estrogen receptor (ER), progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2)\n   2. Received ≥1 prior systemic regimen and eligible for paclitaxel or gemcitabine\u002Fcarboplatin. Patients who have previously received the planned SOC in this study (paclitaxel or gemcitabine\u002Fcarboplatin) cannot be enrolled. If at least 6 months have elapsed since the completion of a prior SOC (paclitaxel, gemcitabine, and\u002For carboplatin) and the patient showed a tumor response to that regimen, the same SOC can be used in this trial.\n   3. Bisphosphonate or denosumab for bone metastases is allowed if started before Cycle 1 Day 1. Prophylactic use of bisphosphonates or denosumab in patients without bone diseases is not permitted, except for the treatment of osteoporosis.\n\n   3-4. Part 2, BTC Cohort:\n   1. Histologically or cytologically proven metastatic or locally advanced of biliary tract cancer (gallbladder cancer, cholangiocarcinoma)\n   2. Received ≥1 prior systemic therapy; lenvatinib-naive and eligible for lenvatinib\n\n   3-5. Part 2, B-cell lymphoma Cohort:\n   1. Histologically or cytologically proven CD20+ mature B-cell lymphoma according to 2016 WHO classification including:\n\n      * diffuse large B-cell lymphoma (de novo or transformed)\n      * Mantle cell lymphoma\n      * Follicular lymphoma\n      * Marginal zone lymphoma (nodal, extranodal or mucosa associated)\n   2. Received ≥2 prior systemic therapies and eligible for rituximab treatment\n\n      * For all cancer type, neo-adjuvant and\u002For adjuvant chemotherapy is not regarded as chemotherapeutic regimen for metastatic or recurrent cancer unless recurrence within 6 months after the last dose of anti-cancer drugs as neo-adjuvant and\u002For adjuvant therapy.\n4. Subject must have at least 1 measurable lesion by RECIST 1.1\n5. Availability of tumor archival material or fresh biopsies\n6. ECOG performance status 0 or 1 and life expectancy ≥3 months\n7. Adequate hematologic function, hepatic function, and renal function\n8. Prior RT permitted if measurable disease exists outside the RT field or if disease progressed post-RT. RT must be completed ≥4 weeks before Cycle 1 Day 1\n9. Agree to use effective contraception\n10. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n\nExclusion Criteria:\n\n1. Treatment with nonpermitted drugs\n2. Prior treatment with a CD47 or SIRPα targeting agent\n3. Concurrent anticancer treatments\n4. Major surgery or significant traumatic injury prior to Screening or planned major surgery during the study period\n5. Previous malignant disease other than the target malignancy for this study\n6. Active infection requiring systemic therapy before Day 1\n7. Any active autoimmune disease, or history of autoimmune disease\n8. Any psychiatric or cognitive condition\n9. Known severe hypersensitivity reaction\n10. Pregnant or lactating\n11. Currently enrolled in another clinical study","19 Years",{"count":603,"type":20},62,[221],"This is an Open-Label, Dose-Escalation and Expansion, Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of IMC-002 in Patients with Advanced Cancer Failed to Standard Therapy",[26],[608,609,610,611],"IMC-002","Phase I","CD47","SIRPα","2026-04-21",{"date":614,"type":31},"2026-04-24",{"date":616,"type":31},"2022-06-02",{"date":618,"type":20},"2029-08-30",{"name":620,"class":241},"ImmuneOncia Therapeutics Inc."]