[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Immunome, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,63,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100579351","phase-1-a-phase-1-study-of-im-1021-in-participants-with-advanced-cancer-100579351",false,"NCT06823167","A Phase 1 Study of IM-1021 in Participants With Advanced Cancer","A Phase 1 Study of IM-1021 in Participants With Advanced Malignancies","Inclusion Criteria:\n\n1. Informed consent signed by the participant prior to conducting study-specific procedures\n2. ≥18 years of age\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n4. Histological or cytological diagnosis of:\n\n   Part A: advanced B-cell lymphomas or solid tumors, of the following subtypes:\n\n   B-cell Lymphomas:\n   * Mantle cell lymphoma (MCL)\n   * Diffuse large B-cell lymphoma (DLBCL) (including Richter's transformation)\n   * Follicular lymphoma\n   * Small lymphocytic lymphoma (SLL)\n\n   Solid Tumors:\n   * Pancreatic cancer\n   * Non-squamous non-small cell lung cancer (NSCLC)\n   * Malignant mesothelioma\n   * Epithelial ovarian cancer. Participants with fallopian tube and\u002For peritoneal malignancies are also eligible.\n   * Triple-negative breast cancer.\n   * Liposarcoma\n\n   Other, unlisted histologies, if approved by the Sponsor Medical Monitor\n\n   Part B Cohorts B1, B2, and B3:\n\n   Histological or cytological diagnosis of the cohort-specific disease indication. Indications may include those listed in Inclusion Criterion 4.a\n5. Participants must have adequate organ function.\n6. Participants must have a negative pregnancy test, be willing to practice highly effective methods of birth control, use condoms, and refrain from oocyte\u002Fsperm donation, as applicable, as detailed in the protocol.\n7. Participants must be refractory to or have relapsed after at least one prior standard therapeutic regimen. Participants must be relapsed or refractory to, have developed an intolerance to, or not be candidates for available therapies with established benefit. Participants with B-cell malignancies should have received at least two lines of therapy, including available therapies with established benefit. Participants with SLL should have received at least three prior lines of therapy.\n8. Participants must have measurable disease as per the relevant response assessment framework: Lugano Classification for lymphoma (except SLL) , per iwCLL criteria for SLL , and per RECIST v.1.1 for solid tumors.\n\nExclusion Criteria:\n\n1. Previously treated with an ADC with a topoisomerase-1 inhibitor payload, except: Participants with triple negative breast cancer may have received up to one prior ADC with a topoisomerase-1 inhibitor payload.\n2. Previously received a ROR1-targeted therapy (eg, ADC, cell therapy, or monoclonal antibody).\n3. History of an anaphylactic reaction to irinotecan or ≥ grade 3 GI toxicity to prior irinotecan.\n4. Life expectancy \\\u003C 12 weeks.\n5. Prior solid organ transplant.\n6. Participants with symptomatic ascites or pleural effusion. Participants who are clinically stable for at least 2 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis or catheter) are eligible.\n7. Participant has a known active central nervous system (CNS) primary tumor or metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no radiological evidence of new or enlarging brain metastases, and are off steroids or on a stable dose up to an equivalent of prednisone 10 mg\u002Fday for at least 15 days prior to first dose of study medication. Participants who have symptoms consistent with CNS metastasis must have a negative magnetic resonance imaging (MRI) or other clinically appropriate imaging study if the participant is not able to undergo contrast-enhanced MRI and approved by the Sponsor Medical Monitor during the screening period.\n8. Participant has a known history of malignant primary brain tumor, or another primary solid or hematologic malignancy (other than that under study), unless the participant has undergone potentially curative therapy with no evidence of that disease for at least 2 years. Exception: The time requirement does not apply to participants who underwent successful definitive resection of certain cancers.\n9. Participant has certain other significant medical conditions including cardiac, pulmonary, and infectious disease as detailed in the protocol.\n10. Participant is pregnant, breastfeeding, or expecting to conceive within the projected duration of the study.","ALL","18 Years",{"count":19,"type":20},117,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer.",[26,27],"Solid Malignancies","Hematologic Malignancies","RECRUITING","2026-06-17",{"date":31,"type":32},"2026-06-22","ACTUAL",{"date":34,"type":32},"2025-02-26",{"date":36,"type":20},"2029-02",{"name":38,"class":39},"Immunome, Inc.","INDUSTRY",17,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100631829","early-phase-1-a-phase-1-study-of-177lu-im-3050-in-participants-with-advanced-cancer-100631829","NCT07505771","A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Cancer","A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Malignancies","Inclusion Criteria:\n\n* ≥18 years of age\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1 or 2\n* Histological or cytological diagnosis of a solid tumor\n* Participants must be refractory to or have relapsed after at least one prior standard therapeutic regimen. Participants must be relapsed or refractory to, have developed an intolerance to, or not be candidates for available therapies with established benefit.\n* Participants must have measurable disease as per RECIST v.1.1 based on imaging performed during Screening.\n* During screening, participants must have positive FAP PET\u002FCT uptake as described in criteria for continuation of IM-3050 treatment.\n* Participants must have adequate organ function.\n\nExclusion Criteria:\n\n* Participant has received certain prior radiation therapy as detailed in the protocol\n* Participant has undergone major surgery within 4 weeks or minor surgery within 2 weeks of starting 177Lu-IM-3050 or has known active central nervous system (CNS) primary tumor or metastases and\u002For carcinomatous meningitis.\n* Participant has a known history of malignant primary brain tumor, or another primary solid or hematologic malignancy (other than that under study), unless the participant has undergone potentially curative therapy with no evidence of that disease for at least 3 years.\n\nException: The time requirement does not apply to participants who underwent successful definitive resection of certain cancers.\n\n* Recent or ongoing serious infection or other significant medical condition as detailed in the protocol.\n* Participant has received an investigational product or been treated with an investigational device within 30 days, or 5 half-lives prior to receiving the FAP PET\u002FCT imaging tracer or 177Lu-IM-3050.",{"count":49,"type":20},105,[51],"EARLY_PHASE1","IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.",[26],"2026-06-16",{"date":56,"type":32},"2026-06-18",{"date":58,"type":20},"2026-06",{"date":60,"type":20},"2034-12",{"name":38,"class":39},2,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100642624","phase-1-a-phase-1-study-of-im-1617-in-participants-with-advanced-cancer-100642624","NCT07578571","A Phase 1 Study of IM-1617 in Participants With Advanced Cancer","A Phase 1 Study of IM-1617 in Participants With Advanced Malignancies","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n2. Part A: Histological diagnosis of one of the following unresectable locally advanced or metastatic solid tumors:\n\n   * CRC, all subtypes\n   * NSCLC:\n\n     * Non-squamous cell carcinoma subtypes, such as adenocarcinoma\n     * Squamous cell carcinoma subtype\n   * Breast cancer (subtypes based on estrogen\u002Fprogesterone receptor and HER2 testing according to American Society of Clinical Oncology - College of American Pathologists guidelines):\n\n     * Triple-negative breast cancer\n     * HR+, HER2- subtype\n   * Esophageal, esophagogastric junction, and gastric cancer:\n\n     * Adenocarcinoma subtype\n   * Other histologies, if approved by the Medical Monitor, which may include: head and neck squamous cell carcinoma; cervical cancer; bladder cancer; squamous cell carcinoma subtype of esophageal, esophagogastric junction, and gastric cancer; HER2+ breast cancer\n3. Part B Cohorts - Histological diagnosis of one of the following unresectable locally advanced or metastatic solid tumors:\n\n   * Cohort B1: CRC, all subtypes\n   * Cohort B2: NSCLC\n\n     * Non-squamous cell carcinoma subtypes, such as adenocarcinoma\n     * Squamous cell carcinoma subtype\n   * Cohorts B3 and B4: Cohort-specific disease indications may include those listed for Part A\n4. Participants must have disease that is considered to be noncurative and meet the appropriate criteria below:\n\n   * Part A only: Participants have progressed on, were intolerant to, or have a contraindication to prior SOC treatments, with no satisfactory SOC treatment options available.\n   * Part B only:\n\n     * Cohort B1 (CRC):\n\n       * Participants must have previously progressed on, were intolerant to, or have a contraindication to fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, bevacizumab, and for those with RAS wild-type tumors, an anti-epidermal growth factor receptor (EGFR)-directed monoclonal antibody in advanced disease setting.\n       * Participants with actionable biomarkers must have been treated with at least one prior appropriate biomarker-directed therapy.\n       * If any of these therapies was given in the adjuvant setting, disease must have progressed within 6 months after completing therapy.\n     * Cohort B2 (NSCLC):\n\n       * Participants must have previously progressed on, were intolerant to, or have a contraindication to platinum-based chemotherapy and a programmed cell death-1 (PD-1)\u002Fprogrammed death ligand 1 (PD-L1) monoclonal antibody (given concurrently or sequentially with chemotherapy) in advanced disease setting.\n       * Participants with actionable biomarkers must have been treated with at least one prior appropriate targeted therapy.\n       * If any of these therapies was given in the adjuvant setting, disease must have progressed within 6 months after completing therapy.\n     * Cohorts B3 and B4: Criteria will be specified based on the disease indications selected.\n5. Participants must have measurable disease as defined per RECIST v1.1\n\nExclusion Criteria:\n\n1. Previously treated with an antibody-drug conjugate (ADC) with a topoisomerase-1 (TOP1) inhibitor payload. Exception: Participants with NSCLC or breast cancer may have received up to one prior ADC with a TOP1 inhibitor payload\n2. History of anaphylactic reaction to TOP1 inhibitors (e.g., irinotecan) or TOP1 inhibiting ADCs\n3. Life expectancy \\\u003C 12 weeks\n4. Prior solid organ transplant\n5. Symptomatic ascites or pleural effusion\n6. Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n7. Known history of another primary solid or hematologic malignancy (other than that under study), unless the participant has undergone potentially curative therapy with no evidence of recurrence for at least 2 years and approved by the Medical Monitor",{"count":71,"type":20},175,[23],"This study will test the safety and effectiveness of a drug called IM-1617 in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).\n\nThis study will have two parts. Part A will test increasing doses of IM-1617 to find out the safe dose and schedule of IM-1617 for participants. Part B will use the dose and schedule found in Part A to further study the safety of IM-1617 and if it works to treat solid tumor cancers.",[75,76,77,78,79,80],"Colorectal Cancer","Non-Small Cell Lung Cancer","Breast Cancer","Esophageal Cancer","Stomach Cancer","Cancer","2026-06-11",{"date":83,"type":32},"2026-06-15",{"date":85,"type":32},"2026-05-21",{"date":87,"type":20},"2029-01",{"name":38,"class":39},1,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":109,"leadSponsor":110,"locationsCount":89},"100643600","phase-1-a-relative-bioavailability-and-bioequivalence-study-of-varegacestat-in-healthy-participants-100643600","NCT07610005","A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants","A Phase 1, Open-Label, Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Varegacestat Administered in Different Dose Forms in Healthy Participants","Inclusion Criteria:\n\n* Healthy, adult, female of non childbearing potential or male, 18 to 55 years of age, inclusive, at the screening visit\n* Male participants must follow protocol-specified contraception guidance\n* Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing\n* BMI ≥ 18.0 and ≤ 32.0 kg\u002Fm2 and with a body weight \\> 50 kg at the screening visit\n* Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee\n* Able to swallow multiple capsules\n\nExclusion Criteria:\n\n* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study\n* History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee\n* History of any illness that, in the opinion of the PI or designee might confound the results of the study or poses an additional risk to the participant by their participation in the study\n* History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing\n* History or presence of hypersensitivity or idiosyncratic reaction to varegacestat or related compounds\n* History or presence of:\n\n  * Autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus\n  * Thrombophlebitis or deep vein thrombosis\n  * Hematologic or coagulation disorders\n  * Liver disease or dysfunction; Gilbert's syndrome\n  * Renal dysfunction or glomerulonephritis\n  * Cancer (except treated basal cell carcinoma of the skin and cancer-free for 5 years, non metastatic basal or squamous cell carcinoma of the skin, and cervical carcinoma in situ)\n  * Clinically significant cardiovascular, gastrointestinal, pulmonary, endocrine, central nervous system disorders, or other major active and uncontrolled disease in the opinion of the PI or designee.",true,"55 Years",{"count":100,"type":20},20,[23],"This is an open-label, randomized, crossover study to evaluate the relative bioavailability (rBA) and bioequivalence (BE) of a test capsule formulation of varegacestat compared to reference capsules formulation under fasting conditions.",[104],"Healthy","2026-06-04",{"date":107,"type":32},"2026-06-08",{"date":85,"type":32},{"date":58,"type":20},{"name":38,"class":39},""]