[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ImmunoGenesis\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100517204","phase-1-study-to-evaluate-imgs-001-treatment-in-patients-with-relapsed-or-refractory-advanced-solid-tumors-100517204",false,"NCT06014502","Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors","A Phase 1a\u002F1b, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMGS-001 in Patients With Relapsed or Refractory Advanced Solid Tumors","Inclusion Criteria:\n\n* Part 1 Dose-escalation: Patients must have histologically confirmed locally advanced, or metastatic solid tumors who have progressed after receiving appropriate lines of standard therapy known to potentially confer clinical benefit.\n* Part 2 Dose-expansion: Patients must have histologically confirmed locally advanced, or metastatic cancer in one of the following pre-specified tumor types and meet tumor-specific criteria:\n\n  1. Ovarian: Failed or intolerant to prior lines of appropriate SOC chemotherapy and targeted therapy regimens. Must be naïve to treatment with PD-1 and PD-L1 targeting agents.\n  2. Colorectal (microsatellite stable; PD-L1 positive \\[CPS ≥ 5 or TPS ≥ 5%\\]): Failed or intolerant to prior lines of appropriate SOC chemotherapy and targeted therapy regimens. Must be naïve to treatment with PD-1 and PD-L1 targeting agents.\n  3. Non-small cell lung (EGFR wild-type): Failed or intolerant to prior lines of appropriate SOC chemotherapy and targeted therapy regimens. Failed, did not respond, or intolerant to prior immune checkpoint therapy (e.g., anti-PD-1).\n  4. Nasopharyngeal: Failed or intolerant to prior lines of appropriate SOC chemotherapy and targeted therapy regimens. Failed, did not respond, or intolerant to prior immune checkpoint therapy (e.g., anti-PD-L1).\n  5. Head and neck\u002Fcervical (HPV positive): Failed or intolerant to prior lines of appropriate SOC chemotherapy and targeted therapy regimens. Failed, did not respond, or intolerant to prior immune checkpoint therapy (e.g., anti-PD-L1).\n* Prostate cancer patients enrolled in Part 1 dose escalation must continue ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analog or have undergone a bilateral orchiectomy (surgical or medical castration) and must have a serum testosterone ≤1.73 nmol\u002FL (50 ng\u002FdL) at screening.\n* Patients eligible to enroll in cohorts with prior immune checkpoint therapy must meet the following criteria:\n\n  1. Received at least 2 doses of an approved or investigational anti PD-1 or anti-PD-L1 inhibitor.\n  2. Last dose of therapy must have been ≥ 28 days prior to Cycle 1 Day 1.\n  3. Eligible patients include those patients treated with anti PD-1\u002Fanti PD-L1 drugs who have progressed following response to prior therapy, and those that have failed to demonstrate any response to prior therapy.\n* Colorectal patients participating in Part 2 (Phase 1b) must have confirmed PD-L1 positive expression (CPS ≥ 5 or TPS ≥ 5%) using local laboratory results based on prior results obtained within 6 months of baseline, expression testing done on archived tissue within 6 calendar months of baseline, or fresh biopsy.\n* Male or female ≥ 18 years of age.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Life expectancy \\> 3 months.\n* At least one measurable lesion as defined by RECIST 1.1.\n\n  a. A lesion that was previously irradiated may be considered a target lesion only if it is measurable per RECIST 1.1, has documented progression, and is clearly defined.\n* Patients must have a non-target lesion that can be biopsied. If a patient only has one target lesion (and no non-target lesions) the target lesion used for biopsy must be ≥ 2 cm in longest diameter. Eligible subjects for biopsy must be clinically appropriate, including specimens attainable and on appropriate subjects without presenting high risk of major complications. Subjects who are unable to undergo a biopsy at screening must submit archival tumor tissue retrieved within the last 6 months.\n* Patients must have adequate bone marrow and organ function as defined by:\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL.\n  2. Platelet count of ≥ 100.0×10\\^9\u002FL.\n  3. Hemoglobin of ≥ 9.0 g\u002FdL.\n  4. Creatinine clearance ≥ 30 mL\u002Fmin.\n  5. Liver function test: AST (SGOT) and ALT (SGPT) ≤ 2.5 times the institutional ULN.\n  6. Total bilirubin: ≤ 1.5 x ULN.\n\nExclusion Criteria:\n\n* Receipt of any investigational or conventional anti-cancer drug\u002Ftherapy within 21 days of Cycle 1 Day 1.\n* Current or prior use of immunosuppressive medication within 14 days of Cycle 1 Day 1. Inhaled and intranasal corticosteroids are allowed.\n* Current or prior use of interleukin-2, interferon, or other immunotherapy medication within 28 days of Cycle 1 Day 1.\n* Live vaccine within 28 days prior to Cycle 1 Day 1.\n* Any toxicity from prior standard therapy that has not resolved to ≤ Grade 1 or baseline per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 at the time of consent. Alopecia is an exception. Any patients with irreversible Grade 1 or Grade 2 toxicities that are considered stable may be enrolled after discussion with the Medical Monitor.\n* Prior anti-PD-1 or anti-PD-L1-related Grade 3 or Grade 4 toxicity resulting in treatment discontinuation of the drug.\n* Secondary malignancy other than the target malignancy to be investigated in this trial within the last 2 years.\n* History of myocardial infarction, ischemic heart disease, symptomatic congestive heart failure (New York Heart Association (NYHA) Class III IV), or significant cardiac arrhythmias within 3 months of study enrollment.\n* Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) or pulmonary embolism within 3 months of study enrollment.\n* History of acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis, bowel perforation, or other known risk factors for bowel perforation.\n* Active, uncontrolled, or prior documented autoimmune disorders including but not limited to inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, systemic sclerosis (scleroderma), Systemic Lupus Erythematosus, or autoimmune vasculitis (e.g., Wegener's Granulomatosis). Alopecia, vitiligo, celiac disease controlled by diet, and chronic skin conditions not requiring systemic therapy\u002Fimmunosuppressive treatment is permitted.\n* Uncontrolled intercurrent illness, including active infection requiring systemic therapy, uncontrolled hypertension (\\> 150\u002F90mm Hg despite optimal medical management), uncontrolled asthma, psychiatric illness\u002Fsocial situations, substance abuse, or other underlying medical conditions that would limit compliance with study requirements, obscure the interpretation of AEs, substantially increase the risk of developing AEs, or make the administration of study treatment hazardous.\n* Active human immunodeficiency virus (HIV) infection (Exception: patients with well-controlled HIV \\[e.g., CD4 ≥ 350 cells\u002FuL and undetectable viral load\\] who have been on an effective \\[drug, dosage, and schedule associated with reduction and control of the viral load\\] antiretroviral therapy \\[ART\\] for ≥ 4 weeks are eligible). Patients with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last 12 months are not eligible.\n* Active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with a history of HCV infection must have completed curative antiviral treatment and must have a viral load below the limit of quantification. A patient who is HCV antibody (Ab) positive but HCV RNA negative due to prior treatment or natural resolution is eligible.\n* History of solid organ transplantation.\n* Newly diagnosed, uncontrolled, and\u002For untreated cancer-related central nervous system disease. Patients with treated brain metastases that are radiographically or clinically stable for at least 28 days after therapy and have no evidence of cavitation or hemorrhage in the brain lesion(s) are eligible if they are asymptomatic and do not require corticosteroids (the patient must have discontinued steroids at least 14 days prior to Cycle 1 Day 1).\n* Major surgery, open biopsy, or significant traumatic injury within 28 days of Cycle 1 Day 1, or still recovering from prior surgery. Port placement and other local procedures are allowed if completed at least 48 hours prior to Cycle 1 Day 1.\n* Abnormal pulmonary function within the previous 6 months prior to Cycle 1 Day 1, including history of or active pneumonitis, interstitial lung disease requiring the use of steroids, idiopathic pulmonary fibrosis, recurrent pleural effusion (including malignant origin), severe dyspnea at rest or requiring supplementary oxygen therapy.\n* Patients who have experienced any infusion related reaction Grade 3 or higher from prior therapy per NCI CTCAE version 5.0","ALL","18 Years",{"count":19,"type":20},105,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this Phase 1a\u002F1b clinical trial is to test the safety of an investigational drug called IMGS-001 and to determine how well it can work in treating patients with advanced solid tumors that have come back or are not improving after receiving other drugs that are commonly used for their cancer. Phase 1a (Part 1) will test the safety of five different doses of IMGS-001 to use in further studies. Patients with cancer that have advanced or spread to other parts of the body following treatment with other available therapies will be treated in Part 1. Phase 1b (Part 2) will test two doses of IMGS-001 identified in Part 1 to further determine the safety and potential effectiveness in select cancer types.",[26],"Solid Tumor","RECRUITING","2026-05-06",{"date":30,"type":31},"2026-05-08","ACTUAL",{"date":33,"type":31},"2023-09-07",{"date":35,"type":20},"2027-12",{"name":37,"class":38},"ImmunoGenesis","INDUSTRY",6,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100576227","phase-1-a-study-of-evofosfamide-in-combination-with-zalifrelimab-and-balstilimab-100576227","NCT06782555","A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab","A Phase 1\u002F2 Immunotherapy Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab in Patients with Advanced Solid Malignancies","Inclusion Criteria:\n\n1. Histologically confirmed locally advanced or metastatic castration-resistant prostate cancer, pancreatic cancer, or HPV-negative SCCHN for which no other lines of standard therapy with demonstrated clinical benefit are available or appropriate as treatment.\n2. Appropriate to enter a clinical trial with a minimum estimated life expectancy of at least 3 months.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n4. Measurable disease as defined by RECIST 1.1. Patients with castration-resistant prostate cancer can have measurable or evaluable disease per PCWG3 criteria. Patients with evaluable disease must have documented evidence of PD as defined by any of the following:\n\n   * PSA progression: minimum of 2 rising values (3 measurements) obtained a minimum of 7 days apart with the last result being at least ≥4.0 ng\u002FmL.\n   * New or increasing non-bone disease per RECIST 1.1 criteria.\n   * Positive bone scan with 2 or more new lesions (PCWG3).\n5. Adequate bone marrow function as defined by the following laboratory test results obtained within 7 days of Cycle 1 Day 1:\n\n   * White blood cell count ≥2500 cells\u002Fmm3.\n   * Absolute neutrophil count ≥1500 cells\u002Fmm3.\n   * Absolute lymphocyte count \\>500 cells\u002Fmm3.\n   * Hemoglobin ≥9 g\u002FdL.\n   * Platelets ≥75,000 cells\u002Fmm3.\n6. Adequate liver function as defined by the following laboratory test results obtained within 7 days of Cycle 1 Day 1:\n\n   * Bilirubin ≤1.5 × institutional ULN; for patients with known Gilbert's syndrome, ≤3 × institutional ULN.\n   * Aspartate aminotransferase (SGOT) and alanine aminotransferase (SGPT) ≤3 × institutional ULN; if liver metastases are present, then ≤5 × ULN is allowed.\n7. At least 3 weeks from previous cytotoxic chemotherapy or radiation therapy and at least 5 half-lives or 6 weeks, whichever is shorter, from targeted or biologic therapy with the exception of CTLA-4, PD-1, or PD-L1 blocking antibodies for which only a 2 week interval is required. Patients with prostate cancer, unless they have undergone prior orchiectomy, may continue to receive androgen deprivation therapy, anti-androgen therapy, or therapy that interferes with androgenic stimulation.\n8. All patients must be willing to undergo a biopsy to provide a new tumor sample within 14 days of Cycle 1 Day 1. Patients who are unable to undergo a biopsy at screening must submit archival tumor tissue retrieved within the last 6 calendar months. Patients must also consent to undergo a biopsy between Day 15 of Cycle 2 and Day 8 of Cycle 3 in those subjects which it is clinically safe and attainable. A biopsy is not required for participants with metastatic prostate cancer with bone-only disease or inaccessible soft tissue lesions.\n9. Calculated creatinine clearance ≥ 60 mL\u002Fmin (by the Cockcroft Gault formula) within 7 days of Cycle 1 Day 1\n\nExclusion Criteria:\n\n1. A history of currently active\u002Funcontrolled autoimmune diseases or disorders, including inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, systemic sclerosis (scleroderma), systemic lupus erythematosus, or autoimmune vasculitis (eg, Wegener's granulomatosis).\n2. Patients with prior history of any Grade 3 or Grade 4 AEs from anti-CTLA-4, anti-PD-1\u002FPD-L1, or anti-CTLA-4 and anti-PD-1\u002FPD-L-1 combination therapy.\n3. History of acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, abdominal carcinomatosis, or other known risk factors for bowel perforation.\n4. Patients on long-term systemic steroids (\\>10 mg daily prednisone equivalent initiated \\>2 weeks prior to study enrollment). Inhaled or topical steroids are permitted in the absence of active autoimmune disease.\n5. Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study treatment hazardous or obscure the interpretation of AEs, e.g., a condition associated with frequent diarrhea or chronic skin conditions, recent surgery (within 30 days) or colonic biopsy from which the patient has not recovered, partial endocrine organ deficiencies, or substance abuse.\n6. Concomitant use of QT-prolonging drugs with a risk of causing Torsades de Pointes (TdP).\n7. History of risk factors for TdP, including family history of long QT syndrome.\n8. Corrected QT (QTc) interval of ≥470 msec calculated according to Fridericia's formula (QTc=QT\u002FRR \\[0.33\\]).\n9. Sustained systolic blood pressure (BP) \\>140 mmHg or \\\u003C90 mmHg and sustained diastolic BP \\>100 mmHg or \\\u003C60 mmHg.\n10. Patients with newly diagnosed, uncontrolled and\u002For untreated cancer-related central nervous system disease. Patients with treated brain metastases that are radiographically or clinically stable for at least 2 weeks after therapy and have no evidence of cavitation or hemorrhage in the brain lesion(s) are eligible if they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to study enrollment).\n11. Uncontrolled intercurrent illness including, but not limited to, myocardial infarction within 6 months, unstable symptomatic ischemic heart disease, significant cardiac arrythmias, active uncontrolled infection requiring systemic therapy, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n12. Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to study enrollment.\n13. Current evidence of active and uncontrolled infection, New York Heart Association Class III-IV chronic heart failure, documented Child's class B and C cirrhosis, active symptomatic pancreatitis, or uncontrolled medical disease which, in the opinion of the investigator, could compromise assessment of study treatment efficacy.\n14. Active human immunodeficiency virus infection (Exception: patients with well-controlled HIV \\[e.g., CD4 ≥ 350 cells\u002FuL and undetectable viral load\\] who have been on an effective (drug, dosage, and schedule associated with reduction and control of the viral load) antiretroviral therapy (ART) for ≥ 4 weeks are eligible). Patients with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last 12 months are not eligible. Note: Drug-drug interactions with ART occur via many mechanisms, with cytochrome P450 CYP3A4-mediated interactions being the most common. Patients who are using concurrent strong or moderate CYP3A4 inhibitors (e.g., ritonavir, cobicistat) or strong or moderate CYP3A4 inducers must be switched to an alternate effective ART regimen ≥ 4 weeks before study enrollment or should be excluded from the study if their regimen cannot be altered.\n15. Active or chronic hepatitis B or C virus infection. Patients with a history of HCV infection must have completed curative antiviral treatment and must have a viral load below the limit of quantification. A patient who is HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution is eligible.\n16. Known hypersensitivity to any components of the study treatment or any of their excipients or analogs or drugs of similar chemical or biologic composition.\n17. Live vaccine within 4 weeks prior to study enrollment.\n18. Concomitant therapy with interleukin-2, interferon, or other non-study immunotherapy agents, or immunosuppressive agents.\n19. Concomitant use of strong or moderate inhibitors or strong or moderate inducers of CYP3A4 within 14 days or 5 half-lives (whichever is longer) prior to study enrollment and for the duration of study treatment.\n20. Concomitant use of anti-cancer chemotherapy, radiotherapy, hormone therapy, or targeted therapy. Patients with prostate cancer may continue treatment with anti-androgen and bone targeted therapies (e.g., zoledronic acid and denosumab). Palliative radiotherapy to nontarget lesions is permitted.",{"count":48,"type":20},71,[23,50],"PHASE2","The purpose of this Phase 1\u002F2 study is to test the overall safety, tolerability, and effectiveness of the combination investigational drugs evofosfamide, zalifrelimab, and balstilimab in treating advanced or metastatic castration-resistant prostate cancer, pancreatic cancer, and human papilloma virus (HPV)-negative squamous cell carcinoma of the head and neck (SCCHN).",[53,54,55],"Metastatic Prostate Cancer","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Pancreatic Cancer","2025-01-17",{"date":58,"type":31},"2025-01-21",{"date":60,"type":31},"2025-01-08",{"date":62,"type":20},"2028-01",{"name":37,"class":38},1,""]