[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ryvu Therapeutics SA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":127},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,77,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100591948","phase-2-rvu120-rollover-study-100591948",false,"NCT06987058","RVU120 Rollover Study","An Open-label Multicenter Rollover Study to Provide Continued Treatment to Participants Previously Enrolled in a RVU120 Clinical Study","ROVER-01","Inclusion Criteria:\n\n1. The participant is enrolled in a RVU120 clinical study and receiving RVU120-based treatment given alone or in combination for at least 5 cycles.\n2. The participant is currently benefiting from, and expected to continue to benefit from, RVU120-based treatment according to the criteria set out in the parent study protocol and according to the judgment of the investigator and sponsor.\n3. The participant does not have access to commercially available comparator anticancer therapy.\n4. Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n5. The participant signed the rollover study ICF prior to any study-related procedure or study data collection.\n6. The participant agrees not to donate blood during study participation and until 28 weeks (\\~6.5 months) after the last dose.\n7. The investigator considers the participant to be eligible for participation in the rollover study.\n\nExclusion Criteria:\n\n1. Presence of toxicity that cannot be adequately managed.\n2. Concurrent participation in any therapeutic clinical study other than the parent study.","ALL","18 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multicenter rollover study to provide continued treatment to eligible participants previously enrolled in a RVU120 clinical study and to evaluate the safety of the treatment and record the time on treatment when continued under the same regimen as in the parent study.\n\nTo be eligible for this rollover study, participants must be continuing to benefit from their treatment, show an acceptable safety profile, and not have access to commercially available comparator anticancer therapy. Once transitioned to this study, participants will continue with their next planned dose per the regimen of their parent study.",[27,28,29],"Advanced Solid Tumors","Acute Myeloid Leukaemia (AML)","High-risk Myelodysplastic Syndrome",[31,32,33,34,35,36,37],"Relapse","Refractory","Metastatic","Advanced","Solid Tumor","AML","Myelodysplastic syndrome","NOT_YET_RECRUITING","2025-09-23",{"date":41,"type":42},"2025-09-24","ACTUAL",{"date":44,"type":21},"2025-12-15",{"date":46,"type":21},"2026-08",{"name":48,"class":49},"Ryvu Therapeutics SA","INDUSTRY",2,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100557155","phase-2-men1703-sel24-to-treat-relapsed-or-refractory-aggressive-b-cell-non-hodgkin-lymphoma-jaspis-01-100557155","NCT06534437","MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)","An Open Label, Phase 2 Clinical Trial of MEN1703 as Monotherapy and in Combination With Glofitamab in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma","JASPIS-01","Inclusion Criteria:\n\n1. Age ≥18 years old\n2. Documented histological confirmation of aggressive B-cell non-Hodgkin lymphoma including DLBCL NOS and transformed indolent B-cell lymphoma\n3. Relapsed or refractory disease having received at least 2 prior lines of systemic treatment and, naïve to anti-CD3xCD20 bispecific antibody treatment (group 1) or exhausted all standard, available treatment options (group 2)\n4. At least 1 measurable site of disease based on computed tomography (CT) or positron emission tomography (PET)-CT scan with involvement of 2 or more clearly demarcated lesions and or nodes.\n5. Availability of lymph node tissue at Screening (or archival sample) (part 2 participants only)\n6. Life expectancy of ≥12 weeks.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2\n8. Adequate organ function at Screening\n9. Adequate hematologic function\n\nExclusion Criteria:\n\n1. Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening.\n2. Received anti-cancer treatments, including cytotoxic chemotherapy, radiotherapy, hormonal therapy, biologic, immunotherapy, or investigational drugs within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug. Prior treatment with CAR-T cell or an anti-CD3xCD20 bispecific antibody therapy (permitted for Group 2 only), requires a wash out period of ≥4 weeks.\n3. Concurrent participation in another therapeutic clinical study.\n4. Ongoing clinically significant toxicity (for example, alopecia is not clinically significant) from any prior anti-cancer therapy that has not resolved to Grade 1 or less prior to the first dose of study drug.\n5. Prior treatment with a PIM inhibitor.\n6. Group 1 only: Any prior therapy with a bispecific antibody targeting CD3 and CD20.\n7. Known risk of allergy to the study drugs, MEN1703 (group 1 and 2) or glofitamab (group 1) or their excipients\n8. Contraindication to all uric acid lowering agents.\n9. Major surgery within 1 month prior to first dose of study drug.\n10. Hematopoietic stem cell transplant within 4 months prior to first dose of study drug.\n11. Requires systemic immune-modulating therapy (regardless of dose) or has confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression.\n12. Exposed to live or live attenuated vaccine(s) within 4 weeks prior to signing the informed consent form (ICF).\n13. Evidence of ongoing and uncontrolled systemic bacterial, fungal, or viral infection, except for documented Grade Common Terminology Criteria for Adverse Events (CTCAE) ≤2 infections with evidence of improvement or without evidence of worsening infection.\n14. Known human immunodeficiency virus (HIV) infection\n15. Current active liver disease from any cause\n16. Ongoing drug-induced pneumonitis.\n17. Ongoing inflammatory bowel disease.\n18. Active known second malignancy\n19. Received an agent known to be a sensitive CYP2D6 substrate or a CYP2D6 substrate with a narrow therapeutic range, a strong or moderate CYP2D6 inhibitor, or a BCRP inhibitor within 14 days or 5 half-lives (whichever is shorter), prior to the first dose of study drug.\n20. Cardiac dysfunction is defined as myocardial infarction within 6 months of study entry, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled dysrhythmias, or poorly controlled angina.\n21. Receiving treatment for active, ongoing thromboembolic event. Note: Does not apply to prophylactic treatment to prevent or avoid reoccurrence of a prior resolved event. To review with Medical Monitor where further risk assessment is needed.\n22. History of serious ventricular arrhythmia (e.g., VT or VF, ≥3 beats in a row), or QT interval corrected for heart rate (QTc) ≥480 ms.\n\n    Note: QTc values up to 500 ms will be acceptable where patient's medical history e.g., bundle branch block, is known to cause mild QTc prolongation and the condition is well controlled.\n23. Any disease, syndrome or condition which may significantly affect drug intake via oral route.\n24. Planning to become pregnant or breastfeed during treatment and for 1 month after the last dose of study drug.\n25. Any other prior or current medical condition, intercurrent illness, surgical history, physical or 12-lead electrocardiogram (ECG) findings, laboratory abnormalities, or extenuating circumstance (e.g., alcohol or drug addiction) that, in the investigator's opinion, could jeopardize patient safety or interfere with the objectives of the study.",{"count":60,"type":21},178,[24],"The goal of the study is to assess the safety and anti-lymphoma activity of MEN1703 (Dapolsertib hydrochloride) when given as a single-agent or combined with glofitamab to patients with relapsed\u002Frefractory (R\u002FR) aggressive B-cell non-Hodgkin lymphoma. The study will be open to groups at the same time:\n\n* Group 1 - patients who have not had anti-CD3xCD20 bispecific antibody therapy but who have had at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma\n* Group 2 - patients who have exhausted all standard treatment options including at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma Group 1 patients will be treated for a maximum of 12 cycles. One cycle is 21 days. Group 2 with be treated until the disease progresses, therefore treatment duration is dependent on the number of treatment cycles a participant receives prior to progression.",[64],"Non-Hodgkin Lymphoma, B-cell",[66,32,67],"Relapsed","Aggressive","RECRUITING",{"date":70,"type":42},"2025-09-29",{"date":72,"type":42},"2024-12-05",{"date":74,"type":21},"2026-12",{"name":48,"class":49},36,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100546620","phase-2-rvu120-in-patients-with-intermediate-or-high-risk-primary-or-secondary-myelofibrosis-100546620","NCT06397313","RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis","An Open-Label Clinical Trial of RVU120 as Monotherapy and in Combination With Ruxolitinib in Patients With Intermediate or High-Risk, Primary or Secondary Myelofibrosis (POTAMI-61)","POTAMI-61","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Diagnosis of Primary or Secondary myelofibrosis (MF) according to the revised World Health Organization (WHO) criteria (Arber 2022).\n3. Intermediate or high-risk disease.\n4. Resistant or refractory to prior Janus kinase (JAK) inhibitor treatment or ineligible for JAK inhibitor treatment in the opinion of the investigator; or Suboptimal response to JAK inhibitor treatment. Note: a suboptimal response to JAK inhibitor treatment is defined as spleen size increase by palpation \\>25% after the first 3 months of treatment with a JAK inhibitor or persistent splenomegaly (spleen volume of \\>450 cm3) after at least 6 months of JAK inhibitor treatment and presence of 1 symptom score ≥5 or 2 symptom scores ≥3, new or persistent red blood cell (RBC) transfusion dependence; or may include participants naïve to previous treatment with JAK inhibitor.\n5. Measurable splenomegaly as demonstrated by palpable spleen measuring ≥5 cm below the left costal margin. The edge of the spleen should be measured from the mid-clavicular line on the left side of the abdomen to the point of greatest splenic protrusion; or spleen volume of ≥450 cm3 measured by magnetic resonance imaging(MRI) or computed tomography (CT).\n6. Active symptoms of MF as demonstrated by a symptom score of at least 5 points (on a 0 to 10 scale) on at least one of the symptoms or a score of 3 or greater on at least 2 of the following symptoms: night sweats, itchiness, abdominal discomfort, pain under ribs on left side, early satiety, bone or muscle pain, and inactivity.\n7. Eastern Cooperative Oncology Group (ECOG) performance score 0-2.\n8. Adequate hematologic function defined as:\n\n   1. absolute neutrophil count (ANC) ≥1.0 × 109\u002FL (without growth factor support)\n   2. platelet count ≥50 × 109\u002FL (Cohort 2 and Cohort 3 only)\n9. Adequate renal function defined as calculated or measured creatinine clearance (CrCl) of ≥30 mL\u002Fminute using the formula of Cockcroft and Gault (see Section 15).\n10. Adequate liver function defined as (a) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN); (b) alkaline phosphatase (ALP) ≤2 × ULN (ALP ≤5 × ULN for participants with isozymes specific to bone); (c) bilirubin \\\u003C2 × ULN or bilirubin ≤3 × ULN if due to Gilbert's disease.\n\nExclusion Criteria:\n\nEach participant must not meet any of the following:\n\n1. Peripheral blood blast count of ≥10% or bone marrow blast count of ≥10%.\n2. Prior history of hematopoietic stem cell transplant.\n3. Participation in any other study in which receipt of an investigational new drug occurred within 4 weeks prior to Cycle 1 Day 1.\n4. Active known second malignancy with the exception of any of the following:\n\n   1. Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer\n   2. Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥2 years\n   3. Low-risk prostate cancer with a Gleason score \\\u003C7 and a prostate-specific antigen (PSA) level \\\u003C10 ng\u002FmL\n   4. Any other cancer from which the participant has been disease-free for ≥3 years.\n5. Known or suspected allergy to RVU120 or RUX.\n6. Impairment of gastrointestinal function or gastrointestinal disease\n7. Major surgical procedure or significant traumatic injury within 28 days Placement of a vascular access device or minor surgery is permitted within 14 days before Cycle 1 Day 1 (provided that the wound has healed).\n8. Ongoing systemic infection requiring antibiotic, antiviral, or antifungal treatment. Note: prophylactic treatment is allowed.\n9. Significant cardiac dysfunction defined as myocardial infarction within 12 months of Cycle 1 Day 1, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled dysrhythmias, poorly controlled angina (Section 17), or left ventricular ejection fraction (LVEF) \\\u003C40% as per echocardiography or multiple gated acquisition (MUGA) scan.\n10. Taking any medications, herbal supplements, or other substances (including smoking) that are known to be strong inhibitors or moderate\u002Fstrong inducers or sensitive substrates of CYP1A2, within less than 5 half-lives prior to Cycle 1 Day 1.\n11. History of ventricular arrhythmia, or QTc ≥470 millisecond (Bazett's formula).\n12. Known active human immunodeficiency virus (HIV) infection\n13. Current active liver disease from any cause\n14. Pregnant or lactating females.\n15. Any other prior or current medical or psychiatric condition, intercurrent illness, surgical history, physical or electrocardiogram (ECG) findings, laboratory abnormalities, or extenuating circumstance (e.g., alcohol or drug addiction) that, in the Investigator's opinion, could jeopardize participant safety or interfere with the objectives of the study.",{"count":86,"type":21},230,[24],"The objective of this clinical trial is to evaluate the efficacy (how well the drug works), safety, pharmacokinetics (PK), and pharmacodynamics (PD) of the study drug, RVU120, in treating adult patients with intermediate or high-risk, primary or secondary myelofibrosis. RVU120 will be given as a single agent or in combination with ruxolitinib.",[90],"Myelofibrosis",[92,93,94,95],"intermediate","high-risk","primary","secondary","2025-09-22",{"date":39,"type":42},{"date":99,"type":42},"2024-09-19",{"date":101,"type":21},"2027-10",{"name":48,"class":49},18,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100530782","phase-2-safety-and-efficacy-of-rvu120-combined-with-venetoclax-for-treatment-of-relapsedrefractory-aml-100530782","NCT06191263","Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed\u002FRefractory AML","A Multicenter, Open-Label, Dose-Finding Clinical Trial to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Efficacy of RVU120 in Combination With Venetoclax in Participants With Acute Myeloid Leukemia Who Failed Prior Therapy With Ventoclax and a Hypomethylating Agent","RIVER-81","Inclusion Criteria:\n\n* Patients must have a diagnosis of AML (per 2022 WHO classification)\n* Patients must have relapsed or refractory AML (per ELN 2022 criteria)\n* Patients must have failed first-line treatment with venetoclax combined with a hypomethylating agent\n* Patients must have no alternative therapeutic options likely to produce clinical benefit\n* Patients must have ECOG performance status of 0 to 2\n* Patients must have adequate end organ function defined as:\n\n  1. WBC \\\u003C 25 x 10(9)\u002FL on Day 1 prior to first dose of study drug\n  2. Platelet count \\> 10,000\u002FmcL on Day 1 prior to first dose of study drug\n  3. AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3 x ULN (upper limit of normal)\n  4. Total bilirubin ≤ 3 x ULN\n  5. Creatinine clearance (Cockcroft \\& Gault formula) ≥ 50 mL\u002Fmin\n  6. LVEF (left ventricular ejection fraction) ≥ 40% by electrocardiography\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document and complete study related procedures\n\nExclusion Criteria:\n\n* APL (acute promyelocytic leukemia), the M3 subtype of AML\n* Active CNS (central nervous system) leukemia\n* Previous treatment with CDK8 and\u002For CDK19-targeted therapy\n* Major surgery within 28 days prior to the first dose of study drug\n* Hematopoietic stem cell transplant within 120 days prior to the first dose of study drug\n* Currently pregnant or breast-feeding. Females of child bearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study drug\n* Uncontrolled intercurrent illness that could limit life expectancy or ability to complete study correlates. This includes but is not limited to:\n\n  1. Active, Grade ≥2 acute GVHD (graft versus host disease) or requirement for systemic immunosuppressive medication for GVHD\n  2. Evidence of ongoing or uncontrolled systemic bacterial, fungal or viral infection and acute inflammatory conditions (including pancreatitis)\n  3. Ongoing significant liver disease such as cirrhosis, drug-induced liver injury, active hepatitis, or chronic persistent hepatitis B and\u002For hepatitis C\n  4. Ongoing drug-induced pneumonitis\n  5. Significant cardiac dysfunction, defined as myocardial infarction within 12 months prior to the first dose of study drug, NYHA (New York Heart Association) Class III or IV heart failure, uncontrolled dysrhythmias, poorly controlled angina\n  6. History of ventricular arrhythmia or QTc ≥ 470 ms (Bazett's formula)\n  7. Prior history of malignancies other than AML, unless disease-free for 5 years or more or prior basal cell carcinoma of the skin, non-metastatic squamous cell carcinoma of the skin, carcinoma in situ of cervix, breast or bladder, and incidental histological finding of prostate cancer (TMN stage T1a or T1b)\n* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RVU120 and\u002For venetoclax\n* Taking any medications, herbal supplements, or other substances (including smoking( that are known to be strong inhibitors or moderate\u002Fstrong inducers or sensitive substrates of CYP1A2\n* Taking any medications, over-the-counter medications, foods or herbal supplements that are known to be strong or moderate inhibitors of CYP3A4 or P-gp (P-glycoprotein)\n* Known allergy or hypersensitivity to any component of RVU120 or venetoclax formulations",{"count":113,"type":21},98,[24],"The goal of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of RVU120 when administered in combination with venetoclax to adult patients with acute myeloid leukemia (AML) who are relapsed or refractory to prior therapy with venetoclax and a hypomethylating agent. The study consists of three parts. Part 1 aims to identify the doses of RVU120 and venetoclax that are considered to be safe and tolerated. Part 2 will assess the safety and efficacy of the doses selected. And Part 3 is a confirmatory cohort where patients will be treated at the same doses assessed in Part 2",[117],"Acute Myeloid Leukemia","2025-04-09",{"date":120,"type":42},"2025-04-13",{"date":122,"type":42},"2024-01-05",{"date":124,"type":21},"2026-09",{"name":48,"class":49},37,""]