[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aurigene Discovery Technologies Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":128},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,77,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100643218","phase-2-aur103-calcium-in-advanced-neuroendocrine-tumours-bharat-3-study-100643218",false,"NCT07640737","AUR103 Calcium in Advanced Neuroendocrine Tumours (BHARAT-3 Study)","A Phase 2 Study Evaluating the Efficacy and Safety Agent AUR103 Calcium in Patients With Advanced, Well or Moderately Differentiated Neuroendocrine Tumours (BHARAT-3)","BHARAT-3","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Eastern Coorperative Oncology Group (ECOG) Performance status of 0 or 1.\n3. Pathologically confirmed, well or moderately differentiated (G1 or G2), advanced (unresectable or metastatic), neuroendocrine tumour.\n4. Patients should have progressed after at least one line of therapy.\n\n   Notes:\n   1. All previous treatments are allowed\n   2. There is no upper limit on the number of prior lines of therapy.\n   3. Patient should have received at least one FDA approved therapy for his\u002Fher disease (i.e., Patient should have received at least one of everolimus, sunitinib, cabozantinib or Lu177 dotatate for his\u002Fher specific NET, as per FDA approved package insert).\n   4. SSA (Somatostatin Analogues) alone is not considered a line of therapy for Inclusion criterion 4.\n5. Disease progression with last line of therapy.\n6. Measurable disease by RECISTv1.1.\n7. If the patient is receiving Somatostatin analouges (SSA), the patient should be on stable doses for at least 2 months.\n\n   \\[Note: Concomitant Somatostatin analouges (SSA) are allowed. No other therapies for NET are allowed along with study drug (e,g., everolimus, sunitinib, cabozantinib, peptide receptor radionuclide therapy (PRRT), chemotherapy etc.)\\].\n8. Acceptable bone marrow and organ function at screening as described below:\n\n   1. ANC ≥1000\u002F μL\n   2. Platelet count ≥ 80,000\u002FμL\n   3. Hemoglobin ≥ 9 g\u002FdL (Transfusion is allowed to achieve this Hb)\n9. Total Bilirubin ≤ 1.5 x ULN (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN).\n10. AST (SGOT) ≤ 3 x ULN (≤ 5 x ULN if known liver metastasis).\n11. ALT (SGPT) ≤ 3 x ULN (≤ 5 x ULN if known liver metastasis).\n12. Creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (either measured or estimated by the Cockcroft-Gault formula).\n\n(Note: Cockcroft-Gault formula for estimated creatinine clearance \\[eCrCl\\]: eCrCl = \\[140- Age\\] × Weight \\[kg\\] × \\[0.85 if Female\\] \u002F \\[72 × serum creatinine (mg\u002FdL)\\]).\n\n\\-\n\nExclusion Criteria:\n\n1. Neuroendocrine carcinoma, such as small cell carcinoma.\n2. Grade 3 neuroendocrine tumours (NET) and\u002For Poorly differentiated NET.\n3. Patients with known MEN-1 (Multiple Endocrine Neoplasia-1) or MEN-2 (Multiple Endocrine Neoplasia-2) syndromes.\n4. Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral AUR103 calcium.\n5. Systemic anti-cancer therapy, such as small molecule TKIs, mTOR inhibitors, chemotherapy, biological therapy, or immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from the Cycle 1 Day 1 of the study.\n\n   \\[Note: Concomitant use of SSA is allowed\\].\n6. Patients who have used PRRT as a previous line would require 6 weeks from the last dose, before Cycle 1 Day 1.\n7. Presence of an acute or chronic toxicity resulting from prior anticancer treatment, except for alopecia or nail changes, that has not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.0.\n8. Use of any investigational agent within 21 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.\n9. Known symptomatic or untreated or recently treated (≤ 6 months of screening) CNS metastases. Patients with previously treated (\\> 6 months of screening) brain metastasis and are now stable and asymptomatic, from CNS perspective, are allowed.\n10. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia).\n11. Hepatic intra-arterial embolization within the last 6 months. Cryoablation or radiofrequency ablation of hepatic metastases within 2 months of randomization.\n12. Presence of any additional malignancy within last 3 years, except basal-cell or squamous cell carcinoma of the skin or carcinoma-in situ of the uterine cervix.\n\n    \\[Note: Patients with other malignancies are eligible if they have remained disease free for at least 2 years prior to trial entry and in the opinion of the investigator deemed to have a low likelihood of recurrence\\].\n13. Active infection requring systemic therapy. \\[Note: Prophylactic use of antibiotics is allowed. Any infection detected during screening period which is resolved adequately according to investigator before the Cycle 1 Day 1, is allowed\\].\n14. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.\n15. Known active or chronic hepatitis B (HBsAg +ve), hepatitis C infection (HCV antibody +ve).\n16. Expected to require any other form of antineoplastic therapy or targeted therapy while on study.\n17. Uncontrolled congestive heart failure (New York Heart Association \\[NYHA\\] Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary\u002Fperipheral artery bypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3 months prior to Cycle 1 Day 1.\n18. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1.\n19. Mean QTcF (Fridericia) interval \\>460 ms on ECG at screening or at Cycle 1 Day 1 pre-dose.\n20. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or significant gastritis, active bleeding diatheses, presence of any major medical illness (e.g., renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or psychiatric illness\u002Fsocial situations or clinically significant laboratory \u002F ECG abnormalities at screening, any or a combination of illnesses), which, in the opinion of the principal investigator (PI), may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.\n21. Current swab-positive or suspected (under investigation) COVID-19 infection or fever and other signs or symptoms suggestive of COVID19 infection with recent contact of person(s) with confirmed COVID19 infection, at screening or Day 1 of Cycle 1.\n22. Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening or enrolment visit, or lactating women.\n23. Women of child-bearing potential (WOCBP) who are neither surgically sterilized nor willing to use reliable contraceptive methods (hormonal contraceptive, IUD, or any double combination of male or female condom, spermicidal gel, diaphragm, sponge, cervical cap).\n\n    \\-","ALL","18 Years","99 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","A phase 2 Study Evaluating the Efficacy and Safety of Single Agent AUR103 Calcium in Patients with Advanced, Well or Moderately differentiated Neuroendocrine Tumours.\n\nThis is a Proof of Concept (PoC) Phase 2 study of AUR103 calcium in patients with advanced, well or moderately differentiated neuroendocrine tumours.\n\nThe main objective is to evaluate the efficacy of AUR103 calcium in patients with well or moderately differentiated neuroendocrine tumors.\n\nPatients with relapsed\u002Frefractory well or moderately differentiated neuroendocrine tumors.\n\nAUR103 calcium will be administered twice daily. Patients will receive AUR103 calcium until disease progression or intolerable toxicity.",[28,29],"Neuroendocrine (NE) Tumors","Advanced NET of GI Origin",[31,32],"NET Neuroendocrine Tumours","Neoplasms","NOT_YET_RECRUITING","2026-06-10",{"date":36,"type":37},"2026-06-11","ACTUAL",{"date":39,"type":22},"2026-06-30",{"date":41,"type":22},"2029-01-31",{"name":43,"class":44},"Aurigene Discovery Technologies Limited","INDUSTRY",5,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100514872","phase-1-a-study-evaluating-the-safety-and-efficacy-of-aur108-in-patients-with-relapsed-advanced-lymphomas-asha-1-100514872","NCT05984147","A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)","A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR108 in Patients With Relapsed Advanced Lymphomas(ASHA-1)","ASHA-1","Inclusion Criteria:\n\n1. Males or females ≥ 18 years of age\n2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1\n3. Acceptable bone marrow and organ function at screening as described below:\n\n   1. ANC ≥ 1000\u002FμL (without WBC growth factor support)\n   2. Platelet count ≥ 75,000\u002FμL without transfusion support\n   3. Hemoglobin ≥ 9 g\u002FdL (Transfusion is allowed to achieve this Hb)\n   4. Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN)\n   5. AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)\n   6. ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)\n   7. Creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (either measured or estimated by the Cockcroft-Gault formula). (Cockcroft-Gault formula for estimated creatinine clearance \\[eCrCl\\]: eCrCl = \\[140- Age\\] × Weight \\[kg\\] × \\[0.85 if Female\\] \u002F \\[72 × serum creatinine (mg\u002FdL)\\]).\n4. Ability to swallow and retain oral medications\n5. Histo-pathological diagnosis of a Non-Hodgkin lymphoma orHodgkin Lymphoma. Note: The lymphoma should be either in Stage III or IV according to Lugano classification (Cheson BD et al, 2014) at screening.\n6. In the case of subjects who have lymphoma for which high-dose chemotherapy and autologous stem cell transplantation (HDASCT) is considered a standard curative therapy, eligibility for this study requires that the subject's disease has relapsed after HDASCT, that the subject is not eligible for HD-ASCT, or that the subject has refused HD-ASCT.\n7. In the case of subjects who have lymphoma for which CAR-T therapy is considered a standard therapy, eligibility for this study requires that the subjects disease has relapsed after CAR-T, or that the subject has refused CAR-T, or that the CAR-T therapy is not accessible to the patient.\n8. Evidence of measurable disease as per Lugano Criteria for Lymphoma (Cheson BD et al, 2014).\n9. Standard curative measures do not exist, and patient must have exhausted all effective therapies, available locally.\n\n   1. At a minimum, the patients must have received at least 2 prior lines of systemic therapies. These systemic therapies could be either in the stage II, III or IV.\n   2. Any cancer patient with access to any effective therapy must not be enrolled.\n\nExclusion Criteria:\n\n1. Systemic anti-cancer therapy, such as chemotherapy, or biological therapy, immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from the Cycle 1 Day 1 of the study.\n\n   Note: Concomitant use of low dose prednisone (up to 10 mg\u002Fday) is allowed.\n2. Presence of an acute or chronic toxicity resulting from prior anticancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.0.\n3. Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial).\n4. Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.\n5. Patients with cutaneous lymphomas, mycosis fungoides (MF) or Sézary syndrome (SS).\n6. Primary CNS lymphoma\n7. Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) lymphoma. Patients with previously treated (\\> 6 months of screening) CNS lymphoma and are now stable and asymptomatic, from CNS perspective, are allowed\n8. Patients with lymphoma that requires immediate cytoreductive therapy\n9. Patients with lymphoma that requires immediate cytoreductive therapy\n10. Patients on the drugs which are sensitive substrates of CYP2C8 and cannot be discontinued at least one week prior to Cycle 1 Day 1\n11. Patients on the drugs which are sensitive substrates of either Poglycoprotein (P-gp) or breast cancer resistance protein (BCRP) and cannot be discontinued at least one week prior to Cycle 1 Day 1\n12. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia)\n13. Active infection requiring systemic therapy. Note: Prophylactic use of antibiotics is allowed. Any infection detected during screening period which is resolved adequately according to investigator before the Cycle 1 Day 1, is allowed.\n14. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness\n15. Known active or chronic hepatitis B (HbsAg +ve) or hepatitis C infection (HCV antibody +ve)\n16. The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study.\n17. Uncontrolled congestive heart failure (New York Heart Association (NYHA) Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary\u002Fperipheral artery bypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3 months prior to Cycle 1 Day 1\n18. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1.\n19. QTc (Bazzett) interval \\>460 ms on ECG at screening and\u002For at Cycle 1 Day 1 pre-dose.\n20. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or significant gastritis, active bleeding diatheses, presence of any major medical illness (e.g. renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or psychiatric illness\u002Fsocial situations or clinically significant laboratory \u002F ECG abnormalities at screening, any or a combination of illnesses, which, in the opinion of the PI, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study\n21. Current swab-positive or suspected (under investigation) Covid-19 infection or fever and other signs or symptoms suggestive of Covid-19 infection with recent contact of person(s) with confirmed Covid-19 infection, at screening or Cycle 1 Day 1.\n22. History of another primary malignancy within 5 years prior to starting study drug, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study.\n23. Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening or enrolment visit\n24. Lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods (hormonal contraceptive, IUD, or any double combination of male or female condom, spermicidal gel, diaphragm, sponge, cervical cap).",{"count":55,"type":22},40,[57],"PHASE1","An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.",[60],"Relapsed Advanced Lymphomas",[62,63,64,65,66],"Relapse Advanced Lymphomas","Diffuse large B-cell lymphoma","Follicular lymphoma","Mature T\u002FNK-cell lymphomas","Other Hodgkin lymphoma","RECRUITING","2026-04-14",{"date":70,"type":37},"2026-04-17",{"date":72,"type":37},"2023-10-19",{"date":74,"type":22},"2027-08-30",{"name":43,"class":44},27,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100505716","phase-1-a-study-evaluating-the-safety-and-efficacy-of-aur107-in-patients-with-relapsed-advanced-malignancies-shakti-1-100505716","NCT05865002","A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)","A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter, First in Human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)","Inclusion Criteria:\n\n1. Males and females ≥ 18 years of age.\n2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.\n3. Acceptable bone marrow and organ function at screening as described below:\n\n   1. ANC ≥ 1500\u002FμL (without WBC growth factor support)\n   2. Platelet count ≥ 100,000\u002FμL without transfusion support\n   3. Hemoglobin ≥ 9 g\u002FdL (Transfusion is allowed to achieve this Hb)\n   4. Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN)\n   5. AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)\n   6. ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)\n   7. Creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (either measured or estimated by the Cockcroft-Gault formula).\n4. Ability to swallow and retain oral medications.\n5. Histopathological diagnosis of a solid tumor. Note: The solid tumors must be in Stage IV at screening.\n6. Evidence of measurable disease per RECIST, v1.1 for solid tumors.\n7. Standard curative measures do not exist, and the patient must have exhausted all effective therapies available locally.\n\nNotes:\n\n7a. At a minimum, solid tumor patients must have received at least two lines of systemic therapies in the metastatic incurable settings (these two lines must be in the metastatic setting and not in the earlier stage of cancer).\n\n7b. Any cancer patient with access to any effective therapy must not be enrolled\n\nExclusion Criteria:\n\n1. Systemic anti-cancer therapy, such as chemotherapy, biological therapy, or immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from Cycle 1 Day 1 of the study.\n\n   Note: Concomitant use of low-dose prednisone (up to 10 mg\u002Fday) or medroxyprogesterone is allowed.\n\n   Note: Patients with CRPC (castrate-resistant prostate cancer) should continue to receive ongoing medical castration with LHRH analogs, and such patients are allowed.\n2. Presence of acute or chronic toxicity resulting from prior anticancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.0.\n3. Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial)\n\n   • Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.\n4. Use of drugs which are moderate \u002F strong CYP3A4 inducers and\u002For drugs which are predominantly metabolized by CYP3A4 within 1week or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.\n\n   • Note: This class of drugs are also prohibited during DLT evaluation period and must be either avoided or used with caution beyond DLT evaluation period.\n5. Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) metastases. Patients with previously treated (\\> 6 months of screening) CNS metastases and are now stable and asymptomatic, from CNS perspective, are allowed.\n6. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia).\n7. Patients with leukemia, myelodysplastic syndrome, multiple myeloma, or lymphoma.\n8. Active infection requiring systemic therapy. Note: Prophylactic use of antibiotics is allowed. Any infection detected during the screening period which is resolved adequately according to investigator before the Cycle 1 Day 1, is allowed.\n9. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.\n10. Known active or chronic hepatitis B (HBsAg +ve) or hepatitis C infection (HCV antibody +ve).\n11. The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study.\n12. Uncontrolled congestive heart failure (New York Heart Association \\[NYHA\\] Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary\u002Fperipheral artery bypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3 months prior to Cycle 1 Day 1.\n13. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in the past 3 months, before Cycle 1 Day 1.\n14. QTc (Bazzett) interval \\>460 ms on ECG at screening and\u002For at Cycle 1 Day 1 pre-dose.\n15. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or significant gastritis, active bleeding diatheses, presence of any major medical illness (e.g., renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or psychiatric illness\u002Fsocial situations or clinically significant laboratory \u002F ECG abnormalities at screening, any or a combination of illnesses, which, in the opinion of the PI, may either put the patient at risk because of participation in the study or influence the results or the patient's ability to participate in the study.\n16. Current swab-positive or suspected (under investigation) Covid-19 infection or fever and other signs or symptoms suggestive of Covid-19 infection with recent contact of the person(s) with confirmed Covid-19 infection, at screening or Day 1 of Cycle 1.\n17. Positive pregnancy test for women of childbearing potential (WOCBP) at the screening or enrolment visit.\n18. Lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods. (hormonal contraceptive, IUD, or any double combination of the male or female condom, spermicidal gel, diaphragm, sponge, cervical cap).",{"count":85,"type":22},50,[57],"An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced malignancies will be done to assess AUR107 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.",[89],"Relapsed Malignant Solid Neoplasm",[91,92,93,94,95,96],"Relapse malignant neoplasm","Non small cell lung cancer","Gastric cancer","Colon cancer","Esophageal cancer","Kidney cancer",{"date":70,"type":37},{"date":99,"type":37},"2023-09-05",{"date":101,"type":22},"2027-06",{"name":43,"class":44},37,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"100574143","phase-1-study-evaluating-safety-pharmacokinetics-and-pharmacodynamics-of-aur112-in-patients-with-relapsed-advanced-lymphoma-100574143","NCT06755450","Study Evaluating Safety Pharmacokinetics and Pharmacodynamics of AUR112 in Patients With Relapsed Advanced Lymphoma","A Phase 1, Open Label, Dose Escalation, Multicenter, First-in-Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR112 In Patients With Relapsed Advanced Lymphoma (ADITI-1)","ADITI-1","Inclusion Criteria:\n\n1. Males and females ≥ 18 years of age\n2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1\n3. Acceptable bone marrow and organ function at screening as described below:\n\n   1. ANC ≥ 1000\u002FμL (without WBC growth factor support)\n   2. Platelet count: For patients with CLL ≥ 50,000\u002FμL; For patients with lymphomas ≥ 75,000\u002FμL without bone marrow involvement and ≥ 50,000\u002FμL with bone marrow involvement. These thresholds should be qualified without platelet transfusion support.\n   3. Hemoglobin ≥ 9 g\u002FdL (RBC Transfusion is allowed to achieve this Hb)\n   4. Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN)\n   5. AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)\n   6. ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)\n   7. Creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (either measured or estimated by the Cockcroft-Gault formula). (Cockcroft-Gault formula for estimated creatinine clearance \\[eCrCl\\]: eCrCl = \\[140- Age\\] × Weight \\[kg\\] × \\[0.85 if Female\\] \u002F \\[72 × serum creatinine (mg\u002FdL)\\]).\n4. Ability to swallow and retain oral medications\n5. Histopathological diagnosis of Non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) or Hodgkin disease. Note:\n\n5a. The lymphoma should be either in Stage III or IV according to Lugano classification (Cheson et al. 2014) at screening. 5b. The lymphomas included in this study must fall within one of the following 2017 World Health Organization categories except lymphoma mentioned in Exclusion criterion #5:\n\n* Mature B-cell neoplasms (excluding plasma cell neoplasms, heavy chain disease, and primary central nervous system \\[CNS\\] lymphoma).\n* Mature T- and NK-cell neoplasms.\n* Hodgkin lymphomas 5c. The CLL should be Binet Stage C\u002FRai stage III or IV, as per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines (Hallek et al. 2018).\n\n  6\\. In the case of subjects who have lymphoma for which high-dose chemotherapy and autologous stem cell transplantation (HDASCT) is considered a standard curative therapy, eligibility for this study requires that the subject's disease has relapsed after HDASCT, or the subject is not eligible for HD-ASCT, or that the subject has refused HD-ASCT.\n\n  7\\. In the case of patients who have lymphoid malignancies for which CAR-T therapy is indicated, eligibility for this study requires that the disease has relapsed after CAR-T, or the patient is not eligible for CAR-T, or the patient has refused CAR-T, or the CAR-T is not available locally.\n\n  8\\. Evidence of measurable disease as per Lugano Criteria for Lymphoma (Cheson et al. 2014) or evidence of measurable disease as per iwCLL Criteria for CLL (Hallek et al. 2018). Note: Patients with Small Lymphocytic Lymphoma (SLL) alone or in combination with CLL are allowed.\n\n  9\\. Standard curative measures do not exist, and the patient must have exhausted all effective therapies available locally. The patients must have relapsed or refractory to at least 2 prior lines of systemic therapies for NHL or CLL, or Hodgkin disease.\n\nNote:\n\n* Any cancer patient with access to any effective therapy locally must not be enrolled.\n* Patients with CLL should have documented evidence for progressive or symptomatic disease (active disease) and must have indications for treatment (Hallek et al 2018).\n* Patients with indolent lymphomas also must have indications for treatment, such as the GELF (Brice et al 1997) or BNLI criterion (Ardeshna et al 2003)\n\nExclusion Criteria:\n\n1. Systemic anti-cancer therapy, such as chemotherapy, biological therapy, or immunomodulatory drug therapy received within the past 28 days or 5 half-lives, whichever is longer, from the Cycle 1 Day 1 of the study. Note: Concomitant use of low dose prednisone (up to 10 mg\u002Fday) is allowed\n2. Presence of an acute or chronic toxicity resulting from prior anticancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.0. 1\n3. Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial).\n4. Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1\n5. Patients with Burkitt's lymphoma, Burkitt-like lymphoma, posttransplant lymphoproliferative disease, primary mediastinal large-B cell lymphoma, cutaneous lymphomas, mycosis fungoides (MF), or Sezary syndrome (SS).\n6. Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) lymphoma. Patients with previously treated (\\> 6 months of screening) CNS lymphoma and are now stable and asymptomatic, from CNS perspective, are allowed.\n7. Patients with lymphoma that requires immediate cytoreductive therapy.\n8. Patients with low-grade lymphoma or indolent lymphoma that does not meet conventional criteria (Jeong SH, 2022) for requiring treatment.\n9. Patients on drugs which are inhibitors of P-gp or BCRP or UGT1A1 and when these drugs cannot be discontinued from at least one week prior to Cycle 1 Day 1. Note: These drugs will be prohibited during Cycle 1 of therapy.\n10. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia)\n11. Active infection requiring systemic therapy. Note: Prophylactic use of antibiotics is allowed. Any infection detected during screening period which is resolved adequately according to investigator before the Cycle 1 Day 1, is allowed.\n12. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.\n13. Known active or chronic hepatitis B (HBsAg +ve) or hepatitis C infection (HCV antibody +ve).\n14. The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study\n15. . Uncontrolled congestive heart failure (New York Heart Association \\[NYHA\\] Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary\u002Fperipheral artery bypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3 months prior to Cycle 1 Day 1.\n16. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1.\n17. QTcF (Fridericia) interval \\>470 ms on ECG at screening and\u002For at Cycle 1 Day 1 pre-dose.\n18. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or significant gastritis, active bleeding diatheses, presence of any major medical illness (e.g. renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or psychiatric illness\u002Fsocial situations or clinically significant laboratory \u002F ECG abnormalities at screening, any or a combination of illnesses, which, in the opinion of the PI, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.\n19. Current swab-positive or suspected (under investigation) Covid19 infection or fever and other signs or symptoms suggestive of Covid-19 infection with recent contact of person(s) with confirmed Covid-19 infection, at screening or Cycle 1 Day 1.\n20. History of another primary malignancy within 5 years prior to starting study drug, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study.\n21. Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening or enrolment visit.\n22. Lactating women or WOCBP or a man with a partner who has childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods(hormonal contraceptive, IUD, or any double combination of male or female condom, spermicidal gel, diaphragm, sponge, cervical cap) during the screening period, while on AUR112 and at least 28 days after last dose",{"count":55,"type":22},[57],"A Phase 1, Open Label, Dose Escalation, Multicenter, First-in-Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR112 in Patients with Relapsed Advanced Lymphoma (ADITI-1)",[60],[117,118,62],"Non-Hodgkin Lymphoma (NHL)","Hodgkin Lymphoma","2026-01-12",{"date":121,"type":37},"2026-01-13",{"date":123,"type":37},"2025-01-15",{"date":125,"type":22},"2028-01-15",{"name":43,"class":44},19,""]