[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bio-Path Holdings, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,66],{"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},"100453894","phase-1-a-clinical-trial-of-bp1002-in-patients-with-refractoryrelapsed-acute-myeloid-leukemia-aml-100453894",false,"NCT05190471","A Clinical Trial of BP1002 in Patients With Refractory\u002FRelapsed Acute Myeloid Leukemia (AML)","A Phase I\u002FIb Study of BP1002 (a Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in Patients With Refractory\u002FRelapsed Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n1. Adults ≥18 years of age, with histologic evidence of refractory\u002Frelapsed AML who have failed treatment with available therapies known to be active for refractory\u002Frelapsed AML\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 or 2\n3. For the dose expansion phase, participants with documented diagnosis of AML who are eligible for decitabine therapy\n4. Participants must have adequate hepatic and renal functions as defined by:\n\n   1. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN); and\n   2. Usually total bilirubin ≤ 1.5 ULN. In specific cases the PI may request a waiver of this requirement with medical justification and agreement with the medical monitor and Bio-Path Holdings. And;\n   3. Estimated creatinine clearance of at least 60 mL\u002Fmin. These estimations are calculated using the Cockcroft-Gault equation.\n5. Female participants of childbearing potential must agree to use an acceptable method of birth control (i.e. a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) for the duration of the study and for at least 6 months after the last dose of study drug or decitabine\n6. Male participants must agree to use an acceptable method of contraception for the duration of the study\n7. Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment\n8. Participants must be willing and able to provide written informed consent\n\nExclusion Criteria:\n\n1. Active non-hematologic or lymphoid malignancy other than AML treated with immunotherapy, targeted therapy or chemotherapy within the previous 12 months\n2. Known, active leptomeningeal leukemia requiring intrathecal therapy. NOTE: Participants with a history of CNS disease may be allowed to participate based on at least 1 documented, negative spinal fluid assessment within 28 days prior to Screening\n3. Isolated potentially treatable extramedullary leukemia without also meeting bone marrow criteria for acute leukemia (for AML usually ≥ 5% blasts in BMA or biopsy). Participants may have leukemia with lower blast counts (Döhner 2017). Bio-Path Holdings and Investigator concurrence required.\n4. Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) PML-RARA\n5. Chronic myeloid leukemia in any phase\n6. Receipt of any anti-cancer therapy within 14 days prior to C1D1, with the exception of hydroxyurea or leukapheresis\n7. Participants may not be receiving any other investigational agents\n8. Female participants who are pregnant or breast-feeding\n9. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n10. Participants with human immunodeficiency virus (HIV) infection who have CD4+ T-cell counts \\\u003C 350 cells\u002FmcL or with clinically active hepatitis B or C infection\n11. History of any hypersensitivity to hypomethylating agents, unless reaction is deemed irrelevant to the study by the Investigator and Medical Monitor\n12. Unresolved toxicity higher than CTCAE Grade 1 attributed to any prior therapy or procedure, excluding alopecia\n13. Presence of concurrent conditions that, in the opinion of the Investigator and\u002For Medical Monitor, may compromise the participant's ability to tolerate study treatment or interfere with any aspect of study conduct or interpretation of results. This includes, but is not limited to, unstable or uncontrolled angina, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia or clinically significant baseline ECG abnormality (e.g., QTcF \\>470 msec)\n14. Within the past 6 months, has had any of the following: myocardial infarction, unstable angina pectoris, coronary\u002Fperipheral artery bypass graft, cerebrovascular accident or transient ischemic attack\n15. Uncontrolled seizure disorder (i.e., seizures within the past 2 months)\n16. Unable or unwilling to communicate or cooperate with the Investigator or follow the protocol for any reason","ALL","18 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study evaluates the safety and tolerability of escalating doses of BP1002 (Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in patients with refractory\u002Frelapsed AML. The study is designed to assess the safety profile, identify DLTs, biologically effective doses, PK, PD and potential anti-leukemic effects of BP1002 as single agent (dose escalation phase) followed by assessing BP1002 in combination with decitabine (dose expansion phase).",[26,27],"Acute Myeloid Leukemia, in Relapse","Acute Myeloid Leukemia Refractory","RECRUITING","2025-03-06",{"date":31,"type":32},"2025-03-10","ACTUAL",{"date":34,"type":32},"2022-08-16",{"date":36,"type":20},"2027-09",{"name":38,"class":39},"Bio-Path Holdings, Inc.","INDUSTRY",4,{"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":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":40},"100377571","phase-1-bp1001-a-in-patients-with-advanced-or-recurrent-solid-tumors-100377571","NCT04196257","BP1001-A in Patients With Advanced or Recurrent Solid Tumors","A Phase I\u002FIb Study of BP1001-A (a Liposomal Grb2 Antisense Oligonucleotide) in Patients With Advanced or Recurrent Solid Tumors","Inclusion Criteria:\n\n1. All participants, ≥ 18 years of age, with histologic evidence of advanced or recurrent solid tumors, who are not candidates for regimens or protocol treatments known to confer clinical benefit.\n2. ECOG Performance Status Score of 0 or 1.\n3. Participants must be willing to undergo pre-treatment biopsies. Participants who complete 1 cycle of treatment will undergo post-treatment biopsies. Post-treatment biopsies will be offered to participants who do not complete 1 cycle of treatment.\n4. For the dose expansion phase, participants must have recurrent or persistent epithelial ovarian, primary peritoneal, fallopian tube or endometrial tumor and must be participants for whom single agent paclitaxel would be considered a reasonable treatment option.\n5. Endometrial cancer patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, squamous cell, transitional cell carcinoma, and mesonephric carcinoma.\n\n   Ovarian tumor patients with the following histologic epithelial cell types are eligible: High-grade serous carcinoma, endometrioid carcinoma, clear cell carcinoma, squamous carcinoma, transitional cell (Brenner) carcinoma, mixed epithelial-stromal carcinoma, undifferentiated or other epithelial carcinoma.\n\n   Uterine carcinosarcoma and other sarcomas of the uterus are not eligible.\n6. Estimated life expectancy \\> 3 months in the Investigator's opinion.\n7. All participants must have measurable disease per RECIST criteria v1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be \\>\u002F= 20 mm when measured by conventional techniques, including plain x-ray, CT, and MRI, or \\>\u002F= 10 mm when measured by spiral CT. Measurable disease lesions must be amenable to pre- and post-treatment biopsy.\n8. Participants must have at least one \"target lesion\" to be used to assess response on this protocol as defined by RECIST v1.1. Tumors within a previously irradiated field will be designated as \"non-target\" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.\n9. Participants must have adequate:\n\n   1. Bone marrow function: HgB \\>\u002F= 9 g\u002FdL, WBC \\>\u002F= 3,000\u002FmcL, ANC \\>\u002F= 1,500\u002FmcL, PLT \\>\u002F= 100,000\u002FmcL\n   2. Hepatic function: Total bilirubin within normal institutional limits, AST and ALT \\\u003C 2.5 X institutional ULN\n   3. Renal function: Serum creatinine \\\u003C 1.5 x ULN or eGFR \\> 60 mL\u002Fmin according to Cockcroft-Gault formula\n   4. Neurologic function: Neuropathy (sensory and motor) \\\u003C\u002F= CTCAE Grade 1\n   5. Blood coagulation parameters: PT such that INR is \\\u003C 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a PTT \\\u003C 1.2 times control\n10. Participants previously treated with docetaxel (regardless of response) are eligible for this trial.\n11. Participants in the dose expansion phase who previously received paclitaxel for primary or recurrent disease are eligible if they did not progress on therapy or relapse within 6 months of completing therapy. Participants with persistent disease at the completion of primary therapy with paclitaxel are not eligible.\n12. Participants should be free of active infection requiring antibiotics, with the exception of uncomplicated UTI.\n13. Any hormonal therapy directed at the malignant tumor must be discontinued at least two weeks prior to BP1001-A treatment. Continuation of hormone replacement therapy is permitted; stable regimens of hormonal therapy for prostate cancer (e.g., leuprolide, a gonadotropin-releasing hormone \\[GnRH\\] agonist), ovarian or breast cancer are not exclusionary.\n14. Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least four weeks prior to first dose of BP1001-A (6 weeks for nitrosoureas or mitomycin C).\n15. Female participants of childbearing potential must have a negative urine pregnancy test performed within 24 hours prior to the start of study treatment. Post-menopausal subjects (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.\n16. Female participants of childbearing potential must agree to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) for the duration of the study and for at least 6 months after the last dose of treatment.\n17. Male participants must agree to use an acceptable method of contraception for the duration of the study.\n18. Participants must be willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. For the dose expansion phase, participants must not have low grade serous ovarian carcinoma or mucinous ovarian carcinoma.\n2. For the dose expansion phase, participants must wait at least two weeks after receiving any strong inhibitor, inducer, or substrate of both CYP3A4 and CYP2C8 before investigational drug administration.\n3. Participants who had previous bone marrow or hematopoietic stem cell transplant.\n4. Participants may not be receiving any other investigational agents.\n5. Female participants who are pregnant or breast-feeding.\n6. History or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months of registration on this study.\n7. Within the past 6 months, participant has had any of the following: myocardial infarction, unstable angina pectoris, coronary\u002Fperipheral artery bypass graft, cerebrovascular accident, or transient ischemic attack.\n8. Presence of concurrent conditions that, in the opinion of the Investigator and\u002For Medical Monitor, may compromise the participant's ability to tolerate study treatment or interfere with any aspect of study conduct or interpretation of results. This includes, but is not limited to, unstable or uncontrolled angina, NYHA class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia, or clinically significant baseline ECG abnormality (e.g., QTcF \\>470 msec).\n9. Active pleural effusion or pleural or pericardial effusion with symptoms. Pleural or pericardial effusion that has received treatment and resolved according to the Investigator, is acceptable.\n10. Participants who are ineligible to undergo an MRI scan for reasons such as claustrophobia or the presence of implanted devices or metallic foreign bodies that are not MR compatible, such as ferromagnetic implants or pacers or with a known history of allergic reaction to gadolinium contrast agents.\n11. Any condition which, in the Investigator's opinion, makes the subject unsuitable for trial participation.\n12. A prior history of ≥ Grade 3 hypersensitivity to paclitaxel or docetaxel or with products mixed in Cremephor EL or Tween 80®.\n13. Unresolved toxicity higher than CTCAE Grade 1 attributed to any prior therapy or procedure, excluding alopecia.\n14. Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.\n15. Participants with HIV infection who have CD4+ T-cell counts \\\u003C 350 cells\u002FmcL or with clinically active hepatitis B or C infection.\n16. Participants who have a major surgical procedure, open biopsy, dental extractions, or other dental surgery\u002Fprocedure that results in an open wound, or significant traumatic injury within 28 days prior to the first date of treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7 days prior to registration.\n17. (For dose expansion phase) Subjects ineligible or unable to receive paclitaxel as treatment for their disease.",{"count":49,"type":20},50,[23],"This is a phase I, open-label, study of BP1001-A in participants with advanced or recurrent solid tumors. The dose escalation phase will determine the safety and the maximum tolerated dose (MTD) or maximum administered dose (MAD) of BP1001-A as a single agent. After the MTD or MAD of BP1001-A is established, the dose expansion phase will commence and determine the safety, toxicity and response of BP1001-A in combination with paclitaxel.",[53,54,55,56,57,58],"Solid Tumor, Adult","Carcinoma, Ovarian Epithelial","Fallopian Tube Neoplasms","Endometrial Cancer","Peritoneal Cancer","Solid Tumor",{"date":60,"type":32},"2025-03-07",{"date":62,"type":32},"2022-08-19",{"date":64,"type":20},"2027-10",{"name":38,"class":39},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100269050","phase-2-clinical-trial-of-bp1001-in-combination-with-with-venetoclax-plus-decitabine-in-aml-100269050","NCT02781883","Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML","A Phase IIa, Open-label, Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination With Venetoclax Plus Decitabine in Patients With AML Who Are Ineligible for Intensive Induction Therapy","Inclusion Criteria\n\nAt the time of Screening, participants must meet all of the following criteria to be considered eligible to participate in the study:\n\n1. Adults ≥18 years of age\n2. Females must be of non-childbearing potential, surgically sterile, postmenopausal, or practice adequate methods of contraception during the study and for 30 days after the last dose of study drug or decitabine\n3. Males must agree to use an adequate method of contraception during the study and for at least 30 days after the last dose of study drug or decitabine\n4. Histologically documented diagnosis (based on the 2008 World Health Organization \\[WHO\\] Classification) (Vardiman et al. 2009) of one of the following:\n\n   1. Newly diagnosed untreated AML; or\n   2. Untreated secondary AML, including AML that has progressed from MDS\n   3. In some cases of AML associated with specific genetic abnormalities, however, the diagnosis of AML may be made if the blast count is less than 20% (Dohner et al. 2017) - specifically AML with t(15;17), t(8;21), inv(16), or t(16;16))\n   4. Relapsed or Refractory AML\n5. Investigator considers previously untreated participant ineligible for (or unwilling to receive) intensive induction therapy based on medical reasons, disease characteristics such as genetics, type of AML (untreated or secondary), or participant characteristics such as age, performance status, co-morbidities, organ dysfunctions, or patient election of low-intensity treatment\n6. Eligible for venetoclax and decitabine therapy, based on Investigator assessment\n7. Participant's WBC count is 25 x 10\\^9\u002FL or less at study initiation. The use of leukapheresis or hydroxyurea before treatment initiation to achieve this is permitted.\n8. Adequate hepatic and renal functions as defined by:\n\n   1. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN); and\n   2. Usually total bilirubin ≤ 1.5 ULN. In specific cases the PI may request a waiver of this requirement with medical justification and agreement with the medical monitor and Bio-Path holdings. And;\n   3. Estimated glomerular filtration rate (eGFR) of at least 40 ml\u002Fmin. These estimations can be calculated using any of the following methods (Appendix E: Formulas):\n\n   i. Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation\n   * GFR = 141 × min (Scr \u002Fκ, 1)\\^α × max(Scr \u002Fκ, 1)\\^-1.209 × 0.993\\^Age × 1.018 \\[if female\\] × 1.159 \\[if black\\] ii. Cockcroft gault equation\n   * Cockcroft Gault equation utilizing the TBW (Total body weight) to calculate an estimated creatinine clearance\n   * CrCl = \\[(140 - age) x TBW\\] \u002F (Scr x 72) x 0.85 \\[if female\\] iii. Modification of Diet in Renal Disease (MDRD) Study equation\n   * GFR (mL\u002Fmin\u002F1.73 m\\^2) = 175 × (Scr)\\^-1.154 × (Age)\\^-0.203 × 0.74 \\[if female\\] x 1.212 \\[if African American (AA)\\] iv. Creatinine clearance estimated by 24-hr urine collection for creatinine clearance\n9. Documented Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n10. Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment\n11. Willing and able to provide written informed consent 7.2. Exclusion Criteria\n\nAt the time of Screening, participants who meet any of the following criteria will be excluded from participating in the study:\n\n1. Active non-hematologic or lymphoid malignancy other than AML treated with immuno- or chemotherapy within the previous 12 months except active non- melanoma, non-invasive skin cancer will be allowed.\n2. Known, active leptomeningeal leukemia requiring intrathecal therapy. NOTE: Patients with a history of CNS disease may be allowed to participate based on at least 1 documented, negative spinal fluid assessment within 28 days prior to Screening\n3. Isolated extramedullary leukemia without also meeting bone marrow criteria for acute leukemia (for AML usually = 20% blasts in BMA or BMB). Patients may have leukemia with lower blast counts (Dohner et al. 2010). Bio-Path Holdings and Investigator concurrence required.\n4. Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) PML-RARA\n5. Chronic myeloid leukemia (CML) in any phase\n6. Receipt of any anti-cancer therapy within 14 days prior to C1D1, with the exception of hydroxyurea or anagrelide (within 24 hours), TKI (within 1day), a single dose of cytarabine (for proliferative disease)\n7. Uncontrolled active, untreated, or progressive infection\n8. Receipt of any investigational agent or study treatment within 30 days prior to C1D1\n9. Females who are capable of becoming pregnant, test positive for pregnancy, or are breast-feeding during the Screening period, or intend to become pregnant or breast-feed during the course of the study or within 30 days after last dose of study drug\n10. Serious intercurrent medical or psychiatric illness which, in the opinion of the Investigator, would interfere with the ability of the participant to complete the study\n11. Known active or clinically significant hepatitis B infection (based on positive surface antigen \\[HBsAg\\]), hepatitis C infection (based on positive antibody \\[HCV Ab\\]), or human immunodeficiency virus (HIV-1 or HIV-2, based on positive antibody)\n12. History of any hypersensitivity to venetoclax or decitabine, unless reaction is deemed irrelevant to the study by the Investigator and Medical Monitor\n13. Presence of concurrent conditions that, in the opinion of the Investigator and\u002For Medical Monitor, may compromise the participant's ability to tolerate study treatment or interfere with any aspect of study conduct or interpretation of results. This includes but is not limited to, unstable or uncontrolled angina, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia or clinically significant baseline ECG abnormality (e.g., QTcF \\>470 msec)\n14. Within the past 6 months, has had any of the following: myocardial infarction, unstable angina pectoris, coronary\u002Fperipheral artery bypass graft, cerebrovascular accident or transient ischemic attack\n15. Uncontrolled seizure disorder (i.e., seizures within the past 2 months)\n16. Cannot receive live attenuated vaccine immunization prior to, during, or after treatment with venetoclax until B-cell recovery occurs\n17. Unable or unwilling to communicate or cooperate with the Investigator or follow the protocol for any reason",{"count":74,"type":20},108,[76],"PHASE2","The primary objectives of this study are to assess: (1) whether the combination of BP1001 plus venetoclax plus decitabine provides greater efficacy (Complete Remission \\[CR\\], Complete Remission with incomplete hematologic recovery \\[CRi\\], Complete Remission with partial hematologic recovery \\[CRh\\], than venetoclax plus decitabine alone (by historical comparison) in participants with untreated AML that cannot or elect not to be treated with more intensive chemotherapy; (2) whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory\u002Frelapsed AML.",[79],"Acute Myeloid Leukemia (AML)",[81,82],"Liposomal Grb-2 treatment of AML","Liposomal Grb-2 with Venetoclax plus decitabine for AML",{"date":60,"type":32},{"date":85,"type":4},"2016-05",{"date":87,"type":20},"2028-12",{"name":38,"class":39},9,""]