[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"castrate-resistant-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:castrate-resistant-prostate-cancer":199},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,81,111,152,175],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100498139","phase-2-pembrolizumab-plus-177lu-psma-617-in-patients-with-castration-resistant-prostate-cancer-100498139",false,"NCT05766371","Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer","A Phase 2 Study of Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Metastatic Castration Resistant Prostate Cancer","Inclusion Criteria:\n\n1. Histologically confirmed prostate adenocarcinoma that is progressive metastatic castration-resistant prostate cancer by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria at the time of study entry.\n2. Male participants who are at least 18 years of age on the day of signing informed consent.\n3. Castrate level of serum testosterone at study entry (\\\u003C 50 ng\u002FdL). Note: Participants without prior bilateral orchiectomy are required to remain on Luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study.\n4. Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and\u002For enzalutamide.\n5. Adverse events related to prior anti-cancer treatment (excluding LHRH analogs) must have recovered to Grade \\\u003C= 1 (except for any grade alopecia and grade \\\u003C= 2 neuropathy).\n6. Prior radiotherapy is allowed if the last radiotherapy treatment was greater than 2 weeks from start of study treatment on cycle 1, day 1 (C1D1). Note- Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (\\\u003C=2 weeks of radiotherapy) to non-central nervous system (CNS) disease.\n7. At least one Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) (PSMA PET) avid lesion on screening PSMA PET. A positive lesion is defined as uptake above background liver.\n8. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C= 1 (Karnofsky \\>= 70%).\n9. Demonstrates adequate organ function as defined below:\n\n   1. Adequate bone marrow function:\n\n      * absolute neutrophil count \\>=1,500\u002Fmicroliter (mcL)\n      * platelets \\>=100,000\u002FmcL\n      * hemoglobin \\> 9.0 g\u002FdL\n   2. Adequate hepatic function:\n\n      * total bilirubin \\\u003C= 1.5 x upper limit of normal (ULN). In patients with known or suspected Gilbert's disease, direct bilirubin \\\u003C= ULN\n      * aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) \\\u003C= 2.5 x institutional ULN (\\\u003C= 5 x ULN in patients with liver metastases)\n      * alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase (SGPT) \\\u003C= 2.5 x institutional upper limit of normal (\\\u003C= 5 x ULN in patients with liver metastases)\n   3. Adequate renal function:\n\n      * creatinine \\\u003C= 1.5 x within institutional upper limit of normal OR\n      * creatinine clearance Glomerular filtration rate (GFR) \\>= 50 mL\u002Fmin\u002F1.73 m\\^2, calculated using the Cockcroft-Gault equation or 24 hour urine collection.\n10. Participants must use appropriate methods of contraception during study treatment and for at least 6 months after last study treatment. Patients who are sexually active should consider their female partner to be of childbearing potential if she has experienced menarche and is not postmenopausal (defined as amenorrhea \\> 24 consecutive months) or has not undergone successful surgical sterilization. Even women who use contraceptive hormones (oral, implanted, or injected), an intrauterine device, or barrier methods (diaphragms, condoms, spermicide) should be considered to be of childbearing potential. Patients who have undergone vasectomy themselves should also be considered to be of childbearing potential. Acceptable methods of contraception include continuous total abstinence, or double-barrier method of birth control (e.g., condoms used with spermicide, or condoms used with oral contraceptives). Periodic abstinence and withdrawal are not acceptable methods of contraception.\n11. Participants must provide consent to comply to recommended radioprotection precautions during study.\n12. Participants willing to undergo a tumor biopsy. Bone or soft tissue lesion is allowed. Note: The biopsy can be waived if there is no safely accessible lesion in the judgement of the treating investigator.\n13. Participants with previously treated brain metastases are eligible provided the following criteria are all met:\n\n    1. Last treatment was \\> 28 days prior to C1D1.\n    2. No evidence of new\u002Fprogressive brain metastases is observed on magnetic resonance imaging (MRI) obtained during screening window\n    3. Patient is clinically stable without requirement of steroid treatment for at least 14 days prior to first dose of study treatment on C1D1.\n14. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n15. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. De novo small cell neuroendocrine prostate cancer will not be allowed due to putative lower PSMA expression in this tumor subtype. Note-Treatment-emergent small cell neuroendocrine prostate cancer detected in metastatic tumor biopsy is not excluded.\n2. Soft tissue lesions (lymph nodes \\> 1.5 centimeter (cm) in short axis, visceral\u002Fsoft tissue lesions \\> 1 cm) on screening Computerized tomography (CT) that are negative on PSMA PET. Note: Negative lesions on PSMA PET are defined as those with uptake below the background liver.\n3. Has received other systemic anti-cancer therapies administered within 14 days, or 5 half-lives, whichever is shorter, prior to initiation of study treatment. Note: LHRH analogues are the exception.\n4. Untreated brain metastases at study entry.\n5. Receipt of prior PSMA-directed treatment (e.g., radiotherapy, immunotherapy, or antibody-drug conjugate).\n6. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-Programmed cell death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX 40, CD137).\n7. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment on C1D1. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n8. Receipt of \\> 2 lines of prior taxane-based chemotherapy.\n9. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n10. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) or treatment with drugs (e.g., neomercazole, carbimazole, etc.) that function to decrease the generation of thyroid hormone by a hyper-functioning thyroid gland (e.g., in Graves' disease) is not considered a form of systemic treatment of an autoimmune disease.\n11. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at a prednisone equivalent dose of \\> 10 mg daily or other form of immunosuppressive therapy within 7 days prior to first dose of study drug.\n12. Has a history of (non-infectious) ≥ grade 2 pneumonitis\u002Finterstitial lung disease that required steroids within past 2 years or has current ≥ grade 1 pneumonitis\u002F interstitial lung disease at the time of study enrollment.\n13. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug on C1D1. Note-Administration of a killed vaccine is allowed.\n14. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.\n15. Has clinically significant cardiovascular disease including, but not limited to:\n\n    1. Uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure.\n    2. Uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months before study entry.\n    3. Clinically significant arrhythmias not controlled by medication. Note: Chronic rate controlled, or paroxysmal atrial fibrillation\u002Fflutter is not an exclusion to study participation.\n16. Prior external beam radiation involving \\> 25 percent (%) of bone marrow or within 14 days of start of protocol therapy on C1D1.\n17. Major surgery within 28 days of study treatment. Note: If participant received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment on C1D1. Minor procedures (e.g., biopsy, cataract surgery, stent placement, endoscopy) are not considered major surgery.\n18. Has an active infection requiring intravenous antibiotics within 7 days prior to C1D1.\n19. Has a known history of Hepatitis B infection (defined as Hepatitis B surface antigen (HBsAg) reactive) or known active Hepatitis C virus infection (defined as (HCV RNA) \\[qualitative\\] detected, with the following exceptions:\n\n    1. Participants who are HbsAg positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to study entry\n    2. Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to study entry.\n20. Has a known history of active Bacillus Tuberculosis (TB).\n21. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n22. History of bleeding diathesis and currently on anti-coagulation therapy that cannot be safely discontinued for the tumor biopsy procedure.\n23. Any condition that, in the opinion of the Principal Investigator, would impair the participant's ability to comply with study procedures.","MALE","18 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a single-center, open-label, study of Prostate-Specific Membrane Antigen (PSMA)-targeted radionuclide therapy with 177Lu-PSMA-617 in combination with pembrolizumab in participants with metastatic castrate-resistant prostate cancer (mCRPC) who have previously progressed on at least one prior androgen pathway inhibitor (e.g., abiraterone, enzalutamide, apalutamide).",[26,27,28,29],"Castrate Resistant Prostate Cancer","Metastatic Castration-resistant Prostate Cancer","Prostate Cancer","Prostate Carcinoma","RECRUITING","2026-04-15",{"date":33,"type":34},"2026-04-17","ACTUAL",{"date":36,"type":34},"2023-12-15",{"date":38,"type":20},"2031-05-31",{"name":40,"class":41},"University of California, San Francisco","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":68,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100546483","phase-1-a-study-of-parg-inhibitor-etx-19477-in-patients-with-advanced-solid-malignancies-100546483","NCT06395519","A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies","ERADIC8","Inclusion Criteria:\n\n* Males and females of age ≥ 18 years at the time of signing the informed consent document.\n* Histologically or cytologically confirmed advanced (incurable recurrent, unresectable, or metastatic) solid cancer, excluding primary central nervous system (CNS) tumors.\n* Any solid tumor malignancy, excluding primary CNS tumors, with progression on or after or intolerance to most recent systemic therapy. Preferential enrollment consideration will be made for patients with known BRCA2 mutations resulting in loss of function.\n* Measurable disease per RECIST v1.1.\n* ECOG performance status 0-1.\n* Progression on or after or intolerance to most recent systemic therapy. Prior treatment in the recurrent\u002Fmetastatic setting; patients must have received approved standard therapy that is available to the patient that is known to confer clinical benefit, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient.\n* No investigational agent within 3 weeks or 5 half-lives (whichever is shorter; minimum of 2 weeks) prior to first dose of study drug.\n* Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Receiving continuous corticosteroids at prednisone-equivalent dose of \\>10 mg\u002Fday. Chronic systemic corticosteroid therapy for physiologic replacement (≤10 mg\u002Fday of prednisone equivalents) and the use of non-systemic corticosteroids (e.g., inhaled, topical, intra-nasal, intra-articular, or ophthalmic) are permitted.\n* Definitive radiotherapy within 6 weeks and palliative radiation within 2 weeks prior to the first dose of study drug.\n* Symptomatic untreated or progressing brain metastases. Stable, treated brain metastases are allowed if no evidence of radiologic or clinical progression or increasing corticosteroid use for at least 4 weeks.\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of ETX-19477 and no history of bowel obstruction within 6 months and\u002For peritoneal fluid drainage within 8 weeks prior to the first dose of study drug.\n* Known symptomatic and radiologically progressing or leptomeningeal disease (LMD). If LMD has been reported radiographically on baseline magnetic resonance imaging (MRI), but is not suspected clinically by the Investigator, the patient must be free of neurological symptoms of LMD.\n* Resting ECG with QT interval calculated using the Fridericia's formula (QTcF) \\>470 msec on 2 or more timepoints within a 24-hour period, or history or family history of congenital long QT syndrome, or taking concomitant medications that are known to prolong the QT\u002FQTc interval, or history of additional risk factors for torsades de pointes (Tdp).\n* History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension, clinically significant uncontrolled arrhythmias, or any history of symptomatic congestive heart failure.\n* Known active or chronic infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B, hepatitis C, or AIDS-related illness. Controlled infections, including HIV and \"cured\" hepatitis C (no active fever, no evidence of systemic inflammatory response syndrome) that are stable with undetectable viral load on antiviral treatment are not exclusionary.\n* Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of patients with Gilbert's Syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per Investigator assessment).\n* Known other previous\u002Fcurrent malignancy requiring treatment within ≤2 years except for limited disease treated with curative intent, such as carcinoma in situ, squamous or basal cell skin carcinoma, or superficial bladder carcinoma and not requiring ongoing chemotherapy.\n* Patients receiving proton pump inhibitors (PPIs), strong cytochrome P450 (CYP)3A inhibitors and inducers, or P-glycoprotein (P-gp) inhibitors. Patients should not receive PPIs within 7 days prior to first dose of study drug. Strong CYP3A inducers or inhibitors or strong P-gp inhibitors should not be given within 6 half-lives prior to first dose of study drug.\n* Patients currently treated with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants","ALL",{"count":52,"type":20},120,[54,23],"PHASE1","This is a two-part, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel reversible small molecule inhibitor of PARG.",[57,58,59,28,60,61,62,26,63,64,65,66,67],"Advanced or Metastatic Solid Tumors","Breast Cancer","Ovarian Cancer","Epithelial Ovarian Cancer","BRCA2 Mutation","ER+ Breast Cancer","BRCA1 Mutation","BRCA Mutation","Endometrial Cancer","Colorectal Cancer","Gastric Cancer",[69],"PARG Inhibitor","2026-03-24",{"date":72,"type":34},"2026-03-27",{"date":74,"type":34},"2024-05-13",{"date":76,"type":20},"2026-12",{"name":78,"class":79},"858 Therapeutics, Inc.","INDUSTRY",14,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100592880","phase-1-a-study-of-dr-0202-in-patients-with-locally-advanced-or-metastatic-relapsed-or-refractory-carcinomas-100592880","NCT06999187","A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas","A Phase 1a\u002F1b, Multicenter, Open-label, Dose Escalation\u002FExpansion, Multiple-dose Study to Evaluate the Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas","Inclusion Criteria:\n\n* Histologically confirmed epithelial cancer of the following tumor types: breast (TNBC, HR+\u002FHER2-\u002F+BC), NSCLC, cervical, CRPC, PDAC, HNSCC, endometrial, ovarian, gastric\u002FGEJ, or urothelial that is unresectable, locally advanced or metastatic\n* Relapsed or refractory with at least 2 prior lines of therapy and for which no standard of care treatment options are available\n* Radiographically measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Life expectancy, in the opinion of the Investigator, of ≥ 3 months\n* Adequate marrow reserve, renal function, and hepatic function\n* Taper of ≥ 2 weeks from high-dose systemic corticosteroids (however, low dose corticosteroids ≤ 25 mg prednisone or equivalent daily are permitted in consultation with the Medical Monitor)\n* Willing to provide archival tumor tissue samples or agree to a baseline biopsy if not available\n* Willing to undergo an on-treatment biopsy if clinically feasible and not contraindicated at the time of procedure\n\nExclusion Criteria:\n\n* Major surgery within 28 days prior to Day 1\n* Have not had an appropriate washout period from systemic therapy, including investigational agents, prior to C1D1:\n\n  1. Systemic chemotherapy and anticancer therapies within 4 weeks or 5 half-lives of the drug, whichever is shorter.\n  2. Antibody-based anticancer therapy: ≥ 4 weeks. Note: Treatment with systemic corticosteroids ≤ 25 mg\u002Fday (prednisone or equivalent) and inhaled or topical steroids are allowed. For participants with CRPC, LHRH agents are allowed.\n* Radiation therapy within 21 days prior to C1D1. Palliative radiation therapy may be allowed following discussion with Medical Monitor\n* Brain metastases either untreated and symptomatic or requiring therapy with steroids or anticonvulsants to control associated symptoms. Brain metastases that have been treated and are no longer symptomatic are allowed if use of high-dose systemic corticosteroids (\\> 25 mg\u002Fday of prednisone or equivalent) is stopped ≥ 12 weeks prior to C1D1.\n* Active Grade ≥ 2 anorexia, nausea or vomiting, and\u002For signs of intestinal obstruction.\n* Another malignancy (except for adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 1 year)\n* Evidence of significant, uncontrolled concomitant disease that could affect compliance with study.\n* Current or past history of CNS disease, such as stroke, epilepsy, central nervous system vasculitis or neurodegenerative disease (participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 6 months and have no residual neurologic deficits may be eligible).\n* QT interval for heart rate using Fridericia's formula (QTcF) \\> 480 msec or history of additional risk factors for Torsades de Pointes\n* Uncontrolled or significant cardiovascular disease\n* History or presence of an abnormal ECG that is clinically significant in the Investigator's opinion or myocardial infarction within 6 months prior to C1D1.\n* Prior solid organ transplantation.\n* Known infection with HIV, HBV, or HCV. The following participants may be enrolled in this study (the Sponsor reserves the right to restrict enrollment of these participants):\n\n  1. Participants who are HIV-positive with undetectable HIV RNA and at least 3 months on antiretroviral therapy.\n  2. Participants with a positive serologic test for HBV (i.e., positive HBcAb and negative HBsAg) and have a negative PCR test.\n  3. Participants who are HCV-positive who have completed at least 1 month of highly effective antiviral therapy and have a negative PCR test.\n* Active infection requiring systemic treatment, defined as requiring IV antimicrobial, antifungal, or antiviral agents within 2 weeks prior to C1D1. Prophylactic antimicrobial treatment is allowed. Infections eligible per Exclusion Criterion 16 may be enrolled.\n* Active clinical interstitial pneumonitis (e.g., shortness of breath, requirement of supplemental oxygen, dry cough) or as confirmed by means of diagnostic imaging within 6 months prior to C1D1.\n* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.",{"count":89,"type":20},96,[54],"A phase 1a\u002F1b, multicenter, open-label, dose escalation\u002Fexpansion, multiple-dose study to evaluate the safety and activity of DR-0202 in patients with locally advanced or metastatic, relapsed or refractory carcinomas",[93,94,95,96,26,97,98,65,59,67,99,100],"Triple Negative Breast Cancer","HER2-negative Breast Cancer","Non Small Cell Lung Cancer","Cervical Cancer","Pancreatic Ductal Adenocarcinoma","Head-and-neck Squamous Cell Carcinoma","Gastroesophageal-junction Cancer","Urothelial Carcinoma","2026-01-05",{"date":103,"type":34},"2026-01-07",{"date":105,"type":34},"2025-06-03",{"date":107,"type":20},"2027-12",{"name":109,"class":79},"Dren Bio",10,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100436903","phase-1-tt-10-port-6-and-tt-4-port-7-as-single-agents-and-in-combination-in-subjects-with-advanced-selected-solid-tumors-100436903","NCT04969315","TT-10 (PORT-6) and TT-4 (PORT-7) as Single Agents and in Combination in Subjects With Advanced Selected Solid Tumors","Phase I\u002FII First-in-Human Study of TT-10 (PORT-6), an Adenosine 2A Receptor Antagonist, and PORT-7, an Adenosine 2B Receptor Antagonist, as Single Agents and in Combination in Participants With Advanced Selected Solid Tumors","ADPORT-601","To be eligible for inclusion in the dose escalation cohorts or expansion cohorts in this study, participants must meet all of the following criteria:\n\n1. Participants must be ≥18 years of age.\n2. Participants or their legal representative must be able to provide written informed consent to participate in the study prior to the performance of any study-specific procedures.\n3. Diagnosis of histologically or cytologically confirmed advanced selected solid tumors:\n\n   Cohort A - TT-10 dose escalation:\n   1. RCC: Participants with locally advanced or metastatic RCC that have previously received at least two prior systemic regimens, including vascular endothelial growth factor (VEGF)-targeted therapy and checkpoint inhibitor therapy\n   2. CRPC: Participants with metastatic CRPC who have previously received a second-generation hormonal agent (unless contraindicated) and a taxane-based chemotherapy.\n   3. SCCHN: Participants with advanced or metastatic SCCHN that is incurable by surgery or radiotherapy and that has progressed during or after a platinum-based chemotherapy and\u002For checkpoint inhibitor therapy (separately or in combination)\n   4. NSCLC: Participants with metastatic NSCLC that is intolerant or resistant to standard therapy or for which no standard therapy is available\n\n   Cohort B - TT-4 dose escalation:\n   1. CRC: Participants with metastatic CRC that is intolerant or resistant to standard therapy or for which no standard therapy is available\n   2. CRPC: Participants with metastatic CRPC who have previously received a second-generation hormonal agent (unless contraindicated) and a taxane-based chemotherapy\n   3. NSCLC: Participants with metastatic NSCLC that is intolerant or resistant to standard therapy or for which no standard therapy is available\n   4. Endometrial cancer: Participants with metastatic endometrial cancer that is intolerant or resistant to standard therapy or for which no standard therapy is available\n   5. Ovarian cancer: Participants with metastatic ovarian cancer that is intolerant or resistant to standard therapy or for which no standard therapy is available\n\n   Cohort C- TT-10 + TT- 4 dose escalation and expansion:\n\n   a. The tumor types will include 1 or more of those enrolled in the respective Escalation Cohorts (A and B), and will be determined following review of the dose escalation data by the SMC.\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0 - 1\n5. Have measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\n   a. Participants with CRPC who have metastatic disease that is non-measurable are eligible if screening PSA ≥ 2.0 ng\u002FmL and with Sponsor approval\n6. Failure to respond to standard therapy, or for whom no appropriate therapies are available (based on the judgment of the investigator)\n7. Consent to baseline biopsy, with the following exceptions:\n\n   1. Participants whose only site(s) of disease are in areas considered moderate or high risk may be enrolled without a fresh biopsy with Sponsor approval;\n   2. Archival tissue may be submitted in lieu of a fresh biopsy if collected within 6 months of screening and without intervening systemic therapy.\n8. Participants must have adequate hematologic function based on the following:\n\n   * ANC ≥ 1.5 x 109\u002FL\n   * Platelet count ≥ 100 x 109\u002FL\n   * Hemoglobin ≥ 9.0 g\u002FdL\n9. Participants must have adequate hepatic function based on the following:\n\n   * Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome)\n   * ALT\u002FAST ≤ 2.5 x ULN (≤ 5 x ULN for participants with known hepatic metastases)\n10. Participants must have adequate renal function based on the following:\n\n    * Serum creatinine ≤ 1.5 x ULN; or\n    * Serum creatinine clearance ≥ 60 mL\u002Fmin, as determined by Cockcroft-Gault equation\n11. For women of childbearing potential (WCBP): negative urine pregnancy test (UPT) within 1 week before first treatment (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 12 consecutive months for women \\> 55 years of age). WCBP should be placed on effective birth control directly after testing negative for pregnancy; if not, then WCBP should have a UPT on Day 1 of every cycle, prior to study intervention administration. Any positive or indeterminant UPT result must be confirmed by serum.\n\n    a. Female participants of childbearing potential must use a highly effective mode of contraception or abstain from heterosexual activity for the duration of the study and for 120 days following the last dose of study intervention. A female is NOT of childbearing potential if she has undergone bilateral salpingoophorectomy or is menopausal, defined as an absence of menses for 12 consecutive months. Male participants must agree to use highly effective contraception.\n12. Ability to adhere to the study visit schedule and all protocol requirements\n13. Must be able to swallow capsules\n\nParticipants will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated:\n\nParticipants are to be excluded from the study if they meet any of the following criteria:\n\n1. Major surgery within 4 weeks prior to Screening\n2. Participants with active CNS metastases; however, participants who have undergone radiation and\u002For surgery for the treatment of CNS metastases, who are neurologically stable and who are no longer taking pharmacologic doses of corticosteroids are eligible; participants with leptomeningeal metastases are not eligible.\n3. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.\n4. Prior anti-cancer therapy within 4 weeks prior to the start of study intervention. A 2 week washout is acceptable for short-acting drugs (eg, tyrosine kinase inhibitors). Any treatment-related toxicities must be resolved to Grade 0 - 1.\n5. Human immunodeficiency virus (HIV)-infected participants\n6. Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to enrollment.\n\n   Note: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.\n\n   Hepatitis B screening tests are not required unless:\n   * Known history of HBV infection\n   * As mandated by local health authority\n7. Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening. Note: Participants must have completed curative antiviral therapy at least 4 weeks prior to enrollment.\n\n   Hepatitis C screening tests are not required unless:\n   * Known history of HCV infection\n   * As mandated by local health authority\n8. Participants who require immunosuppressive therapy including, but not limited to, treatment with corticosteroids in pharmacologic doses (equivalent to ≥ 10 mg prednisone daily), cyclosporine, mycophenolate, azathioprine, methotrexate, adalimumab, infliximab, vedolizumab, tofacitinib, dupilumab, rituximab, etc. or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency)\n9. Participants requiring administration of drugs known to be strong inhibitors or inducers of CYP3A4, 2C9 or 2C19\n10. Participants requiring drugs that modify gastric pH, such as proton-pump inhibitors (PPIs) or H2 blockers. Antacids, such as calcium carbonate or aluminum hydroxide-based products, will be allowed during the study, but are recommended to be taken either 4 hours before or 2 hours after dosing of TT 10 (PORT 6) or PORT-7.\n11. Ongoing systemic bacterial, fungal or viral infections at Screening\n\n    a. NOTE: Participants on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other inclusion\u002Fexclusion criteria are met\n12. Administration of a live vaccine within 6 weeks of first dose of study intervention. Messenger ribonucleic acid (mRNA) vaccines for the prevention of Coronavirus Disease 2019 (COVID-19) infection are permitted.\n13. Baseline QT interval corrected with Fridericia's method (QTcF) \\> 470 ms (average of triplicate readings)\n\n    a. NOTE: Criterion does not apply to participants with a right or left bundle branch block.\n14. Prior surgery or gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)\n15. Female participants who are pregnant or breastfeeding\n16. Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix or prostate intraepithelial neoplasia\n17. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\n18. History of peptic ulcer and\u002For gastrointestinal bleed within the past 6 months prior to Screening\n19. History of stroke, unstable angina, myocardial infarction or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to Screening\n20. Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition including pneumonitis and\u002For interstitial lung disease, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the participant associated with his or her participation in the study",{"count":120,"type":20},90,[54,23],"The goal of this clinical trial is to evaluate TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade) in participants with advanced selected solid tumors, who have failed or are not eligible for standard of care. The main questions it aims to answer are:\n\n1. To evaluate the safety and tolerability of TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade)\n2. To determine the maximum tolerated dose or the recommended phase 2 dose of TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade)\n3. To obtain a preliminary estimate of efficacy of TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade) in advanced solid tumors.",[124,26,95,125,126,65,59],"Renal Cell Cancer","Head and Neck Squamous Cell Carcinoma","Colorectal Cancer (CRC)",[128,129,130,131,132,133,134,135,117,136,137,138,139,140,141],"Failed or not eligible for standard of care","Advanced Selected Solid Tumors","TT-10","Adenosine","Adenosine Antagonist","A2A","A2AR Inhibitor","PORT-6","TT-4","PORT-7","A2B","Dual","A2AR","A2BR","2025-03-28",{"date":144,"type":34},"2025-04-02",{"date":146,"type":34},"2023-06-23",{"date":148,"type":20},"2027-12-31",{"name":150,"class":79},"Portage Biotech",3,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100576271","clinical-outcomes-of-use-of-olaparib-in-castration-resistant-prostate-cancer-100576271","NCT06783127","Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer","Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer: An Observational Study","COROS","Inclusion Criteria:\n\nBRCA mutant Metastatic castration-resistant prostate cancer patients treatment with olaparib in clinical practice\n\nExclusion Criteria:\n\nOlaparib treatment in a clinical trial",{"count":161,"type":20},3000,"OBSERVATIONAL","This is an observational, retrospective\u002Fprospective, multicenter study designed to define, overall survival, clinical outcomes and predictive\u002Fprognostic factors of a consecutive population of mCRPC patients treated with olaparib in clinical practice.",[28,26,64],"2025-02-07",{"date":167,"type":34},"2025-02-11",{"date":169,"type":34},"2023-01-01",{"date":171,"type":20},"2026-12-31",{"name":173,"class":41},"Santa Chiara Hospital",2,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":5},"100476792","phase-1-dual-bet-and-cbpp300-inhibitor-in-patients-with-targeted-advanced-solid-tumors-and-hematological-malignancies-100476792","NCT05488548","Dual BET and CBP\u002Fp300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies","A Phase 1 Study of EP31670, a Dual BET and CBP\u002Fp300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies","Inclusion Criteria:\n\nPart 1\n\n* Relapse or refractory castration-resistant prostate cancer (CRPC) following at least one anti-androgen regimen and a docetaxel-containing regimen OR\n* metastatic or unresectable NUT midline carcinoma for which standard curative or palliative measures do not exist; OR\n\nPart 2\n\n* relapsed or refractory CMML following at least 4 cycles of hypomethylating agent-containing regimen or hydroxyurea unless demonstration of progression or intolerance;\n* advanced MF (intermediate or high-risk) following at least one JAK inhibitor-containing regimen or unsuitable candidates for JAK inhibitor treatments.\n\nPart 3: advanced MF (intermediate or high-risk) with ≤10% blasts in peripheral blood who have not achieved an adequate response or have lost the response to a JAK inhibitor-containing regimen after being on treatment for at least 3 months.\n\nPatients who have other types of relapsed or refractory solid tumors (Part 1) or hematological malignancies (Part 2) with pathological and\u002For biological features suggesting a potential benefit from dual BET and CBP\u002Fp300 inhibition may be enrolled after discussion with and approval from medical monitor and sponsor.\n\nEastern Cooperative Oncology Group (ECOG) performance status 0-1 Life expectancy ≥ 3 months Evaluable disease\n\nAdequate bone marrow function:\n\n* Hemoglobin ≥ 9.0 g\u002FdL (Part 1)\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FdL (Part 1)\n* Platelet count ≥100,000\u002FμL (Part 1) or ≥75,000\u002FμL (Part 3)\n\nAdequate renal function: Creatinine clearance (CLcr) ≥ 60 mL\u002Fmin\n\nAdequate liver function: total bilirubin ≤ 1.5 x ULN; alanine aminotransferase (ALT) or aspartate Aminotransferase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver metastases\n\nInternal normalized ratio for prothrombin time (INR) ≤ 1.2 in patients not receiving chronic anticoagulation\n\nFour weeks from prior anti-cancer therapy including chemotherapy, immunotherapy, investigational anti-cancer therapy or 5 half-lives from targeted agents, radiation and have recovered from prior treatment toxicities to grade 1 or less.\n\nFour weeks from major surgery.\n\nFor fertile men and women, agreement to use effective contraceptive methods duration of study participation and 4 weeks after the last dose of study drug.\n\nAbility to understand and willingness to sign the informed consent form.\n\nExclusion Criteria:\n\n* New and progressive central nervous system (CNS) metastasis; patients with treated brain metastases are eligible if follow-up brain imaging at least 4 weeks after CNS-directed therapy shows no evidence of progression and the patient is neurologically stable\n* Corrected QT interval ≥470 msec\n* Uncontrolled concurrent illnesses including, but not limited to, ongoing active infection requiring intravenous antibiotics or antifungal agents, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness\u002Fsocial situations that would affect compliance with study requirements; patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of EP31670 are eligible for this trial\n* Pregnant or lactating women\n* Known history of hepatitis B, hepatitis C requiring antiviral treatment\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial",{"count":183,"type":20},75,[54],"A Phase 1, first-in-human study of EP31670, a dual BET and CBP\u002Fp300 inhibitor in patients with targeted advanced solid tumors and Hematological Malignancies",[26,187,188,189],"NUT Carcinoma","Chronic Myelomonocytic Leukemia","Myelofibrosis","2025-01-12",{"date":192,"type":34},"2025-01-14",{"date":194,"type":34},"2022-12-21",{"date":196,"type":20},"2025-05",{"name":198,"class":79},"Epigenetix, Inc.","Castrate-Resistant Prostate Cancer"]