[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"penile-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:penile-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100479746","phase-2-study-of-the-combination-dostarlimab-with-niraparib-in-patients-with-penile-carcinoma-100479746",false,"NCT05526989","Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma","A Phase 2 Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma Who Have Progressed Following Chemotherapy","Inclusion Criteria:\n\n* Provide written, informed consent to participate in the study and follow the study procedures\n* Histologically confirmed stage III (unresectable) or stage IV penile cancer, as per American Joint Committee on Cancer (AJCC) staging system.\n* Life expectancy \\>12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1 (ECOG performance status 2 can be included after discussion with PI)\n* Measurable disease per iRECIST\n* Participants who have progressed or had tolerance problems to no more than one prior line of therapy in the locally advanced setting or post platinum-based chemotherapy, including in a neoadjuvant or adjuvant setting or in combination with radiation therapy.\n* Participants must not have received any prior immune-oncology regimens, including but not limited to checkpoint inhibitors such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways, indoleamine 2,3-dioxygenase pathway inhibitors, cancer vaccines, adoptive cell therapies, or other cytokine therapies\n* Demonstrated adequate organ function, as defined in protocol, within 28 days of treatment initiation\n* Clinically significant toxic effect(s) of the most recent prior chemotherapy must be Grade 1 or resolved (except alopecia and sensory neuropathy that may be Grade 2).\n* If the participant received major surgery or radiation therapy of \\> 30 Gy, they must have recovered from the toxicity and\u002For complications from the intervention.\n* Participants and their female partners of childbearing potential must agree and commit to use a highly effective form of contraception (e.g., condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) throughout the duration of the study until 6 months (female participants) and 3 months (male participants and their female partners), respectively, following the last dose of study drug. Female partner may use either an intrauterine device or hormonal contraception and continue until 3 months following the last dose of study drug. This criterion may be waived for male patients who have had a vasectomy 90 days months before signing the informed consent form (ICF) or a penectomy.\n* Participants must not have known active brain metastases.\n* Participants with treated brain metastases are eligible if they have neurologically returned to baseline (except for residual signs or symptoms related to the cns treatment) for at least 4 weeks prior to the first dose of study drug(s).\n* Participant cannot be receiving any chronic systemic steroids (prednisone or equivalent) \\> 20 mg daily, for at least 4 weeks prior to the first dose of study drug(s).\n* Participants with small, untreated, asymptomatic central nervous system (CNS) metastases without associated edema, shift, or requirement for steroids are eligible after discussion with the Medical Monitor, i.e. the Principal Investigator.\n* No stereotactic radiation or craniotomy within 4 weeks of Cycle 1 Day 1\n* No new central nervous system lesions on repeat radiographic imaging 4 weeks or more from last treatment\n* No clinically significant symptoms secondary to brain metastases\n* Participants must also consent to allow acquisition of existing formalin-fixed paraffin-embedded (FFPE) material (archival tumor tissue), either a block or unstained slides for planned correlative studies.\n\nExclusion Criteria:\n\n* Use of an investigational agent or an investigational device within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, before administration of first dose of study drug.\n* Active, known or suspected autoimmune disease requiring systemic treatment within the past 2 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents. (Exceptions include any patient on 10 mg or less of prednisone or equivalent, patients with vitiligo, hypothyroidism stable on hormone replacement, Type I diabetes, Graves' disease, Hashimoto's disease, alopecia areata, eczema, or with PI approval.)\n* History of allergy or hypersensitivity to study drug components\n* History of organ transplant that requires use of immune suppressive agents\n* Current active pneumonitis within 90 days of planned start of the study or a known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis requiring steroid treatment.\n* Prior surgery or radiotherapy encompassing \\>20% of the bone marrow within 14 days of therapy. Patients must have recovered from all radiation-related toxicities.\n* Active infection requiring systemic therapy; a known history of active tuberculosis.\n* Has known active hepatitis B virus (HBV) infection (e.g., hepatitis B surface antigen \\[HBsAg\\] reactive) or hepatitis C virus (HCV) infection (e.g., HCV ribonucleic acid \\[RNA\\] qualitative is detected)\n* Has known immunodeficiency or active human immunodeficiency virus (HIV-1\u002F2 antibodies) with CD 4 count \\\u003C 400 for in the past 6 months.\n* Prolonged corrected QT interval (QTcF) \\> 450 ms for men\n* History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following:\n\n  1. Unstable angina or myocardial infarction\n  2. Congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV)\n  3. Uncontrolled clinically significant arrhythmias\n* Systolic BP \\>140 mmHg or diastolic BP \\>90 mmHg that has not been adequately treated or controlled. Need for \\> 2 antihypertensive medications for management of hypertension (excluding diuretics)\n* Must not have received a transfusion (platelets or red blood cells) ' 4 weeks prior to initiating protocol therapy.\n* Must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.\n* Has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \\> 4 weeks and was related to the most recent treatment.\n* Must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)\n* Has experienced a Grade 3 or greater immune-related Adverse Event with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.\n* Has received a live vaccine within 30 days of initiating protocol therapy","MALE","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of the study is to evaluate the efficacy and safety of the combination of niraparib and dostarlimab in patients participants with advanced relapsed\u002Frefractory penile cancer.",[26],"Penile Carcinoma","RECRUITING","2025-12-03",{"date":30,"type":31},"2025-12-04","ACTUAL",{"date":33,"type":31},"2022-12-28",{"date":35,"type":20},"2027-11",{"name":37,"class":38},"H. Lee Moffitt Cancer Center and Research Institute","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100516044","phase-1-fih-bispecific-cd276xcd3-antibody-cc-3-in-patients-with-colorectal-cancer-100516044","NCT05999396","FIH, Bispecific CD276xCD3 Antibody CC-3 in Patients With Colorectal Cancer","First in Human Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific CD276xCD3 Antibody CC-3 in Patients With Colorectal Cancer","CoRe_CC-3","Inclusion Criteria:\n\nwritten signed informed consent\n\n* Patient is able to understand and comply with the protocol for the duration of the clinical trial including undergoing treatment and scheduled visits and examinations\n* Patients with progressing metastatic CRC who were previously treated with FOLFOX, FOLFIRI, FOLFOXIRI, TAS-102, or regorafenib, if applicable in combination with anti-VEGFR monoclonal antibody (mAb) and anti-EGFR mAb (the latter, if RAS-wild-type and left sided tumors).\n\nIn case of MSI-high\u002FdMMR tumors, patients should have received checkpoint inhibitor therapy and at least two further lines of therapy of that stated above.\n\nIn case of patients BRAF V600E mutation patients should have received: Cetuximab in combination with encorafenib in second- or third-line treatment.\n\n* At least one measurable lesion that can be accurately assessed at baseline by CT or MRI and is suitable for repeated assessment per RECIST 1.1.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2\n* Patient aged ≥ 18, no upper limit\n* Female patients of child bearing potential (FCBP) and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two effective forms (at least one highly effective method) of contraception. This should be started from the signing of the informed consent and continue throughout period of taking study treatment and for 2 months after last dose of study drug.\n* For FCBP two negative pregnancy test (sensitivity of at least 25 mU\u002Fml) prior to first application of CC-3\n* All subjects must agree to refrain from donating blood while on study drug and for 2 months after last dose of CC-3.\n* Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment:\n\n  * Hemoglobin ≥ 9 g\u002Fdl (Transfusion of packed red blood cells prior to enrolment allowed)\n  * Neutrophil count ≥ 1,500\u002Fmm3\n  * Platelet count ≥ 75,000\u002Fµl\n  * Serum creatinine ≤ 1.5mg\u002Fdl or creatinine clearance ≥ 60ml\u002Fmin\n  * hepatic function of patients without current hepatic metastasis:\n\n    * Bilirubin ≤ 1.5x upper limit of normal (ULN), in case of known Gilbert syndrome higher values are allowed if due to increase of indirect bilirubin\n    * ALT and AST ≤ 2.5 x ULN\n  * hepatic function of patients with current hepatic metastasis:\n\n    * Bilirubin ≤ 2.5 x upper limit of normal (ULN)\n    * ALT and AST ≤ 5. x ULN\n\nExclusion Criteria:\n\n* Other malignancy requiring treatment within the last year except: adequately treated non-melanoma skin cancer and low-grade non-muscle invasive papillary bladder cancer.\n* Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anticancer therapy\n* Persistent toxicity (≥ Grade 2 according to Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0) caused by previous cancer therapy, excluding alopecia and neurotoxicity\n* Clinical signs of active infection (\\> grade 2 according to CTCAE version 5.0)\n* Known cerebral\u002Fmeningeal manifestation of CRC\n* History of HIV infection\n* Viral active or chronic hepatitis (HBV or HCV)\n* Ongoing autoimmune disease\n* History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia\u002Fhemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)\n* Therapeutic anticoagulation therapy\n* Major surgery within 4 weeks of starting study treatment. Patients must have recovered from any effects of major surgery.\n* Patients receiving any systemic chemotherapy, mAb or radiotherapy within 2 (for mAb 4) weeks prior to study treatment or a longer period depending on the defined characteristics of the agents used\n* Heart failure NYHA III\u002FIV\n* Severe obstructive or restrictive ventilation disorder\n* Known intolerance to CC-3 or other immunoglobulin drug products as well as hypersensitivity to any of the excipients present in CC-3\n* Live and live-attenuated vaccination 30 days prior to treatment\n* Pregnant or breast-feeding women\n* Current ileus with severely altered GI function","ALL",{"count":49,"type":20},89,[51],"PHASE1","This trial is a first in human (FIH) clinical trial in patients with Colorectal cancer (CRC) after failure of at least three lines of previous therapy aiming to evaluate safety and efficacy of CC-3, a bispecific antibody (bsAb) with CD276xCD3 specificity developed within DKTK. CC-3 binds to CD276 on cancer cells as well as to tumor vessels of CRC, thereby allowing for a dual mode of anti-cancer action. CC-3 was developed in a novel format which not only prolongs serum half-life, but most importantly reduces off-target T cell activation with expected fewer side effects. A similar construct in this format with PSMAxCD3 specificity is presently undergoing clinical evaluation in patients with prostate cancer (NCT04104607), with very favorable safety and preliminary efficacy. The optimized format that CC-3 shares with its PSMAxCD3 \"sister molecule\" allows for application of effective bsAb doses with expected high anticancer activity. The clinical trial comprises two phases: The first phase is a dose-escalation part to evaluate the maximally tolerated dose (MTD) of CC-3. This is followed by a dose-expansion part to defined the recommended phase II dose. A translational research program comprising, among others, analysis of CC-3 half-life and the induced immune response will serve to better define the mode of action of CC-3.",[54,55,56,26],"Colorectal Cancer","Breast Carcinoma","Sarcoma",[58,59,60],"new therapy","bispecific antibody","colorectal cancer","2025-05-16",{"date":63,"type":31},"2025-05-21",{"date":65,"type":31},"2024-01-12",{"date":67,"type":20},"2027-03-31",{"name":69,"class":38},"German Cancer Research Center",1]