[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"papillary-renal-cell-carcinoma-prcc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:papillary-renal-cell-carcinoma-prcc":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100576996","phase-1-a-phase-i-study-of-sim0505-in-participants-with-advanced-solid-tumors-100576996",false,"NCT06792552","A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors","A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Written informed consent is obtained prior to any procedures that are not considered standard of care.\n2. ≥18 years of age.\n3. In Part 1:\n\n   1. Participants with histologically or cytologically confirmed advanced solid tumors, who have failed or are ineligible for standard of care therapies.\n   2. Have progressed on at least one prior systematic anti-tumor regimen, and presence of at least one evaluable lesion according to RECIST Version 1.1. Measurable lesions are required in the backfill period.\n   3. In the backfill period, eligible tumor types are limited to high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, USC, clear cell RCC, papillary RCC and adenocarcinoma of NSCLC without actionable mutation of epidermal growth factor receptor (EGFR). For participants with NSCLC, presence of CDH6 expression through immunohistochemical examination of tumor tissue by central laboratory is required.\n4. In Part 2: Participants must have a diagnosis of specific type of metastatic or locally advanced solid tumors and have progressed on or cannot benefit from the most recent systematic anti-tumor regimen (unless otherwise specified), with presence of at least one measurable lesion according to RECIST Version 1.1.\n\n   Platinum-resistant ovarian cancer cohort:\n   1. Participants with histologically or cytologically confirmed high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n   2. Have platinum-resistant disease, defined as: participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a best response of CR or PR, and then progressed between \\>90 days and ≤180 days after the date of the last dose of platinum; participants who have received ≥2 lines of platinum therapy must have progressed ≤180 days after the date of the last dose of platinum.\n   3. At least one line of therapy containing anti-VEGF therapy (e.g., bevacizumab or suvemcitug or their biosimilar), unless the participant is not eligible for treatment with anti- angiogenic treatment due to precautions\u002Fintolerance. Has had prior poly-ADP ribose polymerase (PARP) inhibitors for subjects with documented breast cancer gene (BRCA) mutation (germline and\u002For somatic), unless the subject is not eligible for treatment with a PARP inhibitor. Has had prior treatment with mirvetuximab soravtansine for participants with documented high folate receptor alpha expression, unless the subject is not eligible for treatment with mirvetuximab soravtansine due to precautions\u002Fintolerance, or if the treatment is not approved or available locally. In the PROC cohort, topoisomerase inhibitor payload ADC-pretreated participants should have received at least one prior topoisomerase inhibitor payload ADC.\n\n   Renal cell carcinoma cohort:\n   1. Participants with histologically- or cytologically-confirmed clear cell RCC or papillary RCC.\n   2. For clear cell RCC: Participants who have progressed on or after systemic treatment including a programmed cell death protein 1 or programmed death ligand 1 (PD-1\u002FPD-L1) checkpoint inhibitor and a vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI), either given concurrently or in separate lines of therapy.\n   3. For papillary RCC: Participants without any prior systemic treatment is acceptable.\n\n   Uterine serous carcinoma cohort:\n   1. Participants with histologically- or cytologically-confirmed USC.\n   2. Have progressed on or after systemic treatment that contained platinum-based chemotherapy.\n\n   Non-Small Cell Lung Cancer cohort:\n   1. Participants with histologically- or cytologically-confirmed adenocarcinoma of NSCLC without actionable mutation of EGFR.\n   2. Presence of CDH6 expression through immunohistochemical examination of tumor tissue.\n   3. For participants without actionable mutations: Have progressed on or after systemic treatment including anti-PD-1\u002FPD-L1 antibody and platinum-based chemotherapy, either given concurrently or in separate lines of therapy. Progression within 6 months after completion of adjuvant therapy is considered failure of first-line therapy.\n   4. For participants with actionable mutations other than EGFR: Have failed at least one established standard anti-cancer targeted therapy, anti-PD-1\u002FPD-L1 antibody and platinum-based chemotherapy (PD-1\u002FPD-L1 and chemotherapy either given concurrently or in separate lines of therapy) or in the opinion of the Investigator have been considered ineligible for a particular form of standard of care therapy on medical grounds.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n6. Life expectancy of ≥12 weeks.\n7. Have adequate organ function as indicated by the laboratory values listed within the protocol.\n8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the start of study treatment. WOCBP or male participants who have sexual relations with WOCBP are required to use highly effective contraceptive methods, and agree to refrain from donating sperm\u002Fegg from signing of informed consent through 180 days after the last dose of study treatment.\n9. Able to provide tumor tissue sample (archival or newly obtained core or excisional biopsy). For Part 1: At biomarker-screening (for NSCLC) or screening (for non-NSCLC) visit of a tumor lesion not previously irradiated for CDH6 testing.\n\nFor Part 2: Willing to undergo fresh tumor biopsy at biomarker-screening visit (for NSCLC) and screening visit (non-NSCLC) from a lesion that can be biopsied at an acceptable clinical risk as judged by the investigator.\n\nExclusion Criteria:\n\n1. For Part 2: has clear cell, mucinous or sarcomatous histology, mixed tumors containing any histology, or low-grade\u002Fborderline ovarian cancer; mixed nonsmall cell and small cell carcinoma, or adenosquamous cell lung cancer with an adenocarcinoma component \\\u003C50% (the participant is eligible if the adenocarcinoma component is ≥50%).\n2. For Part 2: Participants with primary platinum refractory ovarian cancer, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy.\n3. Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.\n4. Known untreated CNS metastases and\u002For leptomeningeal metastases. Participants are eligible if CNS metastases have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment). In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to the first dose of study treatment. Imaging performed within 28 days prior to the first dose of study treatment must document radiographic stability of CNS lesions and be performed after completion of any CNS-directed therapy.\n5. History of bowel obstruction within 3 months prior to the first dose of study treatment.\n6. Known psychiatric disorder or drug abuse that would interfere the study requirements.\n7. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment.\n8. Any active infection requires systemic treatment via intravenous infusion within 2 weeks prior to the first dose of study treatment.\n9. History of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease (ILD) or severe obstructive pulmonary disease.\n10. Prior exposure to other CDH6-targeted agents.\n11. Prior exposure to an ADC with a topoisomerase I inhibitor payload (e.g., raludotatug deruxtecan\u002FDS-6000) for all cohorts except for the topoisomerase inhibitor payload ADC-pretreated participants in PROC cohort.\n12. Has not recovered (i.e., to CTCAE version 5.0 Grade 1 or to baseline) from previous anticancer therapy-induced AEs. Grade ≤2 AEs with no impact on participant safety are exceptions to this criterion and may qualify for the study.\n13. Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of SIM0505.\n14. Major surgery within 2 weeks of receiving the first dose of study treatment.\n15. Has received prior anti-cancer therapies within the following time frames prior to the first dose of study treatment: previous cytotoxic therapy, anticancer targeted small molecules (e.g., tyrosine kinase inhibitors), hormonal agents within 2 weeks; anti-cancer antibody or ADC within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study treatment; Chinese medicines\u002Fherbal preparations with anticancer indication taken within 2 weeks; and\u002For radiation therapy within 2 weeks for focal radiation or within 4 weeks for wide-field radiation.\n16. Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment.\n17. Administration of strong or moderate CYP3A4 inhibitors or drugs with known risk of Torsades de Pointes (TdP) ≤ 7 days or 3 half-lives (whichever is longer) prior to the first dose of SIM0505.\n18. Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).\n19. Active hepatitis B or hepatitis C infection.\n20. Participants with clinically significant cardiovascular diseases.\n21. History of allogeneic organ transplantation or graft-versus-host disease.\n22. Known hypersensitivity to study drug or any of the excipients.\n23. Participant is pregnant or breastfeeding.\n24. Other conditions that researchers consider inappropriate for inclusion.","ALL","18 Years",{"count":19,"type":20},738,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid Tumors",[26,27,28,29,30,31,32,33],"Advanced Solid Tumors","Platinum Resistant Ovarian Cancer","Fallopian Tube Cancer","Renal Cell Carcinoma (RCC)","Papillary Renal Cell Carcinoma (Prcc)","Uterine Serous Carcinoma (USC)","NSCLC (Non-small Cell Lung Cancer)","Primary Peritoneal Cancer","RECRUITING","2026-08-13",{"date":37,"type":38},"2026-08-17","ACTUAL",{"date":40,"type":38},"2025-02-26",{"date":42,"type":20},"2028-08",{"name":44,"class":45},"NextCure, Inc.","INDUSTRY",17,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100490379","phase-1-palbociclib-and-sasanlimab-for-the-treatment-of-advanced-clear-cell-renal-cell-carcinoma-ccrcc-or-papillary-renal-cell-carcinoma-prcc-100490379","NCT05665361","Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)","A Phase I\u002FII Study of Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)","* INCLUSION CRITERIA:\n* Cytologically or histologically confirmed clear cell renal cell carcinoma (presence of a clear cell component) (ccRCC) (Cohort 1) or papillary renal cell carcinoma (pRCC) (presence of a papillary component) (Cohort 2)\n* Participants must have advanced RCC with at least one measurable lesion as outlined in RECIST 1.1.\n* Participants with ccRCC (Cohort 1) must have received checkpoint inhibitor therapy and must have received or been ineligible to receive a VEGF pathway antagonist (as a single agent or as part of a combination)\n* Participants with pRCC (Cohort 2) can be treatment-na(SqrRoot) ve or have previously received systemic treatment for pRCC\n* Age \\>= 18 years\n* ECOG performance status \\\u003C= 1\n* Adequate hematologic function at screening, as follows:\n\n  * Absolute neutrophil count (ANC) \\>= 1,000\u002Fmicroliter\n  * Hemoglobin (Hb) \\>= 9 g\u002FdL with no blood transfusion within 2 weeks prior to treatment initiation\n  * Platelets \\>= 100,000\u002Fmicroliter\n* Adequate renal and hepatic function at screening, as follows:\n\n  * Serum creatinine \\\u003C= 1.5 x upper limit of normal (ULN) OR, if \\>1.5x ULN, creatinine clearance (CrCl) \\>= 30 mL\u002Fmin\u002F1.73 m\\^2 (calculated CrCl (CKD-EPI or calculated eGFR provided by laboratory))\n  * Total bilirubin \\\u003C= 1.5 x ULN OR in participants with known or suspected Gilbert's syndrome, total bilirubin \\\u003C= 3.0 x ULN\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C= 2.5 x ULN, (unless liver metastases are present, then values must be \\\u003C= 5 x ULN)\n* Participants serologically positive for hepatitis C virus (HCV) are eligible if HCV viral load is undetectable\n* Participants serologically positive for human immunodeficiency virus (HIV) are eligible if they are on stable antiretroviral therapy for at least 4 weeks before treatment initiation, have no reported opportunistic infections or Castleman s disease within 12 months prior to treatment initiation, have a viral load that is undetectable by quantitative polymerase chain reaction (PCR) and CD4 count \\>= 200 cells per cubic millimeter\n* Participants with brain metastasis are eligible if at least 4 weeks status post radiotherapy or surgery before treatment initiation with no evidence of progression or associated symptoms\n* Women of child-bearing potential (WOCBP) must agree to use one (1) highly effective method of contraception (e.g.,hormonal, intrauterine device (IUD), surgical sterilization) prior to study entry, for the duration of study therapy, and for up to 6 months following the last dose of any study agent(s). Women must refrain from donating eggs during this same period. NOTE: WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n* Men with female partners of reproductive potential and pregnant partners are required to use a condom (even after vasectomy), during treatment and for at least 6 months after the final dose and must refrain from donating sperm during this same period.\n* Breastfeeding participants must be willing to discontinue breastfeeding from study enrollment through 6 months after study treatment discontinuation\n* Participants must be able to understand and be willing to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\n* Prior treatment for RCC with chemotherapy, hormonal therapy, immunotherapy, treatment with an experimental agent, and\u002For radiation therapy within 4 weeks or 5 halflives, whichever is shorter, prior to treatment initiation\n* More than four prior lines of systemic therapy in the metastatic setting\n* Participants who have wound dehiscence from prior surgeries\n* Active inflammatory bowel disease, chronic diarrhea, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of palbociclib\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents\n* Prior history of grade \\>=3 immune-related adverse event(s) with checkpoint inhibitor therapy. Note: participants who had endocrine toxicity of grades 3 or 4 are eligible\n* An active autoimmune disease. Note: participants with type 1 diabetes, eczema, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease, adrenal insufficiency on systemic oral corticosteroid therapy (\\\u003C= the equivalent of prednisone 10 mg\u002Fday) or other mild autoimmune disorders not requiring immunosuppressive treatment are eligible.\n* Participants receiving systemic corticosteroids at doses equivalent \\> 10 mg\u002Fdaily of prednisone, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, sirolimus, thalidomide, or anti-tumor necrosis factor \\[anti-TNF\\] agents. Note: participants on steroids through a route known to result in minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) are eligible\n* Prior allogeneic\u002Fautologous bone marrow or solid organ transplant\n* Participants with current or past hepatitis B (HBV) infection\n* Participants with a history of interstitial lung disease, non-infectious pneumonitis, or untreated active\u002Flatent pulmonary tuberculosis (TB)\n* Participants taking medications that are strong inhibitors or inducers of CYP3A (https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-druginteractions-table-substrates-inhibitors-and-inducers#table3-2) within 21 days or 5 half-lives of the agent (whichever is shorter) prior to initiation of study therapy\n* Participants taking any herbal supplements within 14 days prior to initiation of study therapy\n* History of a non RCC malignancy within 2 years of treatment initiation except for the following: adequately treated localized skin cancer, ductal carcinoma in situ, cervical carcinoma in situ, superficial bladder cancer, or other malignancy which does not require treatment at the current time per Standard of Care\n* Pregnant women (confirmed by beta-HCG serum pregnancy test performed at screening)\n* Uncontrolled intercurrent illness that would limit compliance with study requirements, evaluated by history, physical exam, and chemistry panel.","100 Years",{"count":56,"type":20},100,[23,58],"PHASE2","Background:\n\nKidney cancer is the 12th leading cause of cancer-related death in the United States. Some kidney tumors do not respond well to current treatments. Better treatments are needed.\n\nObjective:\n\nTo test a pair of drugs (sasanlimab and palbociclib) in people with kidney cancers.\n\nEligibility:\n\nPeople aged 18 years and older with kidney cancer; specifically, clear cell renal cell carcinoma (ccRCC) or papillary renal cell carcinoma (pRCC).\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have an imaging scan and a test of their heart function. They may have a biopsy; that is, a sample of tissue will be cut from the tumor.\n\nParticipants will be treated in 28-day cycles for up to 2 years.\n\nPalbociclib is a pill taken by mouth. Participants will take this drug once a day for 21 days during each 28-day treatment cycle. They will write down the dates and times they take these pills in a diary.\n\nSasanlimab is an injection under the skin. Participants will receive this injection on the first day of each treatment cycle.\n\nImaging scans and blood tests will be repeated throughout the treatment. Tumor biopsies may be repeated up to 3 times; these biopsies are optional.\n\nParticipants will have follow-up visits every month for 3 months after treatment ends. They will continue to have imaging scans every 3 months; these scans may be done close to home. The results can be sent to researchers.\n\nParticipants will remain in the study up to 6 years.",[61,30],"Advanced Clear Cell Renal Carcinoma (Ccrcc)",[63,64,65,66,67,68],"Papillary Renal Cell Carcinoma","Kidney Neoplasms","Kidney Cancer","Clear Cell Renal Cell Carcinoma","Translocation Renal Cell Carcinoma","TFE3-rearranged renal cell cancer","2026-07-28",{"date":71,"type":38},"2026-07-29",{"date":73,"type":38},"2024-04-24",{"date":75,"type":20},"2027-06-01",{"name":77,"class":78},"National Cancer Institute (NCI)","NIH",1]