[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484179":3},{"organization":4,"armGroups":7,"interventions":82,"overallOfficials":113,"centralContacts":117,"locations":124,"responsibleParty":481,"collaborators":88,"id":483,"slug":484,"hasResults":485,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":88,"eligibilityCriteria":489,"healthyVolunteers":485,"sex":490,"minAge":491,"maxAge":88,"enrollmentInfo":492,"targetDuration":88,"studyType":495,"phases":496,"briefSummary":499,"conditions":500,"keywords":88,"overallStatus":127,"whyStopped":88,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":511},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8,14,19,24,28,31,35,39,42,46,50,53,58,62,66,69,75,79],{"label":9,"type":10,"description":11,"interventionNames":12},"SAR445877 Escalation Phase (Part 1A)","EXPERIMENTAL","SAR445877 monotherapy will be administered intravenously in participants with solid tumors over a 14-day cycle.",[13],"Drug: SAR445877",{"label":15,"type":10,"description":16,"interventionNames":17},"SAR445877 Escalation Phase (Part1B)","SAR445877 will be administered intravenously in combination with ADG126 in participants with advanced unresectable or metastatic melanoma, non-small cell lung cancer (NSCLC); renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), colorectal cancer (MSIH\u002FdMMR), malignant pleural mesothelioma or esophageal squamous cell carcinoma (ESCC).",[13,18],"Drug: ADG126",{"label":20,"type":10,"description":21,"interventionNames":22},"SAR445877 Escalation Phase (Part 1C)","SAR445877 will be administered intravenously in combination with bevacizumab in participants with metastatic colorectal cancer (CRC).",[13,23],"Drug: Bevacizumab",{"label":25,"type":10,"description":26,"interventionNames":27},"SAR445877 Expansion\u002FOptimization Phase: Cohort A1 (Part 2A)","SAR445877 monotherapy will be 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unresectable or metastatic solid tumor, from Japan.",[13],{"label":63,"type":10,"description":64,"interventionNames":65},"SAR445877 Expansion\u002FOptimization Phase Cohort G1 (Part 2C)","SAR445877 will be administered intravenously in combination with ADG126 in participants with metastatic melanoma.",[13,18],{"label":67,"type":10,"description":64,"interventionNames":68},"SAR445877 Expansion\u002FOptimization Phase Cohort G2 (Part 2C)",[13,18],{"label":70,"type":10,"description":71,"interventionNames":72},"SAR445877 Expansion\u002FOptimization Phase Cohort G3 (Part 2C)","The Standard of Care (nivolumab and ipilimumab) will be administered intravenously in participants with metastatic melanoma.",[73,74],"Drug: Nivolumab","Drug: Ipilimumab",{"label":76,"type":10,"description":77,"interventionNames":78},"SAR445877 Expansion\u002FOptimization Phase Cohort H1 (Part 2D)","SAR445877 will be administered intravenously in combination with bevacizumab in participants with advanced unresectable 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Site Number : 1520002","Rancagua","General Bernardo O'Higgins","2852424","Chile","CL",{"type":134,"coordinates":285},[286,287],-70.74053,-34.1691,{"lat":287,"lon":286},[290,294],{"name":291,"role":120,"phone":292,"phoneExt":88,"email":293},"Plinio Fernandez","56 9 8902 2206","pliniofernandez@urumed.cl",{"name":291,"role":145,"phone":88,"phoneExt":88,"email":88},{"facility":296,"status":127,"city":297,"state":298,"zip":299,"country":282,"countryCode":283,"cosmosGeoPoint":300,"geoPoint":304,"contacts":305},"BIOCINETIC Ltda_Investigational Site Number : 1520008","Santiago","Reg Metropolitana de Santiago","8331143",{"type":134,"coordinates":301},[302,303],-70.64827,-33.45694,{"lat":303,"lon":302},[306,310],{"name":307,"role":120,"phone":308,"phoneExt":88,"email":309},"Nicolas Obando Martínez","569 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1520007","Providencia","7500000",{"type":134,"coordinates":328},[329,330],-70.60454,-33.43107,{"lat":330,"lon":329},[333,338],{"name":334,"role":120,"phone":335,"phoneExt":336,"email":337},"Christian Caglevic Medina","(562) 242-0509","8","christian.caglevic@falp.org",{"name":334,"role":145,"phone":88,"phoneExt":88,"email":88},{"facility":340,"status":127,"city":341,"state":341,"zip":342,"country":343,"countryCode":344,"cosmosGeoPoint":345,"geoPoint":349,"contacts":350},"Hadassah Medical Center - PPDS_Investigational Site Number : 3760005","Jerusalem","9112001","Israel","IL",{"type":134,"coordinates":346},[347,348],35.21633,31.76904,{"lat":348,"lon":347},[351,355],{"name":352,"role":120,"phone":353,"phoneExt":88,"email":354},"Jonathan Cohen","972505172537","cohenjon@hadassah.org.il",{"name":352,"role":145,"phone":88,"phoneExt":88,"email":88},{"facility":357,"status":127,"city":358,"state":88,"zip":359,"country":343,"countryCode":344,"cosmosGeoPoint":360,"geoPoint":364,"contacts":365},"Sheba Medical Center - PPDS_Investigational Site Number : 3760003","Ramat Gan","5262100",{"type":134,"coordinates":361},[362,363],34.81065,32.08227,{"lat":363,"lon":362},[366,370],{"name":367,"role":120,"phone":368,"phoneExt":88,"email":369},"Tamar Beller","972545964434","Tamar.Beller@sheba.health.gov.il",{"name":367,"role":145,"phone":88,"phoneExt":88,"email":88},{"facility":372,"status":127,"city":373,"state":88,"zip":374,"country":343,"countryCode":344,"cosmosGeoPoint":375,"geoPoint":379,"contacts":380},"Tel Aviv Sourasky Medical Center Ichilov - PPDS_Investigational Site Number : 3760001","Tel Aviv","6423906",{"type":134,"coordinates":376},[377,378],34.78057,32.08088,{"lat":378,"lon":377},[381,385],{"name":382,"role":120,"phone":383,"phoneExt":88,"email":384},"Ravit Geva","97236973494","ravitg@tlvmc.gov.il",{"name":382,"role":145,"phone":88,"phoneExt":88,"email":88},{"facility":387,"status":127,"city":388,"state":88,"zip":389,"country":343,"countryCode":344,"cosmosGeoPoint":390,"geoPoint":394,"contacts":395},"Shamir Medical Center_Investigational Site Number : 3760004","Tzrifin","7033001",{"type":134,"coordinates":391},[392,393],34.84002,31.95649,{"lat":393,"lon":392},[396,400],{"name":397,"role":120,"phone":398,"phoneExt":88,"email":399},"Carmell Fink","972584882432","carmelf@shamir.gov.il",{"name":397,"role":145,"phone":88,"phoneExt":88,"email":88},{"facility":402,"status":403,"city":404,"state":405,"zip":406,"country":407,"countryCode":408,"cosmosGeoPoint":409,"geoPoint":413,"contacts":88},"Investigational Site Number : 3920001","ACTIVE_NOT_RECRUITING","Kashiwa","Chiba","277-8577","Japan","JP",{"type":134,"coordinates":410},[411,412],139.97732,35.86224,{"lat":412,"lon":411},{"facility":415,"status":127,"city":416,"state":417,"zip":418,"country":419,"countryCode":420,"cosmosGeoPoint":421,"geoPoint":425,"contacts":426},"Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis_Investigational Site Number : 5280001","Amsterdam","North Holland","1066 CX","Netherlands","NL",{"type":134,"coordinates":422},[423,424],4.88969,52.37403,{"lat":424,"lon":423},[427,431],{"name":428,"role":120,"phone":429,"phoneExt":88,"email":430},"Marloes van Dongen","31205129111","mg.v.dongen@nki.nl",{"name":428,"role":145,"phone":88,"phoneExt":88,"email":88},{"facility":433,"status":127,"city":434,"state":435,"zip":436,"country":419,"countryCode":420,"cosmosGeoPoint":437,"geoPoint":441,"contacts":442},"Erasmus MC_Investigational Site Number : 5280003","Rotterdam","South Holland","3015 CE",{"type":134,"coordinates":438},[439,440],4.47917,51.9225,{"lat":440,"lon":439},[443,447],{"name":444,"role":120,"phone":445,"phoneExt":88,"email":446},"Ferry Eskens","31107034897","f.eskens@erasmusmc.nl",{"name":444,"role":145,"phone":88,"phoneExt":88,"email":88},{"facility":449,"status":127,"city":450,"state":451,"zip":452,"country":453,"countryCode":454,"cosmosGeoPoint":455,"geoPoint":459,"contacts":460},"Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON_Investigational Site Number : 7240007","Barcelona","Barcelona [Barcelona]","08035","Spain","ES",{"type":134,"coordinates":456},[457,458],2.15899,41.38879,{"lat":458,"lon":457},[461,465],{"name":462,"role":120,"phone":463,"phoneExt":88,"email":464},"Elena Garralda","34932746085","egarralda@vhio.net",{"name":462,"role":145,"phone":88,"phoneExt":88,"email":88},{"facility":467,"status":127,"city":468,"state":88,"zip":469,"country":453,"countryCode":454,"cosmosGeoPoint":470,"geoPoint":474,"contacts":475},"START MADRID_Hospital Universitario HM Sanchinarro - CIOCC_Investigational Site Number : 7240005","Madrid","28050",{"type":134,"coordinates":471},[472,473],-3.70256,40.4165,{"lat":473,"lon":472},[476,480],{"name":477,"role":120,"phone":478,"phoneExt":88,"email":479},"Emiliano Calvo","34917567825","emiliano.calvo@startmadrid.com",{"name":477,"role":145,"phone":88,"phoneExt":88,"email":88},{"type":482,"investigatorFullName":88,"investigatorTitle":88,"investigatorAffiliation":88,"oldNameTitle":88,"oldOrganization":88},"SPONSOR","100484179","phase-1-a-first-in-human-dose-escalation-and-dose-expansion-study-of-sar445877-in-adult-participants-with-advanced-solid-tumors-100484179",false,"NCT05584670","A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors","A Phase 1\u002F2, Open Label, First-in-human, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR445877 Administered as Monotherapy or in Combination With Other Anticancer Therapies in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Dose escalation Part 1A and Japan Cohort F\n\n   * Participants with advanced unresectable or metastatic solid tumors for which, in the judgement of the investigator, no standard alternative therapy is available or is not in the best interest of the participant\n2. Dose escalation Part 1B\n\n   * Participants with advanced unresectable or metastatic melanoma, NSCLC; renal cell carcinoma (RCC); HCC, colorectal cancer (MSI-H\u002FdMMR), malignant pleural mesothelioma or esophageal squamous cell carcinoma (ESCC). and for who, in the judgement of the investigator, no standard alternative therapy is available or is not in the best interest of the participant.\n3. Dose escalation Part 1C\n\n   * Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic colorectal cancer\n   * Participants with RAS-mutant and BRAF-mutant colorectal cancer are eligible for enrollment.\n4. Dose expansion\u002Foptimization Part 2\n\n   Cancer diagnosis:\n   * Participants in Cohorts A1 and A2 (Part 2A): Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)\n   * Participants in Cohort B (part 2A): Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic hepatocellular carcinoma (HCC), or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants (participants without cirrhosis must have had histological confirmation of diagnosis)\n   * Participants in Cohorts C1 and C2 (part 2A):\n\n     * Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic gastric cancer (GC) or Siewert Type 2 \\& 3 gastro esophageal junction (GEJ) adenocarcinoma\n     * Disease with any CPS scoring. No need for CPS determination at local laboratory\n     * Participants must have MSI (metastatic microsatellite instability) or MMR (mismatch repair) status known or determined locally and must have non-MSI-H or proficient MMR (pMMR) disease to be eligible.\n     * Participants with unknown HER2\u002Fneu status must have their HER2\u002Fneu status determined locally. Participants with HER2\u002Fneu negative are eligible. Participants with HER2\u002Fneu positive tumors must have documentation of disease progression on treatment containing an approved HER2 targeted therapy to be eligible.\n   * Participants in Part 2A Cohorts E1 and E2, Part 2B Cohort E3 and Part 2D Cohorts H1 and H2: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic colorectal cancer.\n   * Participants in Part 2A Cohorts E1, and E2 and Part 2B Cohort E3 MSI status:\n\n   Participants must have MSI status known or determined locally and must have non- MSI-H disease to be eligible.\n   * Participants in Part 2A Cohorts E1, E2, Part 2B Cohort E3 and Part 2D Cohorts H1 and H2: Participants with RAS-mutant and BRAF-mutant colorectal cancer are eligible for enrollment.\n   * Part 2C Cohorts G1, G2 and G3: Participants with histologically confirmed unresectable locally advanced or metastatic melanoma\n5. Prior anticancer therapy (For dose expansion\u002Foptimization Part 2 only)\n\n   * Participants in Cohorts A1 and A2: Participants must have received at least 1 systemic therapy for the metastatic setting and must not be amenable to the available SOC.\n   * Participants in Cohort B: Participants who have received at least 1 prior anticancer therapy, including an anti-PD1\u002FPD-L1 containing regimen, and for whom have progressed after a primary or secondary resistance to an anti-PD1\u002FPD-L1.\n   * Participants in Cohorts C1 and C2: Participants should have failed or relapsed after at least 1 prior line of treatment which may or may not include an anti-PD1\u002FPD-L1-based treatment depending on local standard of care.\n   * Participants in Cohort D: Participants must have received at least 1 systemic therapy for their advanced\u002F metastatic setting and must not be amenable to the available SOC.\n   * Participants in Part 2A Cohorts E1 and E2 and Part 2D Cohorts H1 and H2 should have failed or relapsed on at least 2 prior regimens.\n   * Participants in cohort E3 should have failed or relapsed on at least 1 prior regimen. Participants who have received cetuximab or other anti-EGFR therapy as part of their prior line of treatment are eligible.\n   * Part 2C Cohorts G1, G2 and G3: Participants must have received at least one prior line of therapy for advanced\u002Fmetastatic melanoma and\u002For does not have any standard of care (SoC) treatment option or decline or is intolerant to be treated with SoC treatment.\n\nMeasurable Disease:\n\n* At least 1 measurable lesion per RECIST 1.1 criteria\n\nPart 1C and Part 2D: Adequate coagulation function for all participants. For participants receiving anti-coagulant therapy (except platelet anti-aggregates) the adequate therapeutic levels of INR should be confirmed.\n\nCapable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≥2\n* Predicted life expectancy ≤3 months\n* For participants with HCC- Cohort B (Part 2): Child Pugh Class B or C liver score. Participants with Child Pugh Class B-7 score are allowed for Part 1.\n* Diagnosed of any other malignancies, either progressing or requiring active treatments, within 2 years prior to enrollment\n* Known active brain metastases or leptomeningeal metastases\n* History of treatment-related immune-mediated (or immune-related) AEs from immune-modulatory agents (including but not limited to anti-PD1\u002FPD-L1 agents and anti-cytotoxic T lymphocyte associated protein 4 monoclonal antibodies) that caused permanent discontinuation of the agent, or that were Grade 4 in severity or have not resolved to Grade ≤1\n* Has any condition requiring ongoing\u002Fcontinuous corticosteroid therapy (\\>10 mg prednisone\u002Fday or an anti-inflammatory equivalent) within 1 week prior to the first dose of the study medicine\n* Any clinically significant cardiac (including valvular) or vascular (thromboembolic disorders) disease, within 6 months prior to the first IMP administration\n* Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events\n* Has a known history or any evidence of interstitial lung disease or active, non-infectious pneumonitis within 3 years prior to the first dose of the study drug.\n* Organ transplant requiring immunosuppressive treatment\n* Uncontrolled or active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or has a diagnosis of immunodeficiency\n\nNOTE: Other Inclusion\u002FExclusion criteria may apply.\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.","ALL","18 Years",{"count":493,"type":494},542,"ESTIMATED","INTERVENTIONAL",[497,498],"PHASE1","PHASE2","This is a Phase 1\u002F2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy or in combination with other anticancer therapies for participants aged at least 18 years with advanced unresectable or metastatic solid tumors.\n\nThe study will include 2 parts:\n\nA dose escalation Part 1: for finding the therapeutic dose(s) of SAR445877 in a monotherapy given every 2 weeks (Q2W) or weekly (QW) and in combination with other anticancer therapies when applicable.\n\nA multicohort dose expansion\u002Fdose optimization Part 2: for the assessment of safety and preliminary efficacy of SAR445877 in monotherapy and in combination with cetuximab or with next generation aCTLA4 (ADG126) or with bevacizumab. 2 recommended doses for expansion\u002Foptimization of SAR445877 identified from dose escalation part 1 will be tested in different indications in monotherapy and in combination with other anticancer therapies as applicable.\n\nApproximately 542 participants will be exposed to the study intervention:\n\n* approximately 123 participants in part 1,\n* up to 410 participants in expansion\u002Fdose optimization part (part 2)\n* and up to 9 participants in Japan cohort F.",[501],"Solid Tumor","2026-06-19",{"date":504,"type":505},"2026-06-23","ACTUAL",{"date":507,"type":505},"2022-11-29",{"date":509,"type":494},"2028-06-28",{"name":5,"class":6},22]