[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Crescent Biopharma, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":57},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100618736","phase-1-cr-001-in-adult-participants-with-locally-advanced-or-metastatic-solid-tumors-100618736",false,"NCT07335497","CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors","A Phase 1\u002F2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors","ASCEND","Key Inclusion Criteria\n\n* Life expectancy ≥ 3 months\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1\n* Adequate organ function and hematologic reserve based on laboratory parameters\n* Have measurable disease defined by RECIST v1.1\n* For Backfill and Dose Optimization: Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy\n* Tumor Indication specific inclusion criteria:\n* For dose escalation or backfill: progressing from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have one of the following locally advanced or metastatic tumor types:\n\n  * Hepatocellular carcinoma\n  * Biliary tract cancer\n  * Endometrial carcinoma\n  * Cervical cancer\n  * Ovarian cancer\n  * Gastric or gastroesophageal cancer\n  * Colorectal cancer\n  * Non-small cell lung cancer\n\nKey Exclusion Criteria\n\n* Has malignancies other than disease under study within the past 3 years\n* Has conditions requiring treatment with clinically significant or increasing doses of systemic steroid therapy\n* Has not adequately recovered from recent major surgery\n* Has ongoing clinically significant toxicity related to prior therapy\n* Has active central nervous system (CNS) metastases\n* Has active autoimmune disease requiring systemic therapy in the past 2 years (replacement therapy is permitted)\n* Has a history of serious Grade ≥ 3 immune-related adverse event (irAE)\n* Has a history of noninfectious pneumonitis\u002Finterstitial lung disease\n* Has an active severe infection\n* Has received a live or attenuated vaccine within 30 days of the first dose\n* Has undergone prior allogeneic stem cell or solid organ transplantation\n* Has protocol-specified events related to gastrointestinal perforation, surgery, wound healing complications, and bleeding\n* Has clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},290,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this study is to determine the safety and tolerability of monotherapy CR-001 and identify the maximum tolerated dose (MTD), and\u002For optimal biologic dose and Recommended Phase 2 Dose(s) (RP2D) in participants with locally advanced or metastatic solid tumors.",[28],"Locally Advanced \u002F Metastatic Solid Tumors",[30,31,32,33,34,35,36,37,38,39,40,41,42,43],"solid tumors","metastatic","VEGF","PD-1","anti-PD-1","anti VEGF","immuno-oncology","anti-angiogenic therapy","checkpoint inhibitor","metastatic cancer","advanced cancer","First-in-Human","Dose Escalation","Dose Optimization","RECRUITING","2026-09-08",{"date":47,"type":48},"2026-09-10","ACTUAL",{"date":50,"type":48},"2026-02-17",{"date":52,"type":21},"2029-02",{"name":54,"class":55},"Crescent Biopharma, Inc.","INDUSTRY",31,""]