{"entity":{"id":"nct04977453","kind":"trial","name":"GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors","aka":["Keynote B59"],"tldr":"A phase 1/2 trial of Pembrolizumab, Lenvatinib in cervical cancer and non-small-cell lung cancer, run by GI Innovation, Inc., now recruiting.","summary":"GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT04977453 by GI Innovation, Inc., with 317 participants planned, started 2021-08-02 and due to reach its primary completion in 2028-06-30. Interventions recorded: GI-101, Pembrolizumab (KEYTRUDA®), Lenvatinib, GI-101A. Conditions listed: Advanced Solid Tumor, Metastatic Solid Tumor, Cervical Cancer, Urothelial Carcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04977453","url":"https://clinicaltrials.gov/study/NCT04977453"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cervical","nsclc","sclc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["pembrolizumab","lenvatinib"],"companies":["gi-innovation"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04977453","phase":"1/2","setting":"A Phase 1/2, Open-label, Dose-escalation, Dose-optimization and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101/GI-101A as a Single Agent and in Combination With Pembrolizumab or Lenvatinib in Patients With Advanced or Metastatic Solid Tumors (Keynote B59)","sponsor":"GI Innovation, Inc.","participation":[{"nct":"NCT04977453","source":"https://clinicaltrials.gov/study/NCT04977453","fetchedAt":"2026-10-07T16:53:31.375Z","studySha256":"b23011ee89c544b11ab97241aca1a4c66e1a1d67fd19b80321bdaa220307111f","overallStatus":"RECRUITING","lastUpdatePosted":"2026-09-14","leadSponsor":"GI Innovation, Inc.","collaboratorCount":1,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":317,"enrolmentType":"ESTIMATED","siteCount":13,"recruitingSiteCount":13,"countries":["South Korea","United States"]}],"started":"2021-08-02","startedType":"actual","enrolled":317,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04977453/","neighbours":{"cancer":[{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"lenvatinib","kind":"drug","name":"Lenvatinib","route":"/drugs/lenvatinib/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"gi-innovation","kind":"company","name":"GI Innovation","route":"/companies/gi-innovation/"}]}}