{"entity":{"id":"nct05824975","kind":"trial","name":"A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizu","aka":["KEYNOTE-G08"],"tldr":"A phase 1/2 trial of Doxorubicin, Paclitaxel / nab-paclitaxel, Bevacizumab in sarcomas and ovarian cancer, run by GI Innovation, Inc., now recruiting.","summary":"A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08) is a phase 1/2 interventional study registered as NCT05824975 by GI Innovation, Inc., with 358 participants planned, started 2023-05-30 and due to reach its primary completion in 2025-11-12. Interventions recorded: GI-102 subcutaneous (SC), GI-102, doxorubicin, paclitaxel, bevacizumab. Conditions listed: Advanced Solid Tumor, Metastatic Solid Tumor, Soft Tissue Sarcoma (STS), Platinum-resistant Ovarian Cancer (PROC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05824975","url":"https://clinicaltrials.gov/study/NCT05824975"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sarcoma","ovarian","hcc","colorectal","melanoma"],"sections":[],"technologies":["adc","checkpoint-inhibitor","topoisomerase-inhibitors"],"targets":[],"drugs":["doxorubicin","paclitaxel","bevacizumab","eribulin","trastuzumab-deruxtecan","pembrolizumab"],"companies":["gi-innovation"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05824975","phase":"1/2","setting":"An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)","sponsor":"GI Innovation, Inc.","started":"2023-05-30","startedType":"actual","enrolled":358,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05824975/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"drug":[{"id":"bevacizumab","kind":"drug","name":"Bevacizumab","route":"/drugs/bevacizumab/"},{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"eribulin","kind":"drug","name":"Eribulin","route":"/drugs/eribulin/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"},{"id":"trastuzumab-deruxtecan","kind":"drug","name":"Trastuzumab deruxtecan","route":"/drugs/trastuzumab-deruxtecan/"}],"company":[{"id":"gi-innovation","kind":"company","name":"GI Innovation","route":"/companies/gi-innovation/"}]}}