{"entity":{"id":"nct05761223","kind":"trial","name":"A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by 1ST Biotherapeutics, Inc., now recruiting.","summary":"A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849 is a phase 1/2 interventional study registered as NCT05761223 by 1ST Biotherapeutics, Inc., with 151 participants planned, started 2023-12-13 and due to reach its primary completion in 2026-06. Interventions recorded: Phase Ia dose-escalation part of FB849 Monotherapy, Phase Ib dose-expansion of FB849 monotherapy, Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab, Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer), Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer) and Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05761223","url":"https://clinicaltrials.gov/study/NCT05761223"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"nct":"NCT05761223","phase":"1/2","setting":"A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FB849 Administered in Subjects With Advanced Solid Tumors Alone and in Combination With Pembrolizumab","sponsor":"1ST Biotherapeutics, Inc.","enrolled":151,"outcomes":[]},"route":"/trials/nct05761223/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"drug":[{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}]}}