{"entity":{"id":"ck-301-101","kind":"trial","name":"CK-301-101","aka":["Study CK-301-101","Cosibelimab pivotal study"],"tldr":"CK-301-101 was the first study of cosibelimab, and its skin squamous cell cancer groups, where about half of tumours shrank, led to the drug's US approval in December 2024.","summary":"CK-301-101 was an open-label, multicentre, first-in-human phase 1 study of the PD-L1 antibody cosibelimab given alone to adults with advanced cancers, with a dose-escalation part followed by expansion cohorts in several tumour types (272 patients in all on the registry, which lists the study as active and no longer recruiting). Its pivotal cohorts enrolled 109 patients with cutaneous squamous cell carcinoma not suitable for curative surgery or radiotherapy, 78 with metastatic and 31 with locally advanced disease. The primary efficacy endpoint was objective response rate by independent central review using RECIST 1.1, with digital photography under WHO criteria for externally visible lesions; there was no control arm.\n\nIn the metastatic cohort, treated with 800 mg every 2 weeks, 37 of 78 patients responded (47.4 percent, 95% CI 36.0 to 59.1) at a median follow-up of 15.4 months; the median duration of response was not reached and 73 percent of responders were still responding at data cut-off. Immune-related adverse events occurred in 23 percent, grade 3 in 2.6 percent, with no grade 4 or 5 events and no treatment-related deaths (Journal for ImmunoTherapy of Cancer 2023). The current US label reports the same cohorts at a later cut: 39 of 78 (50 percent) in metastatic and 17 of 31 (55 percent) in locally advanced disease, with median duration of response not reached in either. A longer follow-up report (median 29.3 months metastatic, 24.1 months locally advanced) gave 50.0 and 54.8 percent (Journal of the American Academy of Dermatology 2026).\n\nCosibelimab was approved in the US in December 2024, the third PD-1 pathway antibody for this cancer after cemiplimab (EMPOWER-CSCC-1) and pembrolizumab (KEYNOTE-629).","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03212404","url":"https://clinicaltrials.gov/study/NCT03212404"},{"label":"Journal for ImmunoTherapy of Cancer 2023 (metastatic cohort)","url":"https://doi.org/10.1136/jitc-2023-007637"},{"label":"Unloxcyt label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=06bdadd5-d2db-406f-a3f8-de47f48a52e3"},{"label":"Journal of the American Academy of Dermatology 2026 (longer follow-up)","url":"https://doi.org/10.1016/j.jaad.2025.09.009"}],"tags":[],"related":["empower-cscc-1","keynote-629"],"cancers":["cutaneous-scc","advanced-cutaneous-scc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pdl1"],"drugs":["cosibelimab"],"companies":["checkpoint-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-ck-301-101-jitc-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03212404","phase":"1","setting":"Metastatic or locally advanced cutaneous squamous cell carcinoma not suitable for curative surgery or radiotherapy: cosibelimab expansion cohorts within a first-in-human phase 1 study in advanced cancers","sponsor":"Checkpoint Therapeutics","result":"Objective response 47% (37 of 78) in metastatic disease by independent central review at the primary report, median duration of response not reached; the current label reports 50% (39 of 78) metastatic and 55% (17 of 31) locally advanced.","yearReported":2023,"enrolled":272,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate, independent central review (metastatic cohort)","primary":true,"unit":"%","arms":[{"name":"Cosibelimab","n":78,"value":47.4,"note":"37 of 78 (95% CI 36.0 to 59.1); 800 mg every 2 weeks; median follow-up 15.4 months"}],"source":"https://doi.org/10.1136/jitc-2023-007637"},{"endpoint":"Objective response rate, independent central review (locally advanced cohort, US label)","unit":"%","arms":[{"name":"Cosibelimab","n":31,"value":55,"note":"17 of 31 (95% CI 36 to 73) in the September 2026 label, which also reports 39 of 78 (50%) metastatic at the same cut"}],"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=06bdadd5-d2db-406f-a3f8-de47f48a52e3"}],"replication":"Response rates of the same order as EMPOWER-CSCC-1 (cemiplimab) and KEYNOTE-629 (pembrolizumab); no trial has compared cosibelimab with a PD-1 antibody directly."},"route":"/trials/ck-301-101/","neighbours":{"trial":[{"id":"empower-cscc-1","kind":"trial","name":"EMPOWER-CSCC-1","route":"/trials/empower-cscc-1/"},{"id":"keynote-629","kind":"trial","name":"KEYNOTE-629","route":"/trials/keynote-629/"}],"cancer":[{"id":"advanced-cutaneous-scc","kind":"cancer","name":"Advanced cutaneous squamous cell carcinoma","route":"/cancers/advanced-cutaneous-scc/"},{"id":"cutaneous-scc","kind":"cancer","name":"Cutaneous squamous cell carcinoma","route":"/cancers/cutaneous-scc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}],"drug":[{"id":"cosibelimab","kind":"drug","name":"Cosibelimab","route":"/drugs/cosibelimab/"}],"company":[{"id":"checkpoint-therapeutics","kind":"company","name":"Checkpoint Therapeutics","route":"/companies/checkpoint-therapeutics/"}],"paper":[{"id":"paper-ck-301-101-jitc-2023","kind":"paper","name":"Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma","route":"/key-papers/paper-ck-301-101-jitc-2023/"}]}}