{"entity":{"id":"ibi363","kind":"drug","name":"IBI363","aka":[],"tldr":"IBI363 is an experimental fusion protein from Innovent Biologics (Suzhou) in phase 2 trials for melanoma, non-small-cell lung cancer and colorectal cancer, aimed at PD-1.","summary":"IBI363 is a fusion protein developed by Innovent Biologics (Suzhou). Its target is PD-1 (the sponsor names IL-2 pathway x PD-1). The sponsor states: A mutated IL-2 cytokine fused to an anti-PD-1 antibody, combining IL-2 pathway stimulation with PD-1 checkpoint blockade in a single molecule. ClinicalTrials.gov describes the intervention as: a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade. It is the investigational product in 4 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, in melanoma, non-small-cell lung cancer, colorectal cancer and renal cell carcinoma. The largest, NCT06797297, plans to enrol 180 participants with primary completion was scheduled for 2026-03-31 on the registry. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-2","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of IBI363","url":"https://clinicaltrials.gov/search?intr=IBI363"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["melanoma","nsclc","colorectal","rcc"],"sections":[],"technologies":[],"targets":["pd1"],"drugs":[],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07722494","nct06797297","nct06081920","nct06281678","nct07122687"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"fusion protein","mechanism":"A mutated IL-2 cytokine fused to an anti-PD-1 antibody, combining IL-2 pathway stimulation with PD-1 checkpoint blockade in a single molecule.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ibi363/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"rcc","kind":"cancer","name":"Renal cell carcinoma","route":"/cancers/rcc/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"company":[{"id":"innovent","kind":"company","name":"Innovent Biologics","route":"/companies/innovent/"}],"trial":[{"id":"nct06081920","kind":"trial","name":"A Study of IBI363 in Subjects With Advanced Melanoma","route":"/trials/nct06081920/"},{"id":"nct06281678","kind":"trial","name":"A Study of IBI363 in Subjects with Advanced Solid Malignancies","route":"/trials/nct06281678/"},{"id":"nct06797297","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastat","route":"/trials/nct06797297/"},{"id":"nct07402070","kind":"trial","name":"IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer","route":"/trials/nct07402070/"},{"id":"nct07722494","kind":"trial","name":"IBI363 Combined With Bevacizumab for Advanced Colorectal Cancer","route":"/trials/nct07722494/"},{"id":"nct07122687","kind":"trial","name":"IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small","route":"/trials/nct07122687/"},{"id":"nct07342725","kind":"trial","name":"Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Met","route":"/trials/nct07342725/"}]}}