# IBI363

Source: https://onco.cc/drugs/ibi363/  
OnCo record `ibi363` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-2
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- 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.

## Sources

- ClinicalTrials.gov: trials of IBI363: https://clinicaltrials.gov/search?intr=IBI363

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Melanoma](https://onco.cc/cancers/melanoma/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Renal cell carcinoma](https://onco.cc/cancers/rcc/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- companies: [Innovent Biologics](https://onco.cc/companies/innovent/)
- trials: [A Study of IBI363 in Subjects With Advanced Melanoma](https://onco.cc/trials/nct06081920/), [A Study of IBI363 in Subjects with Advanced Solid Malignancies](https://onco.cc/trials/nct06281678/), [A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastat](https://onco.cc/trials/nct06797297/), [IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer](https://onco.cc/trials/nct07402070/), [IBI363 Combined With Bevacizumab for Advanced Colorectal Cancer](https://onco.cc/trials/nct07722494/), [IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small](https://onco.cc/trials/nct07122687/), [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](https://onco.cc/trials/nct07342725/)

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