San Francisco, USA and Suzhou, China, August 6, 2026
Innovent Biologics has completed dosing of the first patient in a pivotal Phase III clinical trial evaluating IBI363/TAK-928 in combination with bevacizumab for advanced colorectal cancer (CRC) in patients who have failed or cannot tolerate prior standard therapies. The milestone marks the third pivotal registrational clinical study for IBI363, Innovent’s next-generation PD-1/IL-2α-biased bispecific fusion protein, and expands its late-stage development into colorectal cancer, a tumor type where many patients derive limited benefit from existing immune checkpoint inhibitors. Innovent and Takeda are jointly developing IBI363/TAK-928 globally under their development and commercialization collaboration.
Phase III Trial Targets Advanced Colorectal Cancer
The pivotal study, NCT07722494, is a multicenter, randomized, open-label Phase III trial designed to compare IBI363 plus bevacizumab with investigator-selected treatment in patients with advanced colorectal cancer following failure or intolerance of standard therapy. Innovent plans to enroll approximately 550 participants, with overall survival serving as the study’s primary endpoint. The trial is being conducted in China, where Innovent retains development and commercialization rights for IBI363/TAK-928. The program is particularly relevant to microsatellite-stable/mismatch-repair-proficient (MSS/pMMR) colorectal cancer, which accounts for approximately 95% of advanced CRC according to the company. These tumors generally have limited responsiveness to existing checkpoint immunotherapies, creating a substantial need for new therapeutic strategies capable of overcoming an immunosuppressive tumor microenvironment.
IBI363 Combines PD-1 Blockade With IL-2 Signaling
IBI363/TAK-928 is designed to simultaneously block the PD-1/PD-L1 immune checkpoint pathway and activate IL-2 signaling, providing a differentiated dual mechanism intended to enhance tumor-specific immune responses. The molecule’s IL-2 arm has been engineered to retain affinity for IL-2Rα while weakening interactions with IL-2Rβ and IL-2Rγ, an approach intended to reduce toxicity. Its PD-1-binding component simultaneously blocks PD-1 and selectively delivers the IL-2 signal, potentially enabling more targeted activation of tumor-specific T-cell populations. Earlier Phase I results presented at the 2025 ASCO meeting provided preliminary clinical support for advancing the combination. Among 73 patients receiving IBI363 plus bevacizumab, the confirmed objective response rate was 15.1% and the disease control rate reached 61.6%, while reported median progression-free survival was 4.7 months. Grade 3 or higher treatment-related adverse events occurred in 35.6% of patients, with no new safety signals reported. These early findings require confirmation in the larger randomized Phase III study.
Advertisement
Innovent Expands Global IBI363 Registrational Program
The colorectal cancer study strengthens a broader late-stage clinical development strategy for IBI363. The candidate is also being evaluated in a pivotal Phase II study in immunotherapy-naive mucosal and acral melanoma and a global multicenter pivotal Phase III study in immunotherapy-resistant squamous non-small cell lung cancer, alongside additional Phase Ib/II trials exploring monotherapy and combination approaches across several tumor types. IBI363 has also received two Fast Track designations from the U.S. FDA and three Breakthrough Therapy designations from China’s NMPA, reflecting regulatory interest across its development program. In May 2026, the IBI363 plus bevacizumab combination was included in China’s Breakthrough Therapy program for previously treated advanced MSS/pMMR colorectal cancer. Under the collaboration established in October 2025, Innovent and Takeda are jointly developing IBI363/TAK-928 worldwide and plan to co-commercialize the therapy in the United States, while Takeda holds commercialization rights outside Greater China and the U.S. The new Phase III trial will now test whether the encouraging activity observed during earlier development can translate into a meaningful overall survival benefit in advanced colorectal cancer, potentially establishing a new immunotherapy strategy for patients with difficult-to-treat disease.
Source: Innovent Biologics press release
