Innovent displays Phase I trial results for bispecific ADC IBI3001
Biopharmaceutical manufacturer Innovent Biologics showcased Phase I trial results at ESMO 2026 for IBI3001 a bispecific antibody drug conjugate targeting solid tumours
Innovent Biologics, Inc. unveiled the initial clinical findings for IBI3001, a novel EGFR/B7H3 ADC, during a Proffered Paper session at the 2026 European Society for Medical Oncology (ESMO) Congress. Conducted in a multinational Phase 1 trial encompassing China, Australia, and the United States, the study aimed to assess the safety, tolerability, and preliminary efficacy of IBI3001 in patients with advanced solid tumors.
The data encompassed 57 participants, including 21 with non-small cell lung cancer (NSCLC), 15 with pancreatic cancer, 8 with small cell lung cancer (SCLC), and 13 with other malignancies. A significant portion—78.9%—had undergone at least two prior treatments prior to receiving IBI3001.
IBI3001 exhibited a favorable safety profile in dose escalation, with a single dose-limiting toxicity (DLT) observed in the 8 mg/kg and 10 mg/kg cohorts. All DLTs were deemed manageable, and the majority of treatment-related adverse events (TRAEs) were classified as Grade ≥3. Hematologic toxicities were the most prevalent, and no TRAE-related fatalities were reported.
Notably, IBI3001 displayed promising efficacy across multiple solid tumors in a later-stage setting. Among the 53 efficacy-evaluable patients, an overall objective response rate (ORR) of 30.2% and a disease control rate (DCR) of 88.7% were observed. In the 8 mg/kg cohort, the ORR reached 45.0% and the DCR was 100%.
The results were particularly noteworthy in the EGFR-mutant NSCLC subgroup (16 patients), where IBI3001 demonstrated a 31.3% ORR, 93.8% DCR, and a median progression-free survival (PFS) of 7.7 months. In pancreatic cancer, the ORR was 15.4% and the DCR reached 92.3%, with a median PFS of 6.9 months. In SCLC (8 patients) and head and neck squamous cell carcinoma/esophageal squamous cell carcinoma (5 patients), the ORR and DCR were 62.5% and 100%, respectively.
Professor Yi Hu of the Chinese PLA General Hospital emphasized the limited treatment options for advanced solid tumors, particularly EGFR-targeted therapy-resistant NSCLC, SCLC, and pancreatic cancer. He highlighted IBI3001 as a first-in-class bispecific ADC targeting both EGFR and B7H3, which leverages dual-targeting to enhance tumor recognition specificity and incorporates a topoisomerase I inhibitor payload for potent antitumor activity.
The Phase 1 data showcased manageable safety and impressive efficacy across multiple refractory tumor types, with particularly strong results in pancreatic cancer (92.3% DCR and a median PFS of nearly 7 months) and EGFR-mutant NSCLC (31.3% ORR, 93.8% DCR, and a median PFS of 7.7 months).
Dr. Hui Zhou, Chief R&D Officer of Innovent Biologics, underscored the potential of IBI3001 as a leading bispecific ADC program within the company's oncology portfolio. The Phase 1 clinical data presented at ESMO validated the differentiated advantages of Innovent's ADC technology platform, which aims to improve tumor-targeting specificity and reduce off-target toxicity while expanding to a broader patient population.
Innovent is now advancing to the dose-optimization stage of a Phase 1b proof-of-concept study to further validate IBI3001's efficacy and safety in these challenging cancer populations.
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