ArticleBMC medicine2026
Safety and preliminary efficacy results of IBI389, an anti-Claudin18.2×CD3 bispecific antibody, in patients with solid tumors and gastric or gastro-esophageal tumors: a phase 1 dose escalation and expansion study.
Article in BMC medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05164458 (A Phase Ia/Ib, Open Label, Multicenter Study of the Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, Administered to Patients With Advanced Malignancies), which is not on this map. Cited by 18 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase Ia/Ib, Open Label, Multicenter Study of the Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, Administered to Patients With Advanced Malignancies
Who cites it
18 citing papers in PubMed.
- Trial Watch - bispecific T cell engagers and higher-order multispecific immunotherapeutics.Oncoimmunology · 2026Review
- Research Progress and Optimization Strategies of Bispecific Antibody Therapies for CLDN18.2-Positive Gastric Cancer.Journal of gastrointestinal cancer · 2026Review
- Article
- Beyond Zolbetuximab: Next-Generation Targeting Strategies for CLDN18.2.Journal of gastrointestinal cancer · 2026Review
- Claudin18.2 and the PD-1/PD-L1 axis in gastric cancer: mechanistic insights and implications for combination immunotherapy.Journal of translational medicine · 2026Review
- Bispecific Antibodies and Antibody-Drug Conjugates in Advanced Gastric Adenocarcinoma.Cancers · 2026Review
- Revolutionizing cancer immunotherapy: T cell engagers beyond hematologic malignancies toward solid tumors.Frontiers in immunology · 2026Review
- Bispecific antibodies in gastrointestinal cancers: current applications and future perspectives.Frontiers in oncology · 2026Review
- CLDN18.2 in Gastric Cancer: Current Therapeutic Landscape and Future Perspectives.Journal of gastric cancer · 2026Review
- Resistance mechanisms and countermeasures in CLDN18.2-positive tumors: from molecular networks to clinical practice.Frontiers in oncology · 2026Review
- CLDN18.2-Directed Therapeutics in Gastric and Gastroesophageal Junction Adenocarcinoma: Biomarker Assessment, Expression Dynamics, and Treatment Sequencing.Cancer management and research · 2026Review
- Rewiring Antitumor Immunity: Targeting CLDN18.2 with Conditional 4-1BB Activation.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Article
- CLDN18.2-Targeted Therapy in Gastrointestinal Cancers.Cancers · 2025Review
- Temporal dynamics of CLDN18.2 expression following zolbetuximab treatment in advanced gastric cancer.ESMO gastrointestinal oncology · 2025Article
- CLDN18.2-targeting antibody-drug conjugate IBI343 in advanced gastric or gastroesophageal junction adenocarcinoma: a phase 1 trial.Nature medicine · 2025Article
- Future Landscape of Anti-Claudin 18.2 Antibodies in Gastric Adenocarcinoma.Antibodies (Basel, Switzerland) · 2025Review
- Emerging evidence of targeting non-oncogenic drivers for gastric cancer: Claudin18.2 and beyond.Therapeutic advances in medical oncology · 2025Review
- Claudin 1, 4, 6 and 18 isoform 2 as targets for the treatment of cancer (Review).International journal of molecular medicine · 2024Review
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Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundClaudin18.2 is a promising therapeutic target expressed in various solid tumors, particularly gastric cancer. IBI389 is a novel anti-Claudin18.2 × CD3 bispecific antibody designed to engage T cells by binding CD3 and Claudin18.2, thereby induce immune synapse formation. Herein, we report preliminary results from a phase I study to evaluate safety and efficacy of IBI389 in patients with advanced solid tumors.
methodsEligible patients with advanced solid tumors refractory to standard treatments were enrolled. The dose escalation of IBI389 monotherapy used intra-patient dose escalation with accelerated titration (0.003/0.01/0.03/0.1/0.3/1 µg/kg Q2W) and the classical 3 + 3 design (3/5/10/30/100/300/600 µg/kg Q3W). Selected dose levels were expanded in patients with advanced gastric/gastroesophageal junction cancer (GC/GEJC) and pancreatic ductal adenocarcinoma. The primary objective was safety. Secondary objective was efficacy assessed by investigator per RECIST v1.1 including objective response rate (ORR) and disease control rate (DCR).
resultsA total of 121 patients with solid tumors were enrolled, comprising 23 gastric cancer, 14 gastroesophageal junction cancer, 73 pancreatic adenocarcinoma, and 11 other gastrointestinal solid tumors. No dose-limiting toxicity (DLT) was observed during escalation, and the maximum tolerated dose was not reached. Treatment-related adverse events (TRAEs) occurred in 120 patients (99.2%), with the most common grade ≥ 3 TRAE being gamma-glutamyltransferase increased (21.5%) and lymphocytopenia (14.0%) and other grade ≥ 3 TRAEs were ≤ 5%. Cytokine release syndrome (CRS) related adverse events occurred in 72 patients (59.5%), all grades 1-2 except one grade 3 event. No neurotoxicity or treatment-related deaths were observed. Among 37 patients with GC/GEJC, 27 of them expressing Claudin18.2 at levels of 2 + or 3 + ≥ 10%. In this subgroup, the ORR was 22.2% (6/27; 95% CI, 8.6-42.3) and DCR was 74.1% (20/27; 95% CI, 53.7-88.9). Median progression-free survival (PFS) was 4.3 months (95% CI, 2.7-7.2), and median overall survival (OS) was 10.3 months (95% CI, 6.6-not calculable). IBI389 exhibited dose-proportional exposure, with a terminal half-life (t
conclusionsIBI389 showed manageable safety profiles in patients with advanced solid tumors and preliminary efficacy in Claudin18.2-positive patients with GC/GEJC.
trial registrationwww. CLINICALTRIALS: gov . NCT05164458 (December 20, 2021).
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