ArticleClinical cancer research : an official journal of the American Association for Cancer Research2025
Preclinical Evaluation of DB-1419, a Novel Bifunctional and Bispecific Anti-B7-H3 × PD-L1 Antibody-Drug Conjugate.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06554795 (A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in Participants With Advanced/Metastatic Solid Tumors), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.
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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 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in Participants With Advanced/Metastatic Solid Tumors
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Evolution and recent advances in antibody-drug conjugate therapy for lung cancer: a comprehensive systematic review based on the Trialtrove database (inception to July 1, 2025).Frontiers in oncology · 2026Pooled it
- Antibody-drug conjugate engineering: from design to efficacy and safety.Signal transduction and targeted therapy · 2026Review
- Evaluation of Tissue from Patients with Prostate Cancer Identifies B7-H3 as an Androgen-Regulated, Broadly Expressed, Combinatorial Therapeutic Target.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Advancements in Immune Checkpoint-Based Immunotherapy for Triple-Negative Breast Cancer.Current issues in molecular biology · 2026Review
- Tumor-infiltrating lymphocytes in triple-negative breast cancer: molecular mechanisms, spatial regulation, and therapeutic implications.Breast cancer research : BCR · 2026Review
- The Bioinformatics and Experimental Analysis of CD276 for Prognosis and Immune Infiltrates in Colon Adenocarcinoma.Cancer reports (Hoboken, N.J.) · 2026Article
- Engineering the Future of ADCs in Non-Small Cell Lung Cancer.Oncology research · 2026Review
- Immunosuppressive cells as barriers to cancer therapy: mechanisms and emerging solutions.Frontiers in immunology · 2026Review
- Bispecific antibody-drug conjugates: a modular blueprint for next-generation cancer therapeutics.Archives of pharmacal research · 2026Review
- Overcoming resistance to anti-PD-L1 immunotherapy: mechanisms, combination strategies, and future directions.Molecular cancer · 2025Review
- DB-1419: Augmenting the Translational Potential of Preclinical Findings for Implementation in the Clinic.Journal of cellular and molecular medicine · 2025Article
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeWe developed a bifunctional B7-H3 × PD-L1-targeting bispecific antibody-drug conjugate (named DB-1419) conjugated with a novel topoisomerase I inhibitor, P1003 (drug-to-antibody ratio, 8), and assessed its preclinical profiles. EXPERIMENTAL
designThe pharmacologic activities of DB-1419 were assessed in multiple cancer cell lines and immunodeficient and immunocompetent cell line-/patient-derived xenograft (PDX) models. The mechanisms of action behind the efficacy, pharmacokinetics in cynomolgus monkeys, and the safety profiles in vitro and in cynomolgus monkeys were also explored.
resultsWith high stability in circulation, DB-1419 displayed efficient cellular internalization and trafficked to the lysosome within 48 hours to release the payload P1003. In vitro, we observed inhibitory effects on the proliferation of lung cancer cell lines and beyond, mechanically by P1003-mediated direct cytotoxicity, antibody-mediated antibody-dependent cellular cytotoxicity, and bystander effects. Excellent tumor growth inhibition of DB-1419 was revealed in liver cancer cell line-derived xenografts and lung cancer PDX, along with the verification of DNA damage and apoptosis induced by P1003 using tumor tissues. Furthermore, DB-1419 has driven a robust antitumor response in immunocompetent PDX; the blockade of the interaction between PD-1 and PD-L1 and significant induction of markers of immunogenic cell death were also found, suggesting the activation of tumor-specific immunity. DB-1419 was well tolerated in cynomolgus monkeys (highest nonseverely toxic dose, 120 mg/kg) and did not elicit the production of inflammatory cytokines in vitro.
conclusionsDB-1419 demonstrated potent antitumor activity against multiple tumors, with favorable pharmacokinetic and safety profiles. These preclinical data potentially position DB-1419 as a promising treatment approach, currently in the ongoing phase I/IIa study in advanced tumors (NCT06554795).
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