ArticleClinical cancer research : an official journal of the American Association for Cancer Research2025
Izalontamab (SI-B001), a Novel EGFRxHER3 Bispecific Antibody in Patients with Locally Advanced or Metastatic Epithelial Tumor: Results from First-in-Human Phase I/Ib Study.
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. Cited by 12 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
12 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
- Review
- Advances in Bispecific Antibodies and Antibody-Drug Conjugates for Colorectal Cancer Treatment.Antibodies (Basel, Switzerland) · 2026Review
- Colorectal cancer pathogenesis, oncogenic signaling networks and targeted therapeutic advances.Molecular biomedicine · 2026Review
- Targeting T-Cells for Cancer Treatment: Current Clinical Strategies and Challenges.Biomedicines · 2026Review
- Engineering the Future of ADCs in Non-Small Cell Lung Cancer.Oncology research · 2026Review
- Innovative use of therapeutic antibodies in lung cancer: the current landscape of ADCs and other antibody-based therapies.Frontiers in oncology · 2026Review
- Antibody-drug conjugates in recurrent or metastatic HNSCC: relevant targets, clinical development, and future prospects.Frontiers in immunology · 2026Review
- Review
- Bispecific antibodies: unleashing a new era in oncology treatment.Molecular cancer · 2025Review
- Review
- Antibody-drug conjugate: a newly developed biological missile for tumor treatment.Frontiers in oncology · 2025Review
Corrections and comments
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Authors and funding
16 authors.
Funding
Abstract
purposeIzalontamab (SI-B001) is a novel EGFR×HER3 bispecific antibody. This first-in-human phase I study presents the safety and pharmacokinetics of izalontamab. PATIENTS AND
methodsPreviously treated patients with locally advanced or metastatic epithelial tumors were enrolled in the dose-escalation or dose-expansion phases. The dose-escalation phase consisted of an accelerated titration and a "3 + 3" design with nine dose levels from 0.4 to 28.0 mg/kg. The dose-expansion phase included five dose levels from 6.0 to 21.0 mg/kg. Izalontamab was administered intravenously weekly or every 2 weeks in a 4-week cycle. Available pretreatment specimens were obtained to explore the relationship between EGFR/HER3 expression and efficacy.
resultsSixty patients were enrolled. Among the 60 enrolled patients, 49 had non-small cell lung cancer (NSCLC), 6 had nasopharyngeal cancer, 3 had head and neck cancer squamous cell carcinoma, and 2 had other types of cancer. The most common treatment-related adverse events were rash (42%), paronychia (25%), and infusion-related reactions (23%). No drug-related death occurred. Izalontamab displayed a nonlinear pharmacokinetic behavior, and clearance at steady state seemed to be approaching a dose-independent value at 6 mg/kg and above. The best response included two confirmed partial responses in patients with NSCLC and head and neck cancer squamous cell carcinoma; 18 patients had stable disease, including NSCLC (n = 17) and colorectal cancer (n = 1). The recommended phase II dose for izalontamab was determined as 9 to 16 mg/kg weekly.
conclusionsIzalontamab was well tolerated and demonstrated preliminary antitumor activity in patients with locally advanced or metastatic epithelial tumors, supporting it as a promising therapeutic candidate for combination therapies, with a phase III study currently underway.
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