A phase Ib/IIa study of BAT8010+BAT1006, an anti-HER2 monoclonal antibody-exatecan conjugate combined with an ADCC-enhanced HER2 mAb in patients with advanced solid tumors: Results from the HER2-positive GC/GEJC cohort.
Year: 2026
Type: conference-abstract
Study design: Clinical Trial
Abstract: e16034 Background: BAT8010 is an ADC argeting HER2, while BAT1006 is a humanized monoclonal antibody targeting another epitope of HER2, with ADCC enhancement activity via completely devoid of fucose. Expansion cohort of ≥1st-line HER2-positive gastric/gastroesophageal junction cancer patients enrolled, treated with BAT8010 + BAT1006. Methods: Patients in this open-label, multicenter clinical trial received BAT8010 +BAT1006 on day 1 of a 21-day cycle until intolerable or disease progression occurred. The study objectives included assessing tolerability, safety, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy. Results: As of January 5, 2026, 34 HER2-positive GC/GEJC patients were enrolled, with a median of 2 prior lines of therapy, and received BAT8010 2.4 mg/kg in combination with BAT1006 15 mg/kg.Favorable efficacy was observed with a manageable and predictable safety profile; dose optimization is ongoing in the BAT8010 2.1 mg/kg in combination with BAT1006 15 mg/kg dose cohort. Safety: Among the 34 patients who received at least one dose of BAT8010 in combination with BAT1006, at least one treatment-emergent adverse event (TEAE) was reported in 32/34 (94.1%) patients. The most common TEAEs (≥25%) were neutropenia, leukopenia, anemia, thrombocytopenia, elevated alanine aminotransferase, hypoalbuminemia, diarrhea, and infusion-related reaction (IRR). Most TEAEs were Grade 1/2; however, Grade 3 or higher AEs were reported in 68.8% of patients, including neutropenia (22/34, 64.7%), leukopenia (10/34, 29.4%), thrombocytopenia and anemia (each 5/34, 14.7%). No cases of interstitial lung disease (ILD)/pneumonitis were reported. Efficacy: Among 34 patients with at least one tumor assessment, 15 achieved PR and 18 SD, yielding an ORR of 44.1% (15/34) and a DCR of 97.1% (33/34); the mPFS was 7.52 months (95% CI: 4.53–NR).The overall survival (OS) data remain immature due to insufficient follow-up duration. Conclusions: BAT8010 in combination with BAT1006 is well-tolerated with manageable toxicity, and demonstrates promising preliminary antitumor activity in HER2-positive GC/GEJC. Dose expansion studies in this patient population are ongoing, and further confirmatory clinical trials are planned to initiate for the additional validation of its safety and efficacy. Clinical trial information: NCT06376136 .
Source: Journal of Clinical Oncology
Institutions: Shanxi Provincial Cancer Hospital, Sun Yat-sen University Cancer Center, Shandong Tumor Hospital, Shandong First Medical University, Zhejiang Cancer Hospital, Third Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Anhui Medical University, Hubei Cancer Hospital, Hubei University of Arts and Science, Xiangyang Central Hospital
Language: English
Topic: HER2/EGFR in Cancer Research
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W7162687349
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