SMET-12 / Zhejiang Shimai - LARVOL DELTA

Efficacy and safety of SMET12 in combination with toripalimab and chemotherapy in advanced non-small-cell lung cancer patients tested positive for EGFR protein who are treatment-naïve or harbor acquired resistance to standard therapy: a phase 2, multi-cohort clinical trial. (PubMed, Front Immunol) - P1 | "The functional phenotype and differentiation pattern of peripheral blood T lymphocytes exert a critical impact on the therapeutic response to this triple therapy. https://www.clinicaltrials.gov/study/, identifier NCT06208033."

Clinical • IO biomarker • Journal • P2 data • Preclinical • Constipation • Dyslipidemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hypertriglyceridemia • Infectious Disease • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • CD69 • EGFR • LAG3 • PD-1

An Open-label, Phase I/IIa Clinical Study of the Pharmacokinetics and Safety of SMET12 in Patients with Advanced Solid Tumors with Positive Epidermal Growth Factor Receptor (EGFR) Expression (ChiCTR) - P1/2 | N=165 | Recruiting | Sponsor: Fujian Cancer Hospital; Fujian Cancer Hospital

New P1/2 trial • Cholangiocarcinoma • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

SMET12 and toripalimab combined chemotherapy in patients with advanced non-small cell lung cancer who are treatment-naive or have developed resistance to standard therapy. (ASCO 2025) - P1 | "Specific chemotherapy regimens are: Cohort A: pemetrexed + carboplatin Q3W for lung adenocarcinoma; nab-paclitaxel + cisplatin Q3W for lung squamous cell carcinoma; Cohort B: docetaxel Q3W; Cohort C: pemetrexed + carboplatin Q3W. SMET12 in combination with toripalimab and chemotherapy shows good tolerability and efficacy in treatment-naïve, post-immune therapy-resistant EGFR protein-expressing, and post-TKI treatment-resistant EGFR mutation-positive advanced NSCLC patients."

Clinical • IO biomarker • Metastases • Anemia • Hepatology • Immunology • Infectious Disease • Leukopenia • Lung Adenocarcinoma • Lung Cancer • Myositis • Non Small Cell Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor

Shimai Pharmaceuticals' EGFR×CD3 dual antibody SMET12 combined treatment for advanced non-small cell lung cancer research results unveiled at 2025 ASCO [Google translation] (bydrug.pharmcube.com) - P1 | N=40 | NCT06208033 | "Safety: Grade ≥3 treatment-related adverse events included leukopenia (19.4%), pneumonia (16.1%), immune-related pneumonia (13.0%), immune-related hepatitis (3.2%), immune-related myositis (3.2%), and anemia (3.2%). The overall safety was controllable, and no new safety signals were found in the combination regimen; Efficacy: Cohort A: objective response rate (ORR) was 83.3%, disease control rate (DCR) was 100%, and median progression-free survival (PFS) was 8.3 months; Cohort B: ORR was 22.2%, DCR was 66.7%, and median PFS was 4.2 months; Cohort C: ORR was 41.7%, DCR was 100%, and median PFS was 7.2 months."

P1 data • Non Small Cell Lung Cancer

SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Fujian Cancer Hospital

Checkpoint inhibition • Metastases • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor