BL-B01D1 plus glecirasib for advanced non-small cell lung cancer with a KRAS G12C mutation

Trial details

Who runs it

Sichuan Baili Pharmaceutical Co., Ltd.

Trial code

NCT07827261

Record updated

18 September 2026

Original description

This Phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 for injection in combination with glecirasib in the treatment of patients with locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation confirmed by histopathology and/or cytology.Read full original descriptionShow less

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection Combined With Glecirasib in Patients With KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This Phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 for injection in combination with glecirasib in the treatment of patients with locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation confirmed by histopathology and/or cytology.

Inclusion: Voluntarily sign the informed consent form and comply with protocol requirements; No restriction on gender; Age ≥18 years and ≤75 years; Expected survival time ≥3 months; Patients with locally advanced or metastatic non-small cell lung cancer; Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 2 years, or fresh tissue samples; Must have at least one measurable lesion as defined by RECIST v1.1; ECOG performance status score ≤1; Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v6.0; No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%; Organ function levels must meet the requirements; Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5×ULN; Urine protein ≤1+ or <1000 mg/24 h; For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy testing must exclude pregnancy, and the patient must be non-lactating; all enrolled patients (regardless of male or female) should use adequate barrier contraception throughout the entire treatment period and for 7 months after treatment completion.

Exclusion: Prior treatment with drugs targeting KRAS G12C; Prior use of ADC drugs with small-molecule toxins as topoisomerase I inhibitors; Prior history of intestinal disease or major gastric surgery; Participation in any other clinical trial within 4 weeks before the first administration of this trial; Receipt of radical radiotherapy, major surgery, extensive radiotherapy, etc., within 4 weeks before randomization in the study; Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; History of interstitial lung disease/interstitial pneumonia treated with steroids, etc; Concurrent pulmonary disease leading to clinically severe impairment of respiratory function; Severe infection occurring within 4 weeks before randomization in the study; Severe and unhealed wounds, ulcers, or fractures within 4 weeks before signing informed consent; Trial participants with clinically obvious bleeding or a clear bleeding tendency within 4 weeks before signing informed consent; Trial participants planning to receive vaccination or who received a live vaccine within 28 days before randomization in the study; History of severe heart disease or cerebrovascular disease; Patients at risk of active autoimmune disease, or patients with a history of autoimmune disease; Diagnosis of active malignancy within 5 years before randomization in the study; Positive human immunodeficiency virus antibody, active tuberculosis, active syphilis, active hepatitis B virus infection, or hepatitis C virus infection; Hypertension poorly controlled with two antihypertensive drugs; History of allogeneic stem cell, bone marrow, or organ transplantation; Patients with a history of allergy to recombinant humanized antibodies or allergy to any excipient component of BL-B01D1; History of severe neurological or psychiatric disease; History of autologous or allogeneic stem cell transplantation; QTc interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias; Patients with poorly controlled blood glucose; Coexisting other known oncogenic driver gene mutations that can be targeted therapeutically; Presence of a large amount of serous cavity effusion, or serous cavity effusion with obvious symptoms caused by the serous cavity effusion, etc; Active central nervous system metastasis; Imaging examination suggesting that the tumor has invaded or encased the abdomen, chest, etc; Pregnant or breastfeeding women; Other circumstances in which the investigator considers it inappropriate to participate in this clinical trial.

ClinicalTrials.gov NCT07827261