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.
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;
Prior treatment with drugs targeting KRAS G12C;
Prior use of ADC drugs with small-molecule toxins as topoisomerase I inhibitors;
Coexisting other known oncogenic driver gene mutations that can be targeted therapeutically;
Prior history of intestinal disease or major gastric surgery;
Single group
BL-B01D1
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Glecirasib
DrugOral administration at a fixed daily dose for a cycle of 3 weeks.
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Progression-free survival (PFS)
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Disease Control Rate (DCR)
Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.
Duration of Response (DOR)
Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
Treatment Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
