Non-small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DRUGBL-B01D1
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGGlecirasib
Oral administration at a fixed daily dose for a cycle of 3 weeks.
Sponsors
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign the informed consent form and comply with protocol requirements; 2. No restriction on gender; 3. Age ≥18 years and ≤75 years; 4. Expected survival time ≥3 months; 5. Patients with locally advanced or metastatic non-small cell lung cancer; 6. Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 2 years, or fresh tissue samples; 7. Must have at least one measurable lesion as defined by RECIST v1.1; 8. ECOG performance status score ≤1; 9. Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v6.0; 10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%; 11. Organ function levels must meet the requirements; 12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5×ULN; 13. Urine protein ≤1+ or \<1000 mg/24 h; 14. 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 criteria
1. Prior treatment with drugs targeting KRAS G12C; 2. Prior use of ADC drugs with small-molecule toxins as topoisomerase I inhibitors; 3. Coexisting other known oncogenic driver gene mutations that can be targeted therapeutically; 4. Prior history of intestinal disease or major gastric surgery; 5. Participation in any other clinical trial within 4 weeks before the first administration of this trial; 6. History of severe heart disease or cerebrovascular disease; 7. Receipt of radical radiotherapy, major surgery, extensive radiotherapy, etc., within 4 weeks before randomization in the study; 8. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 9. QTc interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias; 10. History of interstitial lung disease/interstitial pneumonia treated with steroids, etc.; 11. Concurrent pulmonary disease leading to clinically severe impairment of respiratory function; 12. Severe infection occurring within 4 weeks before randomization in the study; 13. Patients at risk of active autoimmune disease, or patients with a history of autoimmune disease; 14. Diagnosis of active malignancy within 5 years before randomization in the study; 15. Positive human immunodeficiency virus antibody, active tuberculosis, active syphilis, active hepatitis B virus infection, or hepatitis C virus infection; 16. Hypertension poorly controlled with two antihypertensive drugs; 17. Patients with poorly controlled blood glucose; 18. Presence of a large amount of serous cavity effusion, or serous cavity effusion with obvious symptoms caused by the serous cavity effusion, etc.; 19. Active central nervous system metastasis; 20. Imaging examination suggesting that the tumor has invaded or encased the abdomen, chest, etc.; 21. Severe and unhealed wounds, ulcers, or fractures within 4 weeks before signing informed consent; 22. Trial participants with clinically obvious bleeding or a clear bleeding tendency within 4 weeks before signing informed consent; 23. History of allogeneic stem cell, bone marrow, or organ transplantation; 24. Patients with a history of allergy to recombinant humanized antibodies or allergy to any excipient component of BL-B01D1; 25. History of severe neurological or psychiatric disease; 26. History of autologous or allogeneic stem cell transplantation; 27. Pregnant or breastfeeding women; 28. Trial participants planning to receive vaccination or who received a live vaccine within 28 days before randomization in the study; 29. Other circumstances in which the investigator considers it inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to approximately 24 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Up to approximately 24 months | 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) | Up to approximately 24 months | 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) | Up to approximately 24 months | 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) | Up to approximately 24 months | 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. |
Countries
China
Contacts
CONTACTSa Xiao, PHD
Outcome results
None listed