A Study of BL-B01D1 Combined With Glecirasib in Patients With KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: BL-B01D1; Drug: Glecirasib

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sa Xiao, PHD; Phone Number: 15013238943; Email: xiaosa@baili-pharm.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen University Cancer Center
      • Contact: Likun Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BL-B01D1 + Glecirasib; Participants receive BL-B01D1 + Glecirasib in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.	Drug: BL-B01D1; Administration by intravenous infusion for a cycle of 3 weeks.; Other Names: BMS-986507; iza-bren; izalontamab brengitecan; Drug: Glecirasib; Oral administration at a fixed daily dose for a cycle of 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 24 months
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.	Up to approximately 24 months
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.	Up to approximately 24 months
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.	Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
• Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: September 14, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: BL-B01D1-219

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No