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

NCT07827261 | Not Yet Recruiting Phase 2

• 1 other identifier: BL-B01D1-219
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression-free survival (PFS)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

Study Arms (1)

BL-B01D1 + Glecirasib

EXPERIMENTAL

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; Drug: Glecirasib

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Also known as: iza-bren, izalontamab brengitecan, BMS-986507

BL-B01D1 + Glecirasib

Glecirasib DRUG

Oral administration at a fixed daily dose for a cycle of 3 weeks.

BL-B01D1 + Glecirasib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Participation in any other clinical trial within 4 weeks before the first administration of this trial;
• History of severe heart disease or cerebrovascular disease;
• 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;
• QTc interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
• 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;
• 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;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

CN (1)