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Non-small Cell Lung CancerPhase 2NCT07827261

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 2 study testing BL-B01D1 and Glecirasib in people with Non-small Cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
BL-B01D1 and Glecirasib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
Sep 2026to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • Hypertension poorly controlled with two antihypertensive drugs;
  • Patients with poorly controlled blood glucose;
  • 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.;
  • 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;
  • 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;
  • Pregnant or breastfeeding women;
  • Trial participants planning to receive vaccination or who received a live vaccine within 28 days before randomization in the study;
  • Other circumstances in which the investigator considers it inappropriate to participate in this clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

15013238943

xiaosa@baili-pharm.com

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

    Likun Chen

Other trials in China

About this study

Official title: 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.

Being tested
BL-B01D1, Glecirasib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL-B01D1Drug

    Also called iza-bren, izalontamab brengitecan, BMS-986507

    Administration by intravenous infusion for a cycle of 3 weeks.

  • GlecirasibDrug

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

Study groups in NCT07827261
Study groupRoleWhat they receive
BL-B01D1 + GlecirasibExperimentalParticipants 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.
Receives: Drug: BL-B01D1; Drug: Glecirasib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to approximately 24 months

Secondary outcomes (4)

  1. 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.

    Measured: Up to approximately 24 months

  2. 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.

    Measured: Up to approximately 24 months

  3. 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.

    Measured: Up to approximately 24 months

  4. 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.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07827261
Sponsor's protocol ID
BL-B01D1-219
Status last verified
Sep 2026
First submitted
14 Sep 2026
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BL-B01D1 and Glecirasib in people with Non-small Cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07827261.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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