Non-squamous Non-small Cell Lung CancerPhase 2NCT07264816
A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC
A Phase 2 study testing BL-M07D1 and Pembrolizumab in people with Non-squamous Non-small Cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This trial is a multicenter, open-label, Phase II clinical study to explore the efficacy and safety of BL-M07D1 in combination with pembrolizumab in patients with locally advanced or metastatic HER2-overexpressing non-squamous non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- BL-M07D1 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2026to Dec 2027
- 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 the protocol requirements;
- No gender restrictions;
- Age at the time of signing the informed consent form ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Patients with locally advanced or metastatic non-squamous non-small cell lung cancer;
- Confirmed known HER2 overexpression;
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- Agree to provide archived tumor tissue specimens from primary or metastatic lesions within the past 2 years;
- Must have at least one measurable lesion meeting the RECIST v1.1 criteria;
- ECOG performance status score of 0 or 1;
- Toxicities from prior anti-tumor treatments have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- Organ function levels must meet the requirements;
- For premenopausal women with childbearing potential, a pregnancy test must be conducted within 7 days before starting treatment, serum pregnancy must be negative, and they must not be breastfeeding; all enrolled patients (regardless of gender) should take adequate and highly effective contraception throughout the treatment cycle and for 7 months after the end of treatment.
Who cannot join
- Underwent surgical treatment, radical radiotherapy, immunotherapy, etc., within 4 weeks before the first dose or within 5 half-lives;
- Pathology indicates non-small cell carcinoma containing small cell carcinoma components and sarcomatoid carcinoma;
- Previously received HER2-targeted therapy or ADC drug treatment with camptothecin derivatives as toxins;
- History of severe cardiovascular or cerebrovascular diseases within the past 6 months before screening;
- Concurrent pulmonary disease leading to severe impairment of lung function;
- QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
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- Diagnosed with other primary malignancies within 5 years before the first dose;
- Poorly controlled hypertension;
- History of non-infectious ILD requiring steroid treatment, or currently suffering from ILD/interstitial pneumonia, etc.;
- Patients with central nervous system metastases, carcinomatous meningitis, and/or spinal cord compression;
- Patients with a history of allergy to recombinant humanized antibodies or allergy to BL-M07D1, pembrolizumab, or any excipient components;
- Required systemic corticosteroid or immunosuppressive therapy within 2 weeks before the study administration;
- Patients with massive serous cavity effusion, symptomatic serous cavity effusion, or poorly controlled serous cavity effusion;
- New deep vein thrombosis within 14 days, excluding patients with venous filters implanted;
- Systemic severe infection within 4 weeks before screening;
- Active autoimmune diseases and inflammatory diseases;
- Human immunodeficiency virus antibody positivity, active hepatitis B virus infection, or hepatitis C virus infection;
- History of allogeneic stem cell, bone marrow, or organ transplantation;
- Presence of severe neurological or psychiatric disorders;
- Presence of other severe physical or laboratory abnormalities, poor compliance, etc., which may increase the risk of participation in the study, interfere with study results, or patients deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
Qian Chu
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous Non-Small Cell Lung Cancer
This trial is a multicenter, open-label, Phase II clinical study to explore the efficacy and safety of BL-M07D1 in combination with pembrolizumab in patients with locally advanced or metastatic HER2-overexpressing non-squamous non-small cell lung cancer.
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Being tested
- BL-M07D1, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-M07D1Drug
Administration by intravenous infusion for a cycle of 3 weeks.
PembrolizumabDrug
Administration by intravenous infusion for a cycle of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BL-M07D1+pembrolizumab | Experimental | Participants received BL-M07D1+pembrolizumab in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons. Receives: Drug: BL-M07D1; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Measured: Up to approximately 24 months
Combined optimal dosage
The combined optimal dosage will be investigated.
Measured: Up to approximately 24 months
Combination method
The combination method will be investigated.
Measured: Up to approximately 24 months
Secondary outcomes (10)
Progression-free Survival (PFS)
The PFS is defined as the time from the participant's first dose of BL-M07D1 to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 24 months
Disease Control Rate (DCR)
The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).
Measured: Up to approximately 24 months
Duration of Response (DOR)
The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 24 months
Overall survival (OS)
Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.
Measured: Up to approximately 24 months
Cmax
Maximum serum concentration (Cmax) of BL-M07D1 will be investigated.
Measured: Up to approximately 24 months
Tmax
Time to maximum serum concentration (Tmax) of BL-M07D1 will be investigated.
Measured: Up to approximately 24 months
Ctrough
Ctrough is defined as the lowest serum concentration of BL-M07D1 prior to the next dose will be administered.
Measured: Up to approximately 24 months
Anti-drug antibody (ADA)
Frequency of anti-BL-M07D1 antibody (ADA) will be investigated.
Measured: Up to approximately 24 months
Drug-drug interactions (DDI)
Drug-drug interactions (DDI) will be investigated.
Measured: 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-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1.
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.
- First posted4 Dec 2025
- Study start3 Feb 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-squamous Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264816
- Sponsor's protocol ID
- BL-M07D1-207
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07264816
- Acronym / sponsor ID
- BL-M07D1-207
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a multicenter, open-label, Phase II clinical study to explore the efficacy and safety of BL-M07D1 in combination with pembrolizumab in patients with locally advanced or metastatic HER2-overexpressing non-squamous non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BL-M07D1+pembrolizumab | Experimental | Drug: BL-M07D1, Drug: PembrolizumabParticipants received BL-M07D1+pembrolizumab in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restrictions;
- Age at the time of signing the informed consent form ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Patients with locally advanced or metastatic non-squamous non-small cell lung cancer;
Key exclusion criteria (20 listed)
- Underwent surgical treatment, radical radiotherapy, immunotherapy, etc., within 4 weeks before the first dose or within 5 half-lives;
- Pathology indicates non-small cell carcinoma containing small cell carcinoma components and sarcomatoid carcinoma;
- Previously received HER2-targeted therapy or ADC drug treatment with camptothecin derivatives as toxins;
- History of severe cardiovascular or cerebrovascular diseases within the past 6 months before screening;
- Concurrent pulmonary disease leading to severe impairment of lung function;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-M07D1Administration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-M07D1+pembrolizumab |
| PembrolizumabAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-M07D1+pembrolizumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Combined optimal dosage
Time frame: Up to approximately 24 months
The combined optimal dosage will be investigated.
Combination method
Time frame: Up to approximately 24 months
The combination method will be investigated.
10 secondary outcomes
Progression-free Survival (PFS)
Time frame: Up to approximately 24 months
Disease Control Rate (DCR)
Time frame: Up to approximately 24 months
Duration of Response (DOR)
Time frame: Up to approximately 24 months
Overall survival (OS)
Time frame: Up to approximately 24 months
Cmax
Time frame: Up to approximately 24 months
Tmax
Time frame: Up to approximately 24 months
Ctrough
Time frame: Up to approximately 24 months
Anti-drug antibody (ADA)
Time frame: Up to approximately 24 months
Drug-drug interactions (DDI)
Time frame: Up to approximately 24 months
Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BL-M07D1 and Pembrolizumab in people with Non-squamous 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 13 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 5 Mar 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.