Non-small Cell Lung CancerPhase 1/2NCT05949619

A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors

A Phase 1/2 study testing BL-M02D1 in people with Non-small Cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Phase Ib: To explore the safety and preliminary efficacy of BL-M02D1 to further define RP2D in a variety of solid tumors such as locally advanced or metastatic non-small cell lung cancer. Phase II: To explore the efficacy of BL-M02D1 using single-agent RP2D obtained from phase I clinical studies. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: BL-M02D1
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteChina
Study dates: 4 Sep 2023to Dec 2025
Phase: Phase 1/2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntarily sign the informed consent and follow the requirements of the protocol;
No gender limit;
Age: ≥18 years old;
expected survival time ≥3 months;
Histologically and/or cytologically confirmed locally advanced or metastatic non-small cell lung cancer and other solid tumors that have failed standard treatment;
Consent to provide archival tumor tissue specimens (10 unstained sections (anti-slip) surgical specimens (thickness 4-5μm)) or fresh tissue samples from primary or metastatic lesions within 3 years. If participants cannot provide tumor tissue samples, they can be enrolled if they meet other inclusion and exclusion criteria, after the evaluation of the investigator;

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Must have at least one measurable lesion according to RECIST v1.1 definition;
ECOG 0 or 1;
Toxicity from previous antineochemical therapy has returned to grade 1 or less as defined by NCI-CTCAE v5.0 (asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, elevated serum amylase/lipase, and elevated blood glucose were considered by the investigator, and toxicity with no safety risk was judged by the investigator; Excluding alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, or decreased hemoglobin (≥90g/L).
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
The level of organ function must meet the following requirements and meet the following standards:
Bone marrow function: absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90 g/L;
Liver function: total bilirubin (TBIL≤1.5 ULN), AST and ALT ≤2.5 ULN in patients without liver metastasis, AST and ALT ≤5.0 ULN in patients with liver metastasis;
Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula).
Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
Urine protein ≤2+ or ≤1000mg/24h;
Female subjects of childbearing potential or male subjects with a fertile partner must use highly effective contraception from 7 days before the first dose until 6 months after the dose. Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose.

Who cannot join

Antineoplastic therapy, including chemotherapy, biologic therapy, immunotherapy, definitive radiotherapy, major surgery (investigator-defined), or targeted therapy (including small-molecule tyrosine kinase inhibitors), has been administered within 4 weeks or 5 half-lives (whichever is shorter) before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral fluorouracil drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks before the first dose; The TCM with anti-tumor indications was within 2 weeks before the first administration.
Prior treatment with Trop2-targeted ADC drugs or with camptothecin derivatives (topoisomerase I inhibitors) as toxins;
A history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, third degree atrioventricular block, complete left bundle branch block, frequent and uncontrollable arrhythmias, such as atrial fibrillation, atrial flutter, ventricular fibrillation, and ventricular flutter (except transient);
prolonged QT interval at rest (QTc > 450 msec in men or QTc > 470 msec in women);
acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before the first dose;

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patients with New York Heart Association (NYHA) functional class ≥II heart failure;
Patients at risk for active autoimmune disease, or with a history of autoimmune disease, Including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome), etc. Exceptions were type I diabetes, hypothyroidism that was stable with hormone-replacement therapy (including that due to autoimmune thyroid disease), psoriasis or vitiligo that did not require systemic therapy, and hypothyroidism that was stable with hormone-replacement therapy.
Patients with other malignant tumors within 5 years before the first administration, except those who have been cured skin squamous cell carcinoma, basal cell carcinoma, superficial bladder cancer, prostate/cervix/breast cancer in situ and so on are considered to be eligible for enrollment;
Unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening; Infusion-related thrombosis was excluded.
Patients with massive or symptomatic effusions, or poorly controlled effusions (poorly controlled was defined as requiring 2 or more paracentesis within a month).
Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases;
Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases). Patients who had received treatment for brain metastases (radiotherapy or surgery; Patients with stable brain metastases who had stopped radiotherapy or surgery 28 days before the first dose were eligible. Patients with cancerous meningitis (meningeal metastasis) were excluded even if they were treated and judged to be stable. Stable disease was defined as being asymptomatic, in stable condition, and not requiring steroid therapy for more than 4 weeks before starting study treatment.
Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or any of the excipients of BL-M02D1;
Previous history of allogeneic stem cell, bone marrow, or organ transplantation;
Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBsAg positive or HBcAb positive and HBV-DNA copy number > central detection lower limit) or hepatitis C virus infection (HCV antibody positive and HCV-RNA > central detection lower limit);
Severe systemic infection occurred within 4 weeks before screening, including but not limited to severe pneumonia caused by fungi, bacteria, viruses, bacteremia, or serious infectious complications;
A history of autologous or allogeneic stem cell transplantation;
Pregnant or lactating women;
Other conditions for participation in the trial were not considered appropriate by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M02D1 for Injection in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Non-small Cell Lung Cancer

Conditions: Non-small Cell Lung Cancer
Being tested: BL-M02D1
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-M02D1Drug
Administration by intravenous infusion

Study groups in NCT05949619
Study group	Role	What they receive
Study treatment	Experimental	Participants receive BL-M02D1 as intravenous infusion for 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-M02D1

What is being measured

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

Phase Ib: Recommended Phase II Dose (RP2D)
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M02D1.
Measured: Up to 21 days after the first dose
Phase II: 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

Secondary outcomes (12)

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-M02D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M02D1.
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
Phase Ib: 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
Phase II: Progression-free Survival (PFS)
The PFS is defined as the time from the participant's first dose of BL-M02D1 to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 24 months
Cmax
Maximum serum concentration (Cmax) of BL-M02D1 will be investigated.
Measured: Up to 21 days after the first dose
Tmax
Time to maximum serum concentration (Tmax) of BL-M02D1 will be investigated.
Measured: Up to 21 days after the first dose
Ctrough
Ctough is defined as the lowest serum concentration of BL-M02D1 prior to the next dose will be administered.
Measured: Up to 21 days after the first dose
Phase Ib: T1/2
Half-life (T1/2) of BL-M02D1 will be investigated.
Measured: Up to 21 days after the first dose
Phase Ib: AUC0-T
AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.
Measured: Up to 21 days after the first dose
Phase Ib: CL
CL in the serum of BL-M02D1 per unit of time will be investigated.
Measured: Up to 21 days after the first dose
ADA (anti-drug antibody)
Frequency of anti-BL-M02D1 antibody (ADA) will be investigated.
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.

4 Sep 2023Dec 2025

First posted18 Jul 2023
Study start4 Sep 2023
Primary completionDec 2025 (estimated)
Study completionDec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05949619
Sponsor's protocol ID: BL-M02D1-103
Status last verified: Sep 2025
First submitted: 10 Jul 2023
Last updated: 29 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non-small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M02D1 for Injection in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05949619
Acronym / sponsor ID: BL-M02D1-103
Conditions: Non-small Cell Lung Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 14 participants (actual)
Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 4 Sep 2023 (actual)
Primary completion: Dec 2025 (estimated)
Study completion: Dec 2025 (estimated)
First posted: 18 Jul 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study treatment	Experimental	Drug: BL-M02D1Participants receive BL-M02D1 as intravenous infusion for 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Voluntarily sign the informed consent and follow the requirements of the protocol;
No gender limit;
Age: ≥18 years old;
expected survival time ≥3 months;
Histologically and/or cytologically confirmed locally advanced or metastatic non-small cell lung cancer and other solid tumors that have failed standard treatment;

Key exclusion criteria (21 listed)

Antineoplastic therapy, including chemotherapy, biologic therapy, immunotherapy, definitive radiotherapy, major surgery (investigator-defined), or targeted therapy (including small-molecule tyrosine kinase inhibitors), has been administered within 4 weeks or 5 half-lives (whichever is shorter) before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral fluorouracil drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks before the first dose; The TCM with anti-tumor indications was within 2 weeks before the first administration.
Prior treatment with Trop2-targeted ADC drugs or with camptothecin derivatives (topoisomerase I inhibitors) as toxins;
A history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
Patients at risk for active autoimmune disease, or with a history of autoimmune disease, Including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome), etc. Exceptions were type I diabetes, hypothyroidism that was stable with hormone-replacement therapy (including that due to autoimmune thyroid disease), psoriasis or vitiligo that did not require systemic therapy, and hypothyroidism that was stable with hormone-replacement therapy.
Patients with other malignant tumors within 5 years before the first administration, except those who have been cured skin squamous cell carcinoma, basal cell carcinoma, superficial bladder cancer, prostate/cervix/breast cancer in situ and so on are considered to be eligible for enrollment;

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-M02D1Administration by intravenous infusion	Drug	Study treatment

Primary outcome

Phase Ib: Recommended Phase II Dose (RP2D)
Time frame: Up to 21 days after the first dose
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M02D1.
Phase II: 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.

12 secondary outcomes

Treatment-Emergent Adverse Event (TEAE)
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
Phase Ib: Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Phase II: Progression-free Survival (PFS)
Time frame: Up to approximately 24 months
Cmax
Time frame: Up to 21 days after the first dose
Tmax
Time frame: Up to 21 days after the first dose
Ctrough
Time frame: Up to 21 days after the first dose
Phase Ib: T1/2
Time frame: Up to 21 days after the first dose
Phase Ib: AUC0-T
Time frame: Up to 21 days after the first dose
Phase Ib: CL
Time frame: Up to 21 days after the first dose
ADA (anti-drug antibody)
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 29 Sep 2025.

Related trials for Non-small Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

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. This study is not recruiting at the moment.

Caicun Zhou, PHD principal investigator

Shanghai Pulmonary Hospital, Shanghai, China

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BL-M02D1 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 17 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2025. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib: Recommended Phase II Dose (RP2D) (time frame: Up to 21 days after the first dose). The study lists 2 primary outcomes in all. 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 NCT05949619.

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 29 Sep 2025.