Non-small Cell Lung CancerPhase 2NCT05956587

A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors

A Phase 2 study testing BL-B01D1 and SI-B003 in people with Non-small Cell Lung Cancer and Nasopharyngeal Carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 16 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Phase II: To explore the efficacy, safety and tolerability of BL-B01D1+SI-B003 in patients with locally advanced or metastatic non-small cell lung cancer and nasopharyngeal carcinoma, and to further explore the optimal dose and mode of combination. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma
What is being tested?: BL-B01D1 and SI-B003
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 16 sitesChina
Study dates: 29 Jan 2024to 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

Sign the informed consent form voluntarily and follow the protocol requirements;
Gender is not limited;
Age: ≥18 years old and ≤75 years old;
Expected survival time ≥3 months;
Patients with histologically and/or cytologically confirmed locally advanced or metastatic solid tumors such as non-small cell lung cancer and nasopharyngeal carcinoma;
Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years;

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At least one measurable lesion meeting the RECIST v1.1 definition was required;
ECOG 0 or 1;
The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
No blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before the first use of the study drug, and the level of organ function must meet the requirements;
Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time≤1.5 ULN;
Urinary protein ≤2+ or ≤1000mg/24h;
For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum or urine must be negative for pregnancy, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

Who cannot join

For stage 3 Cohort_A, patients with MET 14 exon skipping detected by gene sequencing report before signing informed consent;
Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;
Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis;
Use of immunomodulatory drugs within 14 days before the first dose of study drug;
History of severe heart disease;
QT prolongation, complete left bundle branch block, III degree atrioventricular block;

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Systemic corticosteroids or immunosuppressive agents are required within 2 weeks before study dosing;
Active autoimmune and inflammatory diseases;
Other malignancies diagnosed within 5 years before the first dose;
Hypertension poorly controlled by two antihypertensive drugs;
Pulmonary disease was defined as grade ≥3 according to CTCAE v5.0; Patients with current or history of ILD;
Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
Patients with a large amount of serous cavity effusion, or serous cavity effusion with symptoms, or within 4 weeks before signing informed consent;
Patients with active central nervous system metastases;
Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipients of the test drug;
Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
Active infection requiring systemic therapy;
Had participated in another clinical trial within 4 weeks before the first dose;
The investigator did not consider it appropriate to use other conditions for participation in the trial.

Trial locations and contacts

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

Sa Xiao, PHD contact

+8615013238943

xiaosa@baili-pharm.com

City, postcode or hospital

Sites recruiting now only

16 sites in 1 country

China16 sites, 16 recruiting

Hunan Cancer Hospita
Changsha, Hunan
Yaqian Han
Not yet recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality
Xiaolei Shu
Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Wu Zhuang
Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Li Zhang
Not yet recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Xiaoming Huang
Not yet recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Yong Chen
Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Yun Fan
Not yet recruiting
Linyi Cancer Hospital
Linyi, Shangdong
Zhen Wang
Recruiting
Liuzhou People's Hospital
Liuzhou, Guangxi
Zhanxiong Luo
Not yet recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Zhiye Zhang
Not yet recruiting
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi
Fei Xu
Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Diansheng Zhong
Not yet recruiting
Union Hospital Tongji Medical College， Huazhong University of Science and Technology
Wuhan, Hubei
Kunyu Yang
Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
Conghua Xie
Yahua Zhong
Not yet recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi
Yi Yao
Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Yanqiu Zhao
Not yet recruiting

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors

Read the detailed description

Phase II: To explore the efficacy of BL-B01D1+SI-B003 combination in patients with locally advanced or metastatic solid tumors such as non-small cell lung cancer and nasopharyngeal carcinoma. To explore the safety and tolerability of BL-B01D1+SI-B003 combination in patients with locally advanced or metastatic non-small cell lung cancer and nasopharyngeal carcinoma, and to further explore the optimal dose and mode of combination.

Conditions: Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma
Being tested: BL-B01D1, SI-B003
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Nasopharyngeal Carcinoma

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
SI-B003Drug
Administration by intravenous infusion

Study groups in NCT05956587
Study group	Role	What they receive
Study treatment	Experimental	Participants received SI-B003 and BL-B01D1+SI-B003 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-B01D1; Drug: SI-B003

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
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 SI-B003.
Measured: Up to approximately 24 months

Secondary outcomes (4)

Progression-free survival (PFS)
The PFS is defined as the time from the first dose of medication to disease progression or death, whichever occurred 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
Treatment-Emergent Adverse Event (TEAE)
TEAE is defined as any adverse and unexpected change in body structure, function, or chemistry or any exacerbation of an existing condition (i.e., any clinically significant adverse change in frequency and/or intensity) during treatment. The type, frequency, and severity of TEAE will be assessed during treatment.
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.

29 Jan 2024Dec 2027

First posted21 Jul 2023
Study start29 Jan 2024
Primary completionDec 2026 (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-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: 121 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05956587
Sponsor's protocol ID: BL-B01D1-SI-B003-201-01
Status last verified: Sep 2025
First submitted: 13 Jul 2023
Last updated: 26 Sep 2025
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 26 Sep 2025. 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 SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors
ClinicalTrials.gov ID: NCT05956587
Acronym / sponsor ID: BL-B01D1-SI-B003-201-01
Conditions: Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 121 participants (estimated)
Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Study start: 29 Jan 2024 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 21 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.

Detailed description

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-B01D1, Drug: SI-B003Participants received SI-B003 and BL-B01D1+SI-B003 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 (14 listed)

Sign the informed consent form voluntarily and follow the protocol requirements;
Gender is not limited;
Age: ≥18 years old and ≤75 years old;
Expected survival time ≥3 months;
Patients with histologically and/or cytologically confirmed locally advanced or metastatic solid tumors such as non-small cell lung cancer and nasopharyngeal carcinoma;

Key exclusion criteria (20 listed)

For stage 3 Cohort_A, patients with MET 14 exon skipping detected by gene sequencing report before signing informed consent;
Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;
Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis;
Use of immunomodulatory drugs within 14 days before the first dose of study drug;
History of severe heart disease;

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-B01D1Also: iza-bren, izalontamab brengitecan, BMS-986507Administration by intravenous infusion	Drug	Study treatment
SI-B003Administration by intravenous infusion	Drug	Study treatment

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.
Recommended Phase II Dose (RP2D)
Time frame: Up to approximately 24 months
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 SI-B003.

4 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
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 26 Sep 2025.

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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.

Sa Xiao, PHD contact

+8615013238943

xiaosa@baili-pharm.com

Li Zhang, PHD principal investigator

Sun Yat-sen University

16 sites 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-B01D1 and SI-B003 in people with Non-small Cell Lung Cancer and Nasopharyngeal Carcinoma, run by Sichuan Baili Pharmaceutical Co., Ltd. at 16 sites 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 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 26 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 16 sites 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 (+8615013238943, 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 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 NCT05956587.

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 26 Sep 2025.