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

September 25, 2025 updated by: Sichuan Baili Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Sign the informed consent form voluntarily and follow the protocol requirements;
  2. Gender is not limited;
  3. Age: ≥18 years old and ≤75 years old;
  4. Expected survival time ≥3 months;
  5. Patients with histologically and/or cytologically confirmed locally advanced or metastatic solid tumors such as non-small cell lung cancer and nasopharyngeal carcinoma;
  6. Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years;
  7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
  8. ECOG 0 or 1;
  9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
  10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
  11. 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;
  12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time≤1.5 ULN;
  13. Urinary protein ≤2+ or ≤1000mg/24h;
  14. 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.

Exclusion Criteria:

  1. For stage 3 Cohort_A, patients with MET 14 exon skipping detected by gene sequencing report before signing informed consent;
  2. 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;
  3. Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis;
  4. Use of immunomodulatory drugs within 14 days before the first dose of study drug;
  5. History of severe heart disease;
  6. QT prolongation, complete left bundle branch block, III degree atrioventricular block;
  7. Systemic corticosteroids or immunosuppressive agents are required within 2 weeks before study dosing;
  8. Active autoimmune and inflammatory diseases;
  9. Other malignancies diagnosed within 5 years before the first dose;
  10. Hypertension poorly controlled by two antihypertensive drugs;
  11. Pulmonary disease was defined as grade ≥3 according to CTCAE v5.0; Patients with current or history of ILD;
  12. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
  13. Patients with a large amount of serous cavity effusion, or serous cavity effusion with symptoms, or within 4 weeks before signing informed consent;
  14. Patients with active central nervous system metastases;
  15. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipients of the test drug;
  16. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
  17. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
  18. Active infection requiring systemic therapy;
  19. Had participated in another clinical trial within 4 weeks before the first dose;
  20. The investigator did not consider it appropriate to use other conditions for participation in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study treatment
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.
Drug: BL-B01D1
Administration by intravenous infusion
Other Names:
  • BMS-986507
  • iza-bren
  • izalontamab brengitecan
Drug: SI-B003
Administration by intravenous infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 24 months
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.
Up to approximately 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: Up to approximately 24 months
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]).
Up to approximately 24 months
Duration of response (DOR)
Time Frame: Up to approximately 24 months
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.
Up to approximately 24 months
Progression-free survival (PFS)
Time Frame: Up to approximately 24 months
The PFS is defined as the time from the first dose of medication to disease progression or death, whichever occurred first.
Up to approximately 24 months
Treatment-Emergent Adverse Event (TEAE)
Time Frame: Up to approximately 24 months
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.
Up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sichuan Baili Pharmaceutical Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Li Zhang, PHD, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BL-B01D1-SI-B003-201-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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