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 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
1 other identifier
interventional
121
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Jan 2024
Typical duration for phase_2 nonsmall-cell-lung-cancer
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2023
CompletedFirst Posted
Study publicly available on registry
July 21, 2023
CompletedStudy Start
First participant enrolled
January 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
September 26, 2025
September 1, 2025
2.8 years
July 13, 2023
September 25, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Up to approximately 24 months
Secondary Outcomes (4)
Progression-free survival (PFS)
Up to approximately 24 months
Disease control rate (DCR)
Up to approximately 24 months
Duration of response (DOR)
Up to approximately 24 months
Treatment-Emergent Adverse Event (TEAE)
Up to approximately 24 months
Study Arms (1)
Study treatment
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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;
- 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;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital Tongji Medical College， Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Hunan Cancer Hospita
Changsha, Hunan, China
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Linyi Cancer Hospital
Linyi, Shangdong, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li Zhang, PHD
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2023
First Posted
July 21, 2023
Study Start
January 29, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
September 26, 2025
Record last verified: 2025-09