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

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: Recruiting
• Conditions: Nasopharyngeal Carcinoma; Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: BL-B01D1; Drug: SI-B003

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: Interventional
• Enrollment (Estimated): 121
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sa Xiao, PHD; Phone Number: +8615013238943; Email: xiaosa@baili-pharm.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]).	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.	Up to approximately 24 months
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.	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.	Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
• Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Li Zhang, PHD, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma; Otorhinolaryngologic Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Carcinoma, Non-Small-Cell Lung
• Other Study ID 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