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

Last updated: May 5, 2025
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Nasopharyngeal Cancer

Carcinoma

Treatment

SI-B003

BL-B01D1

Clinical Study ID

NCT05956587
BL-B01D1-SI-B003-201-01
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ormetastatic solid tumors such as non-small cell lung cancer and nasopharyngealcarcinoma;

  6. Consent to provide archival tumor tissue samples or fresh tissue samples fromprimary 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 definedby 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 drugswithin 14 days before the first use of the study drug, and the level of organfunction must meet the requirements;

  12. Coagulation function: international normalized ratio ≤1.5, and activated partialthromboplastin time≤1.5 ULN;

  13. Urinary protein ≤2+ or ≤1000mg/24h;

  14. For premenopausal women with childbearing potential, a pregnancy test must beperformed within 7 days before starting treatment, serum or urine must be negativefor pregnancy, and must be non-lactating; All enrolled patients (male or female)were advised to use adequate barrier contraception throughout the treatment cycleand for 6 months after the end of treatment.

Exclusion

Exclusion Criteria:

  1. For stage 3 Cohort_A, patients with MET 14 exon skipping detected by gene sequencingreport before signing informed consent;

  2. Chemotherapy, biological therapy and other anti-tumor therapies have been usedwithin 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureaswere administered within 6 weeks before the first dose; Oral drugs such asfluorouracil;

  3. Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-relatedmyocarditis;

  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 atrioventricularblock;

  7. Systemic corticosteroids or immunosuppressive agents are required within 2 weeksbefore 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 withcurrent or history of ILD;

  12. Unstable thrombotic events requiring therapeutic intervention within 6 months beforescreening;

  13. Patients with a large amount of serous cavity effusion, or serous cavity effusionwith 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-mousechimeric 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, activehepatitis 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 forparticipation in the trial.

Study Design

Total Participants: 121
Treatment Group(s): 2
Primary Treatment: SI-B003
Phase: 2
Study Start date:
January 29, 2024
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian
    China

    Site Not Available

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Liuzhou People's Hospital

    Liuzhou, Guangxi
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Union Hospital Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei
    China

    Site Not Available

  • Hunan Cancer Hospita

    Changsha, Hunan
    China

    Site Not Available

  • The Second Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi
    China

    Site Not Available

  • Linyi Cancer Hospital

    Linyi, Shangdong
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an, Shanxi
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

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