Testing a new drug combination for advanced lung and nasopharyngeal cancers

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

This study is testing a new combination of drugs to see if it can help people with advanced lung cancer and nasopharyngeal cancer feel better and tolerate the treatment well.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 121 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: Chemotherapy, immunotherapy
• Locations: 16 sites (Chongqing, Chongqing Municipality and 15 other locations)
• Trial ID: NCT05956587 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial investigates the efficacy, safety, and tolerability of a combination treatment involving BL-B01D1 and SI-B003 in patients with locally advanced or metastatic non-small cell lung cancer and nasopharyngeal carcinoma. The study aims to determine the optimal dosage and administration method for this drug combination. Participants will be monitored for their response to treatment and any adverse effects experienced during the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed locally advanced or metastatic solid tumors, specifically non-small cell lung cancer or nasopharyngeal carcinoma.

Not a fit: Patients with severe cardiac dysfunction or those who have not recovered from previous cancer treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced lung and nasopharyngeal cancers.

How similar studies have performed: Other studies have shown promise with similar drug combinations in treating advanced cancers, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Chongqing, Chongqing Municipality and 15 other locations

• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (NOT_YET_RECRUITING)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (NOT_YET_RECRUITING)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• Liuzhou People's Hospital — Liuzhou, Guangxi, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (NOT_YET_RECRUITING)
• Henan Cancer Hospital — Zhengzhou, Henan, China (NOT_YET_RECRUITING)
• Union Hospital Tongji Medical College， Huazhong University of Science and Technology — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• Hunan Cancer Hospita — Changsha, Hunan, China (NOT_YET_RECRUITING)
• The Second Affiliated Hospital Of Nanchang University — Nanchang, Jiangxi, China (NOT_YET_RECRUITING)
• Linyi Cancer Hospital — Linyi, Shangdong, China (RECRUITING)
• The First Affiliated Hospital of Xi'an Jiao Tong University — Xi’an, Shanxi, China (NOT_YET_RECRUITING)
• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (NOT_YET_RECRUITING)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Li Zhang, PHD — Sun Yat-sen University
• Study coordinator: Sa Xiao, PHD

Conditions: Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma