A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors

Phase 2

Recruiting

• Conditions: Nasopharyngeal Carcinoma; Non-small Cell Lung Cancer; Solid Tumor
• Interventions: Drug: BL-B01D1; Drug: PD-1 Monoclonal Antibody

• Registration Number: NCT06475300
• Lead Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

Brief Summary

This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 Monoclonal Antibody in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma and other solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-06-20
• Study Start: 2024-06-25
• Study First Posted: 2024-06-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

1. Sign the informed consent form voluntarily and follow the protocol requirements;
2. Any gender;
3. Age: ≥18 years old;
4. Expected survival time for 3 months or more;
5. Patients with locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma confirmed by histopathology and/or cytology;
6. Subjects were able to provide 6-10 slides of archived tumor tissue samples or fresh tissue samples of 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 serious cardiac dysfunction, left ventricular ejection fraction 50% or higher;
11. screening period not allowed within 14 days before a blood transfusion, are not allowed to use any cell growth factor, and/or liters of platelet medicine, organ function level must conform to the requirements;
12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
13. The urine protein + 2 or 1000 mg / 24 h or less or less;
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. Stage 1 EGFR-sensitive mutant non-small cell lung cancer patients with systemic chemotherapy; Stage 2 patients who had received previous systemic therapy;
2. In the second stage queue one signed informed consent before gene sequencing report suggests patients such as mutation of ALK fusion;
3. Anti-tumor therapy such as chemotherapy or biological therapy has 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; Fluorouracil class oral drugs, etc.;
4. Serious heart disease;
5. Long QT, complete left bundle branch block, III degree atrioventricular block; Serious arrhythmia;
6. Active autoimmune and inflammatory diseases;
7. Before the first delivery within 5 years diagnosed as other malignant tumor;
8. Two antihypertensive drugs poorly controlled hypertension;
9. Patients with poor glycemic control;
10. With a history of ILD, current ILD or suspected suffering from such diseases during screening;
11. Complicated with pulmonary diseases leading to severe respiratory function impairment;
12. There is a lot of serous cavity effusion, or have a serous cavity effusion and has symptoms, or poorly controlled serous cavity effusion patients;
13. Imaging studies suggest tumor has violated or package around the chest, neck, pharyngeal large blood vessels;
14. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
15. Active central nervous system of patients;
16. For restructuring or human mouse chimeric antibody on study of humanized anti-platelet antibody has a history of allergies or allergic to BL - B01D1 any supplementary material composition of patients;
17. Before transplant or allogeneic hematopoietic stem cell transplantation (Allo - HSCT);
18. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
19. Active infection requiring systemic therapy;
20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
21. Had participated in another clinical trial within 4 weeks before the first dose;
22. Other conditions for trial participation were not considered appropriate by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BL-B01D1+PD-1 Monoclonal Antibody	BL-B01D1	Participants receive BL-B01D1+PD-1 Monoclonal Antibody as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
BL-B01D1+PD-1 Monoclonal Antibody	PD-1 Monoclonal Antibody	Participants receive BL-B01D1+PD-1 Monoclonal Antibody as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Primary Outcome Measures

Name	Time	Method
Recommended Phase II Dose (RP2D)	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 BL-B01D1.
Objective Response Rate (ORR)	Up to approximately 24 months	Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	Up to approximately 24 months	Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.
Progression-free survival (PFS)	Up to approximately 24 months	Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Duration of Response (DOR)	Up to approximately 24 months	Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
Treatment Emergent Adverse Event (TEAE)	Up to approximately 24 months	TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China