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

Official title

A Phase II Clinical Trial to Evaluate the Efficacy and Safety 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

Overview

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.

Interventions

• Drug BL-B01D1
  Administration by intravenous infusion for a cycle of 3 weeks.
• Drug PD-1 Monoclonal Antibody
  Administration by intravenous infusion for a cycle of 3 weeks.
• Drug Pemetrexed Disodium
  Administration by intravenous infusion for a cycle of 3 weeks.

Primary outcome measures

• Objective Response Rate (ORR) [Time frame: Up to approximately 24 months]
• Recommended Phase II Dose (RP2D) [Time frame: Up to approximately 24 months]

Secondary outcome measures (4)

• Progression-free survival (PFS) [Time frame: Up to approximately 24 months]
• Disease Control Rate (DCR) [Time frame: Up to approximately 24 months]
• Duration of Response (DOR) [Time frame: Up to approximately 24 months]
• Treatment Emergent Adverse Event (TEAE) [Time frame: Up to approximately 24 months]

Eligibility criteria

Inclusion criteria

• Sign the informed consent form voluntarily and follow the protocol requirements;
• Any gender;
• Age: ≥18 years old;
• Expected survival time for 3 months or more;
• Patients with locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma confirmed by histopathology and/or cytology;
• 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;
• 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 serious cardiac dysfunction, left ventricular ejection fraction 50% or higher;
• 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;
• Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
• The urine protein + 2 or 1000 mg / 24 h or less or less;
• 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

• Stage 1 EGFR-sensitive mutant non-small cell lung cancer patients with systemic chemotherapy; Stage 2 patients who had received previous systemic therapy;
• In the second stage queue one signed informed consent before gene sequencing report suggests patients such as mutation of ALK fusion;
• 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.;
• Serious heart disease;
• Long QT, complete left bundle branch block, III degree atrioventricular block; Serious arrhythmia;
• Active autoimmune and inflammatory diseases;
• Before the first delivery within 5 years diagnosed as other malignant tumor;
• Two antihypertensive drugs poorly controlled hypertension;
• Patients with poor glycemic control;
• With a history of ILD, current ILD or suspected suffering from such diseases during screening;
• Complicated with pulmonary diseases leading to severe respiratory function impairment;
• There is a lot of serous cavity effusion, or have a serous cavity effusion and has symptoms, or poorly controlled serous cavity effusion patients;
• Imaging studies suggest tumor has violated or package around the chest, neck, pharyngeal large blood vessels;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
• Active central nervous system of patients;
• 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;
• Before transplant or allogeneic hematopoietic stem cell transplantation (Allo - HSCT);
• Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
• Active infection requiring systemic therapy;
• Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
• Had participated in another clinical trial within 4 weeks before the first dose;
• Other conditions for trial participation were not considered appropriate by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT06475300 · BL-B01D1-204-05

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗