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

Official title

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

Overview

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.

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.

Interventions

• Drug BL-B01D1
  Administration by intravenous infusion
• Drug SI-B003
  Administration by intravenous infusion

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;
• Gender is not limited;
• Age: ≥18 years old and ≤75 years old;
• Expected survival time ≥3 months;
• Patients with histologically and/or cytologically confirmed locally advanced or metastatic solid tumors such as non-small cell lung cancer and nasopharyngeal carcinoma;
• Consent to provide archival tumor tissue samples or fresh tissue samples from 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 severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• 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;
• Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time≤1.5 ULN;
• Urinary protein ≤2+ or ≤1000mg/24h;
• 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

• For stage 3 Cohort\_A, patients with MET 14 exon skipping detected by gene sequencing report before signing informed consent;
• 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;
• Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis;
• Use of immunomodulatory drugs within 14 days before the first dose of study drug;
• History of severe heart disease;
• QT prolongation, complete left bundle branch block, III degree atrioventricular block;
• Systemic corticosteroids or immunosuppressive agents are required within 2 weeks before study dosing;
• Active autoimmune and inflammatory diseases;
• Other malignancies diagnosed within 5 years before the first dose;
• Hypertension poorly controlled by two antihypertensive drugs;
• Pulmonary disease was defined as grade ≥3 according to CTCAE v5.0; Patients with current or history of ILD;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
• Patients with a large amount of serous cavity effusion, or serous cavity effusion with symptoms, or within 4 weeks before signing informed consent;
• Patients with active central nervous system metastases;
• Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipients of the test drug;
• Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
• Active infection requiring systemic therapy;
• Had participated in another clinical trial within 4 weeks before the first dose;
• The investigator did not consider it appropriate to use other conditions for participation in the trial.

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 · 16 centers

• Chongqing University Cancer Hospital — Chongqing
• Fujian Cancer Hospital — Fuzhou
• Sun Yat-sen University Cancer Center — Guangzhou
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou
• Liuzhou People's Hospital — Liuzhou
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang
• Henan Cancer Hospital — Zhengzhou
• … and 8 more centers

Identifiers

NCT: NCT05956587 · BL-B01D1-SI-B003-201-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗