A Study of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer

Official title

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer

Overview

This study is a clinical study to explore the efficacy and safety of BL-B01D1+PD-1/PD-L1 monoclonal antibody in patients with advanced biliary tract cancer.

Interventions

• Drug BL-B01D1
  Administration by intravenous infusion for a cycle of 3 weeks.
• Drug Pembrolizumab
  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;
• Gender is not limited;
• Age ≥18 years old and ≤75 years old;
• Expected survival time ≥3 months;
• Patients with advanced biliary tract cancer confirmed by histology or cytology;
• Patients must provide a documented tumor tissue specimen of the primary or metastatic tumor within 3 years for PD-L1 testing and other testing;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG score 0-1;
• 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%;
• Organ function level must meet the requirements;
• Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
• Urinary protein ≤2+ or ≤1000mg/24h;
• For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.

Exclusion criteria

• Patients with active central nervous system metastases;
• Who had participated in any other clinical trial within 4 weeks before the trial dose;
• Received anti-tumor therapy such as chemotherapy, radiotherapy and biological therapy within 4 weeks before the first use of study drug;
• Had undergone major surgery (investigator-defined) within 4 weeks before the first dose;
• 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;
• Systemic corticosteroids or immunosuppressive agents were required within 2 weeks before the study administration;
• Pulmonary disease grade ≥3 according to NCI-CTCAE v5.0; A history of ILD/pulmonary inflammation requiring steroid treatment;
• Severe systemic infection occurred within 4 weeks before screening;
• Patients at risk for active autoimmune disease or with a history of autoimmune disease;
• Other malignant tumors within 5 years before the first dose;
• Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
• Poorly controlled hypertension by two antihypertensive drugs with different mechanisms;
• Diabetic patients with poor glycemic control;
• Had a history of severe cardiovascular and cerebrovascular diseases;
• Previous history of autologous or allogeneic stem cell, bone marrow or organ transplantation;
• Subjects with clinically significant bleeding or significant bleeding tendency within the preceding 4 weeks were screened;
• Patients with massive or symptomatic effusions or poorly controlled effusions;
• Imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large arteries or invaded the pericardium and heart;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
• Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin;
• Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of the trial drug;
• The cumulative dose of anthracyclines > 360 mg/m2 in previous (new) adjuvant therapy;
• Pregnant or lactating women;
• Who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
• The investigator did not consider it appropriate to apply other criteria 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 · 1 center

• Zhongshan Hospital Fudan University — Shanghai

Identifiers

NCT: NCT06978114 · BL-B01D1-204-10

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗