A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT05880706 | Active Not Recruiting Phase 2

• 1 other identifier: BL-B01D1-203
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase II clinical study to evaluate the efficacy and safety of BL-B01D1 for injection and BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with locally advanced or metastatic non-small cell lung cancer.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Recommended Phase II Dose (RP2D)

  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.

  Up to approximately 24 months

• Objective response rate (ORR)

  ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

  Up to approximately 24 months

Secondary Outcomes (4)

• Progression-free survival (PFS)

  Up to approximately 24 months

• Disease control rate (DCR)

  Up to approximately 24 months

• Duration of response (DOR)

  Up to approximately 24 months

• Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 24 months

Study Arms (1)

Study treatment

EXPERIMENTAL

Participants receive BL-B01D1 and BL-B01D1 in combination with Osimertinib Mesylate Tablets in 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.

Drug: BL-B01D1; Drug: Osimertinib Mesylate Tablets

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion

Also known as: iza-bren, izalontamab brengitecan, BMS-986507

Study treatment

Osimertinib Mesylate Tablets DRUG

Osimertinib Mesylate Tablets will be administered at a fixed dose of 80mg daily.

Study treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent form voluntarily and follow the protocol requirements;
• Gender is not limited;
• Age ≥18 years old;
• Expected survival time ≥3 months;
• Patients with locally advanced or metastatic non-small cell lung cancer confirmed by histopathology and/or cytology;
• Consent to provide an archived tumor tissue sample or fresh tissue sample from the primary or metastatic site within 6 months for biomarker testing;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG ≤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%;
• The level of organ function must meet the requirements on the premise that no blood transfusion and no use of any cell growth factor drugs are allowed within 14 days before the screening period;
• Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
• Urinary protein ≤2+ or ≤1000mg/24h;
• Fertile female subjects, or male subjects with fertile partners, must use highly effective contraception from 7 days before the first dose until 6 months after the first dose. Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose.

You may not qualify if:

• Patients with previous systemic therapy;
• Cohort\_B and Cohort\_C were previously treated with EGFR-TKI;
• Who had participated in any other clinical trial within 4 weeks before the study dose;
• Received chemotherapy, radiotherapy, biological therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of study drugs;
• Had undergone major surgery within 4 weeks before the first dose;
• History of severe heart disease and cerebrovascular disease;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
• QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
• Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases;
• Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
• Severe systemic infection within 4 weeks before screening;
• Patients at risk for active autoimmune disease or with a history of autoimmune disease;
• Complicated with other malignant tumors within 5 years before the first dose of medication;
• Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
• Hypertension poorly controlled by two antihypertensive drugs;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Caicun Zhou, PHD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 30, 2023
• Study Start: July 19, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)