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

NCT06498986 | Recruiting Phase 2

• 1 other identifier: BL-B01D1-207
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II clinical study is a study to explore the efficacy and safety of BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with histologically and/or cytologically confirmed 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 (8)

• 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

• Cmax

  Up to approximately 24 months

Study Arms (1)

BL-B01D1+Osimertinib Mesylate Tablets

EXPERIMENTAL

Participants receive BL-B01D1+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 for a cycle of 3 weeks.

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

BL-B01D1+Osimertinib Mesylate Tablets

Osimertinib Mesylate Tablets DRUG

Oral administration, 80mg daily for a cycle of 3 weeks.

BL-B01D1+Osimertinib Mesylate Tablets

Eligibility Criteria

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

You may qualify if:

• Voluntarily sign the informed consent and follow the requirements of the protocol;
• No gender limit;
• Age ≥18 years old;
• Expected survival time ≥3 months;
• Patients with histologically and/or cytologically confirmed locally advanced or metastatic non-small cell lung cancer;
• Documentation of EGFR sensitive mutations detected from tumor tissue or blood samples;
• Consent to provide archived tumor tissue or fresh tissue samples from primary or metastatic sites within 2 years for biomarker testing;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG ≤1;
• Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 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 blood transfusion is not allowed within 14 days before the screening period and no cell growth factor drugs are allowed;
• Blood coagulation function: international standardization ratio of 1.5 or less, and the part activated clotting time live enzymes acuities were 1.5 x ULN;
• Urine 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 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 prior systemic therapy;
• Previous treatment with EGFR-TKI;
• Participants who participated in any other clinical trial within 4 weeks before the trial dose;
• Traditional Chinese medicine (TCM) which had received radiotherapy within 4 weeks before the first use of the study drug and had anti-tumor indications within 2 weeks before the first use of the study drug;
• Had undergone major surgery within 4 weeks before the first dose;
• History of severe heart disease or cerebrovascular disease;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
• QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
• Previous history of interstitial lung disease requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis;
• Complicated 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;
• Other malignant tumors within 5 years before the first dose;
• HIV 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
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

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

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

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: July 7, 2024
• First Posted: July 12, 2024
• Study Start: July 31, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

CN (1)