A Clinical Study of BT02 in Treating Patients With Advanced Lung Cancer

NCT ID: NCT07110363

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2027-05-31

Brief Summary

The goal of this clinical trial is to assess whether an investigational treatment is safe and tolerable for patients with advanced lung cancer, and to get a preliminary idea of its effectiveness. Participants of all genders, aged between 18 and 75(inclusive), are eligible to join. These patients will receive the investigational drug intravenously every two weeks. If their condition doesn't worsen and they don't experience unbearable side effects, they can continue the treatment for up to two years.

Conditions

Advanced Malignant Solid Tumor; Advanced Lung Cancer; Non-Small Cell Lung Cancer; Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dose escalation and expansion

Group Type: EXPERIMENTAL

BT02

Intervention Type: DRUG

monoclonal antibody injection with intravenous administration every 2 or 3 weeks

Interventions

BT02

monoclonal antibody injection with intravenous administration every 2 or 3 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with pathologically confirmed locally advanced/unresectable or metastatic or recurrent non-small cell lung cancer (NSCLC, according to AJCC TNM staging) and advanced/unresectable limited-stage or extensive-stage small cell lung cancer (SCLC, according to VALG combined with AJCC TNM staging)，who have failed in the prior systemic therapy .

2. Adequate organ and hematologic function.

3. At least 1 extracranial measurable lesion.

4. An ECOG activity status score of 0-1.

5. A life expectancy of ≥ 3 months.

6. Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.

7. Good compliance and willingness to follow up.

Exclusion Criteria

1. Patients with sensitive mutations or gene fusions related to lung cancer.

2. Prior to the first dose , received systemic antitumor therapy, scheduled major surgical procedure within 4 weeks, received systemic immunostimulants within 5 half-lives and systemic corticosteroids or other immunosuppressive medications within 14 days.

3. A history of active autoimmune disease within the past 2 years.

4. A history of clinically significant cardiovascular disease, severe cardiac rhythm /conduction abnormalities or LVEF <50% . A history of severe pulmonary disease that may lead to severe episodes of dyspnea.

5. A severe acute or chronic infection when enrollment.

6. Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .

7. Unresolved > Grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.

8. Clinically active CNS metastases or meningeal metastases.

9. A history of other type of malignancies.

10. Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.

11. Poor compliance.

12. A history of alcohol or drugs abuse.

13. Current pregnancy or breastfeeding.

14. Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotroy Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shun Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital of Shanghai Jiao Tong University

Central Contacts

Clinical development director

Role: CONTACT

clin.oper@biotroy.cn

+8618602185973

Other Identifiers

BT02-103

Identifier Type: -

Identifier Source: org_study_id