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

NCT07110363 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: BT02-103
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• Adverse events

  through study completion, an average of 2 years

• Dose limited toxicity incidence

  Through the dose escalation phase , an average of 8 months

• Maximum tolerated dose(MTD)

  Through the dose escalation phase, an average of 8 months

• Recommended Phase II dose (RP2D)

  Through study completion, an average of 2 years

Secondary Outcomes (8)

• Objective response rate (ORR) on tumor assessments

  Through the study completion, an average of 2 years

• Progression-free survival (PFS) on tumor assessments

  Through the study completion，an average of 2 years

• Overall survival (OS) on tumor assessments

  Through the study completion, an average of 2 years

• Duration of response (DoR) on tumor assessments

  Through the study completion, an average of 2 years

• Disease control rate (DCR) on tumor assessments

  Through the study completion, an average of 2 years

Study Arms (1)

dose escalation and expansion

EXPERIMENTAL

Drug: BT02

Interventions

BT02 DRUG

monoclonal antibody injection with intravenous administration every 2 or 3 weeks

dose escalation and expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .
• Adequate organ and hematologic function.
• At least 1 extracranial measurable lesion.
• An ECOG activity status score of 0-1.
• A life expectancy of ≥ 3 months.
• Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.
• Good compliance and willingness to follow up.

You may not qualify if:

• Patients with sensitive mutations or gene fusions related to lung cancer.
• 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.
• A history of active autoimmune disease within the past 2 years.
• 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.
• A severe acute or chronic infection when enrollment.
• Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .
• 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.
• Clinically active CNS metastases or meningeal metastases.
• A history of other type of malignancies.
• Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.
• Poor compliance.
• A history of alcohol or drugs abuse.
• Current pregnancy or breastfeeding.
• 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.

Sponsors & Collaborators

• Biotroy Therapeutics: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

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

• Shun Lu, MD

  Shanghai Chest Hospital of Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical development director

CONTACT

+8618602185973; clin.oper@biotroy.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 7, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-07