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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBiotroy Therapeutics

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • BT02

Treatment groups

58 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators