NCT07110363Not yet recruitingPhase 1
A Clinical Study of BT02 in Treating Patients With Advanced Lung Cancer
An Open-label Phase Ib Study on the Safety, Tolerability, and Efficacy of BT02 in Treating Patients With Advanced Lung Cancer
Source: ClinicalTrials.gov · Last updated 7 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 21 Jul 2025
- Start date
- Aug 2025
- Primary completion date
- Mar 2027
- Lead sponsor
- Biotroy Therapeutics
- Diseases
- Lung cancer
- NCT number
- NCT07110363
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 58
- From Aug 2025 to the primary completion date, Mar 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
- Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.
Other illness
- Patients with sensitive mutations or gene fusions related to lung cancer.
- A history of active autoimmune disease within the past 2 years.
- A severe acute or chronic infection when enrollment.
- A history of other type of malignancies.
- A history of alcohol or drugs abuse.
Lab values
- 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.
- 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.
Other
- Clinically active CNS metastases or meningeal metastases.
- Poor compliance.
- Current pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.