Advanced Malignant Solid TumorPhase 1NCT07110363
A Clinical Study of BT02 in Treating Patients With Advanced Lung Cancer
A Phase 1 study testing BT02 in people with Advanced Malignant Solid Tumor and Advanced Lung Cancer, run by Biotroy Therapeutics.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Solid Tumor, Advanced Lung Cancer, Non-Small Cell Lung Cancer
- What is being tested?
- BT02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 .
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label Phase Ib Study on the Safety, Tolerability, and Efficacy of BT02 in Treating Patients With Advanced Lung Cancer
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
- Being tested
- BT02
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT02Drug
monoclonal antibody injection with intravenous administration every 2 or 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| dose escalation and expansion | Experimental | Not described Receives: Drug: BT02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: through study completion, an average of 2 years
Dose limited toxicity incidence
Measured: Through the dose escalation phase , an average of 8 months
Maximum tolerated dose(MTD)
Measured: Through the dose escalation phase, an average of 8 months
Recommended Phase II dose (RP2D)
Measured: Through study completion, an average of 2 years
Secondary outcomes (8)
Objective response rate (ORR) on tumor assessments
Measured: Through the study completion, an average of 2 years
Progression-free survival (PFS) on tumor assessments
Measured: Through the study completion，an average of 2 years
Overall survival (OS) on tumor assessments
Measured: Through the study completion, an average of 2 years
Duration of response (DoR) on tumor assessments
Measured: Through the study completion, an average of 2 years
Disease control rate (DCR) on tumor assessments
Measured: Through the study completion, an average of 2 years
Mean and median Area under the curve (AUC) of BT02 following first dose and repeated administration at each dose level
Measured: Through study completion, an average of 2 years
Mean and median Maximum concentration (Cmax) of BT02 following first dose and repeated administration at each dose level
Measured: Through study completion, an average of 2 years
ADA and NAb incidence
Measured: Through the study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotroy Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shun Lu, MD, Principal investigator, Shanghai Chest Hospital of Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110363
- Sponsor's protocol ID
- BT02-103
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase Ib Study on the Safety, Tolerability, and Efficacy of BT02 in Treating Patients With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT07110363
- Acronym / sponsor ID
- BT02-103
- Conditions
- Advanced Malignant Solid Tumor, Advanced Lung Cancer, Non-Small Cell Lung Cancer, Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Biotroy TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dose escalation and expansion | Experimental | Drug: BT02 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BT02monoclonal antibody injection with intravenous administration every 2 or 3 weeks | Drug | dose escalation and expansion |
Primary outcome
Adverse events
Time frame: through study completion, an average of 2 years
Dose limited toxicity incidence
Time frame: Through the dose escalation phase , an average of 8 months
Maximum tolerated dose(MTD)
Time frame: Through the dose escalation phase, an average of 8 months
Recommended Phase II dose (RP2D)
Time frame: Through study completion, an average of 2 years
8 secondary outcomes
Objective response rate (ORR) on tumor assessments
Time frame: Through the study completion, an average of 2 years
Progression-free survival (PFS) on tumor assessments
Time frame: Through the study completion，an average of 2 years
Overall survival (OS) on tumor assessments
Time frame: Through the study completion, an average of 2 years
Duration of response (DoR) on tumor assessments
Time frame: Through the study completion, an average of 2 years
Disease control rate (DCR) on tumor assessments
Time frame: Through the study completion, an average of 2 years
Mean and median Area under the curve (AUC) of BT02 following first dose and repeated administration at each dose level
Time frame: Through study completion, an average of 2 years
Mean and median Maximum concentration (Cmax) of BT02 following first dose and repeated administration at each dose level
Time frame: Through study completion, an average of 2 years
ADA and NAb incidence
Time frame: Through the study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shun Lu, MD principal investigator
Shanghai Chest Hospital of Shanghai Jiao Tong University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BT02 in people with Advanced Malignant Solid Tumor and Advanced Lung Cancer, run by Biotroy Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical development director (+8618602185973, clin.oper@biotroy.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: through study completion, an average of 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.