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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose escalation and expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT02 | Drug | monoclonal antibody injection with intravenous administration every 2 or 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical development director | Contact | +8618602185973 | clin.oper@biotroy.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shun Lu, MD | Shanghai Chest Hospital of Shanghai Jiao Tong University | Principal Investigator |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| 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 |
| Mean and median Area under the curve (AUC) of BT02 following first dose and repeated administration at each dose level | 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 | Through study completion, an average of 2 years |
| ADA and NAb incidence | Through the study completion, an average of 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |