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| Name | Class |
|---|---|
| Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. | INDUSTRY |
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This Phase II study is a clinical study exploring the efficacy and safety of BL-M14D1 in combination with Atezolizumab in patients with extensive-stage small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BL-M14D1+ Atezolizumab | Experimental | Participants receive BL-M14D1+ Atezolizumab for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BL-M14D1 | Drug | Administration by intravenous infusion for a cycle of 3 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1. | Up to approximately 12 months |
| Treatment-Emergent Adverse Event (TEAE) | TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M14D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M14D1. | Up to approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death. | Up to approximately 12 months |
| Disease Control Rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sa Xiao, PHD | Contact | 15013238943 | xiaosa@baili-pharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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| Atezolizumab |
| Drug |
Administration by intravenous infusion for a cycle of 3 weeks. |
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The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]). |
| Up to approximately 12 months |
| Duration of Response (DOR) | The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first. | Up to approximately 12 months |
| Overall Survival (OS) | Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death. | Up to approximately 12 months |
| Cmax | Maximum serum concentration (Cmax) of BL-M14D1 will be investigated. | Up to approximately 12 months |
| Tmax | Time to maximum serum concentration (Tmax) of BL-M14D1 will be investigated. | Up to approximately 12 months |
| Ctrough | Ctrough is defined as the lowest serum concentration of BL-M14D1 prior to the next dose will be administered. | Up to approximately 12 months |
| ADA (anti-drug antibody) | Frequency of anti-BL-M14D1 antibody (ADA) will be investigated. | Up to approximately 12 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |