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| Name | Class |
|---|---|
| Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. | INDUSTRY |
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Phase II: To explore the efficacy, safety and tolerability of BL-B01D1+SI-B003 in patients with locally advanced or metastatic non-small cell lung cancer and nasopharyngeal carcinoma, and to further explore the optimal dose and mode of combination.
Phase II: To explore the efficacy of BL-B01D1+SI-B003 combination in patients with locally advanced or metastatic solid tumors such as non-small cell lung cancer and nasopharyngeal carcinoma. To explore the safety and tolerability of BL-B01D1+SI-B003 combination in patients with locally advanced or metastatic non-small cell lung cancer and nasopharyngeal carcinoma, and to further explore the optimal dose and mode of combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study treatment | Experimental | Participants received SI-B003 and BL-B01D1+SI-B003 in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BL-B01D1 | Drug | Administration by intravenous infusion |
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| 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 24 months |
| Recommended Phase II Dose (RP2D) | The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of SI-B003. | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | The PFS is defined as the time from the first dose of medication to disease progression or death, whichever occurred first. | Up to approximately 24 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 | +8615013238943 | xiaosa@baili-pharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, PHD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing University Cancer Hospital | Not yet recruiting | Chongqing | Chongqing Municipality | China |
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| SI-B003 | Drug | Administration by intravenous infusion |
|
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 24 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 24 months |
| Treatment-Emergent Adverse Event (TEAE) | TEAE is defined as any adverse and unexpected change in body structure, function, or chemistry or any exacerbation of an existing condition (i.e., any clinically significant adverse change in frequency and/or intensity) during treatment. The type, frequency, and severity of TEAE will be assessed during treatment. | Up to approximately 24 months |
| Fujian Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | China |
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| Sun Yat-sen University Cancer Center | Not yet recruiting | Guangzhou | Guangdong | 510000 | China |
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| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | China |
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| The First Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | China |
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| Liuzhou People's Hospital | Not yet recruiting | Liuzhou | Guangxi | China |
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| The First Affiliated Hospital of Henan University of Science and Technology | Not yet recruiting | Luoyang | Henan | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | China |
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| Union Hospital Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | China |
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| Zhongnan Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | China |
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| Hunan Cancer Hospita | Not yet recruiting | Changsha | Hunan | China |
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| The Second Affiliated Hospital Of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | China |
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| Linyi Cancer Hospital | Recruiting | Linyi | Shangdong | China |
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| The First Affiliated Hospital of Xi'an Jiao Tong University | Not yet recruiting | Xi’an | Shanxi | China |
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| Tianjin Medical University General Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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