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| Name | Class |
|---|---|
| Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. | INDUSTRY |
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This study is an open-label, multicenter, dose-escalation and cohort expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics or preliminary efficacy and antitumor activity in patients with locally advanced or metastatic breast cancer and other solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GNC-077 | Experimental | Participants receive GNC-077 as intravenous infusion 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 |
|---|---|---|---|---|
| GNC-077 | Drug | Administration by intravenous infusion for a cycle of 3 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase Ia: Dose limiting toxicity (DLT) | DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration. | Up to 21 days after the first dose |
| Phase Ia: Maximum tolerated dose (MTD) | MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle . | Up to 21 days after the first dose |
| Phase Ia: 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 GNC-077 . The type, frequency and severity of TEAE will be evaluated during the treatment of GNC-077. | Up to approximately 24 months |
| Phase Ib: 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 GNC-077. | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum serum concentration (Cmax) of GNC-077 will be investigated. | Up to approximately 24 months |
| Tmax | Time to maximum serum concentration (Tmax) of GNC-077 will be investigated. |
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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 |
| Name | Affiliation | Role |
|---|---|---|
| Binghe Xu, PHD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Up to approximately 24 months |
| AUC0-inf | AUC0-inf is defined as area under the concentration-time curve from 0 to inf. | Up to approximately 24 months |
| AUC0-t | AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration. | Up to approximately 24 months |
| CL (Clearance) | CL in the serum of GNC-077 per unit of time will be investigated. | Up to approximately 24 months |
| T1/2 | Half-life (T1/2) of GNC-077 will be investigated. | Up to approximately 24 months |
| ADA (anti-drug antibody) | Frequency of anti-GNC-077 antibody (ADA) will be investigated. | Up to approximately 24 months |
| 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 |
| Disease Control Rate (DCR) | 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 |
| Progression-free survival (PFS) | The PFS is defined as the time from the participant's first dose of GNC-077 to the first date of either disease progression or death, whichever occurs first. | Up to approximately 24 months |
| Overall survival (OS) | Overall survival (OS) is defined as the time between the subject's randomization date and subject's death. | Up to approximately 24 months |
| D017437 |
| Skin and Connective Tissue Diseases |