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The purpose of this study is evaluate the efficacy of 3D185 in subjects with advanced/metastatic cholangiocarcinoma with FGFR2 Gene Alterations who have failed at least 1 previous treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All eligible subjects | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D185 | Drug | All eligible subjects will receive the RP2D regimen to be established based on the results of the ongoing phase I study from Cycle 1 Day 1 (C1D1) until disease progression, intolerable toxicity, withdrawal of consent, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | defined as the proportion of subjects who achieved a confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by investigators. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DoR) | DoR is defined as the time from the date of first CR or PR based on RECIST v1.1 to the date of first documented progressive disease based on RECIST v1.1 or death, whichever occurs first. | 24 months |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| silong xiang, MD | Contact | ( 86)15901312398 | silong.xiang@3d-medicines.com |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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defined as the proportion of subjects who achieve a confirmed complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST v1.1 as assessed by investigators. |
| 24 months |
| Progression-free survival (PFS) | PFS is defined as the time from the date of first study dose to disease progression based on RECIST v1.1 or death, whichever occurs first. | 24 months |
| Overall survival (OS) | OS is defined as the date of first study dose to the date of death from any cause. | 24 months |
| 3D185 Plasma concentration | The pharmacokinetic and pharmacodynamics assessments will be analyzed descriptively and presented in appropriate tables or figures. | 24 months |
| Serum phosphate levels | The pharmacokinetic and pharmacodynamics assessments will be analyzed descriptively and presented in appropriate tables or figures. | 24 months |
| D009369 | Neoplasms |