| Accession |
PRJCA010850 |
| Title |
A Phase IIb, single arm, multicenter trial of sacituzumab govitecan in Chinese patients with metastatic triple-negative breast cancer who received at least two prior treatments |
| Relevance |
Medical |
| Data types |
PK, biomarker and gene analysis result data
|
| Organisms |
Homo sapiens
|
| Description |
1.Primary objective: To evaluate efficacy as measured by objective response rate (ORR) by RECIST v 1.1 of sacituzumab govitecan in Chinese patients with metastatic triple-negative breast cancer (mTNBC) who received at least 2 systemic chemotherapy regimens. 2. Secondary objectives: To evaluate anti-tumor activity (duration of response (DOR), Clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS)) of sacituzumab govitecan. To evaluate the safety and tolerability (adverse events [AEs], safety laboratories, incidence of dose delays and dose reductions, treatment discontinuations due to AEs) of sacituzumab govitecan. To characterize the pharmacokinetics (PK) of sacituzumab govitecan. To assess the immunogenicity of sacituzumab govitecan with respect to anti-drug antibody (ADA) testing. 3.Other objectives: To assess exposure-response analysis for the efficacy (ORR, PFS and OS). To evaluate tumor tissue biomarkers. To assess safety (incidence of Grade 3 to 5 AEs, related to UDP glucuronosyltransferase 1A1 [UGT1A1] genotype). |
| Sample scope |
human blood and tumor slides |
| Release date |
2024-07-28 |
| Grants |
| Agency |
program |
Grant ID |
Grant title |
| Everest Medicines (Suzhou) Inc.
|
|
N/A
|
|
|
|
| Submitter |
Yan
Sun (yan.sun@everestmedicines.com)
|
| Organization |
Everest Medicines (Suzhou) Inc. |
| Submission date |
2022-07-28 |
