| Accession |
PRJCA011095 |
| Title |
To assess the safety and tolerability of PD-L1/TGF-βRII antibody SHR-1701 in subjects with advanced solid malignancy phase I clinical studies |
| Relevance |
Medical |
| Data types |
biomarker,gene,protein,metabolic data,etc
|
| Organisms |
Homo sapiens
|
| Description |
Purpose: Primary purpose: To evaluate the safety and tolerability of SHR-1701 in subjects with advanced malignant solid tumors and to determine the maximum tolerated dose (MTD, if possible) and recommended dose for phase II clinical studies (RP2D). Secondary study objectives: To evaluate the pharmacokinetic (PK) properties of SHR-1701; The pharmacokinetic properties of SHR-1701 were evaluated. To evaluate the host immunogenicity of ShR-1701. To evaluate the antitumor efficacy of SHR-1701. Objective: Primary objective: To evaluate the antitumor efficacy of SHR-1701 in selected subjects with advanced malignant solid tumors. Secondary study objectives: To further evaluate the safety of SHR-1701 in selected subjects with advanced malignant solid tumors; The immunogenicity of ShR-1701 was evaluated. To evaluate the pharmacokinetic properties of SHR-1701. Objective: To evaluate the antitumor efficacy of SHR-1701 based on Immunotherapy response Evaluation criteria (iRECIST). Blood and/or tissue samples were collected for biomarker analysis to explore the relationship between corresponding markers and treatment, including TGFβ/pSmad signaling pathway activity, PD-L1 expression in tumor tissues, tumor mutation burden, tumor infiltrating lymphocytes and other biomarkers. |
| Sample scope |
Multiisolate |
| Release date |
2022-08-09 |
| Grants |
| Agency |
program |
Grant ID |
Grant title |
| NA
|
NA
|
NA
|
NA
|
|
|
| Submitter |
luchongyang
chongyang
lu (chongyang.lu@hengrui.com)
|
| Organization |
Jiangsu Hengrui Pharmaceutical Co. LTD |
| Submission date |
2022-08-09 |
