Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588324
Status:
UNKNOWN
Last Update Posted:
2020-10-19
First Post:
2020-09-30
Brief Title:
Study of SHR2150 TLR7 Agonist in Combination With Chemotherapy Plus PD-1 or CD47 Antibody in Subjects With Unresectable Metastatic Solid Tumors
Sponsor:
Chinese PLA General Hospital
Organization:
Chinese PLA General Hospital
Study Overview
Official Title:
Phase III Study Evaluating Safety and Clinical Efficacy of SHR2150 TLR7 Agonist in Combination With Chemotherapy Plus PD-1 or CD47 Antibody in Subjects With Unresectable Metastatic Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial aims to evaluate safety and efficacy of SHR2150 in combination with chemotherapy plus PD-1 or CD47 antibody in subjects with unresectable metastatic solid tumors Patients will receive the combined regimen in 3-week treatment cycles During the Phase 1 dose escalation portion of the trial three oral doses of SHR2150 will be combined with intravenous administration of chemotherapy and PD-1 or CD47 antibody In the Phase 2 dose expansion portion patients will be treated with the Recommended Phase 2 Dose RP2D of SHR2150 in combination with chemotherapy plus PD-1 or CD47 antibody
Detailed Description:
Identification of T cell inhibitory signals including PD-1L1 has prompted the development of a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses However elimination of cancer by T cells is only one step in the cancer-immunity cycle which enable providing several therapeutic targets and tailoring of combinations of immune therapies SHR2150 is a small molecule agonist of toll-like receptors TLRs 7 designed to activate antigen-presenting cells and functions as mucosal immunoadjuvants in pre-clinical studies This study is a first-in-man Phase III dose escalationexpansion study of a combined regimen of SHR2150 in combination with chemotherapy plus PD-1 or CD47 antibody in subjects with unresectable metastatic solid tumors This study is designed to assess the safety tolerability RP2D and clinical efficacy of this regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None