Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05829057
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-03-14
Brief Title:
The IIT Study of Evaluation of P-IL-2 Single Agent and With Anti-PD-1
Sponsor:
Zhejiang University
Organization:
Zhejiang University
Study Overview
Official Title:
The IIT Study of Evaluation of Platelet-coupled IL-2 Cell Injection P-IL-2 Single Agent and With Anti-PD-1 Monoclonal Antibody on the Safety Tolerance and Preliminary Effectiveness in Patients With Advanced Malignant Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
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:
Phase Ia single-dose escalation study accelerated titration combined with traditional 33 dose Sample size is correlated with the DLT occurring in each dose group 4 dose groups are expected the first dose group is the accelerated titration group which includes only 1 subject subsequent dose groups are in traditional 33 dose increments with 3-6 subjects in each group a total of 10-19 subjects are expected in all dose groups If the DLT is still not present in the highest dose the safety monitoring committeeSMC to determine if it is necessary to continue incrementally to a higher dose
Detailed Description:
P-IL-2 injection was injected intravenously the screening period was 28 days and the DLT observation period was 28 days from the beginning of the first infusion including the day of administration After the end of the DLT observation period subjects can continue to receive treatment on a voluntary basis The safety follow-up after drug withdrawal was carried out 28 days after the last medication During the survival follow-up after drug withdrawal imaging examination and survival information were collected every 12 weeks as far as possible within 2 years after drug withdrawal until the subjects developed disease or received other anti-tumor specific therapy Subjects with disease progression or other treatment received telephone survival follow-up every 12 weeks After 2 years of drug withdrawal telephone survival follow-up was conducted every 12 weeks according to the wishes of the subjects
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