Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581419
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Clinical Study Evaluating Safety Tolerability and Efficacy of IAP0971 in Advanced Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I To evaluate the safety tolerance and effectiveness of IAP0971 for the treatment of advanced malignant tumors
Phase II Evaluation of IAP0971 therapy driver negative and PD-L1 positive TPS50 The initial treatment is effective in subjects with advanced or metastatic non-small cell lung cancer
Phase II Evaluation of IAP0971 therapy driver negative and PD-L1 positive TPS50 The initial treatment is effective in subjects with advanced or metastatic non-small cell lung cancer
Detailed Description:
The study includes dose-escalation Phase I and dose-expansion Phase II clinical trials Phase I clinical trials will be conducted first After completing the dose-escalation phase the plan is to determine the recommended Phase II dose RP2D in the maximum tolerated dose MTD group and proceed with the subsequent Phase II exploratory studies
The objective of the Phase I dose-escalation phase is to preliminarily assess the safety and tolerability of IAP0971 and to determine the MTD based on the incidence of dose-limiting toxicities DLTs in each dose group Phase II will use an open-label non-randomized single-arm multicenter design The study will evaluate adverse events and adverse reactions through clinical observation vital sign monitoring and laboratory tests Tumor assessments will be conducted using RECIST 11 criteria within 48 weeks of the first infusion of the investigational drug assessments will be performed after every two cycles 7 days and after 48 weeks assessments will occur every four cycles 7 days until disease progression initiation of new anti-tumor therapy investigator-determined ineligibility eg intolerable adverse reactions loss to follow-up voluntary withdrawal death or study terminationsuspension
The objective of the Phase I dose-escalation phase is to preliminarily assess the safety and tolerability of IAP0971 and to determine the MTD based on the incidence of dose-limiting toxicities DLTs in each dose group Phase II will use an open-label non-randomized single-arm multicenter design The study will evaluate adverse events and adverse reactions through clinical observation vital sign monitoring and laboratory tests Tumor assessments will be conducted using RECIST 11 criteria within 48 weeks of the first infusion of the investigational drug assessments will be performed after every two cycles 7 days and after 48 weeks assessments will occur every four cycles 7 days until disease progression initiation of new anti-tumor therapy investigator-determined ineligibility eg intolerable adverse reactions loss to follow-up voluntary withdrawal death or study terminationsuspension
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None