Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04614740
Status:
UNKNOWN
Last Update Posted:
2022-12-13
First Post:
2020-10-12
Brief Title:
The Phase IPhase II Clinical Study of VC004 in Patients With Localized AdvancedMetastatic Solid Tumors
Sponsor:
Jiangsu vcare pharmaceutical technology co LTD
Organization:
Jiangsu vcare pharmaceutical technology co LTD
Study Overview
Official Title:
Single-arm Open Multi-center Phase IPhase II Clinical Study to Assess the Safety Tolerability Pharmacokinetic and Effectiveness of VC004
Status:
UNKNOWN
Status Verified Date:
2022-10
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:
Dose-escalation study will be conducted in patients with locally advancedmetastatic solid tumors who have failed standard treatment or cannot tolerate standard treatment or have no recommended standard treatment or do not apply standard treatment to evaluate the safety PK tolerability and effectiveness of VC004 According to the efficacy safety and PK of dose-escalation study the investigator and the sponsor jointly determine the dose for dose extension and evaluate the anti-tumor effect of VC004 on NTRK fusion-positive subjects and provide more information for RP2D
According to the tolerability and pharmacokinetic results of dose-escalation study an appropriate dose or MTD will be selected namely RP2D to further assess anti-tumor efficacy and safety in patients with NTRK fusion-positive locally advancedmetastatic solid tumors ORR will be chosen as the main efficacy indicator to evaluate the anti-tumor efficacy and safety of VC004
According to the tolerability and pharmacokinetic results of dose-escalation study an appropriate dose or MTD will be selected namely RP2D to further assess anti-tumor efficacy and safety in patients with NTRK fusion-positive locally advancedmetastatic solid tumors ORR will be chosen as the main efficacy indicator to evaluate the anti-tumor efficacy and safety of VC004
Detailed Description:
None
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