Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621615
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Clinical Study of CVL006 Injection in Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open Label Multicenter Phase I Clinical Study on the Safety Tolerability Pharmacokinetics and Efficacy of CVL006 Injection in Patients With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Evaluate the safety and tolerability of CVL006 monotherapy in patients with advanced solid tumors Observe the dose limiting toxicity DLT of CVL006 monotherapy in patients with advanced solid tumors evaluate the maximum tolerated dose MTD and recommend the dosage for phase II clinical trials RP2D
Detailed Description:
This study is a phase I clinical trial of single arm open label multicenter dose escalationdose extensionefficacy extension The research process for each dose group includes a screening period from the signing of the informed consent form by the subjects to 1 day before the first study medication a medication period from the first study medication to termination of medication and a follow-up period 90 days after termination of medication This study is divided into three stages I Dose escalation stage Accelerated titration combined with a 33 design is used to dose up CVL006 injection Accelerated titration is preset with three doses starting at 003 mgkg Only one subject is enrolled in each dose group After completing the three preset doses four dose groups are designed according to the 33 principle with 3-6 subjects enrolled in each dose group up to a maximum of 42 subjects enrolled Ib Dose extension stage Based on the observed safety tolerability efficacy and PK characteristics during the dose escalation process in the dose group where a certain therapeutic effect is observed in the subjects such as 1 PRCR or 2 SD the SMC meeting will decide whether to extend the dose in that dose group Plan to expand each dose group by no more than 10 subjects including subjects with the same dose during the dose escalation phase And determine RP2D based on data from dose escalation and expansion stages Ic Efficacy expansion stage RP2D was selected for expansion with each tumor type expanded to 10-30 cases This study is expected to enroll approximately 100-120 cases depending on the actual situation Dose escalation dose expansion and efficacy expansion are the same CVL006 injection intravenous infusion once every 2 weeks every 28 days as a cycle The subsequent administration time is calculated based on the actual date of the previous CVL006 administration SMC can adjust the dosing frequency based on safety tolerability and PK results data
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