Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579196
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Trabedersen OT-101 With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Trabedersen OT-101 With Pembrolizumab in Patients With Newly Diagnosed Advanced Non-Small Cell Lung Cancer and Positive PD-L1
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:
The goal of this clinical trial is to 1 evaluate the safety and recommended dose of the drug OT-101Trabedersen when combined with Pembrolizumab and 2 determine the efficacy of the combination therapy in adults with certain types of Non-Small Cell Lung Cancer The main questions it aims to answer are
What medical problems to participants have when taking OT101 together with Pembrolizumab
What is the correct dose of OT-101 to use when evaluating the safety and efficacy of the combination therapy
Does the combination therapy delay progression or relapse of the participant39s Non-Small Cell Lung Cancer
Participants will
Receive intravenous OT-101Trabedersen for 4 days once every 2 weeks Clinic visits are required to receive and disconnect the infusion
Receive intravenous Pembrolizumab once every 6 weeks
What medical problems to participants have when taking OT101 together with Pembrolizumab
What is the correct dose of OT-101 to use when evaluating the safety and efficacy of the combination therapy
Does the combination therapy delay progression or relapse of the participant39s Non-Small Cell Lung Cancer
Participants will
Receive intravenous OT-101Trabedersen for 4 days once every 2 weeks Clinic visits are required to receive and disconnect the infusion
Receive intravenous Pembrolizumab once every 6 weeks
Detailed Description:
The goal of this clinical trial is to 1 evaluate the safety and recommended dose of the drug OT-101Trabedersen when combined with Pembrolizumab and 2 determine the efficacy of the combination therapy in adults with certain types of Non-Small Cell Lung Cancer The main questions it aims to answer are
What medical problems to participants have when taking OT101 together with Pembrolizumab
What is the correct dose of OT-101 to use when evaluating the safety and efficacy of the combination therapy
Does the combination therapy delay progression or relapse of the participants Non-Small Cell Lung Cancer
Participants will
Receive intravenous OT-101Trabedersen for 4 days once every 2 weeks Clinic visits are required to receive and disconnect the infusion
Receive intravenous Pembrolizumab once every 6 weeks
In Phase I dose escalationde-escalation of OT101Trabedersen is performed using a BOIN design to determine dose limiting toxicity DLT and the recommended phase 2 dose RP2D when combined with Pembrolizumab
In Phase II subjects receive the RP2D of OT101Trabedersen together with Pembrolizumab until disease relapse progression as determined by immune Response Evaluation Criteria in Solid Tumours iRECIST criteria or death
What medical problems to participants have when taking OT101 together with Pembrolizumab
What is the correct dose of OT-101 to use when evaluating the safety and efficacy of the combination therapy
Does the combination therapy delay progression or relapse of the participants Non-Small Cell Lung Cancer
Participants will
Receive intravenous OT-101Trabedersen for 4 days once every 2 weeks Clinic visits are required to receive and disconnect the infusion
Receive intravenous Pembrolizumab once every 6 weeks
In Phase I dose escalationde-escalation of OT101Trabedersen is performed using a BOIN design to determine dose limiting toxicity DLT and the recommended phase 2 dose RP2D when combined with Pembrolizumab
In Phase II subjects receive the RP2D of OT101Trabedersen together with Pembrolizumab until disease relapse progression as determined by immune Response Evaluation Criteria in Solid Tumours iRECIST criteria or death
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