Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06150183
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-11-21
Brief Title:
Safety and Preliminary Efficacy of BNT314 with or Without an Immune Checkpoint Inhibitor in Cancer Patients with Malignant Solid Tumors
Sponsor:
BioNTech SE
Organization:
BioNTech SE
Study Overview
Official Title:
A First-in-Human Open-label Dose Escalation Trial with Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of BNT314 in Monotherapy and in Combination with an Immune Checkpoint Inhibitor in Patients with Advanced Malignant Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The purpose of this first-in-human study is to find out if BNT314 is safe when it is used alone and when it is used together with another antibody cancer drug pembrolizumab in patients with different types of cancer Patients will receive either BNT314 alone or BNT314 combined with pembrolizumab
Phase 1 of the study consists of a dose escalation part and a safety run-in SRI and expansion part
Dose escalation In this part of the study patients will be assigned to multiple dose levels DLs of BNT314 given alone By escalating the dose with a small group of patients the Maximum Tolerated Dose MTD which is the highest dose with acceptable safety and manageable side effects or the maximum administered dose MAD will be investigated At the end of this part the Recommended Phase 2 Dose RP2D which is the dose to be tested in Phase 2 will be decided
Safety Run-In In this part of the study BNT314 will be combined with pembrolizumab Before starting the expansion part the combination will be tested in another small group of participants 12-28 to find out how safe this combination is
Expansion In this part of the study BNT314 will be combined with pembrolizumab After the SRI is completed the study will continue with the expansion part where up to 199 participants with different types of cancer will be included
The Phase 2 part of the study will be introduced via an amendment to the study protocol
Phase 1 of the study consists of a dose escalation part and a safety run-in SRI and expansion part
Dose escalation In this part of the study patients will be assigned to multiple dose levels DLs of BNT314 given alone By escalating the dose with a small group of patients the Maximum Tolerated Dose MTD which is the highest dose with acceptable safety and manageable side effects or the maximum administered dose MAD will be investigated At the end of this part the Recommended Phase 2 Dose RP2D which is the dose to be tested in Phase 2 will be decided
Safety Run-In In this part of the study BNT314 will be combined with pembrolizumab Before starting the expansion part the combination will be tested in another small group of participants 12-28 to find out how safe this combination is
Expansion In this part of the study BNT314 will be combined with pembrolizumab After the SRI is completed the study will continue with the expansion part where up to 199 participants with different types of cancer will be included
The Phase 2 part of the study will be introduced via an amendment to the study protocol
Detailed Description:
This is a multicenter multinational safety study in patients with metastatic or advanced malignant solid tumors for whom at the discretion of the investigator there is no available standard therapy likely to confer clinical benefit evaluating the safety tolerability preliminary antitumor activity pharmacokinetics PK pharmacodynamics PD and immunogenicity of BNT314
In the dose escalation part of the study patients will periodically receive one infusion of BNT314 In the combination therapy SRI and expansion part BNT314 will be combined with pembrolizumab and administered intravenously in periodic cycles to patients with selected cancer indications
Additional cohorts backfill cohorts administering BNT314 as monotherapy will assign patients to specific DLs based on the emerging safety PK and pharmacodynamic data This would allow for further assessment of dose- and exposure-response relationships for clinical activity safety and tolerability to support BNT314 dose optimization
The treatment period will last until progressive disease PD confirmed PD as per immune response evaluation criteria in solid tumors iRECIST unacceptable toxicity or withdrawal of consent whichever happens first
For the combination therapy the maximum treatment period will be 2 years The maximum study duration is 3 years after the last participants first treatment in the study
In the dose escalation part of the study patients will periodically receive one infusion of BNT314 In the combination therapy SRI and expansion part BNT314 will be combined with pembrolizumab and administered intravenously in periodic cycles to patients with selected cancer indications
Additional cohorts backfill cohorts administering BNT314 as monotherapy will assign patients to specific DLs based on the emerging safety PK and pharmacodynamic data This would allow for further assessment of dose- and exposure-response relationships for clinical activity safety and tolerability to support BNT314 dose optimization
The treatment period will last until progressive disease PD confirmed PD as per immune response evaluation criteria in solid tumors iRECIST unacceptable toxicity or withdrawal of consent whichever happens first
For the combination therapy the maximum treatment period will be 2 years The maximum study duration is 3 years after the last participants first treatment in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506053-38-00 | OTHER | EU CT | None |