Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05262530
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2022-02-21
Brief Title:
Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid Tumors
Sponsor:
BioNTech SE
Organization:
BioNTech SE
Study Overview
Official Title:
First-in-human Open-label Multicenter Phase IIIa Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT142 in Patients With CLDN6-positive Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-05
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:
This study is an open-label multicenter Phase IIIa dose escalation safety and pharmacokinetics PK study of BNT142 followed by expansion cohorts in patients with Claudin 6 CLDN6-positive advanced tumors
Detailed Description:
Part 1 Dose escalation of this study is a first-in-human FIH open-label dose escalation safety and PK study of BNT142 in patients with advancedmetastatic CLDN6-positive solid tumors
Part 2 Expansion will be a Phase IIa proof-of-concept study in up to three expansion cohorts of CLDN6 positive advancedmetastatic ovarian cancer non-small cell lung cancer NSCLC of non-squamous type and testicular cancer patients who have progressed on or after last prior treatment
Part 2 Expansion will be a Phase IIa proof-of-concept study in up to three expansion cohorts of CLDN6 positive advancedmetastatic ovarian cancer non-small cell lung cancer NSCLC of non-squamous type and testicular cancer patients who have progressed on or after last prior treatment
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 |
|---|---|---|---|
| 2021-005481-18 | EUDRACT_NUMBER | None | None |