Ignite Creation Date:
2024-05-06 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05317078
Status:
TERMINATED
Last Update Posted:
2024-07-08
First Post:
2022-03-30
Brief Title:
A Phase 1 Safety Tolerability and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-small Cell Lung Cancer Epithelial Ovarian Cancer and Other Malignant Solid Tumor Indications
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
Phase 1 First-In-Human Study to Explore the Safety Tolerability and Pharmacokinetics of AMG 794 in Participants With Claudin 6-positive AdvancedMetastatic Non-small Cell Lung Cancer Epithelial Ovarian Cancer and Other Malignant Solid Tumor Indications
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Amgen has made the business decision to discontinue development of AMG 794 The safety profile of AMG 794 remains unchanged
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives of this study are to evaluate the safety and tolerability of AMG 794 in adult participants and to determine the optimal biological active dose OBD at or below the maximum tolerated dose MTD with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose
Detailed Description:
None
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