Ignite Creation Date:
2024-05-06 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03596372
Status:
COMPLETED
Last Update Posted:
2022-06-02
First Post:
2018-06-26
Brief Title:
Study of BAY1834942 in Patients With Solid Tumors
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
An Open-label Phase 1 First-in-human Dose Escalation and Expansion Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Tumor Response Profile of the Anti-CEACAM6 Antibody BAY1834942 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2022-05
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 is an open-label Phase 1 first-in-human dose escalation and expansion study designed to assess the safety tolerability pharmacokinetics pharmacodynamics and tumor response profile of the anti-Carcinoembryonic-antigen-related-cell-adhesion-molecule-6 CEACAM6 antibody BAY1834942 in patients with advanced solid tumors known to have a prevalence for CEACAM6 expression
The study consists of dose escalation and a tumor type-specific expansion
The study consists of dose escalation and a tumor type-specific expansion
Detailed Description:
The primary objectives of the study are to evaluate and characterize the tolerability and safety profile of repeated doses of BAY1834942 and to characterize the pharmacokinetics of BAY1834942 after single dose
Secondary objectives are to evaluate the tumor response profile pharmacodynamics pharmacokinetics and immunogenicity after multiple doses of the drug
Secondary objectives are to evaluate the tumor response profile pharmacodynamics pharmacokinetics and immunogenicity after multiple doses of the drug
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 |
|---|---|---|---|
| 2018-002561-19 | EUDRACT_NUMBER | None | None |