Ignite Creation Date:
2024-05-06 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05094336
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2021-10-14
Brief Title:
A Study of AMG 193 in Subjects With Advanced MTAP-null Solid Tumors
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 11b2 Study Evaluating the Safety Tolerability Pharmacokinetics Pharmacodynamics and Efficacy of AMG 193 Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
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:
MTAP
Brief Summary:
The primary objective of Parts 1 and 2 of this study is to evaluate the safety tolerability and to determine the maximum tolerated dose MTD or recommended phase 2 dose RP2D of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase MTAP-null solid tumors
The primary objective of Part 3 of this study is to evaluate the efficacy of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors
The primary objective of Part 3 of this study is to evaluate the efficacy of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504363-17 | OTHER | None | None |