Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05841563
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-03-31
Brief Title:
Clinical Trial of PM54 in Advanced Solid Tumors Patients
Sponsor:
PharmaMar
Organization:
PharmaMar
Study Overview
Official Title:
Phase IIb Open-label Dose-escalating Clinical and Pharmacokinetic Study of PM54 Administered Intravenously to Patients With Selected Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-08
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 first part of the study phase Ia - dose escalation will evaluate the safety and tolerability and identify the dose-limiting toxicities DLTs of PM54
The second part of the study phase Ib - expansion will be to evaluate the antitumor activity of PM54 in terms of clinical benefit response or stable disease SD 4 months associated with tumor shrinkage according to the RECIST v11 or modified RECIST mRECIST v11 in case of malignant pleural mesothelioma MPM andor serum markers as appropriate in patients with selected advanced solid tumors
The second part of the study phase Ib - expansion will be to evaluate the antitumor activity of PM54 in terms of clinical benefit response or stable disease SD 4 months associated with tumor shrinkage according to the RECIST v11 or modified RECIST mRECIST v11 in case of malignant pleural mesothelioma MPM andor serum markers as appropriate in patients with selected advanced 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 |
|---|---|---|---|
| 2022-002031-65 | EUDRACT_NUMBER | None | None |