Ignite Creation Date:
2024-05-06 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05271318
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2022-02-04
Brief Title:
Oncolytic Adenovirus Coding for TNFa and IL2 TILT-123 With Pembrolizumab or Pembrolizumab and Pegylated Liposomal Doxorubicin as Treatment for Ovarian Cancer
Sponsor:
TILT Biotherapeutics Ltd
Organization:
TILT Biotherapeutics Ltd
Study Overview
Official Title:
A Two-part Phase IIb Open-Label Dose-escalation Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus TILT-123 in Combination With Pembrolizumab Phase I Part and Pembrolizumab and Pegylated Liposomal Doxorubicin Phase Ib Part in Patients With Platinum Resistant or Refractory Ovarian Cancer
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:
PROTA
Brief Summary:
This is an open-label phase 1 dose-escalation multicenter and multinational trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with Pembrolizumab or Pembrolizumab and Pegylated Liposomal Doxorubicin in patients with platinum resistant or refractory ovarian cancer
Detailed Description:
This is an open-label phase 1 dose-escalation multicenter and multinational trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with Pembrolizumab or Pembrolizumab and Pegylated Liposomal Doxorubicin in patients with platinum resistant or refractory ovarian cancer TILT-123 is an oncolytic adenovirus coding for tumor necrosis factor alpha TNFa and interleukin 2 IL-2 Pembrolizumab is a monoclonal antibody binding program cell death 1 PD-1 Pegylated Liposomal Doxorubicin is a chemotherapy and a pegylated liposomal form of the anthracycline topoisomerase inhibitor doxorubicin
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 |
|---|---|---|---|
| KEYNOTE-C70 | OTHER | Merck Sharp Dohme LLC | None |
| OC220391 | OTHER_GRANT | None | None |
| 2021-005083-22 | EUDRACT_NUMBER | None | None |
| MK-3475-C70 | OTHER | None | None |