Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT07231458
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Test a New Immunotherapy, ABX-001, Alone and in Combination With the Marketed Drug, Pembrolizumab, for the Treatment of Tumors Previously Treated With Other Therapies
Sponsor:
Abalos Therapeutics GmbH
Organization:
Study Overview
Official Title:
A Phase I/Ib Open-Label Study of ABX-001 Administered With and Without the Anti-PD-1 Immune Checkpoint Inhibitor Pembrolizumab in Participants With Advanced Solid Tumors Who Are Beyond Standard of Care
Status:
RECRUITING
Status Verified Date:
2025-11
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 a Phase I/Ib first-in-human, open-label, non-randomized, multicenter, multi-country study to evaluate the safety and tolerability and to establish a recommended Phase 2 dose (RP2D) as well as assess preliminary clinical activity of ABX-001 administered intravenously (IV) alone (Part A) or co-administered with pembrolizumab (Part B) in participants with refractory/relapsed advanced solid tumors.
Detailed Description:
The study will consist of the following periods or visits:
* A 28-day screening period
* Treatment period -
* Parts A and B: On Day 0, participants will be admitted to hospital for 22-24 hours after injection of ABX-001, which will be administered by a single IV injection as described in the Pharmacy Manual. In the absence of clinical signs and symptoms, participants will be discharged from hospital.
* Part B: Beginning at Week 3, participants in Part B will receive treatment with pembrolizumab every 3 weeks.
* A 28-day screening period
* Treatment period -
* Parts A and B: On Day 0, participants will be admitted to hospital for 22-24 hours after injection of ABX-001, which will be administered by a single IV injection as described in the Pharmacy Manual. In the absence of clinical signs and symptoms, participants will be discharged from hospital.
* Part B: Beginning at Week 3, participants in Part B will receive treatment with pembrolizumab every 3 weeks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-512403-39-01 | CTIS | None | View |