Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT07231458
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.
Study:
NCT07231458
Study Brief:
Protocol Section:
NCT07231458