Clinical Trial

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

Recruiting Phase 1
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-11-14; most recent amendment 2026-01-15.
Trial Details
NCT Number NCT07231458
Lead Sponsor Abalos Therapeutics GmbH
Conditions Advanced Solid Tumors
Enrollment 27 participants
Start Date 2025-10-14
Primary Completion 2026-10-30 (estimated)
Study Completion 2026-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-16