drugset / Trial / NCT07231458

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

NCT07231458 ↗

Phase 1 Recruiting 27 enrolled Abalos Therapeutics GmbH
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2025-10-14
Primary completion
2026-10-30
Completion
2026-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject ABX-001 Unknown — Intravenous
Subject Pembrolizumab Monoclonal antibody — Intravenous

Indications