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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Abalos Therapeutics GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	ABX-001	ABX-001 administered intravenously (IV)
DRUG	Pembrolizumab	Pembrolizumab administered intravenously (IV)

Timeline

• Start date: 2025-10-14
• Primary completion: 2026-10-30
• Completion: 2026-10-30
• First posted: 2025-11-17
• Last updated: 2026-01-16

Locations

5 sites across 2 countries: Germany, Spain