NCT07159828

A Study to Assess AXN-2510 Treatment in Adult Patients With Advanced Solid Tumors

A Phase 1 Open-label Study to Assess AXN-2510 Monotherapy in Adult Patients With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Axion Bio, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn more about the side effects and best dose of AXN-2510 in adults with advanced solid tumors. The main questions it aims to answer are: * What are the side effects of AXN-2510? * Which is the best tolerated dose of AXN-2510? * How long does AXN-2510 stay in your body? Participants will receive AXN-2510 every 3 weeks. Participants will visit the clinic for checkups and tests several days during the first and third doses, and once every 3 weeks for other doses.

Detailed description

This is a phase 1 study where all adult participants will receive AXN-2510. There will be 2 increasing doses of AXN-2510 given to participants, the dose given depends on when a participant enters the study. Next will be enrollment of 20 participants at the different doses to obtain more information about side effects, tolerability, and if the drug is helping.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
BIOLOGICAL	AXN-2510	AXN-2510 is an antibody with PD-L1 blocking and VEGF inhibition activity in one drug. This is called a bispecific antibody, because it has 2 activities. This immuno-oncology treatment is in development for the treatment of solid tumors. AXN-2510 is differentiated from other PD-L1 and VEGF bispecific antibodies by its ability to inhibit multiple VEGF molecules and also increased antibody-dependent cellular cytotoxicity (ADCC) that can directly kill PD-L1-positive tumor cells.

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-07-01
• Completion: 2027-05-15
• First posted: 2025-09-08
• Last updated: 2026-01-09

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study