NCT06154291

FIH XON7 in Advanced/Metastatic Solid Tumors

Phase I/II, Multi Center, Open Label, First-in-human, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-tumors Efficacy of the Glyco-humanized Polyclonal Antibody XON7 in Patients With Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 255 (estimated)
• Sponsor: Xenothera SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two-stage trial consisting of a Part I, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), if any, and Recommended Part 2 Dose (RP2D) of XON7, followed by a Part II component to investigate anti-tumors efficacy in selected solid tumor types and to further evaluate safety and tolerability of XON7 at RP2D.

Conditions

• Advanced Solid Tumor
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	XON7	The trial intervention (XON7) is a glyco-humanized polyclonal antibody drug which is formulated for intravenous (IV) administration

Timeline

• Start date: 2023-11-14
• Primary completion: 2026-12-01
• Completion: 2027-11-01
• First posted: 2023-12-04
• Last updated: 2025-06-22

Locations

5 sites across 2 countries: Belgium, France