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RECRUITING
NCT06154291
PHASE1/PHASE2

FIH XON7 in Advanced/Metastatic Solid Tumors

Sponsor: Xenothera SAS

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

255

Start Date

2023-11-14

Completion Date

2027-11

Last Updated

2025-06-22

Healthy Volunteers

No

Interventions

DRUG

XON7

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

Locations (5)

Institut Jules Bordet

Anderlecht, Belgium

Institut Bergonié

Bordeaux, France

Centre Léon Bérard

Lyon, France

Hôpital Foch

Suresnes, France

IUCT-Oncopole

Toulouse, France