NCT06952010

A Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors

A Phase 1 Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Exelixis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, first-in-human, open-label, dose-escalation study of XB628, a first-in-class bispecific antibody natural killer (NK) cell engager that targets NK group 2 member A (NKG2A), an inhibitory receptor on NK cells, and programmed cell death-ligand 1 (PD-L1).

Detailed description

This study consists of a Dose-Escalation Stage. The Dose-Escalation Stage is designed to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE\[s\]) of XB628 as a single agent.

Conditions

• Solid Tumor
• Advanced Solid Tumor
• Metastatic Solid Tumor
• Immune Sensitive Tumor

Interventions

Type	Name	Description
BIOLOGICAL	XB628	Intravenous infusion(s)

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-05-01
• Completion: 2027-11-01
• First posted: 2025-04-30
• Last updated: 2025-12-26

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study