NCT06276491

Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors

A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 282 (estimated)
• Sponsor: Xencor, Inc. · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.

Conditions

• Ovarian Cancer
• Endometrial Cancer
• Germ Cell Tumor
• Testicular Germ Cell Tumor
• Ovarian Germ Cell Tumor

Interventions

Type	Name	Description
BIOLOGICAL	XmAb541	Monoclonal bispecific antibody

Timeline

• Start date: 2024-04-04
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-02-26
• Last updated: 2026-03-17

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study