NCT05052268

XTX202 in Patients With Advanced Solid Tumors

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Xilio Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors

Detailed description

This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, and efficacy of XTX202, an engineered IL-2 prodrug with its activity masked, as monotherapy in patients with advanced solid tumors. Phase 1 Part 1a will examine XTX202 monotherapy in an accelerated and standard 3+3 dose-escalation design. Based on the results of Part 1a, Part 1b will be initiated to further examine XTX202 in patients with select advanced solid tumors and to further characterize XTX202. Based on results of Phase 1 patients with select advanced solid tumors will be enrolled in Phase 2.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	XTX202	XTX202 Monotherapy

Timeline

• Start date: 2022-01-18
• Primary completion: 2025-03-22
• Completion: 2025-03-25
• First posted: 2021-09-22
• Last updated: 2025-05-07

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study