NCT05800964

Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors

Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to: * Evaluate the safety and tolerability of AMG 305 in adult participants * Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose * Determine the recommended phase 2 dose (RP2D)

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	AMG 305	Short-term intravenous (IV) infusion

Timeline

• Start date: 2023-06-13
• Primary completion: 2026-01-22
• Completion: 2026-01-22
• First posted: 2023-04-06
• Last updated: 2026-02-17

Locations

27 sites across 9 countries: United States, Australia, Canada, France, Germany, Japan, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study