Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
NCT05800964 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2026-02-17
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
Interventions
- DRUG
-
AMG 305
Short-term intravenous (IV) infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-13
- Primary Completion
- 2026-01-22
- Completion
- 2026-01-22
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- France
- Germany
- Japan
- South Korea
- Spain
- United Kingdom
Study Locations
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