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

ClinicalTrials.gov ID: NCT05800964

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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)

Study identification

NCT ID: NCT05800964
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 1
Lead sponsor: Amgen; Industry
Enrollment: 37 participants

Conditions and interventions

Conditions

Advanced Solid Tumors

Interventions

AMG 305 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 100 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 13, 2023 (Actual)
Primary completion: Jan 22, 2026 (Actual)
Completion: Jan 22, 2026 (Actual)
Last update posted: Oct 19, 2026

2023 – 2026

United States locations

U.S. sites: 6
U.S. states: 6
U.S. cities: 6

Facility	City	State	ZIP	Site status
City of Hope National Medical Center	Duarte	California	91010	—
Hackensack University Medical Center	Hackensack	New Jersey	07601	—
New York University Cancer Institute	New York	New York	10016	—
Thomas Jefferson University	Philadelphia	Pennsylvania	19107	—
Sarah Cannon Research Institute	Nashville	Tennessee	37203	—
Next Oncology	San Antonio	Texas	78229	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05800964, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 19, 2026 · Synced Nov 13, 2026