AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors

Active:	Yes
Cancer Type:	Solid Tumor Unknown Primary	NCT ID:	NCT07094113
Trial Phases:	Phase I	Protocol IDs:	20240031 (primary) NCI-2025-07560
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Amgen, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT07094113

Summary

The purpose of this first-in-human study is to evaluate the safety, tolerability,
pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AMG 410 when
administered alone or in combination with other agents in participants with advanced or
metastatic solid tumors harboring KRAS alterations.

This is a dose-escalation study in which participants will be assigned to multiple dose
levels (DLs) of AMG 410, either as monotherapy or in combination with other agents,
followed by expansion cohorts. The goal is to determine the Maximum Tolerated Dose
(MTD)-the highest dose with acceptable safety and manageable side effects-or the
Recommended Phase 2 Dose (RP2D) of AMG 410 in adult participants with KRAS-altered
advanced or metastatic solid tumors.

Objectives

This is a multicenter, multinational, open-label Phase 1/1b study designed to evaluate
the safety, tolerability, PK, PD, and preliminary antitumor activity of AMG 410 in adult
participants with advanced or metastatic solid tumors characterized by KRAS alterations.

The study will begin with a dose-escalation phase, during which AMG 410 will be
administered orally, either as monotherapy or in combination with other agents. Dose
escalation will follow a model-based approach to identify the MTD or RP2D.

Following dose escalation, additional expansion cohorts may be enrolled at selected dose
levels to further characterize the safety profile, PK/PD relationships, and preliminary
efficacy in specific tumor types or molecular subgroups.

Participants will continue treatment until disease progression, unacceptable toxicity,
withdrawal of consent, or other protocol-defined discontinuation criteria. The maximum
duration of AMG 410 administration in this study is 3 years.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.