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

Conditions

• KRAS Altered Advanced or Metastatic Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AMG 410 — DRUG
  Administered as an oral tablet.
• Pembrolizumab — DRUG
  Administered as an intravenous (IV) infusion.
• Panitumumab — DRUG
  Administered as an IV infusion.

Study Details

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.

Key Dates

Start date

Jul 31, 2025

Status verified

Feb 2026

Primary completion

Apr 18, 2028

Completion

Apr 20, 2031

Study Design

Enrollment

434 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Monotherapy Dose Exploration
  Participants will receive escalating doses of AMG 410.
• Experimental: Part 1: Food Effect Substudy Cohort
  A food effect substudy will be conducted. During the substudy, participants will receive AMG 410 under fasted and fed conditions.
• Experimental: Part 1: China-specific Cohort
  Participants identified through regionally approved molecular KRAS testing will receive AMG 410.
• Experimental: Part 2: Monotherapy Dose Expansion
  Monotherapy dose expansion of AMG 410 may proceed in KRAS altered tumors in non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), and other KRAS altered tumor types.
• Experimental: Part 3a: Combination Therapy Dose Exploration and Dose Expansion
  Part 3a allows for AMG 410 dose exploration and expansion in combination with pembrolizumab in KRAS altered advanced or metastatic solid tumors.
• Experimental: Part 3b: Combination Therapy Dose Exploration and Dose Expansion
  Part 3b allows for AMG 410 dose exploration and expansion in combination with panitumumab in advanced or metastatic CRC and/or PDAC.

Primary Outcome Measure

Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]

Central Contacts

• Amgen Call Center
  866-572-6436
  [email protected]

Locations (9)

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