Recruiting
Phase 1

AMG 436

Sponsor:

Amgen

Code:

NCT07403721

Conditions

Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

AMG 436

Study Details

Brief summary:

The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for AMG 436 as monotherapy and in combination with other anti-cancer therapies in participants with MSI-H/dMMR solid tumors.

Conditions

Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)

Study ID

NCT07403721

Start date

Apr 8, 2026

Status verified date

Aug, 2026

Completion date

Jul 28, 2028

Anticipated

Primary completion date

Jul 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
  • Histologically confirmed MSI-H or dMMR metastatic or locally advanced solid tumor by local testing or central testing.
  • Tumor tissue (formalin-fixed, paraffin-embedded sample) archival block must be available. Participants without archived tumor tissue may enroll by undergoing tumor biopsy before dosing.
  • Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
  • Eastern Cooperative Oncology Group performance (ECOG) 0-1.
  • Adequate organ function as defined in the protocol.

Exclusion Criteria:

  • Participants with primary central nervous system (CNS) tumors.
  • Impaired cardiac function or clinically significant cardiac disease.
  • Major surgery within 28 days of trial day 1.
  • Antitumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 21 days of first dose of trial treatment, unless anti-tumor therapy is a therapy with 5 times the half-life being shorter than 21 days (in this case, enrollment may be allowed with washout from prior therapy of < 21 days.
  • Radiation therapy within 28 days of the first dose of trial treatment (or local or focal radiotherapy with palliative intent within 14 days of the first dose).
  • Gastrointestinal tract disease causing the inability to take per os (PO) medication, malabsorption syndrome, requirement for intravenous (IV) alimentation, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).

Study Design

Enrollment

464 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1A

AMG 436 monotherapy dose escalation.

experimental: Part 1B: Food Effect Substudy

Participants will receive AMG 436 under fasted and fed conditions (United States only).

experimental: Part 2

AMG 436 + combination dose escalation.

experimental: Part 3

AMG 436 monotherapy Dose expansion and optimization.

experimental: Part 4

AMG 436 + chemotherapy combination dose expansions.

Interventions

AMG 436

AMG 436 will be administered.

Primary outcome measure

  • Number of Participants with a Dose Limiting Toxicity (DLT) [ Time Frame: Up to 21 days ]
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

City of Hope Orange County Lennar Foundation Cancer Center

Recruiting

Irvine, California, United States, 92618

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Midwestern Regional Medical Center dba City of Hope Chicago

Recruiting

Zion, Illinois, United States, 60099

Community Health Network MD Anderson Cancer Center - North

Recruiting

Indianapolis, Indiana, United States, 46250

New England Cancer Specialists

Recruiting

Westbrook, Maine, United States, 04092

Tennessee Oncology PLLC

Recruiting

Nashville, Tennessee, United States, 37203

Next Oncology - Dallas

Recruiting

Irving, Texas, United States, 75039

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 1Z5

More Information

Sponsor

Amgen

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • AMG 436
  • MSI-H
  • dMMR
  • Solid Tumors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amgen on 2026-08-27.