AMG 436 alone and with other treatments for adults with MSI‑High or dMMR advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 dose‑finding trial of AMG 436 given as monotherapy and in combination with other anti‑cancer agents in adults with metastatic or locally advanced MSI‑H/dMMR solid tumors. The study enrolls participants with measurable disease, ECOG performance status 0–1, and adequate organ function, and requires available tumor tissue or a fresh biopsy. The primary goals are to define the safety profile and to determine the maximum tolerated dose or recommended phase 2 dose for AMG 436 in each treatment setting. Safety monitoring and dose escalation procedures will guide decisions about dose levels and combination cohorts.

Why it matters

Who can join: the full rules

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).

Where it's running

• City of Hope Orange County Lennar Foundation Cancer Center
  Irvine, California, United States Recruiting
• Hoag Memorial Hospital Presbyterian
  Newport Beach, California, United States Recruiting
• Midwestern Regional Medical Center dba City of Hope Chicago
  Zion, Illinois, United States Recruiting
• Community Health Network MD Anderson Cancer Center - North
  Indianapolis, Indiana, United States Recruiting
• New England Cancer Specialists
  Westbrook, Maine, United States Recruiting
• Tennessee Oncology PLLC
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.