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AMG 436 for MSI-H/dMMR Solid Tumors

This study is testing a drug called AMG 436, both by itself and with other cancer treatments, for people with metastatic (spread to other parts of the body) or locally advanced solid tumors that have specific genetic changes called MSI-H (microsatellite instability-high) or dMMR (mismatch repair deficiency). The main goals are to understand the safety of AMG 436 and to find the best dose. You may be able to join if you are 18 or older and have a confirmed MSI-H or dMMR solid tumor, and a tumor tissue sample is available. The study plans to enroll 464 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 464 participants. It is designed to evaluate the safety and dosage of AMG 436 as a targeted therapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events (side effects) and serious adverse events for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07403721

AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors

Recruiting
PHASE1Ages 18–99InterventionalTreatment
Amgen
~464 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:AMG 436

At a glance

Recruiting sites
25 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with a Dose Limiting Toxicity (DLT)
Measured over Up to 21 days
+1 more outcome measured

Conditions

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

Explore related trials

Solid NeoplasmMRC1 wt AlleleMSI1 Gene

Where it's being run

25 sites across 20 states
California2
Belgium2
France2
Tokyo2
Catalonia2
Illinois1
Indiana1
Maine1

Study leadership

  • MD · STUDY_DIRECTOR · Amgen

Who to contact

Amgen Call Center
[email protected]
866-572-6436
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

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