Recruiting

AMG 436 Safety and Dose Evaluation in MSI-H/dMMR Solid Tumors

Study Aim

This phase 1 study aims to evaluate the safety and find the appropriate dose of AMG 436 in individuals with MSI-H/dMMR solid tumors, by observing the number of participants with dose limiting toxicity and treatment-emergent adverse events.

What is being tested

AMG 436

Drug

Who is being recruted

Neoplasm Metastasis+2

+ Neoplasms

+ Neoplastic Processes

From 18 to 99 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: March 2026

See protocol details

Summary

Principal SponsorAmgen

Study ContactAmgen Call Center

Last updated: March 20, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 23, 2026

Actual date on which the first participant was enrolled.

This clinical trial focuses on evaluating a drug called AMG 436, either used alone or in combination with other therapies, for treating solid tumors with specific genetic traits known as Microsatellite Instability-high (MSI-H) or Mismatch Repair Deficient (dMMR). These genetic traits are often found in certain types of cancers. The main goal of this study is to understand the safety profile of AMG 436, and to identify the maximum dose that patients can tolerate without significant side effects. This research is important as it could potentially lead to improved treatment options for individuals with these specific types of solid tumors. During the study, participants receive AMG 436 either as a standalone treatment or combined with other anti-cancer therapies. The outcomes of interest include the number of participants who experience a dose-limiting toxicity, which is a side effect severe enough to prevent an increase in dose or require a dose reduction. Additionally, the study monitors the number of participants who experience any treatment-emergent adverse events or serious adverse events. These measurements help researchers understand the safety and tolerability of AMG 436.

Official TitleA Phase 1/1b Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AMG 436 as Monotherapy and in Combination With Other Therapies in Participants With Microsatellite Instability-high (MSI-H)/Mismatch Repair Deficient (dMMR) Solid Tumors

NCT07403721

Principal SponsorAmgen

Study ContactAmgen Call Center

Last updated: March 20, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

464 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasm MetastasisNeoplasmsNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

6 inclusion criteria required to participate

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)

Show More Criteria

6 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

AMG 436 monotherapy dose escalation.

Group II

Experimental

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

Group III

Experimental

AMG 436 + combination dose escalation.

Group IV

Experimental

AMG 436 monotherapy Dose expansion and optimization.

Group 5

Experimental

AMG 436 + chemotherapy combination dose expansions.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Next Oncology - Dallas

Irving, United StatesOpen Next Oncology - Dallas in Google Maps

Recruiting

Aichi Cancer Center

Nagoya, Japan

Recruiting

2 Study Centers