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AMG 436

Phase 1

Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR) | Small molecule | Oncology |Amgen Inc.|Last Updated: Aug 27, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment464

FDA Designations

No designations recorded

Clinical trial landscape

AMG 436 · 1 trial · 1 indication

Phase 1 1
NCT07403721AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid TumorsMetastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)
RECRUITING464 Analytics
PHASE1RECRUITING
AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors
Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)Unlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Maximum Serum Concentration (Cmax) of AMG 436
Up to 57 days
Minimum Serum Concentration (Cmin) of AMG 436
Up to 57 days
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 436
Up to 57 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1AEXPERIMENTALAMG 436 monotherapy dose escalation.
Part 1B: Food Effect SubstudyEXPERIMENTALParticipants will receive AMG 436 under fasted and fed conditions (United States only).
Part 2EXPERIMENTALAMG 436 + combination dose escalation.
Part 3EXPERIMENTALAMG 436 monotherapy Dose expansion and optimization.
Part 4EXPERIMENTALAMG 436 + chemotherapy combination dose expansions.

Interventions

NameTypeDescription
AMG 436DRUGAMG 436 will be administered.
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites25

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 mu...

Countries:United StatesAustraliaBelgiumCanadaChinaFranceJapanSouth KoreaSpainTaiwan
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Recent Changes (Last 90 Days)

LOWAug 27, 2026NCT07403721lastUpdatePostDate: changed
LOWAug 27, 2026NCT07403721lastUpdatePostDate: changed
LOWAug 7, 2026NCT07403721lastUpdatePostDate: changed
LOWAug 7, 2026NCT07403721lastUpdatePostDate: changed
LOWJul 27, 2026NCT07403721primaryCompletionDate: changed
LOWJul 27, 2026NCT07403721primaryCompletionDate: changed
LOWJul 27, 2026NCT07403721primaryCompletionDate: changed
LOWJul 10, 2026NCT07403721lastUpdatePostDate: changed
LOWJul 10, 2026NCT07403721lastUpdatePostDate: changed
LOWJul 2, 2026NCT07403721lastUpdatePostDate: changed
LOWJul 2, 2026NCT07403721lastUpdatePostDate: changed
LOWJun 26, 2026NCT07403721lastUpdatePostDate: changed
LOWJun 26, 2026NCT07403721lastUpdatePostDate: changed
LOWJun 12, 2026NCT07403721lastUpdatePostDate: changed
LOWJun 12, 2026NCT07403721lastUpdatePostDate: changed

Frequently asked questions about AMG 436

What is AMG 436 used for?

AMG 436 is an investigational small molecule being developed for the treatment of metastatic or locally advanced solid tumors that are microsatellite instability-high (MSI-H) or have mismatched repair deficiency (dMMR). It is currently being studied in a Phase 1 clinical trial as a monotherapy and in combination therapy.

Who is developing AMG 436?

AMG 436 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker AMGN. The drug is currently in Phase 1 clinical development for the treatment of MSI-H or dMMR solid tumors.

What phase is AMG 436 in?

AMG 436 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to evaluate the drug as a monotherapy and in combination therapy for MSI-H or dMMR solid tumors.

What clinical trials is AMG 436 in?

AMG 436 is being studied in a Phase 1 clinical trial with the identifier NCT07403721. The trial is titled "AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors" and is currently recruiting participants. The trial is enrolling approximately 464 participants across multiple countries.

What is the mechanism of action of AMG 436?

AMG 436 is a small molecule therapeutic. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being investigated for its potential to treat solid tumors characterized by microsatellite instability-high (MSI-H) or mismatched repair deficiency (dMMR).

Where is the AMG 436 clinical trial being conducted?

The Phase 1 clinical trial of AMG 436 (NCT07403721) is being conducted in multiple countries, including the United States, Australia, Belgium, Canada, China, France, Japan, South Korea, Spain, and Taiwan. The trial is open to adults aged 18 years and older.