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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1A 		AMG 436 monotherapy dose escalation.
  • Drug: AMG 436
    AMG 436 will be administered.
Experimental
Part 1B: Food Effect Substudy 		Participants will receive AMG 436 under fasted and fed conditions (United States only).
  • Drug: AMG 436
    AMG 436 will be administered.
Experimental
Part 2 		AMG 436 + combination dose escalation.
  • Drug: AMG 436
    AMG 436 will be administered.
Experimental
Part 3 		AMG 436 monotherapy Dose expansion and optimization.
  • Drug: AMG 436
    AMG 436 will be administered.
Experimental
Part 4 		AMG 436 + chemotherapy combination dose expansions.
  • Drug: AMG 436
    AMG 436 will be administered.

Recruiting Locations

Next Oncology - Dallas
Irving, Texas 75039

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.