AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors
Phase 1 – testing safety in a small group of people
Conditions:
Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)
Sponsor: Amgen
trial.available_in:
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Overview
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.
Who can participate
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).
Interventions
AMG 436
DRUG
Locations
6
Australia (1)
Peter MacCallum Cancer Centre
Melbourne , Victoria
China (1)
Zhongshan Hospital Fudan University
Shanghai , Shanghai Municipality
Japan (3)
National Cancer Center Hospital
Chuo-ku , Tokyo
The Cancer Institute Hospital of Japanese Foundation for Cancer Research