AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAmgen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
AMG 436
DrugAMG 436 will be administered.
Treatment groups
464 Participants
are divided into 5 treatment groupsGroup A: Part 1AExperimental treatment 1 intervention
Group B: Part 1B: Food Effect SubstudyExperimental treatment 1 intervention
Group C: Part 2Experimental treatment 1 intervention
Group D: Part 3Experimental treatment 1 intervention
Group E: Part 4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with a Dose Limiting Toxicity (DLT)
Time frame
Up to 21 days2
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame
Up to 5 yearsSecondary outcomes
1
Maximum Serum Concentration (Cmax) of AMG 436
Time frame
Up to 57 days2
Minimum Serum Concentration (Cmin) of AMG 436
Time frame
Up to 57 days3
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 436
Time frame
Up to 57 days4
Time to Achieve Cmax (Tmax) of AMG 436
Time frame
Up to 57 days Source ClinicalTrials.gov