Informations générales (source: ClinicalTrials.gov)
A 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
Interventional
Phase 1
Amgen (Voir sur ClinicalTrials)
avril 2026
juillet 2028
28 juillet 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Antoine HOLLEBECQUE | 09/07/2026 07:05:05 | Contacter | ||
Critères
Tous
- 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).