The FUTURE trial is a prospective, multicentre, exploratory, open-label phase II platform trial. Its goal is to evaluate the efficacy, feasibility and safety of futibatinib combined with immunotherapeutic, targeted or chemotherapeutic agents in colorectal and other solid tumors and to additionally identify biomarkers that correlate with clinical outcome.
Patient* provides signed informed consent.
Patient is ≥ 18 years at the time of given informed consent.
Specific for FUTURE-001: Patient must agree to participation in the accompanying translational research program.
Specific for FUTURE-001: Patient did not receive previous therapy in palliative setting (1st line situation).
Specific for FUTURE-001: Patient has curative colorectal cancer.
Patient received previous FGFR-addressed therapy with an FGFR inhibitor.
Patient has known presence of tumors other than the entity investigated in the respective cohort (FUTURE-001: colorectal cancer) or a secondary tumor other than squamous or basal cell carcinomas of the skin or in situ carcinomas of the cervix which have been effectively treated. The sponsor decides to include patients who have received curative treatment and have been disease-free for at least 5 years
Patient has known untreated or symptomatic CNS or leptomeningeal metastases.
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead sponsor
Universitätsmedizin Mainz, I. Medizinische Klinik, Forschungslabor Prof. Möhler
Collaborator