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Ensayo clínico de RO7276389 en monoterapia y en combinación con cobimetinib en participantes con tumores sólidos avanzados

THIS RESEARCH STUDY (WHICH IS ALSO KNOWN AS A CLINICAL TRIAL) OF A DRUG CALLED RO7276389, IS BEING DEVELOPED FOR THE POSSIBLE TREATMENT OF AN AGGRESSIVE SOLID TUMOR TYPE, SUCH AS SKIN CANCER (MELANOMA). THIS STUDY INVOLVES RESEARCH. AN EXPERIMENTAL DRUG CALLED RO7276389 WILL BE TESTED AND WILL BE ADMINISTERED ALONE (SEPARATELY) OR IN COMBINATION WITH COBIMETINIB. THE MAIN OBJECTIVES ARE AS FOLLOWS: - TO EVALUATE THE SAFETY OF DIFFERENT DOSES OF RO7276389, GIVEN ALONE OR IN COMBINATION WITH COBIMETINIB, TO FIND OUT WHAT SIDE EFFECTS THE STUDY TREATMENT HAS. - COLLECT DATA TO LEARN WHETHER RO7276389, GIVEN ALONE OR IN COMBINATION WITH COBIMETINIB, IS EFFECTIVE AGAINST SOLID TUMORS OR BRAF-MUTATED MELANOMA. - TO TEST HOW RO7276389, GIVEN ALONE OR IN COMBINATION WITH COBIMETINIB, IS DISTRIBUTED IN AND ELIMINATED FROM THE BODY.

Status
In recruitment
headquarters
Pamplona/Madrid

Technical Summary

  • PHASE IA/B OPEN-LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY CLINICAL ACTIVITY OF RO7276389 IN MONOTHERAPY AND IN COMBINATION WITH COBIMETINIB IN PARTICIPANTS WITH BRAF-V600 MUTATION-POSITIVE ADVANCED SOLID TUMORS OR BRAF-V600 MUTATION-POSITIVE MELANOMA WITH CENTRAL NERVOUS SYSTEM METASTASES
  • Code EudraCT: 2021-003426-77
  • Protocol number: WP43295
  • Promoter: Roche Farma, S.A.
  • Molecule/Drug: RO7276389 en monoterapia y en combinación con cobimetinib

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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