59
Participants
Start Date
November 4, 2020
Primary Completion Date
August 9, 2023
Study Completion Date
August 9, 2023
RO7283420
RO7283420 will be administered to participants by intravenous (IV) infusion Q3W at a starting dose of 0.15mg. Starting dose levels (double step-up regimen, Q3W) for SC injections was the same as the highest dose levels that have been cleared in the IV double step-up cohorts at that timepoint. Each participant will receive up to 6, 9, and 18 cycles of treatment with RO7283420, when treated with Q3W, Q2W, or QW dosing regimens, respectively.
RO7283420
RO7283420 at RP2D will be administered by IV infusion or SC injection as per dosing schedule determined in Part B.
Tocilizumab
Tocilizumab will be administered as an IV infusion 8 mg/kg (for participants with a weight of 30 kg and above) and 12 mg/kg (for participants with a weight of less than 30 kg). Tocilizumab will be given as rescue medication.
Dasatinib
Dasatinib 100 mg film-coated tablets will be administered daily until symptom resolution (up to 100 mg twice daily \[BID\] for a maximum 3 days); orally. Dasatinib will be given as rescue medication.
Dexamethasone
20 mg IV of dexamethasone will be administered as pre-medication at least 60 minutes prior to the all RO7283420 infusions or injections during cycle 1.
Paracetamol/acetaminophen
500 or 1000 mg of paracetamol/acetaminophen will be administered orally or by IV as pre-medication at least 30 minutes prior to each RO7283420 infusion or injection.
Diphenhydramine
25 mg or 50 mg of diphenhydramine will be administered orally or by IV as pre-medication at least 30 minutes prior to each RO7283420 infusion or injection.
National Taiwan Universtiy Hospital; Division of Hematology, Taipei
China Medical University Hospital; Oncology and Hematology, Taichung
Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT, København Ø
Peter MacCallum Cancer Centre; Medical Oncology, Melbourne
The Alfred, Melbourne
Institut Paoli Calmettes; Departement D' Onco-Hematologie, Marseille
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia, Rozzano
ASST PAPA GIOVANNI XXIII; Ematologia, Bergamo
Hospital Univ. 12 de Octubre; Servicio de Hematologia, Madrid
Hopital De Haut Leveque; Hematologie Clinique, Pessac
Hospital Universitario la Fe; Servicio de Hematologia, Valencia
Ospedale Santa Chiara; Unita Operativa Di Ematologia, Pisa
Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III, München
UC Davis Comprehensive Cancer Center, Sacramento
The University of Texas MD Anderson Cancer Center, Houston
Princess Margaret Cancer Center, Toronto
"Uniklinikum Carl Gustav Carus; Med. Klinik 1; Hämatologie, Zelltherapie und Medizinische Onkologie", Dresden
Institut Catala d?Oncologia Hospital Germans Trias i Pujol, Badalona
Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona
Hospital Clínic i Provincial; Servicio de Hematología y Oncología, Barcelona
National Cheng Kung University Hospital; Oncology, Tainan City
Churchill Hospital, Oxford
Royal Marsden NHS Foundation Trust, Sutton
Hoffmann-La Roche
INDUSTRY