Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment

PHASE1CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

July 14, 2021

Primary Completion Date

November 11, 2024

Study Completion Date

November 11, 2024

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

RO7122290

RO7122290 will be administered using a QW (Part I) or Q3W (Part I or Part II) schedule in combination with 100 mg cibisatamab Q3W with obinutuzumab pre-treatment. The maximum dose of RO7122290 to be explored in combination with cibisatamab with obinutuzumab pre-treatment in this study is 500 mg for the QW dosing interval (Part I) or 1500 mg for the Q3W dosing interval (Part I or Part II).

DRUG

Cibisatamab

Cibisatamab will be administered to participants at a fixed dose of 100 mg Q3W (100 mg on Day 1 of each 21-day cycle).

DRUG

Obinutuzumab

"Obinutuzumab will be administered (IV) as pre-treatment on Day - 8/- 7 (split dose) or~\- 8 (single dose) prior to C1D1 of cibisatamab and as re-treatment every 6 months if the participant is still receiving cibisatamab"

Trial Locations (13)

2100

Rigshospitalet, København Ø

28027

Clinica Universidad de Navarra Madrid, Madrid

28040

Fundacion Jimenez Diaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28050

Centro Integral Oncologico Clara Campal, Madrid

31008

Clinica Universitaria de Navarra, Pamplona

1066 CX

NKI/AvL, Amsterdam

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

08003

Hospital del Mar, Barcelona

08035

Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona

M20 4BX

Christie Hospital NHS Trust, Manchester

OX3 7LJ

Churchill Hospital, Oxford

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY