drugset / Trial / NCT04826003

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

NCT04826003

Phase 1 Completed 54 enrolled Hoffmann-La Roche
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open-label, multicenter, Phase Ib study to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) in the weekly (QW) and/or every 3 weeks (Q3W) regimens, safety, tolerability, PK, immunogenicity, PD profile and to evaluate preliminary anti-tumor activity of RO7122290 in combination with cibisatamab Q3W after pretreatment with obinutuzumab, in participants with previously treated metastatic, microsatellite-stable colorectal adenocarcinoma with high CEACAM5 expression

Timeline

Start
2021-07-14
Primary completion
2024-11-11
Completion
2024-11-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cibisatamab Monoclonal antibody 100 mg
Subject RO7122290 Unknown 35 mg
Subject RO7122290 Unknown 500 mg
Subject RO7122290 Unknown 1500 mg
Background Obinutuzumab Monoclonal antibody Intravenous

Indications