drugset / Trial / NCT04826003
Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |