Cibisatamab (Not yet branded)

Immunotherapy

US Experimental EU Experimental ES med_spain_not_available IV 2 Clinical Trials
CEA CD3

Description

Cibisatamab is a bispecific T-cell engager (BiTE) antibody designed to simultaneously bind to CEA (carcinoembryonic antigen) on cancer cells and CD3 on T-cells. In colorectal cancer treatment, it is being evaluated specifically in microsatellite stable (MSS) tumors, which typically respond poorly to conventional immunotherapy. The drug is formulated to redirect the patient's own T-cells to attack CEA-expressing colorectal cancer cells through direct cellular contact.

Mechanism of Action

Cibisatamab functions as a bispecific antibody that creates an immunological synapse between cytotoxic T-lymphocytes and CEA-positive tumor cells. By binding CD3 on T-cells and CEA on colorectal cancer cells simultaneously, it bypasses the need for traditional T-cell activation pathways and directly triggers T-cell mediated cytotoxicity against the tumor. This mechanism is particularly relevant for MSS colorectal cancers, which lack the high mutational burden needed for effective checkpoint inhibitor response.

Molecular Targets

Side Effects

Cytokine release syndrome Infusion-related reactions Fever Fatigue Nausea Diarrhea Elevated liver enzymes Lymphopenia

Not all side effects are listed. Side effects vary by individual. Always consult your oncologist.

Clinical Trials

NCT04826003 med_phase_prefix1
Completed
Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment
Denmark, Netherlands, South Korea, Spain, United Kingdom
NCT03866239 med_phase_prefix1
Archived
A Phase Ib Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Participants With Previously Treated Metastatic Colorectal Adenocarcinoma
United States, Denmark, France, Spain