Budigalimab (Not yet branded)

Immunotherapy

US Experimental EU Experimental ES Not available IV 2 Clinical Trials
PD-1

Description

Budigalimab is a monoclonal antibody immunotherapy agent that targets the PD-1/PD-L1 checkpoint pathway. This agent has been evaluated in early-phase clinical studies for various solid tumors including colorectal cancer, particularly in tumor-agnostic settings where treatment selection is based on specific biomarkers rather than tumor location. In colorectal cancer, budigalimab is being explored for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors.

Mechanism of Action

Budigalimab functions as a PD-1 receptor antagonist, blocking the interaction between PD-1 on T-cells and PD-L1 on tumor cells. By inhibiting this immune checkpoint pathway, the drug prevents tumor cells from evading immune surveillance and allows the patient's immune system to recognize and attack cancer cells more effectively.

Molecular Targets

Side Effects

Fatigue Skin rash Diarrhea Decreased appetite Nausea Pyrexia Pruritus Hypothyroidism

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

Clinical Trials

NCT05005403 Phase 1
Recruiting
Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalima
United States, Canada, Israel, Japan, South Korea, Taiwan
NCT03821935 Phase 1
Active, not recruiting
Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors
United States, Australia, Belgium, Canada, France, Germany, Israel, Italy, Japan