Inavolisib (Not yet branded)

Other Medications

US Experimental EU Experimental ES Not available Oral 3 Clinical Trials
PIK3CA

Description

Inavolisib is a PI3K alpha-selective inhibitor currently in clinical development for metastatic colorectal cancer. This targeted therapy is designed to block the PI3K/AKT/mTOR signaling pathway, which is frequently dysregulated in colorectal tumors harboring PIK3CA mutations. The drug is being evaluated in combination with standard chemotherapy regimens including FOLFOX and FOLFIRI, as well as with bevacizumab for first-line treatment of metastatic disease. Clinical trials are focusing on patients with specific molecular alterations, particularly PIK3CA mutations and certain KRAS mutations.

Mechanism of Action

Inavolisib selectively inhibits the PI3K alpha isoform (PIK3CA), which plays a crucial role in cell survival, proliferation, and metabolism pathways. By blocking PI3K alpha activity, the drug disrupts downstream AKT and mTOR signaling, leading to reduced tumor cell growth and enhanced apoptosis in cancer cells dependent on this pathway.

Molecular Targets

Side Effects

Hyperglycemia Diarrhea Nausea Fatigue Decreased appetite Rash Stomatitis Vomiting

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

Clinical Trials

NCT04929223 Phase 1
Recruiting
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
United States, Australia, Canada, Denmark, Germany, Italy, Poland, South Korea,
NCT07323576 Phase 2
Withdrawn
A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX or FOLFIRI as First Line Therapy in Participants With Colorectal Cancer
NCT04449874 Phase 1
Active, not recruiting
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
United States, Australia, Belgium, Brazil, Canada, Hungary, Israel, Italy, Kenya