Inclusion criteria:
Ivonescimab monotherapy: Tumor harboring classical EGFR sensitizing mutation (i.e., L858R, exon 19 deletion), or ALK, ROS1, RET, or NTRK1-3 fusion, per local testing. Note: The number of patients with EGFR mutation-positive NSCLC enrolled will be capped at maximum of 10 (in order to ensure the assessment of non-EGFR disease subsets). Ivonescimab plus carboplatin/pemetrexed: Tumor harboring ALK, ROS1, RET, or NTRK1-3 fusion, per local testing.
Sponsor/Collaborator: Massachu
Contact and Locations:
Massachusetts General Hospital
Jessica J Lin, MD
617-724-4000
jjlin1@partners.org
Principal Investigator: Jessica J Lin, MD
Mechanism of action: Ivonescimab, also known as AK112 and SMT112 during development, is a specially engineered antibody that can attach to both PD-1 and VEGF-A. PD-1 is a protein found on immune cells that “turn off” the immune response. VEGF-A is a protein that helps tumors grow new blood vessels. By binding to both proteins, ivonescimab can reactivate immune cells so they can attack the tumor, block blood vessel growth that feeds the tumor, and reduce the tumor’s ability to suppress the immune system, making it easier for immune cells to reach and fight the cancer. Carboplatin is a type of chemotherapy drug that contains a special form of platinum. The drug damages DNA inside cancer cells by creating links or bonds between different parts of the DNA that makes it harder for the cancer cells to grow and divide, eventually leading to cell death. Carboplatin works at any stage of the cell’s life cycle, not just when the cell is dividing. Carboplatin is currently sold as Paraplatin. Pemetrexed is a type of chemotherapy drug that works by blocking specific substances, called folates, that cancer cells need to grow and multiply. Folates help cells make DNA and other important cell structures. By preventing folates from working, pemetrexed helps slow down or stop the growth of cancer cells.
Phases: Phase 2
NCT Number:NCT07405190
URL: https://clinicaltrials.gov/study/NCT07405190#study-overview and https://www.dana-farber.org/clinical-trials/26-015
Status: Recruiting
