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Clinical Trials Overview

Summit Clinical Trials for Ivonescimab (SMT112)

Ivonescimab: Most Advanced PD-1/VEGF Bispecific Antibody in the U.S. & EU.*

Brings two validated mechanisms in oncology1-3 into ONE novel tetravalent molecule1.


Phase 3 Study: NCT06396065 (opens in new window)4

A Randomized, Double-blind, Multi-center, Phase III Clinical Study of AK112 or Placebo Combined with Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Have Progressed on or Following Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment.
Learn more. (opens in new window)

HARMONi Fact Sheet (opens in new window)

Phase 3 Study: NCT05899608 (opens in new window)5

A Randomized, Double-blinded, Multiregional Phase 3 Study of ivonescimab Combined with Chemotherapy versus pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer.
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HARMONi-3 Fact Sheet (opens in new window)

Phase 3 Study: NCT06767514 (opens in new window)6

A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression.
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HARMONi-7 Fact Sheet (opens in new window)

Phase 3 Study: NCT07228832 (opens in new window)7

A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination With FOLFOX Versus Bevacizumab in Combination With FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer.
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HARMONi-GI3 Fact Sheet (opens in new window)

For additional information on the HARMONi, HARMONi-3 or HARMONi-7 clinical trials, submit a Medical Information Form

Ivonescimab Mechanism of Action

For More Information on Ivonescimab click here (opens in new window)

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA).


References

  1. Zhong T, et al. iScience. 2024;28(3):111722.
  2. Pardoll, D. Nat Rev Cancer 2012;12(4):252-64.
  3. Tamura R, et al. Med Oncol 2020;37(1):2.
  4. Phase III Study of AK112 for NSCLC Patients. ClinicalTrials.gov identifier: NCT06396065.
    https://clinicaltrials.gov/study/NCT06396065. (Accessed 2024, May 14).
  5. Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients.
    ClinicalTrials.gov identifier: NCT05899608. https://clinicaltrials.gov/study/NCT05899608. (Accessed on Jan. 16, 2025).
  6. HARMONi-7. ClinicalTrials.gov identifier: NCT06767514 Updated Jan 10, 2025 (Accessed on Jan. 10, 2025)

Abbreviations: EGFR-mutant=epidermal growth factor receptor mutation; EGFR-TKI=epidermal growth factor receptor-tyrosine kinase inhibitor; EU=Europe; PD-1=programmed cell death protein 1; PD-L1=programmed cell death-ligand 1; NSCLC=non-small cell lung cancer; TPS=tumor proportion score; VEGF=vascular endothelial growth factor.

*There are no known PD-1-based bispecific antibodies approved by the U.S. Food and Drug Administration (“FDA”) or the European Medicines Agency (“EMA”).

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*Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA).

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