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Clinical Studies Overview

Summit Clinical Studies for Ivonescimab (SMT112)

Ivonescimab: PD-1/VEGF Bispecific Antibody Being Studied in Phase 3 Non-small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC) Studies.

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 clinical studies, 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. MedOncol 2020;37(1):2.
  4. HARMONi. ClinicalTrials.gov identifier: NCT06396065. https://clinicaltrials.gov/study/NCT06396065. Updated Oct 8, 2024. Accessed Dec 5, 2025.
  5. HARMONi-3. ClinicalTrials.gov identifier: NCT05899608. https://clinicaltrials.gov/study/NCT05899608. Updated Nov 26, 2025. Accessed Dec 5, 2025.
  6. HARMONi-7. ClinicalTrials.gov identifier: NCT06767514. https://clinicaltrials.gov/study/NCT06767514. Updated Nov 25, 2025. Accessed Dec 5, 2025.
  7. HARMONi-GI3. ClinicalTrials.gov identifier: NCT07228832. https://clinicaltrials.gov/study/NCT07228832. Updated Nov 14, 2025. Accessed Dec 5, 2025.

Abbreviations: EGFR-mutant=epidermal growth factor receptor mutation; EGFR-TKI=epidermal growth factor receptor- tyrosine kinase inhibitor; FOLFOX=oxaliplatin + leucorovin + 5-fluorouracil (5-FU); NSCLC=non-small cell lung cancer; PD-1=programmed cell death protein 1; PD-L1=programmed death-ligand 1; VEGF=vascular endothelial growth factor.

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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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