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HARMONi-GI3 Clinical Study

Harmoni GI3

HARMONi-GI3 Phase 3 Clinical Study

First-line Metastatic Colorectal Cancer (CRC)

NCT07228832: Click to view on ClinicalTrials.gov (opens in new window)

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.

HARMONi-GI3 Study Design

Ivonescimab vs. bevacizumab

HARMONi-GI3-Schema

Key Eligibility Criteria

Key Inclusion Criteria:

  • ECOG performance status score of 0 or 1
  • Expected life expectancy ≥6 months
  • Patients with histologically or cytologically confirmed metastatic CRC
  • No prior systemic therapy for metastatic CRC
  • At least 1 measurable noncerebral lesion

Key Exclusion Criteria:

  • Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease
  • Known BRAF V600E mutant status
  • Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction
  • Ascites requiring paracentesis within last 30 days
  • Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer
  • Active or prior history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea)
  • Resectable disease

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

Abbreviations: 5-FU=5-fluorouracil; DOR=duration of response; ECOG PS=Eastern Cooperative Oncology Group performance status; IRRC=independent radiology review committee; LV=leucovorin; mFOLFOX6=modified FOLFOX6 [oxaliplatin + leucovorin + 5-fluorouracil (5-FU)]; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; PK=pharmacokinetics; Q2W=every 2 weeks; R=randomization.

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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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