A Study of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer

Last updated: September 28, 2022
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Colorectal Cancer

Colon Cancer; Rectal Cancer

Rectal Cancer

Treatment

N/A

Clinical Study ID

NCT05497336
CIBI351B301
  • Ages 18-75
  • All Genders

Study Summary

Phase 1b consists of combined dose escalation phase and dose expansion phase. Phase 3 study will compare efficacy and safety of IBI351 combined with cetuximab versus chemotherapy in treatment of KRAS G12C-mutated metastatic colorectal cancer

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. male or female subjects, ≥ 18 years and ≤ 75 years
  2. have documentation of KRAS G12C mutation
  3. at least one measurable lesion per RECISTv1.1
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
  5. life expectancy of >12 weeks, in the opinion of the investigator

Exclusion

Exclusion Criteria:

  1. history of deep venous thrombosis or any other serious thromboembolism within 3 monthsprior to enrollment..
  2. history of radiation-induced pneumonitis, idiopathic pneumonia, active pneumonia,pulmonary fibrosis, diffuse pulmonary interstitial disease, or organizing pneumonia.
  3. surgical procedures (excluding needle biopsy) performed within 28 days prior toenrollment that may affect the dosing or study assessments in this study.
  4. received therapeutic or palliative radiation therapy within 14 days prior toenrollment
  5. pregnant or lactating women

Study Design

Total Participants: 80
Study Start date:
August 18, 2022
Estimated Completion Date:
September 30, 2024

Study Description

A Phase 1b study of the safety, tolerability and preliminary efficacy of IBI351 combined with cetuximab in the treatment of KRAS G12C mutant metastatic colorectal cancer will be conducted based on recommended dose of IBI351, which consists of combined dose escalation phase and dose expansion phase. After confirming the efficacy and safety of IBI351 combined with cetuximab in Phase Ib, an open-label Phase 3 study of the efficacy and safety of IBI351 combined with cetuximab versus oxaliplatin-based mFOLFOX6 regimen or irinotecan-based FOLFIRI with or without bevacizumab in treatment of KRAS G12C-mutated metastatic colorectal cancer will be conducted.

Connect with a study center

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

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