A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRemeGen Co., Ltd.

About this trial

This is a Phase Ⅱ/Ⅲ study. The purpose of this study is to evaluate the efficacy and safety of RC148 combined with chemotherapy for the first-line treatment of unresectable metastatic colorectal cancer (CRC)

Eligibility criteria

Qualifiers

Voluntarily agree to participate in the study, sign the informed consent form, and be able to comply with the study protocol.

Aged 18-75 years old (including 18 years old and 75 years old).

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Expected survival period ≥ 12 weeks.

Disqualifiers

Known to have microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR).

Imaging shows obvious tumor necrosis or cavitation, and the investigator judges that participation in the study may increase the risk of bleeding.

Subjects with brain metastases.

Toxicities from prior anti-tumor therapy have not recovered to ≤ grade 1 according to NCI-CTCAE v6.0.

Trial design

Treatments tested in this trial

  • RC148 (Dose 1) plus Capecitabine and Oxaliplatin
  • RC148 (Dose 2) plus Capecitabine and Oxaliplatin

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators