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

May 18, 2026 updated by: RemeGen Co., Ltd.

A Randomized, Multicenter, Phase Ⅱ/Ⅲ Study of RC148 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy as First-line Treatment for Unresectable or Metastatic Colorectal Cancer

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary objective in Phase II: To preliminarily evaluate the efficacy of RC148 combined with chemotherapy as first - line treatment for unresectable or metastatic CRC.

Primary objective in Phase III: To evaluate the efficacy of RC148 combined with chemotherapy compared with bevacizumab combined with chemotherapy as first - line treatment for unresectable or metastatic CRC.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Chongqing University Cancer Hospital
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Medical University Union Hospital
    • Guangdong
      • Meizhou, Guangdong, China
        • Recruiting
        • Meizhou People's Hospital
    • Guangxi
      • Nanjing, Guangxi, China
        • Recruiting
        • Guangxi Medical University Cancer Hospital
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Medical College of Huazhong University of Science &Technology
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Cancer Hospital
      • Wuxi, Jiangsu, China
        • Recruiting
        • Affiliated Hospital of Jiangnan University
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Hospital of Jilin University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Cancer Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • People's Hospital of Tianjin
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • Yunnan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntarily agree to participate in the study, sign the informed consent form, and be able to comply with the study protocol.
  2. Aged 18-75 years old (including 18 years old and 75 years old).
  3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  4. Expected survival period ≥ 12 weeks.
  5. At least one measurable lesion according to RECIST v1.1 criteria.
  6. Histologically or cytologically confirmed colorectal adenocarcinoma, judged by the investigator as unsuitable for curative treatment, and no prior systemic anti-tumor treatment in the recurrent or metastatic stage.
  7. Subjects must be able to provide tumor tissue samples for biomarker detection.
  8. Adequate bone marrow, liver, kidney, and coagulation function.
  9. Female subjects of childbearing potential must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must have a negative blood pregnancy test within 7 days before study enrollment; male subjects must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment.

Exclusion Criteria:

  1. Known to have microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR).
  2. Imaging shows obvious tumor necrosis or cavitation, and the investigator judges that participation in the study may increase the risk of bleeding.
  3. Subjects with brain metastases.
  4. Toxicities from prior anti-tumor therapy have not recovered to ≤ grade 1 according to NCI-CTCAE v6.0.
  5. Known hypersensitivity or delayed-type allergy to any component of the study drug or similar drugs.
  6. Subjects with refractory nausea and vomiting, chronic gastrointestinal diseases, or other diseases that may interfere the adequate absorption, distribution, metabolism, or excretion of oral drugs.
  7. Subjects with acute, chronic, or symptomatic infections.
  8. Subjects with diagnosed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severe impairment of lung function, or other lung diseases.
  9. Subjects with active inflammatory bowel disease, a history of gastrointestinal perforation and/or fistula, or clinical symptoms of gastrointestinal obstruction.
  10. Subjects with severe arterial/venous thromboembolic events within 6 months before randomization.
  11. Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 28 days before randomization; or presence of severe esophagogastric varices or epistaxis.
  12. Presence of symptomatic or intervention-requiring third-space effusions.
  13. Subjects with active or previously diagnosed autoimmune diseases that may recur.
  14. History of other invasive malignant tumors within 5 years before randomization, or presence of any residual evidence of previously diagnosed malignant tumors.
  15. Subjects who are pregnant, lactating, or planning to become pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group 1
Drug: RC148 （Dose1） in combination with CAPEOX
Drug: RC148 (Dose 1) plus Capecitabine and Oxaliplatin
RC148 (Dose 1) plus Capecitabine and Oxaliplatin
Other Names:
  • RC148 (Dose 1) plus CAPEOX
Experimental: Experimental Group 2
Drug: RC148 RC148 (Dose 2) in combination with CAPEOX
Drug: RC148 (Dose 2) plus Capecitabine and Oxaliplatin
RC148 (Dose 2) plus Capecitabine and Oxaliplatin
Other Names:
  • RC148 (Dose 2) plus CAPEOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 24 months
Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DoR)
Time Frame: 24 months
Duration of Response (DoR) assessed by the investigator according to RECIST v1.1
24 months
Disease Control Rate (DCR)
Time Frame: 24 months
Disease Control Rate (DCR) assessed by the investigator according to RECIST v1.1
24 months
Time to Response (TTR)
Time Frame: 24 months
Time to Response (TTR) assessed by the investigator according to RECIST v1.1
24 months
Overall Survival (OS)
Time Frame: 36 months
OS
36 months
AEs/SAE
Time Frame: 36 months
The incidence and severity of adverse events / serious adverse events
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RemeGen Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2026

Primary Completion (Estimated)

May 12, 2027

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC148-C303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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