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

Recruiting now · Phase 2/Phase 3

Conditions studied: Colorectal (Colon or Rectal) Cancer

In brief

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)

Key facts

Study ID

NCT07462143

Run by

RemeGen Co., Ltd.

People needed

80

Starts

2026-05-12

Expected to finish

2030-12-31

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• At least one measurable lesion according to RECIST v1.1 criteria.
• 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.
• Subjects must be able to provide tumor tissue samples for biomarker detection.
• Adequate bone marrow, liver, kidney, and coagulation function.
• 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.

You may not qualify if…

• 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.
• Known hypersensitivity or delayed-type allergy to any component of the study drug or similar drugs.
• 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.
• Subjects with acute, chronic, or symptomatic infections.
• Subjects with diagnosed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severe impairment of lung function, or other lung diseases.
• Subjects with active inflammatory bowel disease, a history of gastrointestinal perforation and/or fistula, or clinical symptoms of gastrointestinal obstruction.
• Subjects with severe arterial/venous thromboembolic events within 6 months before randomization.
• Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 28 days before randomization; or presence of severe esophagogastric varices or epistaxis.
• Presence of symptomatic or intervention-requiring third-space effusions.
• Subjects with active or previously diagnosed autoimmune diseases that may recur.
• History of other invasive malignant tumors within 5 years before randomization, or presence of any residual evidence of previously diagnosed malignant tumors.
• Subjects who are pregnant, lactating, or planning to become pregnant.

Where it is running

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

Full record on ClinicalTrials.gov

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