NCT07462143 A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer
| NCT ID | NCT07462143 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | RemeGen Co., Ltd. |
| Condition | Colorectal (Colon or Rectal) Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-05-12 |
| Primary Completion | 2027-05-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2026-05-12 with a primary completion date of 2027-05-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07462143 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colorectal (Colon or Rectal) Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07462143 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07462143 currently recruiting?
Yes, NCT07462143 is actively recruiting participants. Contact the research team at hongfang.li@remegen.com for enrollment information.
Where is the NCT07462143 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Chongqing, China, Fuzhou, China and 11 additional locations.
Who is sponsoring the NCT07462143 clinical trial?
NCT07462143 is sponsored by RemeGen Co., Ltd.. The trial plans to enroll 80 participants.
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