RC278 treatment for people with solid tumors.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I/II dose‑finding and expansion protocol will escalate RC278 doses to determine the maximum tolerated or administered dose and the recommended phase 2 dose, then treat additional patients at that dose to observe anti‑tumor activity. Eligible adults (18–75 years) must have at least one measurable lesion by RECIST v1.1, ECOG performance status 0–1, and adequate organ and bone marrow function. Key exclusions include pregnancy or breastfeeding, brain metastases, unresolved high‑grade toxicities from prior therapy, active infections, uncontrolled cardiovascular disease, and suspected or confirmed interstitial lung disease. The sponsor is RemeGen, and treatment will be delivered at participating cancer centers in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily participate in this study, sign the informed consent form, and be able to adhere to the study protocol;
2. Age between 18 and 75 years (including 18 and 75 years);
3. ECOG PS score of 0 or 1;
4. Expected survival ≥12 weeks;
5. According to RECIST v1.1 criteria, based on imaging examinations, there is at least one measurable target lesion;
6. Sufficient bone marrow, liver, kidney, and blood clotting function

Exclusion Criteria:

1. Pregnant, breastfeeding, or intending to become pregnant subjects.
2. Subjects with brain metastases.
3. Subjects with unresolved toxicities from prior anti-tumor therapy not recovered to NCI-CTCAE v5.0 Grade 1.
4. Subjects with known hypersensitivity or delayed allergic reactions to any component of the investigational drug or similar drugs.
5. Subjects with acute, chronic, or symptomatic infections.
6. Subjects with uncontrolled cardiovascular diseases.
7. Subjects with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severely impaired pulmonary function, or other pulmonary diseases.
8. Subjects with a history of cirrhosis (Child-Pugh B or C class).
9. Subjects with active inflammatory bowel disease.
10. Subjects with uncontrolled diabetes (HbA1c ≥ 10%).
11. Subjects who experienced arterial/venous thromboembolic events, deep vein thrombosis, pulmonary embolism, or stroke within 6 months prior to the first dose.
12. Subjects with pericardial effusion or cardiac tamponade, or third-space fluid accumulation, which, in the investigator's judgment, cannot be controlled or stabilized by drainage or other methods.
13. Subjects with active autoimmune diseases requiring systemic treatment within the past 2 years.
14. Subjects with a history of other invasive malignancies within 5 years prior to the first dose, or evidence of residual disease from a previously diagnosed malignancy.
15. Subjects with a history of other acquired or congenital immunodeficiency diseases or organ transplantation.
16. Subjects with a history or current diagnosis of uncontrolled psychiatric disorders.
17. Subjects with poor adherence, who are unlikely to comply with the trial procedures.
18. Subjects with any other diseases, metabolic abnormalities, physical examination abnormalities, or laboratory abnormalities, which, in the investigator's judgment, raise suspicion of an underlying condition making the subject unsuitable for the investigational drug, or which may affect the interpretation of the study results, or place the subject at high risk.

Where it's running

• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Recruiting
• The Second Affiliated Hospital of Guilin Medical University
  Guilin, Guangxi, China Recruiting

Study contacts

• Study coordinator: Xiaohong Su
• Email: na.su@remegen.com
• Phone: +8610-65018841

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.