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RC278 treatment for people with solid tumors.

A Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RC278 for Injection in the Treatment of Locally Advanced Unresectable or Metastatic Malignant Solid Tumor

Phase1; Phase2 Interventional RemeGen Co., Ltd. · NCT07105215

This trial will test whether RC278 is safe and can shrink measurable solid tumors in adults.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment312 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorRemeGen Co., Ltd. Industry-sponsored
Drugs / interventionsradiation
Locations39 sites (Beijing, Beijing Municipality and 38 other locations)
Trial IDNCT07105215 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with measurable solid tumors, ECOG 0–1, expected survival ≥12 weeks, and adequate organ function who can consent and attend visits are the ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have brain metastases, unresolved high‑grade toxicities, active infections, uncontrolled cardiovascular disease, or interstitial lung disease are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, RC278 could become a new treatment option that controls some solid tumors while maintaining an acceptable safety profile.

How similar studies have performed: Dose‑escalation followed by expansion cohorts is a standard early‑phase approach that has produced effective cancer drugs, but RC278 itself appears novel with limited published human data.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Beijing, Beijing Municipality and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid Tumors
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.