Combining RC88 with Sintilimab for treating advanced solid tumors
An Open-label, Non-randomised, Multi-center Study to Evaluate the Safety， and Efficacy Off RC88 Combined With Sintilimab in AdvancedSolid Tumours
This study is testing if a new treatment combining RC88 and Sintilimab can help people with advanced solid tumors feel better and improve their health.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | RemeGen Co., Ltd. Industry-sponsored |
| Drugs / interventions | Sintilimab |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05804526 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, pharmacology, and efficacy of intravenous RC88 in combination with Sintilimab for patients with advanced solid tumors. It aims to determine how well this combination works in treating these tumors and to assess any potential side effects. Participants will be monitored for their response to the treatment and overall health during the trial phases.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced solid tumors who have a performance status score of 0 or 1 and meet specific eligibility criteria.
Not a fit: Patients with brain metastases, uncontrolled heart disease, or a history of severe allergies to related treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.
How similar studies have performed: While this approach is novel, similar studies combining targeted therapies with immunotherapies have shown promise in treating various cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntary agreement to provide written informed consen 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 3. Predicted survival ≥ 12 weeks 4. Phase I (Phase I) was included and confirmed as MSLN positive (≥1+ after IHC test by central laboratory).Failure, intolerance, or lack of standard treatment has been identified by tissue or cytology The MSLN test is not required for patients with advanced malignant tumor and for subjects diagnosed with malignant mesothelioma; 5. Adequate organ function required 6. Male and female participants are eligible to participate if they agree to the contraception use as per study protocol. Exclusion Criteria: 1. Cancer metastases in the brain 2. Active infection or past hepatitis B or C infection 3. Major surgery less than 1 month before the start of the study 4. Uncontrolled heart disease 5. History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies related compounds
Where this trial is running
Beijing, Beijing
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Heping Liu
- Email: heping.liu@remegen.com
- Phone: +8610-58075763
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.