A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours

Launched by REMEGEN CO., LTD. · Mar 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called RC88, which is combined with another drug named Sintilimab, for patients with advanced solid tumors. The main goals of the study are to check how safe this combination is and to see if it can help improve patients' health. The trial is currently looking for participants who are between 18 and 75 years old, in good shape according to a specific performance scale, and who have a predicted survival of at least 12 weeks. It’s important that potential participants have tested positive for a specific marker called MSLN, although those with certain advanced cancers like malignant mesothelioma may still be eligible without this test.

If you decide to participate, you will receive the RC88 and Sintilimab through an intravenous (IV) infusion. Before joining, you’ll need to agree to use contraception during the study if you are of childbearing age. There are some health conditions that could prevent you from joining, such as having cancer that has spread to the brain, recent major surgery, or certain heart problems. Overall, this trial aims to provide new options for patients with advanced cancers and is an opportunity to contribute to important medical research.

Gender

ALL

Eligibility 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