eligibility_summary
Eligibility: consent, ECOG 0–1, life expectancy ≥12 weeks, adequate organ function, prior standard therapy failed/intolerant/unavailable, Phase I requires MSLN ≥1+ by central IHC (MSLN test not required for advanced malignant tumor or malignant mesothelioma), contraception agreement. Exclusions: brain metastases, active infection or history of HBV/HCV, major surgery <1 month, uncontrolled heart disease, allergy to mesothelin‑directed antibodies, tubulysin, or related mAbs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05804526 tests RC88 plus sintilimab in advanced solid tumors (MSLN-positive, including mesothelioma). RC88 is an antibody–drug conjugate (ADC) targeting mesothelin, upon binding and internalization in mesothelin-expressing tumor cells, it releases a tubulysin cytotoxic payload to disrupt microtubules and induce cell death. Sintilimab is a PD‑1–blocking IgG4 monoclonal antibody that reactivates T cells by inhibiting the PD‑1/PD‑L1 checkpoint. Targets/pathways: mesothelin on tumor cells and microtubules (RC88), and PD‑1 on T cells/PD‑1–PD‑L1 signaling (sintilimab). Dosing: RC88 1.5–2.5 mg/kg IV q3w, sintilimab 200 mg IV q3w.