Clinical Research Directory

Sacituzumab Tirumotecan Plus Toripalimab for Advanced Penile Cancer After Platinum Chemotherapy

This is a single-center, single-arm, open-label, Phase 2 clinical trial (the SCOPE study) evaluating the efficacy, safety, and tolerability of sacituzumab tirumotecan (SKB264) combined with toripalimab as a second-line, chemo-free treatment for patients with unresectable locally advanced or metastatic penile squamous cell carcinoma whose disease progressed on or who are intolerant to platinum-based chemotherapy. Penile squamous cell carcinoma (PSCC) is a rare and aggressive cancer with limited treatment options once disease progression occurs after initial platinum-based chemotherapy, and standard second-line approaches leave tumors shrinking or disappearing in only 10-15% of cases. Sacituzumab tirumotecan is an antibody-drug conjugate (ADC) designed to target TROP-2, a protein expressed on the surface of nearly all penile cancer cells. By binding to TROP-2, sacituzumab tirumotecan delivers a chemotherapy payload directly to the tumor cells. Toripalimab is an immunotherapy drug (a PD-1 inhibitor) that helps the body's immune system find and attack cancer cells, and combining an ADC with a PD-1 inhibitor may work better than either drug alone. All participants in this trial will receive both study drugs via intravenous (IV) infusion on Day 1 of each 2-week cycle, toripalimab first, followed by sacituzumab tirumotecan about 30 minutes later, for as long as the treatment is helping them and the side effects are tolerable. The main goal of this study is to determine the percentage of participants whose tumors shrink or disappear after receiving the combination (Objective Response Rate). The study will also measure how long the responses last (Duration of Response), how long participants live without their cancer getting worse (Progression-Free Survival), how long participants live overall (Overall Survival), the percentage of participants whose disease is controlled (Disease Control Rate), and the side effects of the combination.