Clinical Research Directory

A Phase II Study of Anlotinib + PD-1 Inhibitor vs. PD-1 Inhibitor Maintenance After First-Line Chemoimmunotherapy in Advanced ESCC (Esophageal Squamous Cell Carcinoma)

Chemotherapy combined with PD-1 inhibitor immunotherapy is the standard treatment for advanced esophageal squamous cell carcinoma (ESCC), yet patient prognosis remains unsatisfactory, with a median PFS of only about 6 months and a 1-year PFS rate of only 25%. Adding anlotinib maintenance therapy on top of PD-1 inhibitor immunotherapy maintenance after chemoimmunotherapy may improve progression-free survival and overall survival. We plan to conduct a randomized, multicenter, open-label Phase II study of anlotinib combined with PD-1 inhibitor maintenance therapy versus PD-1 inhibitor monotherapy maintenance in advanced ESCC. A total of 112 patients with unresectable locally advanced, recurrent, or metastatic ESCC are planned to be enrolled. After enrollment, patients will receive either anlotinib combined with PD-1 inhibitor maintenance therapy or PD-1 inhibitor monotherapy maintenance, with a maximum treatment duration of 2 years. This study aims to evaluate the efficacy and safety of anlotinib combined with PD-1 inhibitor maintenance therapy in advanced ESCC by comparing it with the PD-1 inhibitor monotherapy maintenance group, further optimizing the comprehensive treatment model for esophageal cancer.

SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors

This Phase 1, open-label study will evaluate two investigational radiopharmaceuticals in adults with selected advanced or metastatic solid tumors. SKL35502 is an imaging agent used with SPECT scans to identify tumors with neurotensin receptor 1 (NTSR1), a protein found on some cancer cells, and to assess where the agent travels in the body and the radiation dose delivered to tissues. Participants with sufficient SKL35502 tumor uptake may receive SKL35501, a treatment designed to deliver targeted alpha radiation to NTSR1-expressing tumor cells. Part A will evaluate the safety and imaging performance of SKL35502 and the safety, tolerability, pharmacokinetics, biodistribution, dosimetry, and biologically active dose range of SKL35501, as well as preliminary antitumor activity. Part B will further evaluate selected SKL35501 dose levels, including randomized low- and high-dose groups in participants with colorectal cancer, and will expand evaluation in selected tumor types. The study will also examine relationships among SKL35502 imaging, NTSR1 expression, SKL35501 tumor uptake, and treatment outcomes.