Hetronifly (serplulimab)

P2, N=48, Active, not recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting --> Active, not recruiting

P2/3, N=40, Completed, Sun Yat-sen University | Not yet recruiting --> Completed | N=30 --> 40 | Trial completion date: Mar 2025 --> May 2024 | Trial primary completion date: Mar 2025 --> Mar 2024

P2/3, N=654, Recruiting, Sun Yat-sen University Cancer Center; Sun Yat-Sen University Cancer Center | Not yet recruiting --> Recruiting

We characterized the differences between serplulimab with approved PD-1/PD-L1 inhibitors (pembrolizumab and nivolumab) in terms of their binding features and functions in vitro and anti-tumor activity in vivo. Mechanistically, the serplulimab combination effectively reduces tumor microenvironment Treg cell populations, augments effector and memory T cell populations, and more potently modulates genes associated with diverse facets of the immune system, surpassing the effects of the pembrolizumab combination. In summary, our data underscore serplulimab as a differentiated PD-1 monoclonal antibody with best-in-class therapeutic potential.

P2, N=2, Terminated, Shanghai Henlius Biotech | N=49 --> 2 | Trial completion date: Apr 2026 --> Dec 2023 | Suspended --> Terminated | Trial primary completion date: Aug 2024 --> Dec 2023; Due to poor clinical trial accrual, the study was terminated.

Herein, we describe the case of a 59-year-old male with metastatic pancreatic ductal adenocarcinoma, referred to our center to receive immunotherapy (serplulimab, a novel anti-PD-1 antibody) combined with chemotherapy (gemcitabine/nab-paclitaxel). We investigated the potential mechanisms and reviewed the latest literature on predictive factors for HPD. These findings suggest that while chemotherapy combined with immunotherapy may hold promise for treating pancreatic cancer, it is imperative to identify and closely monitor patients with high-risk factors for HPD when using immunotherapy.

Given the limited therapeutic options, the patient was administered a serplulimab-based immunochemotherapy regimen, achieving a progression-free survival (PFS) of 6 months post-transformation. The study underscores the potential of PD-1 inhibitors, particularly serplulimab, in the treatment landscape for T-SCLC and highlights the need for future comprehensive research.

P2, N=109, Recruiting, Henan Cancer Hospital | Not yet recruiting --> Recruiting

P2, N=90, Recruiting, Fujian Medical University Union Hospital

P=N/A, N=50, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China

P2, N=144, Not yet recruiting, Zhongshan Hospital; Jiangsu Xingsheng Xinhui Pharmaceutical Co., LTD

P=N/A, N=134, Not yet recruiting, Shanghai Chest Hospital

P2, N=116, Not yet recruiting, Xijing Hospital

P3, N=482, Recruiting, Shanghai Henlius Biotech | Trial completion date: Jun 2026 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Jul 2025

P2, N=30, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | N=55 --> 30

P2, N=43, Not yet recruiting, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

P2, N=29, Active, not recruiting, Wuhan Union Hospital, China

P2, N=80, Not yet recruiting, RenJi Hospital

Our analysis showed that the PD-1/PD-L1 + etoposide combined with platinum (EP) and PD-L1 + vascular endothelial growth factor (VEGF) + EP regimens significantly enhanced overall survival and progression-free survival, with subgroup analysis revealing that serplulimab ranked as the most promising option for improving overall survival. Integrating anti-angiogenesis drugs into immunochemotherapy presents potential benefits, with an increased incidence of adverse events necessitating further investigation. Our findings offer valuable insights for future research and for developing more effective treatment strategies for ES-SCLC, underscoring the critical need for continued innovation in this therapeutic area.

This proposed study aims to investigate the safety and efficacy of intraperitoneal infusion of serplulimab in combination with the PRaG regimen in patients with simultaneous advanced solid tumors and cancerous ascites who fail at least the first-line treatment...The dose of intraperitoneal infusion of PD-1 inhibitor for phase II will be determined according to dose-limiting toxicity evaluation in the phase I study. This prospective, open-label, multicenter study will potentially lead to intraperitoneal perfusion of a PD-1 inhibitor being a new strategy for malignant ascites patients and provide a meaningful efficacy and safety of the combination of PRaG regimen with an intraperitoneal infusion of PD-1 inhibitor for these patients.

In advanced ESCC patients irrespective of PD-L1 expression, both sintilimab-chemotherapy and toripalimab-chemotherapy regimens demonstrated comparable OS benefits (HR=0.92, 95% CI: 0.64-1.33)...Notably, camrelizumab-chemotherapy (HR=0.83, 95% CI: 0.59-1.16) and nivolumab-ipilimumab (HR=0.84, 95% CI: 0.60-1.17) demonstrated significant safety profiles over chemotherapy alone...Among patients with PD-L1 expression ≥10%, camrelizumab-chemotherapy (HR=0.52, 95% CI: 0.35-0.78) emerged as the most efficacious in improving OS, while serplulimab-chemotherapy (HR=0.48, 95% CI: 0.34-0.68) was associated with the longest PFS benefit...Since most of the patients in this study originated from Asia, the above findings are more applicable to the Asian population. https://www.crd.york.ac.uk/prospero/, identifier CRD42024504992.

P1, N=162, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting

P2, N=96, Recruiting, Peking Union Medical College Hospital | Not yet recruiting --> Recruiting

P2/3, N=654, Not yet recruiting, Sun Yat-sen University Cancer Center; Sun Yat-Sen University Cancer Center

P2, N=39, Not yet recruiting, shanghai pulmonary hospital; shanghai pulmonary hospital

P2, N=43, Recruiting, West China Hospital, Sichuan University; West China Hospital, Sichuan University | Not yet recruiting --> Recruiting

This patient received disitamab vedotin (an antibody-drug conjugate, targeting Her-2) combined with serplulimab as first-line treatment. Disitamab vedotin combined with immunotherapy demonstrated a long-term clinical benefit in advanced Her-2-positive EMPD. For rare solid tumors with Her-2 overexpression, disitamab vedotin combined with immunotherapy might offer a viable therapeutic choice.

P2, N=35, Recruiting, Tianjin Medical University Cancer Institute and Hospital

Presently, the probability of serplulimab plus chemotherapy being cost-effective was 14.15%. Compared with placebo plus chemotherapy, serplulimab plus chemotherapy might not be cost-effective in the first-line treatment for advanced sqNSCLC.

P2, N=72, Not yet recruiting, Sir Run Run Shaw Hospital

Patients with PD-L1-positive esophageal squamous-cell carcinoma (ESCC) were significantly more likely to survive when treated with serplulimab plus cisplatin plus 5-fluorouracil (serplulimab-CF). There was no cost-effectiveness in general regions of China for serplulimab-CF in PD-L1-positive ESCC compared to CF, although it is probably considered cost-effective in affluent regions. Serplulimab-CF may achieve favorable cost-effectiveness by lowering the price of serplulimab.

P3, N=200, Recruiting, Shanghai Henlius Biotech | Phase classification: P2 --> P3

P=N/A, N=60, Not yet recruiting, Zhou Chengzhi

P2, N=200, Recruiting, Shanghai Henlius Biotech | Phase classification: P3 --> P2

P2, N=75, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2024 --> Sep 2024

Serplulimab plus HLX04 and XELOX exhibits promising efficacy and is safe and tolerable in patients with treatment-naive mCRC.

P2, N=37, Recruiting, Fujian Cancer Hospital

P=N/A, N=19, Not yet recruiting, Shanghai Zhongshan Hospital

P2/3, N=568, Recruiting, Shanghai Henlius Biotech | Active, not recruiting --> Recruiting | N=114 --> 568 | Trial completion date: Jun 2025 --> Dec 2026 | Trial primary completion date: Nov 2024 --> Sep 2025

P2, N=42, Not yet recruiting, The First Affiliated Hospital of Zhengzhou University

P3, N=200, Recruiting, Shanghai Henlius Biotech | Trial primary completion date: Jun 2024 --> Oct 2024

P2, N=60, Recruiting, Sun Yat-sen University