12 unknown, 6 recruiting, 5 not yet recruiting, 3 active not recruiting. 27 Phase 2, 3 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 27 | Unknown 12, Recruiting 6, Not yet recruiting 5, Active not recruiting 3, Terminated 1 |
| Phase 1 | 3 | Not yet recruiting 2, Unknown 1 |
| Phase 3 | 2 | Not yet recruiting 1, Recruiting 1 |
Follow HLX10: new trials by email Literature Review of HLX10 trials Research Report on HLX10
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Luvometinib in Combination With Serplulimab for NF2-Related Tumors Luvometinib, Serplulimab - NF2-related Schwannomatosis, NF2 | Phase 1 / Phase 2 | Not yet recruiting | Beijing Tiantan Hospital | 30 | 2026-07-31 | 2026-07-16 |
| Platform Research for Innovative Medicines in NF2-SWN (PRIME-NF2) Selumetinib 25mg/m2, Luvometinib, Serplulimab - Neurofibromatosis Type 2, Vestibular Schwannoma | Phase 2 | Not yet recruiting | Beijing Tiantan Hospital | 200 | 2026-07-18 | 2026-07-20 |
| Dynamic ctDNA-Guided Adjuvant Therapy in cStage III and IVA Gastric or Gastroesophageal Junction Adenocarcinoma HLX10, SOX Chemotherapy - ctDNA, Gastric Cancer | Phase 2 | Not yet recruiting | Fudan University | 32 | 2026-04-01 | 2026-04-02 |
| Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC HLX10, Chemotherapy, Nimotuzumab - Resectable Esophageal Squamous Cell Carcinoma | Phase 2 | Recruiting | Tianjin Medical University Cancer Institute and Hospital | 46 | 2026-03-12 | 2026-03-11 |
| A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer HLX07, HLX07 placebo, Serplulimab - Squamous NSCLC | Phase 2 / Phase 3 | Not yet recruiting | Shanghai Henlius Biotech | 720 | 2026-03-01 | 2026-01-06 |
| A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC HLX43 DOSE 1, HLX43 DOSE 2, Serplulimab - Non Small Cell Lung Cancer | Phase 2 | Recruiting | Shanghai Henlius Biotech | 60 | 2026-01-20 | 2026-06-04 |
| An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing Serplulimab, Fluzoparib, Topotecan/Irinotecan/Paclitaxel/Temozolomide - SCLC, Extensive Stage | Phase 1 / Phase 2 | Not yet recruiting | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 100 | 2025-12-31 | 2025-08-26 |
| A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. HLX53 (1000mg), HLX53 (2000mg), HLX10 - Carcinoma, Hepatocellular | Phase 2 | Recruiting | Shanghai Henlius Biotech | 117 | 2024-08-05 | 2024-12-18 |
| Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer Serplulimab, Capecitabine, Oxaliplatin - Colon Cancer | Phase 2 | Recruiting | Ruijin Hospital | 56 | 2024-05-01 | 2025-09-24 |
| Testing the Addition of Radiation Therapy to the Immune Therapy Treatment for ES-SCLC Serplulimab, Chest Radiation - Extensive Stage Lung Small Cell Cancer | Phase 2 | Unknown | Zhejiang Cancer Hospital | 100 | 2023-10-18 | 2024-04-05 |
| A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients HLX26, Serplulimab, Chemotherapy drug - NSCLC Stage IV | Phase 2 | Active not recruiting | Shanghai Henlius Biotech | 132 | 2023-07-10 | 2025-08-06 |
| Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients with MCRC HLX26, HLX10 - Colorectal Cancer Metastatic | Phase 2 | Terminated | Shanghai Henlius Biotech | 2 | 2023-06-15 | 2024-10-15 |
| Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure Serplulimab, Bevacizumab Biosimilar HLX04, Pemetrexed - Non-Squamous Non-Small Cell Lung Cancer | Phase 2 | Unknown | Henan Cancer Hospital | 46 | 2023-05-08 | 2024-03-28 |
| Fruquintinib Plus Serplulimab as First-Line Therapy for Metastatic Non-Clear Cell Renal Cell Carcinoma Fruquintinib combined with Serplulimab - Non-clear Cell Renal Cell Carcinoma | Phase 2 | Active not recruiting | RenJi Hospital | 40 | 2023-05-01 | 2026-09-16 |
| A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer HLX07, HLX10, carboplatin and etoposide - Small-cell Lung Cancer | Phase 2 | Unknown | Shanghai Henlius Biotech | 20 | 2023-03-29 | 2022-05-04 |
| Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC serplulimab, Cisplatin, Carboplatin - Extensive-stage Small-cell Lung Cancer | Phase 2 | Active not recruiting | Sichuan University | 61 | 2023-03-07 | 2026-04-29 |
| A Study to Evaluate Serplulimab in Combination With Docetaxel +S-1 VS. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer Serplulimab, Docetaxel, S1 - Serplulimab,Gastric Cancer, Adjuvant Therapy | Phase 2 | Unknown | RenJi Hospital | 70 | 2023-03-01 | 2023-03-15 |
| Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer Serplulimab, Capecitabine, Oxaliplatin - pMMR, MSS | Phase 2 | Recruiting | Zhejiang University | 50 | 2023-02-22 | 2026-03-05 |
| Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC HLX07, HLX10, placebo - Nasopharyngeal Carcinoma by AJCC V8 Stage | Phase 2 | Unknown | Shanghai Henlius Biotech | 75 | 2022-12-14 | 2024-06-17 |
| Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients HLX10, hypofractionated radiotherapy, Prophylactic Cranial Irradiation (PCI) - Limited Stage Small Cell Lung Cancer | Phase 2 | Unknown | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 55 | 2022-09-23 | 2024-05-07 |
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Carcinoma, Non-Small-Cell Lung (2) · Meningioma (2) · Neurofibromatosis 2 (2) · Neuroma, Acoustic (2) · Small Cell Lung Carcinoma (2) · Stomach Neoplasms (2) · Adenocarcinoma (1) · Carcinoma, Hepatocellular (1) · Colonic Neoplasms (1) · Colorectal Neoplasms (1) · Ependymoma (1) · Esophageal Squamous Cell Carcinoma (1) · Hepatitis B, Chronic (1) · Rectal Neoplasms (1) · Squamous Cell Carcinoma of Head and Neck (1)
Shanghai Henlius Biotech (12) · Beijing Tiantan Hospital (2) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (2) · RenJi Hospital (2) · Fudan University (1) · Henan Cancer Hospital (1) · Henlix, Inc (1) · Ruijin Hospital (1) · Second Affiliated Hospital of Soochow University (1) · Sichuan University (1) · Tianjin Medical University Cancer Institute and Hospital (1) · Zhejiang Cancer Hospital (1) · Zhejiang University (1)
China (21) · Japan (1) · Taiwan (1)
Chang Chen, Dr (1) · Cheng-Yuan Peng, MD, PhD (1) · Chia-Yen Dai, MD, PhD (1) · Guangyuan Hu (1) · Guochun Cao (1) · Huichuan Sun, Dr (1) · Jia Fan (1) · Jia-Horng Kao, MD, PhD (1) · Meiyu Fang (1) · Nan Bi, Doctor (1) · Peng Junjie (1) · Qingyuan Zhang (1) · Ren Zhao, PhD (1) · Ruihua Xu (1) · Shubin Wang (1)