Enshuxing (enlonstobart) / CSPC Pharma, Sumgen Biotech - LARVOL DELTA

Phase II/III Trial of SYS6010 plus Enlonstobart Injection ± Chemotherapy in Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ChiCTR) - P2/3 | N=737 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P2/3 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1

Phase I/II clinical study of SYS6043 combined with PD-1/PD-L1 inhibitor ± chemotherapy in the treatment of advanced solid tumor participants (ChiCTR) - P1/2 | N=622 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study of KN026-based Combination Therapy in HER2-positive Gastric Cancer (clinicaltrials.gov) - P2/3 | N=490 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P2/3 trial • Gastric Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

JMT101 in combination with irinotecan and SG001 versus regorafenib in patients with metastatic colorectal adenocarcinoma (mCRC): Results of a randomized, controlled, open-label, phase II study. (ASCO 2025) - P2 | "Our results demonstrated a promising response rate and a tolerable safety profile of JMT101 + irinotecan +/- SG001 in pts with mCRC. Preliminary data support continued investigation, with updated results to follow. Clinical trial information: NCT06089330."

Clinical • Combination therapy • IO biomarker • Late-breaking abstract • Metastases • P2 data • Colorectal Adenocarcinoma • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MSI • PD-L1

A single-Arm, Open-Label Ib/II Study of Mitoxantrone Hydrochloride Liposome and Enlonstobart Combination Treatment in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma(PTCL) (ChiCTR) - P1/2 | N=43 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P1/2 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

An open-label, multicenter, phase II study to evaluate the efficacy and safety of SYS6010 combined with enlonstobart in the recurrent or metastatic head and neck squamous cell carcinoma (ChiCTR) - P2 | N=70 | Not yet recruiting | Sponsor: Shanghai East Hospital, Tongji University(Shanghai East Hospital); Shanghai East Hospital, Tongji University(Shanghai East Hospital)

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Preliminary results of enlonstobart combined with weekly chemotherapy (induction phase) followed by concurrent immunochemoradiotherapy in locally advanced cervical cancer: a multicenter, single- (SGO 2026) - No abstract available

Clinical • Metastases • Cervical Cancer • Oncology • Solid Tumor

A single-arm exploratory clinical study on the sequential concurrent chemoradiotherapy with Enlonstobart in the treatment of locally advanced cervical cancer (SGO 2026) - No abstract available

Clinical • Metastases • Cervical Cancer • Oncology • Solid Tumor

Mitoxantrone Hydrochloride Liposome and Enlonstobart Combination Treatment in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL) (clinicaltrials.gov) - P1/2 | N=43 | Not yet recruiting | Sponsor: Sun Yet-Sen University Cancer Center

New P1/2 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Safety and Efficacy of Paclitaxel Liposome Arterial Infusion Combined With Systemic Therapy for Second-Line Treatment of Advanced Liver Cancer (clinicaltrials.gov) - P1/2 | N=116 | Not yet recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P1/2 trial • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Phase 1b Multicenter Study of SG001, a Humanized Anti-PD-1 Antibody, in Patients with Advanced Solid Tumors. (PubMed, Drug Des Devel Ther) - P1 | "The safety profile was well tolerated. ClinicalTrials.gov identifier: NCT03852823."

Clinical • Journal • P1 data • Epstein-Barr Virus Infections • Lung Cancer • Mesothelioma • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Renal Disease • Solid Tumor • MSI • PD-L1

SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=70 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of SYS6010, Enlonstobart, and Chemotherapy for First-Line Treatment of Esophageal Squamous Cell Carcinoma. (clinicaltrials.gov) - P2/3 | N=737 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

IO biomarker • New P2/3 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1

A Phase II Clinical Study of SYS6002 in combination with SG001 in patients with advanced urothelial cancer and other advanced solid tumor (ChiCTR) - P2 | N=148 | Recruiting | Sponsor: Fudan University Shanghai Cancer Center; CSPC Megalith Biopharmaceutical Co., Ltd..

New P2 trial • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC (clinicaltrials.gov) - P2 | N=430 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. | N=250 ➔ 430 | Initiation date: May 2025 ➔ Aug 2025 | Trial primary completion date: Sep 2027 ➔ Dec 2027

Enrollment change • Trial initiation date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A single-arm, single-center, exploratory, phase II clinical study of spatially fractionated radiotherapy (lattice SFRT) combined with enlonstobart in the treatment of recurrent/metastatic bulky gynecological malignancies (ChiCTR) - P2 | N=20 | Not yet recruiting | Sponsor: Sichuan Cancer Hospital; Sichuan Cancer Hospital

New P2 trial • Gynecologic Cancers • Oncology

The efficacy and safety of combined chemotherapy and immunotherapy as neoadjuvant therapy for advanced cervical cancer (ChiCTR) - P=N/A | N=20 | Recruiting | Sponsor: Jilin Cancer Hospital; Jilin Cancer Hospital

New trial • Cervical Cancer • Oncology • Solid Tumor

Enlonstobart in patients with PD-L1 positive recurrent/metastatic cervical cancer: Updated survival results of the phase II study. (ASCO 2025) - P2 | "Enlonstobart monotherapy showed a promising survival in patients with PD-L1 positive recurrent/metastatic cervical cancer, whose disease experienced progression after first-line platinum-based therapy."

Clinical • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor • PD-L1

JSKN003 Combined Treatment of HER2-positive Gastric Cancer (clinicaltrials.gov) - P2 | N=153 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P2 trial • Gastric Cancer • Oncology • Solid Tumor

SYS6002 Plus JMT101 and Enlonstobart Injection as First-Line Treatment for HNSCC (clinicaltrials.gov) - P2 | N=250 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Single-Arm Exploratory Study of Enlansibumab Sequentially Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer (clinicaltrials.gov) - P2 | N=34 | Not yet recruiting | Sponsor: Chongqing University Cancer Hospital

New P2 trial • Cervical Cancer • Oncology • Solid Tumor

Enlonstobart (SG001) plus platinum-based chemotherapy ± bevacizumab for first-line treatment of PD-L1 positive recurrent/metastatic cervical cancer: safety run-in results of the phase III randomized, double-blind, placebo-controlled study (SGO 2025) - No abstract available

Clinical • Metastases • P3 data • Cervical Cancer • Oncology • Solid Tumor • PD-L1

A phase II, randomized study of JMT101 in combination with irinotecan and SG001 versus regorafenib in patients with metastatic colorectal adenocarcinoma (mCRC). (ASCO-GI 2025) - P2 | "Eligible patients are histologically confirmed mCRC without MSI-H/dMMR, wild-type RAS and BRAF, who progressed on at least 2 prior systemic therapy with chemotherapy based on 5-FU with oxaliplatin and irinotecan, with or without cetuximab and bevacizumab (both parts); no prior treatment with regorafenib, fruquintinib, or TAS-102 (part II)...Secondary endpoints include JMT101 and SG001 pharmacokinetic profile, antidrug antibodies (ADA) (both parts), disease control rate (DCR), duration of response (DOR), progression free survival (PFS), and overall survival (OS), as well as safety (part II). Prespecified goal for safety run-in part was met; randomized treatment part accrual began in February 2024."

Clinical • Combination therapy • Metastases • P2 data • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • MSI

Safety and efficacy study of Irinotecan Hydrochloride Liposome combined with Anlotinib and Enlonstobart in second-line treatment of advanced colorectal cancer (ChiCTR) - P=N/A | N=30 | Sponsor: The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University

New trial • Colorectal Cancer • Oncology • Solid Tumor