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

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

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

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

Novel PD-1 inhibitor Enlonstobart shows activity in the treatment of PD-L1-positive recurrent or metastatic cervical cancer [Google translation] (Haidekang) - P2 | N=104 | NCT04886700 | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | "Enlonstobart...has shown significant therapeutic potential for patients with PD-L1-positive recurrent or metastatic cervical cancer (r/mCC) in a recent study, and its safety has also been preliminarily verified. This is an open-label Phase II clinical study....The primary endpoint of the study was the confirmed objective response rate (ORR) assessed by an independent review committee. After a median follow-up of 14.0 months, the results showed that the ORR reached 29.0%. Specifically, 2 patients achieved complete remission and 29 patients achieved partial remission. The median duration of remission was as long as 16.6 months, and the disease control rate was 54.2%. In addition, the median progression-free survival (PFS) was 3.1 months, and the median overall survival (OS) has not yet been reached."

P2 data • Cervical Cancer

Enlonstobart: First Approval. (PubMed, Drugs) - "Phase III clinical evaluation of enlonstobart for use as first-line treatment (in combination with chemotherapy ± bevacizumab) in patients with recurrent or metastatic PD-L1-positive cervical cancer is also underway in China. Additionally, phase II clinical development of enlonstobart (as a part of combination therapy) for use against a range of other solid tumour types is continuing. This article summarises the milestones in the development of enlonstobart leading to this first approval for recurrent or metastatic cervical cancer."

Journal • Review • Cervical Cancer • Oncology • Solid Tumor • PD-L1

A multicenter, single-arm clinical study of enlonstobart combined with chemoradiotherapy for locally advanced cervical cancer (ENLONG-003) (ChiCTR) - P4 | N=50 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Union Hospital, Tongji Medical College, Huazhong University of

Metastases • New P4 trial • Cervical Cancer • Oncology • Solid Tumor • PD-L1

An open-label and multicenter Phase Ⅰ Clinical Study to Evaluate the Safety and Efficacy of SYS6010 in combination with Enlonstobart and Simmitinib in patients with advanced esophageal cancer (ChiCTR) - P1 | N=60 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Henan University of Science and Technology; The First Affiliated Hospital of Henan University of Science and Technolo

Combination therapy • Metastases • New P1 trial • Esophageal Cancer • Oncology

A Phase Ⅰ/II Clinical Study of SYS6010 in combination with Enlonstobart ± chemotherapy in patients with locally advanced or metastatic NSCLC and other advanced solid tumor (ChiCTR) - P1/2 | N=540 | Not yet recruiting | Sponsor: Shanghai East Hospital; CSPC Megalith Biopharmaceutical Co., Ltd.

Combination therapy • Metastases • New P1/2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

A multicenter, single-arm clinical study of enlonstobart combined with nab-paclitaxel and platinum drugs neoadjuvant therapy for locally advanced cervical cancer (ENLONG-001) (ChiCTR) - P4 | N=34 | Not yet recruiting | Sponsor: Chinese PLA General Hospital; Chinese PLA General Hospital

Metastases • New P4 trial • Cervical Cancer • Oncology • Solid Tumor • PD-L1

Phase II study of enlonstobart (SG001), a novel PD-1 inhibitor in patients with PD-L1 positive recurrent/metastatic cervical cancer. (PubMed, Gynecol Oncol) - P2 | "SG001 monotherapy demonstrated durable anti-tumor activity with acceptable safety in patients with PD-L1 positive r/mCC with progression on or intolerance to the first-line platinum-based chemotherapy."

Journal • Metastases • P2 data • Cervical Cancer • Endocrine Disorders • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Solid Tumor • PD-L1

Efficacy, safety and biomarkers of SG001 for patients with previously treated recurrent or metastatic cervical cancer: an open-label, multicenter, phase Ib trial. (PubMed, Cancer Commun (Lond)) - No abstract available

Biomarker • Journal • Metastases • P1 data • Cervical Cancer • Oncology • Solid Tumor

Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2 | N=17 | Terminated | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. | N=66 ➔ 17 | Not yet recruiting ➔ Terminated; Internal strategy change. Not related to safety concerns.

Enrollment change • Metastases • Trial termination • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor

Efficacy and safety of enlonstobart (SG001), a PD-1 inhibitor in patients with PD-L1 positive recurrent/metastatic cervical cancer: A multicenter, single-arm, open-label, phase II study. (ASCO 2024) - P2 | "Background: Platinum-based chemotherapy with or without bevacizumab is the first-line treatment for patients with recurrent or metastatic cervical cancer, and the treatment options are limited for recurrent or metastatic cervical cancer after first-line treatment. SG001 monotherapy demonstrated durable anti-tumor activity and acceptable safety 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 • Dermatology • Diabetes • Endocrine Disorders • Oncology • Pruritus • Solid Tumor • PD-L1