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

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

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

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

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

A phase II study of liposomal irinotecan-based chemotherapy with or without PD-1 inhibitor in patients with unresectable locally advanced or metastatic biliary tract cancer. (ASCO 2024) - "It was used with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic pancreatic cancer progressing on gemcitabine treatment. These preliminary results suggested that liposomal irinotecan plus 5-FU and LV was well-tolerated and showed promising and durable clinical activity in advanced BTC pts progressed on first-line treatment. Combined use of SG001 further improved clinical outcome in these pts without increased toxicity. Combination of liposomal irinotecan, 5-FU, LV and PD-1 inhibitor is a treatment strategy which is worthy of further exploration."

Clinical • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Fatigue • Febrile Neutropenia • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Leukopenia • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor

A Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma. (clinicaltrials.gov) - P1/2 | N=129 | Not yet recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Combination therapy • IO biomarker • Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Esophageal Cancer • Oncology • Squamous Cell Carcinoma • PD-L1

A Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma. (clinicaltrials.gov) - P1/2 | N=129 | Not yet recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Combination therapy • IO biomarker • Metastases • New P1/2 trial • Esophageal Cancer • Oncology • Squamous Cell Carcinoma • PD-L1

Efficacy and Safety Study of First-line Treatment With SG001 Plus Chemotherapy ± Bevacizumab Versus Placebo Plus Chemotherapy ±Bevacizumab for Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1) (clinicaltrials.gov) - P3 | N=368 | Not yet recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Metastases • New P3 trial • Cervical Cancer • Oncology • Solid Tumor

A Study of Duvelisib Combined With SG001 Injection in Patient With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=128 | Not yet recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P1/2 trial • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Study of the SG001 Injection for Patients With Relapsed or Metastatic Uterine Cervical Cancer (clinicaltrials.gov) - P2; N=104; Recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Cervical Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • Uterine Cancer • MRI • PD-L1

A Study to Evaluate the Efficacy and Safety of SG001 in Combination With Nab-Paclitaxel in Patients With Advanced Triple-Negative Breast Cancer (TNBC) (clinicaltrials.gov) - P2; N=79; Recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Breast Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • MRI • PD-L1 • PGR