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

Phase II Study of SYS6010 Plus Enlonstobart in Actionable Genomic Alteration (AGA)-Negative Advanced Non-Small Cell Lung Cancer (Ansclc) (IASLC-WCLC 2026) - P1/2 | "The confirmed ORR at the data cutoff remains immature, as some responses remain pending confirmation. Phase III regimen selection contingent on further data."

Metastases • P2 data • Interstitial Lung Disease • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Thrombocytopenia • PD-L1

Liposomal irinotecan, capecitabine and enlonstobart with short-course radiotherapy in locally advanced rectal cancer: interim results (ESMO 2026) - No abstract available

Metastases • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Hypofractionated Radiotherapy Combined with Nal-IRI + 5-FU/LV, Enlonstobart and Target Therapy in Locally Recurrent Rectal Cancer (NOVELTY-R): A Single-Arm Open-Label, Phase II Trial (ASTRO 2026) - "The inclusion LRRC patients were failed to oxaliplatin treatment in prior chemotherapy or chemoradiotherapy due to toxicity or progression...This was combined with a chemotherapy regimen administered every two weeks (q2w), consisting of: 5-fluorouracil (2400 mg/m² via 48-hour continuous intravenous infusion), leucovorin (400 mg/m² IV), liposomal irinotecan (70 mg/m² IV), and Enlonstobart (240 mg IV). Targeted therapy with either bevacizumab (5 mg/kg IV on day 1) or cetuximab (with a loading dose of 400 mg/m² IV over >2 hours, followed by 250 mg/m² IV over 60 minutes weekly, or 500 mg/m² IV over >2 hours on day 1, q2w) was administered concurrently... Hypofractionated radiotherapy combined with nal-IRI + 5-FU/LV, Enlonstobart and target therapy demonstrates promising anti-tumor activity and controllable safety in LRRC, and is worthy of further exploration."

Clinical • P2 data • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Efficacy and Safety of Albumin-bound Docetaxel Plus Enlonstobart vs. Paclitaxel, Combined with Cisplatin and Concurrent Radiotherapy in Patients with Locally Advanced Unresectable Esophageal Squamous Carcinoma: Results from a Randomized Phase II Study (ASTRO 2026) - P1/2 | "HB1801 and Enlonstobart plus cisplatin with CCRT exhibits a trend toward better efficacy in unresectable LA-ESCC compared with SOC. The regimen achieved meaningful clinical responses with a tolerable safety profile, strongly supporting its further development."

Clinical • Metastases • P2 data • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Induction Weekly Chemoimmunotherapy with Enlonstobart as a Priming Approach to De-escalated Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer (ESMO 2026) - No abstract available

Metastases • Cervical Cancer • Oncology • Solid Tumor

SPARE: Total Neoadjuvant mFOLFOX6 Plus Suvemcitug and Enlonstobart With Selective Omission of Pelvic Radiotherapy for High-Risk Mid-Rectal Locally Advanced Rectal Cancer (clinicaltrials.gov) - P2 | N=52 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

A Clinical Study of SYS6041 Combination Therapy for Recurrent Ovarian Cancer (clinicaltrials.gov) - P2 | N=171 | Recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor • HRD

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

An Exploratory Study on the Efficacy and Safety of Enlonstobart Combined With Concurrent Radiotherapy and Chemotherapy Following Induction Therapy With Enlonstobart Plus Chemotherapy in Patients With Locally Advanced Cervical Cancer. (clinicaltrials.gov) - P4 | N=31 | Recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P4 trial • Cervical Cancer • Oncology • Solid Tumor

Short-course Radiotherapy in TNT Combined With Enlonstobart for pMMR LARC (clinicaltrials.gov) - P2 | N=128 | Recruiting | Sponsor: Hebei Medical University Fourth Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • pMMR • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

A Clinical Study of SYS6041 Combination Therapy for Recurrent Ovarian Cancer (clinicaltrials.gov) - P2 | N=171 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P2 trial • Platinum resistant • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor • HRD

A Multicenter, Open-label, Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics (PK), and Immunogenicity of the Combination Therapy of SYS6026 in the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P=N/A | N=186 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New trial • Oncology • Solid Tumor

SPC Pharmaceutical Group Limited…is pleased to announce that the Phase III clinical study (Protocol No.: SYS6010–022 (SYNSTAR-04)) of SYS6010 in combination with enlonstobart for the treatment of driver-gene negative…NSCLC developed by the Group officially initiated in China, with the enrolment of the first subject expected to be completed in July 2026 (HKEXnews) - "SYS6010–022 (SYNSTAR-04) is a randomised, open-label, multi-centre, Phase III clinical study designed to evaluate the efficacy and safety of SYS6010 in combination with enlonstobart versus immunotherapy plus platinum-based chemotherapy in subjects with driver gene-negative and programmed cell death ligand-1 (PD-L1)-positive locally advanced or metastatic NSCLC."

Trial status • Non Small Cell Lung Cancer

SYHX2011 in Combination With Carboplatin and Enlonstobart as First-Line Therapy for Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2/3 | N=396 | Not yet recruiting | Sponsor: Shanghai Chest Hospital

New P2/3 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • ROS1

A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P3 | N=570 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Preliminary safety and efficacy of SYS6010 combined with enlonstobart in patients with recurrent or metastatic esophageal cancer: Results from a phase I/II study. (ASCO 2026) - P1/2 | "This study demonstrates that the combination therapy of SYS6010 and Enlonstobart has the potential to represent a novel and effective treatment option for patients with R/M EC. The promising clinical activity, together with a manageable safety profile, supports further clinical development of this regimen."

Clinical • Metastases • P1/2 data • Esophageal Cancer • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology

SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC（SYNSTAR 04） (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P3 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

SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=264 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

IO biomarker • New P1/2 trial • Oncology • Solid Tumor • PD-L1

A Clinical Study of Liposomal Irinotecan for Second-Line Therapy in Metastatic Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=408 | Not yet recruiting | Sponsor: Hebei Medical University Fourth Hospital

New P2/3 trial • Colon Cancer • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Solid Tumor

Liposomal Irinotecan Plus Enlonstobart for Platinum-Resistant Recurrent Ovarian Cancer (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Platinum resistant • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • PD-L1

Preliminary results of enlonstobart combined with weekly chemotherapy (induction phase) followed by concurrent immunochemoradiotherapy in locally advanced cervical cancer: a multicenter, single-arm study (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

Short-course Radiotherapy in TNT Combined With Enlonstobart for pMMR LARC (clinicaltrials.gov) - P2 | N=128 | Not yet recruiting | Sponsor: Hebei Medical University Fourth Hospital

New P2 trial • pMMR • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

The Comparative Effectiveness of Enlonstobart and Camrelizumab as Second-Line Recurrent or Metastatic Cervical Cancer Therapies: Matching-Adjusted and Simulated Treatment Comparisons. (PubMed, Immunotargets Ther) - "This indirect comparison demonstrated that enlonstobart provided a significant OS advantage compared to camrelizumab in patients with second-line R/M CC. These findings suggest enlonstobart may represent a promising therapeutic option for PD-(L)1 positive R/M CC patients."

HEOR • Journal • Cervical Cancer • Oncology • Solid Tumor

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