SYS6010 / CSPC Pharma - LARVOL DELTA

A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=444 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P1/2 trial • Solid Tumor

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

Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC（SYNSTAR01） (clinicaltrials.gov) - P3 | N=380 | Recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase 1 Study (NCT05948865) of CPO301/SYS6010, an EGFR-directed Antibody Drug Conjugate (ADC) in Patients (pts) with Advanced Solid Tumors: Activity in NSCLC pts with and without Actionable Genomic Alterations (AGAs) [WITHDRAWN] (ESMO 2025) - P1 | No abstract available

Clinical • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase Ⅰb/Ⅲ Clinical Study of SYS6010 in combination with Osimertinib in patients with locally advanced or metastatic NSCLC (ChiCTR) - P1 | N=116 | Recruiting | Sponsor: Shanghai Chest Hospital; Shanghai Chest Hospital

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of SYS6010 in Combination With SYH2051 in Patients With Advanced Colorectal Cancer and Other Gastrointestinal Tumors (clinicaltrials.gov) - P=N/A | N=25 | Active, not recruiting | Sponsor: Fujian Cancer Hospital

New trial • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Phase Ib/II Study on the Safety and Efficacy of SYS6010 and SYS6010 in Combination with SYH2051±Bevacizumab in Patients with Advanced Solid Tumors (ChiCTR) - P1/2 | N=138 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center, Fujian Provincial Cancer Hospital; CSPC Megalith Biopharmaceutical Co., Ltd..

New P1/2 trial • Solid Tumor • EGFR

First-in-human trial of SYS6010 combined with SYH2051 in patients with advanced gastrointestinal tumors. (ASCO 2025) - "SYS6010 combined with SYH2051 was well tolerated and demonstrated preliminary antitumor activity in advanced gastrointestinal tumors, particularly in gastric cancer. Further evaluation is ongoing."

Clinical • Metastases • P1 data • Anemia • Colorectal Cancer • Fatigue • Gastric Cancer • Gastrointestinal Cancer • Infectious Disease • Interstitial Lung Disease • Leukopenia • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia • KRAS

CPO301 GRANTED THE THIRD FAST TRACK DESIGNATION BY U.S. FDA FOR THE TREATMENT OF ADULT PATIENTS WITH NSCLC (CSPC Press Release) - "The board of directors (the 'Board') of CSPC Pharmaceutical Group Limited...is pleased to announce that CPO301 (also known as SYS6010 in China), a first-in-class epidermal growth factor receptor ('EGFR') antibody drug conjugate (ADC) developed by the Group, has been granted the third Fast Track designation by the U.S. Food and Drug Administration ('FDA') for the treatment of adult patients with advanced or metastatic non-squamous non-small cell lung cancer (Nsq-NSCLC) without EGFR mutations or other actional genomic alterations (AGA), with prior disease progression on platinum-based chemotherapy and an anti-PD-(L)1 antibody."

Evidence highlight • Fast track • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • EGFR

First-in-human study of SYS6010, a novel EGFR targeting antibody drug conjugate (ADC) for patients with advanced solid tumors (AACR 2025) - "SYS6010 demonstrated a tolerable safety profile with promising efficacy in patients with advanced solid tumors, particularly in nsq-NSCLC subjects with EGFR TKI resistance or EGFR wild type."

Clinical • IO biomarker • Metastases • P1 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of SYS6010 and Platinum-based Chemotherapy in Patients With EGFR-mutated NSCLC. (clinicaltrials.gov) - P3 | N=380 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

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

A Phase Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Different Dosing Regimens of SYS6010 in Patients with Advanced Solid Tumors (ChiCTR) - P1/2 | N=199 | Recruiting | Sponsor: Fujian Provincial Cancer Hospital; CSPC Megalith Biopharmaceutical Co., Ltd..

New P1/2 trial • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

CPO301 RECEIVES FAST TRACK DESIGNATION FROM THE US FDA (CSPC Press Release) - "The board of directors (the 'Board') of CSPC Pharmaceutical Group Limited (the 'Company', together with its subsidiaries, the 'Group') is pleased to announce that CPO301, a first-in-class antibody drug conjugate (ADC) developed by the Group, has received Fast Track Designation from the US Food and Drug Administration (FDA) for the treatment of patients with recurrent or metastatic squamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) overexpression that has progressed on or after treatment with platinum-based chemotherapy and anti-PD-(L1) therapy....This is the second Fast Track Designation granted by the US FDA for CPO301."

Fast track • Lung Non-Small Cell Squamous Cancer

A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=102 | Recruiting | Sponsor: Conjupro Biotherapeutics, Inc.

New P1 trial • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • KRAS

US FDA Grants Fast Track Designation to CSPC Pharma's Lung Cancer Treatment (Market Screener) - "The US Food and Drug Administration granted a Fast Track Designation to CSPC Pharmaceutical's (HKG:1093) CPO301 treatment for metastatic non-small cell lung cancer, according to a Monday filing."

Fast track designation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CSPC (01093): Cancer Drug CPO301 Approved for Clinical Trials in Canada [Google translation] (Yahoo Finance) - "CSPC...announced that the application for clinical trials of CPO301, the first antibody-drug conjugate of its kind developed by the group, has been approved by Health Canada. The approved study is a multi-center, first-in-human, dose-escalation and dose-expansion Phase I clinical trial to evaluate the safety, pharmacokinetics and preliminary efficacy of CPO301 in advanced solid tumors (including non-small cell lung cancer)."

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CSPC (01093): Antibody Drug Conjugate CPO301 Approved for Clinical Trials in the United States [Google translation] (Zhitong Finance) - "Zhitong Finance APP News, CSPC (01093) announced that the Investigational New Drug Application (IND) of the Antibody-Drug Conjugate (Antibody-Drug Conjugate) CPO301 developed by the Group has been approved by the US Food and Drug Administration (FDA). Clinical trials may be conducted in the United States. The study is a multi-center, dose-escalation and dose-expansion phase I clinical trial to evaluate the safety, pharmacokinetics and preliminary efficacy of CPO301 in the treatment of advanced lung cancer with EGFR gene mutation or EGFR overexpression."

IND • Lung Cancer • Oncology