CPO301 / CSPC Pharma - LARVOL DELTA

First-in-human trial of SYS6010 combined with SYH2051 in patients with advanced gastrointestinal tumors. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P1 data • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

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