Product Description
A first-in-class antibody drug conjugate developed by CSPC, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic non-small cell lung cancer (NSCLC) patients with EGFR mutations who are relapsed/refractory to or ineligible for EGFR targeting therapy such as 3rd-generation EGFR inhibitors including Osimertinib. Preclinical studies showed that CPO301 dose dependently inhibited the growth of human tumors with various EGFR-activating mutations or high expression of wild type EGFR protein in immunodeficient mice. In particular, CPO301 showed potent anti-tumor efficacy in a human NSCLC PDX model harboring EGFR triple mutations (Exon19Del, T790M and C797S) that are resistant to the thirdgeneration EGFR-TKI Osimertinib. (Sourced from: https://doc.irasia.com/listco/hk/cspc/announcement/a230612.pdf)
Mechanisms of Action: EGFR Inhibitor
Novel Mechanism: No
Modality: Antibody Drug Conjugate
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: CSPC Pharmaceutical Group Jushi Biopharmaceutical Co., Ltd.
Company Location: Asia Pacific
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China, United States
Active Clinical Trial Count: 13
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Breast Cancer|Esophageal Cancer|Non-Small-Cell Lung Cancer|Small Cell Lung Cancer|Squamous Cell Carcinoma
Phase 2: Head and Neck Cancer|Oncology Solid Tumor Unspecified
Phase 1: Lung Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06927986 |
SYS6010-011 | P3 |
Recruiting |
Non-Small-Cell Lung Cancer|Small Cell Lung Cancer |
2026-07-30 |
59% |
2025-11-18 |
|
NCT06775236 |
SYS6010-008 | P2 |
Not yet recruiting |
Breast Cancer |
2027-06-15 |
12% |
2025-01-16 |
Primary Endpoints|Treatments |
NCT07254585 |
SYS6010-018 | P2 |
Recruiting |
Squamous Cell Carcinoma|Head and Neck Cancer |
2026-06-30 |
12% |
2026-01-27 |
|
NCT07417735 |
SYS6010-019 | P3 |
Not yet recruiting |
Esophageal Cancer |
2028-12-31 |
34% |
2026-02-19 |
|
NCT05948865 |
CPO301-US-101 | P1 |
Recruiting |
Lung Cancer |
2025-06-13 |
21% |
2023-07-18 |
Primary Endpoints|Treatments |
NCT07251062 |
SYS6010-016 | P3 |
Not yet recruiting |
Squamous Cell Carcinoma|Esophageal Cancer |
2029-12-30 |
2025-11-27 |
Primary Endpoints|Treatments |
|
NCT07406542 |
SYS6010-021 | P3 |
Not yet recruiting |
Breast Cancer |
2029-04-01 |
34% |
2026-02-13 |
Primary Endpoints|Treatments |
NCT07442565 |
SYNSTAR03 | P3 |
Not yet recruiting |
Non-Small-Cell Lung Cancer |
2027-12-30 |
27% |
2026-03-05 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT07376382 |
SYNSTAR-02 | P3 |
Not yet recruiting |
Non-Small-Cell Lung Cancer|Small Cell Lung Cancer |
2026-12-12 |
34% |
2026-01-30 |
Primary Endpoints|Treatments |
CTR20244692 |
CTR20244692 | P1 |
Recruiting |
Non-Small-Cell Lung Cancer |
None |
2025-05-17 |
Patient Enrollment|Start Date|Treatments|Trial Status |
|
CTR20231332 |
CTR20231332 | P1 |
Recruiting |
Oncology Solid Tumor Unspecified |
None |
2025-04-29 |
Patient Enrollment|Start Date|Treatments|Trial Status |
|
NCT07256509 |
SYS6010-013 | P2 |
Not yet recruiting |
Non-Small-Cell Lung Cancer |
2026-11-30 |
12% |
2025-12-06 |
Primary Endpoints|Treatments |
CTR20242983 |
CTR20242983 | P2 |
Recruiting |
Oncology Solid Tumor Unspecified |
None |
2025-04-29 |
Patient Enrollment|Start Date|Treatments|Trial Status |
Recent News Events
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