Ozmosi | CPO-301 Drug Profile
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CPO-301

Alternative Names: CPO-301, CPO 301, CPO301, SYS-6010, SYS 6010, SYS6010
Clinical Status: Active
Latest Update: 2025-12-01
Latest Update Note: Clinical Trial Update

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: Conjupro Biotherapeutics
Company Location:
Company CEO:
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for CPO-301

Countries in Clinic: China, United States

Active Clinical Trial Count: 9

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Esophageal Cancer|Non-Small-Cell Lung Cancer|Small Cell Lung Cancer|Squamous Cell Carcinoma

Phase 2: Breast Cancer|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

Small Cell Lung Cancer|Non-Small-Cell Lung Cancer

2026-07-30

39%

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

Not yet recruiting

Squamous Cell Carcinoma|Head and Neck Cancer

2026-06-30

12%

2025-11-29

Primary Endpoints

NCT07251062

SYS6010-016

P3

Not yet recruiting

Esophageal Cancer|Squamous Cell Carcinoma

2029-12-30

39%

2025-11-27

Primary Endpoints|Treatments

NCT05948865

CPO301-US-101

P1

Recruiting

Lung Cancer

2025-06-13

21%

2023-07-18

Primary Endpoints|Treatments

CTR20231332

CTR20231332

P1

Recruiting

Oncology Solid Tumor Unspecified

None

2025-04-29

Patient Enrollment|Start Date|Treatments|Trial Status

CTR20244692

CTR20244692

P1

Recruiting

Non-Small-Cell Lung Cancer

None

2025-05-17

Patient Enrollment|Start Date|Treatments|Trial Status

NCT07256509

SYS6010-013

P2

Not yet recruiting

Non-Small-Cell Lung Cancer

2026-11-30

2025-12-02

Primary Endpoints|Treatments

CTR20242983

CTR20242983

P2

Recruiting

Oncology Solid Tumor Unspecified

None

2025-04-29

Patient Enrollment|Start Date|Treatments|Trial Status

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