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Cadonilimab

Alternative Names: Cadonilimab, ak-104, ak 104, ak104
Clinical Status: Active
Latest Update: 2025-12-09
Latest Update Note: News Article

Product Description

AK104, a PD-1/CTLA-4 bispecific antibody, is designed as a novel tetrameric form. It could preferentially binds to tumor-infiltrating lymphocytes (TILs) co-expressing PD-1 and CTLA-4 with higher avidity in the tumor micro-environment than peripheral sites. Therefore, AK104 is designed to retain the efficacy benefit derived from the combination of anti-PD-1 and anti-CTLA-4 while conferring superior safety compared to the co-administration of these individual agents. (Sourced from: https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.3_suppl.232)

Mechanisms of Action: CTLA4 Inhibitor, PD-1 Inhibitor

Novel Mechanism: No

Modality: Bispecific Antibody

Route of Administration: Intravenous

FDA Designation: Fast Track - Cervical Cancer|Oncology Solid Tumor Unspecified *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Akeso Pharm
Company Location:
Company CEO:
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Cadonilimab

Countries in Clinic: Australia, China

Active Clinical Trial Count: 55

Recent & Upcoming Milestones

  • PDUFA summaries: Priority review for Libtayo in cervical cancer by Jan 30, 2022; Cadonilimab priority review in China.

Highest Development Phases

Phase 3: Adenocarcinoma|Cervical Cancer|Esophageal Cancer|Gastrointestinal Cancer|Hepatocellular Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Lung Cancer|Uterine Cancer

Phase 2: Colorectal Cancer|Kidney Cancer|Liposarcoma|Nasopharyngeal Cancer|Oncology Solid Tumor Unspecified|Ovarian Cancer|Pancreatic Cancer|Pancreatic Ductal Carcinoma|Renal Cell Carcinoma|Squamous Cell Carcinoma|Vulvar Cancer

Phase 1: Healthy Volunteers|Melanoma|Transitional Cell Carcinoma

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT05868876

AK127-103

P1

Recruiting

Cervical Cancer|Small Cell Lung Cancer|Melanoma|Transitional Cell Carcinoma|Non-Small-Cell Lung Cancer

2025-11-01

12%

2023-09-22

Primary Endpoints|Start Date|Treatments|Trial Status

NCT07263919

AK104-312

P2

Not yet recruiting

Squamous Cell Carcinoma|Esophageal Cancer

2030-03-01

12%

2025-12-05

Primary Endpoints|Treatments

NCT05142423

AK109-102

P2

Recruiting

Oncology Solid Tumor Unspecified

2027-04-01

12%

2025-03-13

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments

NCT06646055

AK112-210

P2

Recruiting

Pancreatic Cancer|Pancreatic Ductal Carcinoma|Adenocarcinoma

2026-12-30

12%

2025-01-24

Primary Endpoints|Start Date|Treatments|Trial Status

NCT06560112

AK104-221

P2

Recruiting

Ovarian Cancer

2026-05-01

12%

2025-03-13

Primary Endpoints|Start Date|Treatments|Trial Status

NCT05256472

AK104-213

P2

Active, not recruiting

Renal Cell Carcinoma

2025-12-31

12%

2025-03-07

NCT06187961

CCGLC-011

P2

Recruiting

Hepatocellular Carcinoma

2025-12-31

35%

2024-01-04

Primary Endpoints|Treatments

NCT04982276

AK109-201

P2

Recruiting

Esophageal Cancer|Gastrointestinal Cancer|Adenocarcinoma

2025-12-30

39%

2025-11-20

NCT05932212

AK104-218

P2

Recruiting

Vulvar Cancer

2025-12-15

12%

2025-03-13

NCT05944224

SPH4336-201

P2

Recruiting

Liposarcoma

2025-05-31

34%

2023-10-20

NCT05980689

B2022-766-01

P2

Recruiting

Colorectal Cancer

2024-06-30

12%

2023-10-26

Primary Endpoints|Start Date|Treatments|Trial Status

CTR20192735

CTR20192735

P2

Completed

Nasopharyngeal Cancer

2023-03-09

2025-04-29

Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status

NCT04982237

AK104-303

P3

Active, not recruiting

Uterine Cancer|Cervical Cancer

2025-12-30

29%

2025-11-20

Primary Completion Date|Primary Endpoints|Treatments

NCT06913218

AK154-IIT-001

P1

Not yet recruiting

Pancreatic Cancer|Adenocarcinoma

2028-02-23

12%

2025-04-08

Primary Endpoints|Treatments

NCT07052253

AK104-223

P2

Not yet recruiting

Hepatocellular Carcinoma

2027-05-10

2025-07-08

Primary Endpoints|Treatments

NCT06984718

AK104-225

P2

Not yet recruiting

Hepatocellular Carcinoma

2026-11-30

12%

2025-05-23

Primary Endpoints|Treatments

NCT06586294

AK129-103

P2

Not yet recruiting

Esophageal Cancer|Adenocarcinoma|Gastrointestinal Cancer

2026-07-01

46%

2024-09-20

NCT05824494

AK104-IIT-024

P2

Not yet recruiting

Uterine Cancer|Cervical Cancer

2026-06-01

24%

2023-05-07

Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments

NCT06371157

AK104-308

P3

Recruiting

Hepatocellular Carcinoma

2025-10-25

32%

2025-03-13

Primary Endpoints

NCT07023315

AK104-310

P3

Not yet recruiting

Adenocarcinoma|Gastrointestinal Cancer|Esophageal Cancer

2029-07-01

37%

2025-06-17

Primary Endpoints|Treatments

NCT06221748

RC48-C035

P3

Recruiting

Esophageal Cancer|Adenocarcinoma|Gastrointestinal Cancer

2026-12-01

42%

2024-04-04

NCT06341335

AK109-301

P3

Recruiting

Esophageal Cancer|Adenocarcinoma|Gastrointestinal Cancer

2026-11-01

20%

2024-07-23

Primary Endpoints|Start Date|Treatments|Trial Status

NCT06617416

AK104-309

P3

Recruiting

Non-Small-Cell Lung Cancer

2026-10-28

40%

2025-03-13

Primary Endpoints|Start Date|Treatments|Trial Status

NCT05235516

AK104-305

P3

Active, not recruiting

Cervical Cancer

2026-05-01

23%

2024-08-14

Primary Endpoints|Treatments|Trial Status

NCT05489289

AK104-306

P3

Recruiting

Hepatocellular Carcinoma

2026-01-28

38%

2025-03-13