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
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 |