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Cadonilimab (AK104)

DRUG9 trials

Sponsors

Hubei Cancer Hospital, Fudan University, Xin-Hua Xu, Akeso, Guangzhou Medical University

Conditions

Breast CancerColon Rectal Cancer AdenocarcinomaHepatocellular Carcinoma (HCC)ImmunotherapyLeptomeningeal MetastasisLocally Advanced Lung CarcinomaMSI-H/dMMR Colorectal CancerNSCLC

Phase 1

Intrathecal Combination of Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis
Active, not recruitingNCT06762080
Guangzhou Medical UniversityLeptomeningeal Metastasis
Start: 2025-03-07End: 2026-10-30Target: 39Updated: 2026-10-13

Phase 2

SBRT, Chemotherapy, and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)
RecruitingNCT06401005
Hubei Cancer HospitalBreast Cancer
Start: 2024-11-28End: 2027-09-01Target: 51Updated: 2024-12-02
Cadonilimab(AK104) Plus Concurrent Chemoradiotherapy in Patients With Locally Advanced, Unresectable, Stage III NSCLC
Active, not recruitingNCT06448910
Fudan UniversityLocally Advanced Lung Carcinoma, NSCLC
Start: 2024-07-01End: 2027-06-30Target: 41Updated: 2025-09-24
A Prospective, Open-label, Single-center, Single-arm Phase II Clinical Study of Cadonilimab (AK104) Combined With Monotherapy Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer With Negative Driver Genes and Failed Immunotherapy
RecruitingNCT06467500
Xin-Hua XuNon-small Cell Lung Cancer
Start: 2024-03-01End: 2026-12-30Target: 48Updated: 2024-06-21
A Prospective Study of Cadonilimab in Hepatocellular Carcinoma After Radical Surgery With High Risk of Recurrence
TerminatedNCT06851104
Guangxi Medical UniversityHepatocellular Carcinoma (HCC)
Start: 2025-02-16End: 2025-12-31Updated: 2026-02-18
Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)
RecruitingNCT07263919
AkesoResectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Start: 2025-12-19End: 2031-12-31Target: 90Updated: 2025-12-31

Phase 3

A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC
RecruitingNCT06617416
AkesoNSCLC (Non-small Cell Lung Cancer)
Start: 2024-11-12End: 2028-12-30Target: 560Updated: 2025-03-12
Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
RecruitingNCT07412613
AkesoMSI-H/dMMR Colorectal Cancer, Resectable Colon Cancer
Start: 2026-04-15End: 2031-03-15Target: 386Updated: 2026-04-22
FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02)
RecruitingNCT07815834
Fudan UniversityColon Rectal Cancer Adenocarcinoma, Immunotherapy, Peritoneal (Metastatic) Cancer +2
Start: 2026-10-01End: 2031-03-01Target: 198Updated: 2026-10-13

Related Papers

Intrathecal (IT) PD-1/CTLA-4 antibody combined with pemetrexed (PM) for leptomeningeal metastases (LM) from solid tumors: Preliminary results of two single-center phase I studies.
Journal of Clinical Oncology2026-05-27