AK104

Phase 3Biologic

AAkeso

AK104 is one of 429 biologic programs targeting Gastroesophageal Junction Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

428

Competitors

Pipeline

Status by Indication[3][1]

Indication

Gastroesophageal Junction AdenocarcinomaRecruiting

Non-Small Cell Lung CancerNot yet recruiting

Colorectal CancerActive, not recruiting

Pancreatic CancerRecruiting

Ovarian CancerRecruiting

Hepatocellular CarcinomaRecruiting

Renal Cell CarcinomaRecruiting

Cervical CancerActive, not recruiting

ChemotherapyNot yet recruiting

LenvatinibActive, not recruiting

Gastroesophageal Junction AdenocarcinomaPhase 2

Recruiting

Non-Small Cell Lung CancerPhase 3

Not yet recruiting

Colorectal CancerPhase 2

Active, not recruiting

Pancreatic CancerPhase 2

Recruiting

Ovarian CancerPhase 3

Recruiting

Hepatocellular CarcinomaPhase 3

Recruiting

Renal Cell CarcinomaPhase 2

Recruiting

Cervical CancerPhase 3

Active, not recruiting

ChemotherapyPhase 2

Not yet recruiting

LenvatinibPhase 2

Active, not recruiting

Showing 10 of 16 indications

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Navelbine

PPierre Fabre Medicament

Phase 3

24 2

AK104

AAkeso

Phase 3

6 3

SHR-A1811

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Phase 3

3 4

Ds-1062a

Daiichi Sankyo

Phase 3

3 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—8

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 10

PD-1 Inhibitors

BBioNTech US Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Not yet recruiting

Non-Small Cell Lung Cancer

NCT05990127

Phase 1/2Recruiting

First-Line Treatment

NCT06477523

Q1 2027

Phase 3Recruiting

Adjuvant Therapy

NCT05489289

Phase 1/2Active, not recruiting

Non-Small Cell Lung Cancer

NCT05904379

Phase 1/2Recruiting

Gastroesophageal Junction Adenocarcinoma

NCT04982276

Q2 2027

Phase 2Not yet recruiting

Chemotherapy

NCT05794750

Clinical

Trials by Indication[1]

Cervical Cancer8 trials

A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody in Subjects With Recurrent/Metastatic Cervical Cancer

Completed·AAkeso·Phase 2·NCT04380805·30 enrolled

A Study of AK104 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

Active, not recruiting·AAkeso·Phase 3·NCT04982237·445 enrolled

Efficacy and Safety of AK104 Combined With Chemotherapy and Recombinant Human Adenovirus 5 Injection in Cervical Cancer

Recruiting·FFujian Cancer Hospital·Phase 2·NCT06455046·37 enrolled

Show 5 more trials

A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer

Active, not recruiting·AAkeso·Phase 3·NCT05235516·636 enrolled

AK104 Combined With I-125 Brachytherapy for Recurrent or Metastatic Cervical Cancer

Not yet recruiting·PPeking University Third Hospital··NCT06062589·18 enrolled

A Study of AK104（ an Anti-PD-1 and Anti-CTLA-4 Bispecific Antibody) in Recurrent or Metastatic Cervical Cancer

Completed·AAkeso·Phase 2·NCT04868708·50 enrolled

AK104 in Neoadjuvant Treatment of Cervical Cancer

Completed·AAkeso·Phase 2·NCT05227651·14 enrolled

A Study of Concurrent Chemoradiotherapy Followed by Cadonilimab（AK104） for Newly Diagnosed Local Advanced Cervical Cancer

Recruiting·WWest China Second University Hospital·Phase 2·NCT06251388·50 enrolled

Non-Small Cell Lung Cancer6 trials

Comparison of Neoadjuvant Cadonilimab Versus Chemotherapy Combined With PD-1 in the Treatment of Resectable Non-Small Cell Lung Cancer With High PD-L1 Expression: A Single-Center, Randomized, Exploratory Clinical Study

Not yet recruiting·SShanghai Pulmonary Hospital, Shanghai, China·Phase 2·NCT06946836·80 enrolled

A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer

Active, not recruiting·AAkeso·Phase 2·NCT05215067·44 enrolled

AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer

Active, not recruiting·AAkeso·Phase 1/2·NCT05904379·233 enrolled

Show 3 more trials

A Study of AK104 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Completed·AAkeso·Phase 1/2·NCT04647344·46 enrolled

A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer

Not yet recruiting·AAkeso·Phase 3·NCT05990127·642 enrolled

AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

Recruiting·HHenan Cancer Hospital·Phase 2·NCT05377658·43 enrolled

Hepatocellular Carcinoma3 trials

A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Alone or in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma

Completed·AAkeso·Phase 2·NCT04728321·32 enrolled

A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma

Completed·AAkeso·Phase 1/2·NCT04444167·59 enrolled

A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma

Recruiting·AAkeso·Phase 3·NCT06371157·469 enrolled

Adenocarcinoma2 trials

A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma

Completed·AAkeso·Phase 3·NCT05008783·610 enrolled

A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, for Advanced Solid Tumors or With mXELOX/XELOX as First-line Therapy for Advanced Gastric or GEJ Adenocarcinoma

Completed·AAkeso·Phase 1/2·NCT03852251·338 enrolled

First-line Treatment2 trials

Phase 1b/2 Study of LDRT in Combination With AK104 Plus Chemotherapy as First-line Treatment for ES-SCLC

Recruiting·SSichuan University·Phase 1/2·NCT06477523·57 enrolled

AK104 Alone or in Combination With Chemotherapy in the First-line Treatment of ESCC

Unknown status·CChinese Academy of Medical Sciences·Phase 2·NCT05522894·80 enrolled

28 more indications

Gastroesophageal Junction Adenocarcinoma2 trials

A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

Recruiting·AAkeso·Phase 1/2·NCT04982276·138 enrolled

A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

Not yet recruiting·AAkeso·Phase 3·NCT07449780·422 enrolled

Renal Cell Carcinoma2 trials

A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma

Recruiting·HHao Zeng·Phase 1/2·NCT05808608·33 enrolled

Phase II Trial of Cadonilimab (AK104) Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma (RCC)

Completed·AAkeso·Phase 2·NCT05256472·28 enrolled

Lenvatinib1 trial

A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC

Active, not recruiting·AAkeso·Phase 2·NCT05319431·60 enrolled

Patients With Advanced Solid Tumors1 trial

Study of AK119 Combined With AK104 in Patients With Advanced Solid Tumors

Terminated·AAkeso·Phase 1/2·NCT05559541·33 enrolled

Small Cell Lung Cancer1 trial

A Study of AK104 in Combination With Chiauranib in Patients With Extensive Stage Small Cell Lung Cancer

Completed·AAkeso·Phase 1/2·NCT05505825·36 enrolled

Bladder Cancer1 trial

A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer

Unknown status·—·Phase 2·NCT06074484·36 enrolled

Locally-advanced Rectal Cancer1 trial

Combination of AK104 and Neoadjuvant Chemoradiotherapy in pMMR/MSS Locally Advanced Rectal Cancer

Unknown status·SSun Yat-sen University·Phase 2·NCT05980689·33 enrolled

Solid Tumours1 trial

A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours

Completed·AAkesobio Australia Pty Ltd·Phase 1·NCT05021120·67 enrolled

Selected Advanced Solid Tumors1 trial

Safety and Efficacy of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Selected Advanced Solid Tumors

Completed·AAkeso·Phase 1/2·NCT04172454·68 enrolled

Locally Advanced1 trial

A Study of AK104 in Subjects With Locally Advanced Unresectable or Metastatic MSI-H/dMMR Solid Tumors

Terminated·AAkeso·Phase 2·NCT04547101·6 enrolled

Pancreatic Cancer1 trial

A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer

Recruiting·AAkeso·Phase 2·NCT05859750·78 enrolled

Advanced Solid Tumors1 trial

A Study of AK119 (Anti-CD73) in Combination With AK104 in Subjects With Advanced Solid Tumors

Completed·AAkeso·Phase 1·NCT04572152·23 enrolled

Adjuvant Therapy1 trial

A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection

Recruiting·AAkeso·Phase 3·NCT05489289·570 enrolled

Urothelial Carcinoma1 trial

A Study of RC48-ADC Combined With Cadonilimab（AK104）in the Treatment of HER2-expression Locally Advanced or Metastatic Urothelial Carcinoma

Recruiting·SShanxi Province Cancer Hospital·Phase 2·NCT06178601·36 enrolled

Lymphoma1 trial

A Study of PD-1/CTLA-4 Bispecific AK104 in Relapsed or Refractory Peripheral T-cell Lymphoma

Terminated·AAkeso·Phase 1/2·NCT04444141·6 enrolled

Advanced Malignant Tumors1 trial

A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors

Unknown status·AAkeso·Phase 1/2·NCT05235542·130 enrolled

Neoadjuvant Therapy1 trial

Phase II Study on Neoadjuvant Therapy of AK104 Combined With Nab-paclitaxel/Carboplatin in Fertility Preserving Surgery

Recruiting·XXiaohua Wu·Phase 2·NCT06209294·30 enrolled

Chemotherapy1 trial

Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC（AK104-IIT-13）

Not yet recruiting·JJIN JING·Phase 2·NCT05794750·50 enrolled

Phase II Clinical Study1 trial

A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.

Recruiting·AAkeso·Phase 2·NCT07052253·100 enrolled

Unresectable1 trial

Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer

Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05853172·30 enrolled

Nasopharyngeal Carcinoma1 trial

A Study of a PD-1/CTLA-4 Bispecific Antibody AK104 in Patients With Metastatic Nasopharyngeal Carcinoma

Completed·AAkeso·Phase 2·NCT04220307·34 enrolled

Ovarian Cancer1 trial

An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer

Recruiting·AAkeso·Phase 2·NCT06560112·172 enrolled

Esophageal Squamous Cell Carcinoma1 trial

AK104 Plus Concurrent Chemoradiation Therapy in Esophageal Squamous Cell Carcinoma

Unknown status·TThe First Affiliated Hospital of University of South China·Phase 2·NCT05594914·47 enrolled

Colorectal Cancer1 trial

AK104 in Locally Advanced MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer

Active, not recruiting·PPeking University·Phase 2·NCT04556253·47 enrolled

Advanced Ovarian Cancer1 trial

Efficacy and Safety of AK104 (PD-1/CTLA-4 Bi-specific Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer: a Randomized Controlled, Single-center Clinical Study

Recruiting·AAnhui Provincial Hospital·Phase 3·NCT06542549·100 enrolled

Vulvar Cancer1 trial

A Multicenter, Open-label, Phase II Study of AK104 in the Treatment of Recurrent or Metastatic Vulvar Cancer

Terminated·AAkeso·Phase 2·NCT05932212·20 enrolled

Carcinomas1 trial

Phase II Study of AK104 (Cadonilimab) for Recurrent Small Cell Neuroendocrine Carcinomas of the Cervix

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05063916·18 enrolled

Unspecified1 trial

A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Subjects

Completed·AAkeso·Phase 1·NCT05559554·100 enrolled

Sources

References

[1]
ClinicalTrials.gov — 51 trial records for AK104. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — AK104 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for AK104. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Akeso company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 3[1]
Company: AAkeso

AK104

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Cervical Cancer8 trials

Non-Small Cell Lung Cancer6 trials

Hepatocellular Carcinoma3 trials

Adenocarcinoma2 trials

First-line Treatment2 trials

Gastroesophageal Junction Adenocarcinoma2 trials

Renal Cell Carcinoma2 trials

Lenvatinib1 trial

Patients With Advanced Solid Tumors1 trial

Small Cell Lung Cancer1 trial

Bladder Cancer1 trial

Locally-advanced Rectal Cancer1 trial

Solid Tumours1 trial

Selected Advanced Solid Tumors1 trial

Locally Advanced1 trial

Pancreatic Cancer1 trial

Advanced Solid Tumors1 trial

Adjuvant Therapy1 trial

Urothelial Carcinoma1 trial

Lymphoma1 trial

Advanced Malignant Tumors1 trial

Neoadjuvant Therapy1 trial

Chemotherapy1 trial

Phase II Clinical Study1 trial

Unresectable1 trial

Nasopharyngeal Carcinoma1 trial

Ovarian Cancer1 trial

Esophageal Squamous Cell Carcinoma1 trial

Colorectal Cancer1 trial

Advanced Ovarian Cancer1 trial

Vulvar Cancer1 trial

Carcinomas1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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