Clinical trials: sponsored by Akeso
Advanced Malignant Tumors
A Study of AK130 in Patients With Advanced Malignant Tumors
A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AK130 (TIGIT/TGF-β bifunctional fusion protein) in patients with advanced malignant…
- Trial name
- NCT05653284
- Testing
- AK130
- Where
- China
- Volunteers
- 19 people
- Sponsor
- Akeso
Gastric Adenocarcinoma, Advanced Solid Tumors
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
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activities of AK104，a PD-1/CTLA-4 bispecific antibody, when administered as a single…
- Conditions
- Gastric Adenocarcinoma, Advanced Solid Tumors, Gastroesophageal Junction Adenocarcinoma
- Trial name
- NCT03852251
- Testing
- AK104, Oxaliplatin, Capecitabine
- Where
- China
- Volunteers
- 338 people
- Sponsor
- Akeso
Gastric and Gastroesophageal Junction Adenocarcinoma
A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced…
- Trial name
- NCT06341335
- Testing
- cadonilimab, pulocimab, paclitaxel
- Where
- China
- Volunteers
- 506 people
- Sponsor
- Akeso
Plaque Psoriasis
Open Label Study to Evaluate the Safety and Efficacy of AK101 Injection Subcutaneously in Subjects With Psoriasis
This is an open-label Phase III clinical study to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis.
- Trial name
- NCT05509361
- Testing
- AK101 injection SC
- Where
- China
- Volunteers
- 950 people
- Sponsor
- Akeso
SCLC, Extensive Stage
Anti-PD-1 and VEGF Bispecific Antibody AK112 in Combination With Chemotherapy in Patients With ES-SCLC
Phase Ib open label, multicenter study to evaluate the efficacy and safety of anti-PD-1 and VEGF bispecific antibody (AK112) combined with chemotherapy in patients with ES-SCLC.
- Trial name
- NCT05116007
- Testing
- AK112, Etoposide, Carboplatin
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Akeso
Hepatocellular Carcinoma
A Study of the Combination of Anti-PD-1 AK105 and Anlotinib in First-line Hepatocellular Carcinoma (HCC)
This is a multi-center,open-label study to evaluate the efficacy and safety of anti-PD-1 antibody AK105 plus anlotinib hydrochloride in the first-line treatment of patients with unresectable hepatocellular carcinoma.
- Trial name
- NCT04172571
- Testing
- AK105, Anlotinib Hydrochloride
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Akeso
Healthy Male Subjects
A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Subjects
The purpose of this study is to evaluate the pharmacokinetic similarity of AK104 with different manufacturing process in healthy male subjects.
- Trial name
- NCT05559554
- Testing
- AK104 (before the change), AK104 (after the change)
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Akeso
ACUTE MYELOID LEUKEMIA; AML
A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia
This is a phase 1b/2 study. All patients are diagnosed with Acute Myeloid Leukemia (AML), Eastern Cooperative Oncology Group (ECOG) performance status 0-3.
- Trial name
- NCT06387420
- Testing
- AK117, Azacitidine, Venetoclax
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Akeso
Solid Tumor
Study of AK119 in Subjects With Advanced Solid Tumors
This is Phase 1, Multicenter, Open-Label, Dose-Escalation and Dose-Exploration Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of AK119 (Anti-CD73) in Subjects with Advanced or Metastatic Solid Tumors.
- Trial name
- NCT05173792
- Testing
- AK119
- Where
- 2 sites in China
- Volunteers
- 16 people
- Sponsor
- Akeso
Lung Cancer Non-Small Cell Stage IIIB/IIIC/IV
A Study of AK104 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
This is a phase Ib/II , open-label, multicenter single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of AK104 combined with Carboplatin and Pemetrexed/ Paclitaxel as…
- Trial name
- NCT04647344
- Testing
- AK104 plus Carboplatin and Pemetrexed, AK104 plus Carboplatin and paclitaxel
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Akeso
Hepatocellular Carcinoma
A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma
An open-label multi-center phase Ib/II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 plus lenvatinib as the first-line therapy for patients with advanced hepatocellular carcinoma.
- Trial name
- NCT04444167
- Testing
- AK104, Lenvatinib
- Where
- China
- Volunteers
- 59 people
- Sponsor
- Akeso
Hepatocellular Carcinoma
A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Alone or in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma
An open-label multi-center phase II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 alone or in combination with lenvatinib in patients with advanced hepatocellular carcinoma.
- Trial name
- NCT04728321
- Testing
- AK104 lenvatinib, AK104
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Akeso
Atopic Dermatitis
A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis.
- Trial name
- NCT06383468
- Testing
- AK120
- Where
- 59 sites in China
- Volunteers
- 420 people
- Sponsor
- Akeso
Hodgkin's Lymphoma
A Study of Anti-PD-1 AK105 in Patients With Relapsed or Refractory Classic Hodgkin Lymphoma
This is a single-arm, open-label, multicenter, phase I/II study to evaluate efficacy and safety of AK105 in patients with relapsed or refractory classic Hodgkin lymphoma.
- Trial name
- NCT03722147
- Testing
- AK105
- Where
- China
- Volunteers
- 94 people
- Sponsor
- Akeso
Lung Cancer Non-small Cell Stage IV, Squamous Cell Lung Cancer
A Study of Anti-PD-1 AK105 in Patients With Metastatic Squamous Non-small Cell Lung Cancer
This is a phase III, randomized, double-blinded, multicenter clinical study to evaluate the efficiency and safety of AK105 (Anti-PD1 antibody) plus paclitaxel and carboplatin vs placebo plus paclitaxel and carboplatin as…
- Trial name
- NCT03866993
- Testing
- AK105, Paclitaxel, Carboplatin
- Where
- 2 sites in China
- Volunteers
- 350 people
- Sponsor
- Akeso
Lung Cancer Non-small Cell Stage IV
A Study of Anti-PD-1 AK105 in Patients With Metastatic Nonsquamous Non-small Cell Lung Cancer
This is a phase III , randomized, double-blinded, multicenter clinical study to compare efficacy and safety of AK105 (Anti-PD1 antibody) combined with Carboplatin and Pemetrexed vs Placebo combined with Carboplatin and Pemetrexed…
- Trial name
- NCT03866980
- Testing
- AK105, carboplatin, pemetrexed
- Where
- 2 sites in China
- Volunteers
- 164 people
- Sponsor
- Akeso
Ankylosing Spondylitis
A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis
This is a phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of AK111 in subjects with active ankylosing spondylitis.
- Trial name
- NCT05467995
- Testing
- AK111
- Where
- 15 sites in China
- Volunteers
- 125 people
- Sponsor
- Akeso
Ulcerative Colitis
A Study of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis
This is a Phase Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and efficacy of AK101 in subjects with moderately to severely active ulcerative colitis.
- Trial name
- NCT06281704
- Testing
- AK101 IV, AK101 SC, AK101 IV/AK101 SC
- Where
- 12 sites in China
- Volunteers
- 34 people
- Sponsor
- Akeso
Solid Tumor
A Study of AK131 in Patients With Advanced Solid Tumors
This is a phase Ia/Ib study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK131 in advanced solid tumor patients
- Trial name
- NCT06166888
- Testing
- AK131
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Akeso
Ovarian Neoplasms, Recurrent Ovarian Carcinoma
A Study of AK112 Combined With PARP Inhibitor in the Treatment of Recurrent Ovarian Cancer
Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of anti-PD-1 and VEGF bispecific antibody (AK112) combined with PARP inhibitor in patients with recurrent ovarian cancer.
- Conditions
- Ovarian Neoplasms, Recurrent Ovarian Carcinoma, Relapsed Ovarian Cancer, Ovarian Cancer
- Trial name
- NCT04999605
- Testing
- AK112 low dose, AK112 medium dose, AK112 high dose
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Akeso