Clinical trials: sponsored by Akeso
Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
This is a multicentre, Phase Ib/II Clinical Study of AK109 and AK104 With or Without Chemotherapy in Second-line Treatment of Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma .
- Trial name
- NCT04982276
- Testing
- AK109, paclitaxel, AK104
- Where
- China
- Volunteers
- 138 people
- Sponsor
- Akeso
Cervical Cancer
A Study of AK104 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer
This is A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical…
- Trial name
- NCT04982237
- Testing
- AK104, paclitaxel, carboplatin
- Where
- 5 sites in China
- Volunteers
- 445 people
- Sponsor
- Akeso
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma
A randomized, Double-blind, Multicenter, phase III Clinical Study of Comparing the Efficacy and Safety of AK104 Plus Oxaliplatin and Capecitabine (XELOX) Versus Placebo Plus XELOX as First-line Treatment for locally advanced…
- Trial name
- NCT05008783
- Testing
- AK104
- Where
- 7 sites in China
- Volunteers
- 610 people
- Sponsor
- Akeso
Metastatic Colorectal Cancer
A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer
This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK112 with or without AK117 in participants with metastatic colorectal cancer who are not suitable for surgery.
- Trial name
- NCT05382442
- Testing
- AK112, AK117, Oxaliplatin
- Where
- 4 sites in United States, China
- Volunteers
- 254 people
- Sponsor
- Akeso
Non-Small Cell Lung Cancer
AK112 in Non-squamous Non-small Cell Lung Cancer (NSCLC)Patients With Actionable Genomic Alterations (AGA) Who Have Failed to Previous Tyrosine Kinase Inhibitor (TKI) Treatment
AK112 in non-squamous non-small cell lung cancer patients with actionable genomic alterations (AGA) who have failed to previous tyrosine kinase inhibitor (TKI) treatment
- Trial name
- AGA TKI NSCLC (NCT07158840)
- Testing
- AK112
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Akeso
Advanced Solid Tumors
A Study of AK146D1 for Injection in Advanced Solid Tumors
This is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK146D1 for injection in advanced solid tumors.
- Trial name
- NCT07067567
- Testing
- AK146D1 for injection
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Akeso
NSCLC
A Trial of AK104 Plus Anlotinib in NSCLC
This trial is a single arm, two cohorts, phase Ib/II study. All patients are stage IIIB/C or IV NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Trial name
- NCT04646330
- Testing
- AK104+anlotinib
- Where
- China
- Volunteers
- 114 people
- Sponsor
- Akeso
Advanced Solid Tumors
A Study of AK146D1 for Injection in the Treatment of Advanced Solid Tumors
This is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK146D1 for injection in advanced solid tumors.
- Trial name
- NCT06929663
- Testing
- AK146D1 for injection
- Where
- Australia
- Volunteers
- 48 people
- Sponsor
- Akeso
Non-small Cell Lung Cancer Stage IIIB/IV, Head and Neck Squamous Cell Carcinoma (HNSCC)
AK129 Combination Therapy for Advanced Solid Tumors
This is an open, multicenter phase Ib/II clinical study. The goal of this study is to confirm the Phase II recommended dose (RP2D) of AK129 combinations for advanced solid tumors and evaluate the safety and efficacy of AK129…
- Conditions
- Non-small Cell Lung Cancer Stage IIIB/IV, Head and Neck Squamous Cell Carcinoma (HNSCC), Colorectal Adenocarcinoma, Advanced Solid Tumors
- Trial name
- NCT06943820
- Testing
- AK129(dose 1), Pemetrexed, Paclitaxel
- Where
- China
- Volunteers
- 230 people
- Sponsor
- Akeso
HCC, Hepatocellular Carcinoma
A Phase II Study of AK104 Combination With Lenvatinib Versus Lenvatinib for Second-line HCC
This is a Phase II, randomized, open-label, global, multi-center study to compare the efficacy and safety of AK104 in combination with lenvatinib versus lenvatinib in patients with advanced hepatocellular carcinoma who have…
- Trial name
- NCT06984718
- Testing
- AK104+lenvatinib, lenvatinib
- Volunteers
- 120 people
- Sponsor
- Akeso
Advanced Squamous Non Small Cell Lung Cancer
AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer
This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or stage IV squamous non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Trial name
- NCT05840016
- Testing
- AK112, Carboplatin, Paxlitaxel, Tislelizumab, Carboplatin, Paxlitaxel
- Where
- China
- Volunteers
- 532 people
- Sponsor
- Akeso
Healthy Subjects
A Clinical Study of AK139 in Healthy Subjects
This is a phase I clinical study on dose escalation evaluating the safety, tolerability, PK and PD of a single dose of AK139 administered subcutaneously in healthy subjects.
- Trial name
- NCT06947109
- Testing
- AK111
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Akeso
Platinum-sensitive Ovarian Cancer
Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer
An Exploratory, Multi-cohort Phase II Study of combination therapy of AK112 with chemotherapy and/or olaparib in platinum-sensitive ovarian cancer(PSOC)
- Trial name
- NCT06686030
- Testing
- AK112 low dose, Chemotherapy, Olaparib
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Akeso
Nasopharyngeal Carcinoma
A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma
This study is a randomized, double-blind, multi-center phase III clinical study to compare the efficacy and safety of penpulimab combined with chemotherapy and placebo combined with chemotherapy in the first-line treatment of…
- Trial name
- NCT04974398
- Testing
- Penpulimab
- Where
- 56 sites in United States, Australia and 3 more
- Volunteers
- 296 people
- Sponsor
- Akeso
Pancreas Cancer, Pancreas Cancer, Duct Cell Adenocarcinoma
A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC
To explore safety and efficacy of neoantigen personalized mRNA vaccines AK154 monotherapy or in combination with AK104/AK112 and sequential mFOLFIRINOX regime in Resected PDAC
- Trial name
- NCT06913218
- Testing
- AK154, Cadonilimab, Ivonescimab (SMT112 or AK112) Injection
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Akeso
Advanced Solid Tumor
A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors
This is a multi-center, open label, phase Ib/II clinical study of AK109 and AK104 to evaluate the safety, tolerability, effectiveness, pharmacokinetic characteristics in advanced solid tumors .
- Trial name
- NCT05142423
- Testing
- AK109+AK104
- Where
- China
- Volunteers
- 198 people
- Sponsor
- Akeso
Hepatocellular Carcinoma
A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma
- Trial name
- NCT06371157
- Testing
- AK104, Lenvatinib, TACE
- Where
- 4 sites in China
- Volunteers
- 469 people
- Sponsor
- Akeso
Solid Tumor, Lung Cancer
A Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody AK105 in Patients With Selected Advanced Solid Tumors
This is a multi-center, multi-cohort, open-label, phase Ib/II study to evaluate the efficacy, safety, PK characteristics, immunogenicity and potential biomarkers of AK105 monotherapy in the patients with selected advanced solid…
- Conditions
- Solid Tumor, Lung Cancer, HCC
- Trial name
- NCT04172506
- Testing
- AK105
- Where
- China
- Volunteers
- 65 people
- Sponsor
- Akeso
Unresectable, Non-metastatic Hepatocellular Carcinoma
A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC
To evaluate the efficacy and safety of AK104 plus lenvatinib combined with on-demand TACE in participants with unresectable, non-metastatic hepatocellular carcinoma
- Trial name
- NCT05319431
- Testing
- AK104, Lenvatinib, TACE
- Where
- 5 sites in China
- Volunteers
- 60 people
- Sponsor
- Akeso
SCLC,Extensive Stage
A Study of AK104 in Combination With Chiauranib in Patients With Extensive Stage Small Cell Lung Cancer
A Phase Ib/II open label,international multicentre study to evaluate the efficacy and safety of anti-PD-1 and CTLA-4 bispecific antibody AK104 in combination with Chiauranib in Patients with Extensive Stage Small Cell Lung Cancer…
- Trial name
- NCT05505825
- Testing
- AK104 IV infusion；Chiauranib oral
- Where
- 7 sites in Australia, China
- Volunteers
- 36 people
- Sponsor
- Akeso