Clinical trials: sponsored by Akeso
Advanced Malignant Tumors
A Phase Ia/Ib Open Label，Clinical Study Evaluating the Safety, Tolerability and Preliminary Efficacy of AK127 in Combination With AK104 in Patients With Advanced Malignant Tumors
A Phase Ia/Ib open label，clinical study evaluating the safety, tolerability and preliminary efficacy of AK127 in combination with AK104 in patients with advanced malignant tumors
- Trial name
- NCT05868876
- Testing
- AK127 Q3W IV infusion ,AK104 10mg/kg Q3W IV infusion
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Akeso
Prurigo Nodularis (PN)
A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Prurigo Nodularis.
This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of subjects with prurigo nodularis.
- Trial name
- NCT07883213
- Testing
- AK139
- Volunteers
- 132 people
- Sponsor
- Akeso
Ankylosing Spondylitis
A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis
This is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis.
- Trial name
- NCT06378697
- Testing
- AK111
- Where
- 60 sites in China
- Volunteers
- 510 people
- Sponsor
- Akeso
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
A Study of Anti-PD-1 and LAG-3 Bispecific Antibody(AK129) Combined With Chemotherapy With or Without Cadonilimab in the First-line Treatment of Unresectable Locally Advanced or Metastatic G/ GEJ Adenocarcinoma
Phase Ib/II clinical study of AK129 combined with chemotherapy with or without cadonilimab in first-line treatment of advanced HER2 negative gastric cancer or gastroesophageal junction adenocarcinoma
- Trial name
- NCT06586294
- Testing
- Drug: AK129 Drug：oxaliplatin Drug：capecitabine, Drug: AK129 Drug: cadonilimab Drug: oxaliplatin Drug: capecitabine
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Akeso
Chronic Spontaneous Urticaria
A Trial to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Spontaneous Urticaria
The goal of this clinical trial is to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AK139 injection in patients with chronic spontaneous urticaria (CSU) receiving background…
- Trial name
- NCT07875426
- Testing
- AK139
- Volunteers
- 201 people
- Sponsor
- Akeso
Advanced Malignant Tumors(Stage IA-IB)
A Study of AK129 in Patients With Advanced Malignant Tumors
A Phase Ia/Ib, open label, dose escalation and dose extension trial of Anti-PD-1 and LAG-3 bispecific antibody, AK129, to evaluate the safety, tolerability and antitumor efficacy in patients with advanced malignant tumors
- Trial name
- NCT05645276
- Testing
- AK129 IV infusion
- Where
- China
- Volunteers
- 57 people
- Sponsor
- Akeso
Advanced Solid Tumors
A Study of AK157D1 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 AK157D1 for injection in advanced solid tumors.
- Trial name
- NCT07847281
- Testing
- AK157D1 for injection
- Where
- 3 sites in China
- Volunteers
- 243 people
- Sponsor
- Akeso
Gastric / Gastroesophageal Junction Adenocarcinoma
Phase 3 Study of Cadonilimab Combined With Chemotherapy vs Chemotherapy in Combination With or Without Nivolumab for the 1L Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric/GEJ Adenocarcinoma
The goal of this randomized, double-blind, multi-regional phase 3 study of cadonilimab combined with chemotherapy versus chemotherapy in combination with or without nivolumab for the first-line treatment of participants with…
- Trial name
- G/GEJ (NCT07700979)
- Testing
- Cadonilimab, CAPOX regimen, Nivolumab
- Where
- 25 sites in United States, China and 2 more
- Volunteers
- 900 people
- Sponsor
- Akeso
Vulvar Cancer
AK104 for Recurrent or Metastatic Vulvar Cancer
This is a multicenter, open-label, phase II clinical study, aiming to the evaluate the efficacy and safety of AK104 (an anti- PD-1 and CTLA-4 bispecific antibody), alone or combined with chemotherapy, in subjects with recurrent…
- Trial name
- NCT05932212
- Testing
- AK104, AK104+ Paclitaxel+Cisplatin or Carboplatin
- Where
- 6 sites in China
- Volunteers
- 20 people
- Sponsor
- Akeso
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Rhinosinusitis With Nasal Polyps
This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AK139 injection compared with placebo in…
- Trial name
- NCT07755371
- Testing
- AK139
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Akeso
Resectable Non-small Cell Lung Cancer
AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC
AK112, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable NSCLC
- Trial name
- NCT05247684
- Testing
- AK112, Carboplatin, Cisplatin
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Akeso
Non-Small Cell Lung Cancer
A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer
The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced non-small cell lung cancer.
- Trial name
- NCT07623356
- Testing
- AK138D1, Ivonescimab, Carboplatin
- Where
- China
- Volunteers
- 265 people
- Sponsor
- Akeso
Advanced Breast Cancer
A Phase II Study of AK146D1 Combined With AK112 in Advanced Breast Cancer
This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 combined with AK112 in advanced breast cancer.
- Trial name
- NCT07591090
- Testing
- AK146D1 for injection, AK112 Injection
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Akeso
Advanced Non Small Cell Lung Cancer (NSCLC)
A Phase II Study of AK146D1 in Combination With AK112 in Advanced Non-Small Cell Lung Cancer
This is a phase II clinical study evaluating the safety, tolerability, pharmacokinetics and antitumor efficacy of AK146D1 in combination with AK112 or other anticancer therapies in patients with advanced Non-Small Cell Lung…
- Trial name
- NCT07669779
- Testing
- AK146D1 for injection, AK112 Injection, Platinum chemotherapy
- Where
- China
- Volunteers
- 348 people
- Sponsor
- Akeso
Renal Cell Carcinoma, First-line Treatment
A Study of AK104 Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma
This is a Phase II, open-label trial to evaluate the efficacy and safety of AK104 monotherapy or AK104 in combination with axitinib as a first-line treatment for advanced/metastatic renal cell carcinoma (RCC).
- Trial name
- NCT05256472
- Testing
- AK104, axitinib
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Akeso
Healthy Subjects
A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Healthy Male Chinese Subjects
This is a phase I clinical study to evaluate the pharmacokinetics (PK) similarity of single dose subcutaneous injection of Ebronucimab with different production processes in Chinese healthy male subjects.
- Trial name
- NCT07043283
- Testing
- Ebronucimab
- Where
- China
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Akeso
Advanced Malignant Tumors
A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors
Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) and AK117#AntiCD47 Antibody# combined with or without chemotherapy in advanced malignant tumors
- Trial name
- NCT05235542
- Testing
- AK104, AK117, Capecitabine tablets
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Akeso
Advanced Non-small Cell Lung Cancer
A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer
Phase II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) combined with Docetaxel in Advanced Non-Small Cell Lung Cancer whose disease has progressed after…
- Trial name
- NCT05215067
- Testing
- AK104, Docetaxel
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Akeso
Urothelial Carcinoma (UC)
A Phase II Study of AK146D1 Mono or Combined With AK112 in Advanced Urothelial Carcinoma
This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 monotherapy or combined with AK112 in advanced Urothelial carcinoma.
- Trial name
- NCT07636772
- Testing
- AK146D1 for injection, AK112 Injection
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Akeso
Healthy Male Adults Participants
A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Participations
This study is to evaluate the pharmacokinetic (PK) similarity of AK104 (an anti-PD-1/CTLA-4 bispecific antibody) from the proposed new manufacturing site and the approved original site in healthy male participants.
- Trial name
- NCT07619001
- Testing
- AK104 (New Site), AK104 (Original Site)
- Where
- China
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Akeso