Clinical trials: open to volunteers, sponsored by 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
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 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
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
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
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
Advanced Malignant Solid Tumors
A Phase I Clinical Study of AK150 in Advanced Malignant Solid Tumor
This study is an open-label, multicenter, dose-escalation and dose-expansion Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of AK150…
- Trial name
- NCT07566247
- Testing
- AK150
- Where
- 3 sites in China
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Akeso
Breast Cancer
A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast 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 breast cancer.
- Trial name
- NCT07560124
- Testing
- AK138D1, Ivonescimab, treatment of physician's choice
- Where
- 3 sites in China
- Volunteers
- 286 people
- Sponsor
- Akeso
Locally Advanced Unresectable or Metastatic Gastric Cancer
A Long-term Follow-up Study of Subjects Enrolled in Clinical Trials of Cadonilimab (AK104)
This is an observational and non-interventional clinical study that only collects long-term follow-up data of the subjects. As the world's first approved PD-1/CTLA-4 bispecific antibody for marketing, Cadonilimab may confer…
- Trial name
- NCT07547787
- Where
- China
- Volunteers
- 610 people
- Sponsor
- Akeso
Resectable Colon Cancer, MSI-H/dMMR Colorectal Cancer
Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
This is a randomized, open-label, controlled, multicenter phase 3 study. All patients are resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer.
- Trial name
- NCT07412613
- Testing
- Cadonilimab (AK104), Oxaliplatin, Capecitabine
- Where
- China
- Volunteers
- 386 people
- Sponsor
- Akeso
Non-Small Cell Lung Cancer
Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer
This is a Phase 3 Randomized, double-blind, Multicenter Study of Ivonescimab Combined with Docetaxel Versus Placebo Combined with Docetaxel in Patients with Locally advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) that…
- Trial name
- NSCLC (NCT06928389)
- Testing
- Ivonescimab, docetaxel
- Where
- China
- Volunteers
- 536 people
- Sponsor
- Akeso
Moderate-to-Severe Atopic Dermatitis
A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate-to-severe Atopic Dermatitis
This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of patients with moderate-to-severe atopic dermatitis.
- Trial name
- NCT07502222
- Testing
- AK139
- Volunteers
- 168 people
- Sponsor
- Akeso
Solid Tumor, Adult
Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors
This is a Phase Ib/II study to assess the safety, tolerability and preliminary efficacy of AK119 combined with AK112 in patients with advanced solid tumors.
- Trial name
- NCT05689853
- Testing
- AK119, AK112
- Where
- China
- Volunteers
- 87 people
- Sponsor
- Akeso
Triple-Negative Breast Cancer (TNBC)
AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer
This multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally…
- Trial name
- NCT06767527
- Testing
- AK112, Nab-paclitaxel
- Where
- China
- Volunteers
- 416 people
- Sponsor
- Akeso
Hepatocellular Carcinoma (HCC)
A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.
An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination with TT-00420 Tablet in Patients with Advanced Hepatocellular Carcinoma(HCC).
- Trial name
- NCT07052253
- Testing
- TT-00420 (tinengotinib), AK104, AK112
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Akeso
Small Cell Lung Cancer
A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy
This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK112 to placebo as consolidation treatment for patients with limited stage small cell lung cancer who have not progressed…
- Trial name
- AK112-311 (NCT07010263)
- Testing
- AK112
- Where
- 53 sites in China
- Volunteers
- 560 people
- Sponsor
- Akeso