Clinical trials: sponsored by 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
Advanced Solid Tumors
A Phase Ib/II Clinical Study of AK127 in Combination With AK112 in Patients With Advanced Solid Tumors
A Phase Ib/II Open-label Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AK127 in combination with AK112 in Patients with Advanced Malignant Tumors
- Trial name
- NCT05951608
- Testing
- AK127 in combination with AK112
- Where
- China
- Volunteers
- 216 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
Atopic Dermatitis
A Study to Evaluate the Efficacy and Safety of AK120 in Subjects With Moderate to Severe Atopic Dermatitis
This is a multicenter, open label phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
- Trial name
- NCT06700499
- Testing
- AK120 300mg Q2W (JAK inhibitor users need to double the initial dose)
- Where
- 50 sites in China
- Volunteers
- 450 people
- Sponsor
- Akeso
Metastatic Triple-negative Breast Cancer, Locally Advanced Triple-negative Breast Cancer
A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer
This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK117/AK112 administered with chemotherapy in participants with locally advanced or metastatic triple-negative…
- Trial name
- NCT05227664
- Testing
- AK117, AK112, Nab paclitaxel
- Where
- 2 sites in China
- Volunteers
- 120 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
Metastatic Pancreatic Ductal Adenocarcinoma
AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer
This trial is a Phase Ib/II study. All patients are stage IV pancreatic cancer (PDAC) patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Trial name
- NCT06646055
- Testing
- AK112, Cadonilimab, nab-paclitaxel, gemcitabine, AK112, nab-paclitaxel, gemcitabine, nab-paclitaxel, gemcitabine
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Akeso
Advanced Non-small-cell Lung Cancer
AK112 in Advanced Non-Small Cell Lung Cancer
This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Trial name
- NCT05499390
- Testing
- AK112, Pembrolizumab
- Where
- China
- Volunteers
- 398 people
- Sponsor
- Akeso
NSCLC
Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients
This is a phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 and AK112 With or Without Chemotherapy for NSCLC patients.
- Trial name
- NCT05636267
- Testing
- AK119, AK112, Pemetrexed
- Where
- China
- Volunteers
- 59 people
- Sponsor
- Akeso
Advanced Malignant Tumors
A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors
Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK112 (anti-PD-1 and VEGF bispecific antibody) combined with AK117#AntiCD47 Antibody# in advanced malignant tumors
- Trial name
- NCT05229497
- Testing
- AK112, AK117, Carboplatin
- Where
- China
- Volunteers
- 154 people
- Sponsor
- Akeso
Advanced Non-small-cell Lung Cancer
AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer
This trial is a Phase Ib/II study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Trial name
- NCT05904379
- Testing
- AK112, AK104, Carboplatin
- Where
- 2 sites in China
- Volunteers
- 233 people
- Sponsor
- Akeso
Healthy Male Subjects
A Study to Evaluate the PK Similarity of AK112 in Healthy Chinese Male Subjects
The purpose of this study is to evaluate the pharmacokinetic (PK) similarity of AK112 (an anti-PD-1/VEGF bispecific antibody) from the proposed new manufacturing site and the approved original site in healthy male subjects.
- Trial name
- NCT07340476
- Testing
- AK112 (New Site), AK112 (Original Site)
- Where
- China
- Volunteers
- 108 people, healthy volunteers welcome
- 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
Gastric / Gastroesophageal Junction Adenocarcinoma
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
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…
- Trial name
- NCT07449780
- Testing
- AK104(SC), AK104(IV), Capecitabine
- Volunteers
- 422 people
- Sponsor
- Akeso