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Trial Title:
Study of AK119 Combined With AK104 in Patients With Advanced Solid Tumors
NCT ID:
NCT05559541
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AK119
Description:
AK119 is an anti-CD73 monoclonal antibody.
Arm group label:
AK119+AK104
Intervention type:
Drug
Intervention name:
AK104
Description:
AK104 is an anti-PD-1 and CTLA-4 bispecific antibody.
Arm group label:
AK119+AK104
Summary:
This is a Phase Ib/II Study to evaluate the safety, tolerability, pharmacokinetics, and
anti-tumor activity of AK119 combined with AK104 in tumor patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects must sign the written informed consent form (ICF) voluntarily.
2. Age ≥ 18 years.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 to1.
4. Life expectancy ≥12 weeks.
5. Subjects must have histologically or cytologically confirmed advanced solid tumor
that is refractory or relapsed to the current standard therapies, or for which no
effective standard therapy is available.
6. Subjects must have evaluable lesions according to RECIST v1.1.
7. Subjects must have adequate organ function.
8. Female subjects of childbearing potential and male subjects with female partners of
childbearing potential must agree to use effective barrier methods of contraception
during the study and for 120 days after last dose of study drug.
Exclusion Criteria:
1. Prior malignancy active within the previous 3 years except for the locally curable
cancers that have been apparently cured.
2. Being involved in another clinical study, except for observational clinical studies
or follow-up period of interventional studies.
3. Have exposed to other products targeting T cell costimulation or immune checkpoint
pathway excepts for PD-1/PD-L1 inhibitor.
4. Anticancer therapy (e.g., chemotherapy, radiotherapy, etc.) within 4 weeks prior to
the first dose of investigational product; Anticancer small-molecule targeted agent
(e.g., tyrosine kinase inhibitor) within 2 weeks prior to the first dose of
investigational product.
5. Subjects with spinal cord compression or active brain metastases, except for
subjects with untreated and asymptomatic brain metastases or with stable brain
metastases after treatment.
6. Subjects with pleural effusion, pericardial effusion, or ascites requiring repeated
drainage.
7. Subjects whose imaging shows that the tumor has invaded important blood vessels or
the investigator judges that the tumor is very likely to invade important blood
vessels and cause fatal bleeding during the study.
8. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE
version 5.0).
9. Patients with clinically significant cardio-cerebrovascular or venous thromboembolic
disease.
10. Active autoimmune diseases or history of autoimmune diseases that may relapse.
11. History of interstitial lung disease or noninfectious pneumonitis.
12. Major surgery or trauma within 4 weeks prior to first dose of investigational
product. Unhealed wound, ulcer or fracture within 4 weeks prior to first dose of
investigational product.
13. Any condition that required systemic treatment with corticosteroids (> 10 mg daily
prednisone or equivalent) or other immunosuppressive agents within 14 days prior to
the first dose of investigational product.
14. Receipt of live attenuated vaccines within 4 weeks prior to the first dose of
investigational product.
15. Previous history of severe hypersensitivity reactions to other monoclonal
antibodies.
16. Patients are pregnant or breastfeeding, or plan to breastfeed during the study.
17. Previous organ transplantation or allogeneic hematopoietic stem cell
transplantation.
18. Any other conditions that, in the opinion of the Investigator, would interfere with
evaluation of the investigational product or interpretation of subject safety or
study results.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Insitute & Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Jihui Hao, Doctor
Phone:
022-23340123-3070
Email:
haojihui@tjmuch.com
Start date:
December 15, 2022
Completion date:
September 2024
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05559541
