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Trial Title:
Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors
NCT ID:
NCT05689853
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 in combination with AK112
Intervention type:
Drug
Intervention name:
AK112
Description:
AK112 is a bispecific monoclonal antibody against VEGF and PD-1.
Arm group label:
AK119 in combination with AK112
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily written informed consent and agree to comply with all protocol-specified
procedures and follow-up evaluations
2. Age ≥ 18 years and ≤ 75 years
3. Histologically or cytologically-confirmed diagnosis of advanced/unresectable solid
tumor that have been progressed or intolerant to at least one standard treatment
regimen in the advanced or metastatic setting, if such a therapy exists
4. Measurable lesion based on RECIST v1.1
5. ECOG status of 0 or 1
6. Life expectancy ≥ 3 months
7. Adequate organ function
8. Women of childbearing potential and men with female partners of childbearing
potential must agree to use effective contraception during treatment and for at
least 120 days following the last dose of study treatment
Exclusion Criteria:
1. Known other active malignancy within 3 years prior to the first dose of
investigational product, with the exception of early stage cancers that have treated
with curative intent
2. Currently participating in another study unless it is an observational,
non-interventional clinical study or a follow-up period of an interventional study
3. Received systemic antineoplastic therapy ( e.g. chemotherapy, radiotherapy,
immunotherapy) within 4 weeks prior to the first dose of investigational product;
received small-molecule anticancer agents within 2 weeks prior to the first dose of
investigational product
4. In addition to anti-PD-(L)1 monoclonal antibody, prior exposure to other immune
checkpoint inhibitors or any other treatment directed to tumor immune mechanism
5. Prior therapy targeting CD73 or CD39 or the adenosine signalling pathway
6. Treatment with non-steroidal anti-inflammatory drugs, anti-platelet agents or
anticoagulants within 7 days prior to the first dose of investigational product
7. Current dependency on systemic therapy with glucocorticoids (>10 mg/day prednisone
or equivalent) or other immunosuppressive agents within 14 days prior to the first
dose of investigational product
8. Presence of spinal cord compression or active brain metastases
9. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated
drainage
10. History or presence of a serious hemorrhage or known bleeding tendency within 3
months
11. Active autoimmune disease that has required systemic treatment in past 2 years
12. Clinically significant cardiovascular disease
13. History of interstitial lung disease or noninfectious pneumonitis
14. Received systemic anti-infective therapy (excluding antiviral therapy for hepatitis
B or C) within 14 days prior to the first dose of investigational product
15. Major surgical procedure or serious trauma within 28 days prior to the first dose of
investigational product
16. History of immunodeficiency, human immunodeficiency virus infection (HIV)
17. Active tuberculosis or syphilis infection
18. History of organ transplantation or allogeneic haematopoietic stem cell
transplantation
19. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE
version 5.0)
20. 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:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100005
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenming Wu, PhD
Phone:
+8613811138595
Email:
doctorwuu@126.com
Start date:
April 14, 2023
Completion date:
December 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/NCT05689853
