NCT05689853 Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors
| NCT ID | NCT05689853 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Akeso |
| Condition | Solid Tumor, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 87 participants |
| Start Date | 2023-04-14 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 87 participants in total. It began in 2023-04-14 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Wenming Wu, PhD
PRINCIPAL INVESTIGATOR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT05689853 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Solid Tumor, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05689853 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05689853 currently recruiting?
Yes, NCT05689853 is actively recruiting participants. Contact the research team at clinicaltrials@akesobio.com for enrollment information.
Where is the NCT05689853 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05689853 clinical trial?
NCT05689853 is sponsored by Akeso. The principal investigator is Wenming Wu, PhD at Peking Union Medical College Hospital. The trial plans to enroll 87 participants.