AK119 plus AK112 for advanced solid tumors

An Open-label, Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability and Antitumor Activity of AK119 in Combination With AK112 in Patients With Advanced Solid Tumors

This trial tests whether combining two experimental drugs, AK119 and AK112, is safe and may help adults with advanced solid tumors that have progressed after standard treatment.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 87 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Akeso (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05689853 on ClinicalTrials.gov

What this trial studies

This Phase Ib/II trial combines AK119 and AK112 to characterize safety, tolerability, and preliminary anti-tumor activity in adults with advanced or unresectable solid tumors. The early (Ib) portion will identify tolerated dose levels and the Phase II portion will explore signs of clinical activity in patients with measurable disease by RECIST v1.1 and ECOG 0–1. Eligible participants are 18–75 years old, have progressed after at least one standard regimen if available, and must have adequate organ function and agreed contraception where applicable. The study is being conducted at Peking Union Medical College Hospital in Beijing.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically or cytologically confirmed advanced or unresectable solid tumors that progressed after at least one standard therapy, with measurable disease, ECOG 0–1, and adequate organ function.

Not a fit: Patients with poor performance status (>ECOG 1), uncontrolled medical conditions, recent other active cancers, inadequate organ function, or those unable to attend the Beijing study site are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the combination could provide a new treatment option that controls tumor growth for some patients with advanced solid tumors.

How similar studies have performed: Some early-phase trials combining novel targeted or immune agents have shown activity in select solid tumors, but AK119 and AK112 together are experimental and their combined benefit has not been established.

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

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Wenming Wu, PhD — Peking Union Medical College Hospital
• Study coordinator: Ting Liu, MD

Conditions Solid Tumor, Adult