Combining AK109 and AK104 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety, tolerability, and effectiveness of a combination of AK109 and AK104 in patients with advanced solid tumors. It is a multi-center, open-label study that includes both Phase 1 and Phase 2 components. Participants will receive the investigational treatments and undergo assessments to determine pharmacokinetic characteristics and treatment outcomes. The study aims to provide new therapeutic options for patients whose tumors have not responded to standard therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written and signed informed consent.
2. Age ≥ 18 years and ≤ 75 years.
3. ECOG Performance Status of 0 or 1.
4. Estimated life expectancy of ≥3 months.
5. Histologically or cytologically documented, locally advanced or metastatic solid tumours (NSCLC, mCRC, HCC, GEJ, etc. ), for which standard therapy does not exist or has proven ineffective or intolerable.
6. At least one radiographically measurable lesion per RECIST 1.1.
7. Tumor biopsy (during advanced stage) available.
8. Adequate organ function.
9. Female participants of childbearing potential and male partners 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. Other documented active malignancies other than for this trial within 3 years.
2. Participation in other clincial trials simultaneously.
3. Use of systemic anti-tumor treatments with 4 weeks, non-specific immunomodulating agents within 2 weeks.
4. Prior exposure to other T cell coregulatory proteins except for PD-1/PD-L1 inhibitors (apart from cohort B, i.e. treatment naive HCC patients).
5. Current use corticosteroids/immunosuppressive agents, permanently discontinuation of study drug, or having any unresolved irAEs (≥grade 2) from prior PD-1/PD-L1 inhibitors treatment.
6. Central nervous system (CNS) metastasis, meningeal metastasis, spinal cord compression, or leptomeningeal disease.
7. Uncontrolled pleural/pericardial or peritoneal effusion.
8. History of hemorrhagic event need blood transfusion, invasive approaches to intervene, or hospitalization within 3 months, or having high risks of bleeding.
9. Any thromboembolic event, non-gastrointestinal fistula or female genital tract fistula within 6 months.
10. Uncontrolled gastrointestinal diseases.
11. Use of NSAIDs and anticoagulant agents within 7 days.
12. Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks.
13. Severe or uncontrolled hypertension and cardiovascular/cerebrovascular diseases.
14. Uncontrolled comorbidities need corticosteroids using.
15. Active or prior autoimmune disease or history of immunodeficiency.
16. History of interstitial lung disease.
17. Known history of active tuberculosis (TB).
18. Evidence of active infections including hepatitis B and C.
19. Use of anti-infectious agents within 2 weeks.
20. History of human immunodeficiency virus (HIV) infections.
21. Active syphilis infections.
22. Any unresolved toxicities (≥grade 2) from previous anti-cancer therapies.
23. Mental illness, drug abuse, or alcohol dependence that may affect compliance with the test requirements.

Where it's running

• First affliated hospital of Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Nong Xu, MD — The First Affiliated Hospital of Medicine College, Zhejiang University
• Study coordinator: Ting Liu, MD
• Email: clinicaltrials@akesobio.com
• Phone: +86 (0760) 8987 3999

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.