NCT05142423 A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors
| NCT ID | NCT05142423 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Akeso |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 198 participants |
| Start Date | 2021-11-03 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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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 198 participants in total. It began in 2021-11-03 with a primary completion date of 2027-04.
⚠ 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 multi-center, open label, phase Ib/II clinical study of AK109 and AK104 to evaluate the safety, tolerability, effectiveness, pharmacokinetic characteristics in advanced solid tumors .
Eligibility Criteria
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.
Contact & Investigator
Nong Xu, MD
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of Medicine College, Zhejiang University
Frequently Asked Questions
Who can join the NCT05142423 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Solid Tumor. 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 NCT05142423 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 NCT05142423 currently recruiting?
Yes, NCT05142423 is actively recruiting participants. Contact the research team at clinicaltrials@akesobio.com for enrollment information.
Where is the NCT05142423 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05142423 clinical trial?
NCT05142423 is sponsored by Akeso. The principal investigator is Nong Xu, MD at The First Affiliated Hospital of Medicine College, Zhejiang University. The trial plans to enroll 198 participants.