Actively Recruiting
A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors
Led by Akeso · Updated on 2025-03-12
198
Participants Needed
1
Research Sites
282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 .
CONDITIONS
Official Title
A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written and signed informed consent
- Age 18 to 75 years
- ECOG Performance Status of 0 or 1
- Estimated life expectancy of at least 3 months
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors where standard therapy is unavailable or ineffective
- At least one measurable tumor lesion per RECIST 1.1
- Available tumor biopsy during advanced stage
- Adequate organ function
- Agreement to use effective contraception during the study and for 120 days after last dose for females of childbearing potential and male partners
You will not qualify if you...
- Other active malignancies within 3 years besides the current trial
- Participation in other clinical trials simultaneously
- Use of systemic anti-tumor treatments within 4 weeks or immunomodulating agents within 2 weeks
- Prior exposure to T cell coregulatory proteins except PD-1/PD-L1 inhibitors (except treatment naive HCC patients)
- Current use of corticosteroids or immunosuppressive agents or unresolved immune-related adverse events from prior PD-1/PD-L1 treatment
- Central nervous system metastasis or related conditions
- Uncontrolled pleural, pericardial, or peritoneal effusion
- Recent hemorrhagic events requiring intervention or high bleeding risk
- Recent thromboembolic events or fistulas within 6 months
- Uncontrolled gastrointestinal diseases
- Use of NSAIDs or anticoagulants within 7 days
- Major surgery, open biopsy, or significant injury within 4 weeks
- Severe or uncontrolled hypertension, cardiovascular or cerebrovascular disease
- Uncontrolled comorbidities requiring corticosteroids
- Active or prior autoimmune disease or immunodeficiency
- History of interstitial lung disease
- Known active tuberculosis
- Evidence of active infections including hepatitis B and C
- Use of anti-infectious agents within 2 weeks
- History of HIV infection
- Active syphilis infection
- Unresolved toxicities grade 2 or higher from previous anti-cancer therapies
- Mental illness, drug abuse, or alcohol dependence affecting compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
First affliated hospital of Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
T
Ting Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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