Actively Recruiting
A Study of AK129 in Patients With Advanced Malignant Tumors
Led by Akeso · Updated on 2025-03-03
182
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase Ia/Ib, open label, dose escalation and dose extension trial of Anti-PD-1 and LAG-3 bispecific antibody, AK129, to evaluate the safety, tolerability and antitumor efficacy in patients with advanced malignant tumors
CONDITIONS
Official Title
A Study of AK129 in Patients With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form voluntarily
- Aged 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed advanced solid tumors or selected tumor species
- Patients with advanced metastatic malignancies who have failed or are ineligible for standard therapies
- At least one measurable tumor lesion according to RECIST v1.1 or Lugano 2014 criteria
- Agree to provide archived or freshly obtained tumor tissue samples within 2 years prior to initial administration
- Good organ function based on hematology, kidney, liver, blood clotting, and cardiac assessments
- Fertile female subjects must have a negative serum pregnancy test within 3 days prior to initial medication and agree to use effective contraception
- Male subjects with fertile female partners must use effective contraception from screening to 120 days after last dose
You will not qualify if you...
- Active central nervous system metastasis
- Uncontrolled pleural, pericardial, or abdominal effusion requiring frequent drainage
- Other active malignant tumors within 2 years except certain cured or locally curable tumors
- Known immunodeficiency including HIV positive status
- History of allogeneic organ or stem cell transplantation
- Interstitial lung disease or non-infectious pneumonia requiring glucocorticoids
- Severe infections within 4 weeks prior to initial administration
- Active infections requiring systemic treatment within 2 weeks prior to initial administration
- Active viral hepatitis B or C with high viral load
- Active or documented inflammatory bowel disease
- Recent cardiovascular or cerebrovascular events or severe heart conditions
- Recent treatment with monoclonal antibodies, targeted drugs, chemotherapy, or major surgery within specified timeframes
- Prior use of LAG-3 immune checkpoint inhibitors in dose expansion phase
- Recent use of glucocorticoids or immunosuppressive agents above specified doses
- Live vaccine administration within 4 weeks prior to initial administration
- Unresolved toxicity from previous cancer therapy
- Known severe hypersensitivity to monoclonal antibodies
- Any condition posing risk or interfering with study evaluation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
X
Xiao Xu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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