Actively Recruiting
A Phase Ib/II Study of Anti-PD-1/LAG-3 Bispecific Antibody AK129 Combinations in Advanced Solid Tumors
Led by Akeso · Updated on 2025-06-03
230
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of various combinations including the investigational drug AK129 for treating advanced solid tumors such as non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), colorectal adenocarcinoma (CRC), and other advanced tumors. This open, multicenter phase Ib/II study aims to confirm the recommended dose of AK129 combinations and assess their impact on these cancers. Participants receive different treatment regimens depending on their cancer type and study group. For NSCLC, treatments combine AK129 at different doses with chemotherapy drugs like Pemetrexed, Carboplatin, Paclitaxel, or Docetaxel in 3-week cycles. For HNSCC, AK129 is combined with chemotherapy agents including Carboplatin or Cis-platinum and 5-FU, or with investigator-selected treatments such as Cetuximab or Paclitaxel. Participants with colorectal adenocarcinoma receive AK129 alone until disease progression. Some groups receive Penpulimab plus chemotherapy as an active comparator. During the study, participants are regularly monitored for safety by tracking adverse events and abnormal lab results over about two years. Researchers measure response rates, progression-free survival, overall survival, and other outcomes related to tumor control and treatment duration. Pharmacokinetics and immune responses to the drug are also assessed. Visits occur at regular intervals with ongoing treatment until disease progression or other criteria. The total participation length can be up to approximately two years, with close safety follow-up throughout.
CONDITIONS
Brief Title
AK129 Combination Therapy for Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and comply with study procedures
- Aged 18 to 75 years, any sex
- ECOG performance status of 0 or 1
- Life expectancy longer than 3 months
- Histologically or cytologically confirmed Stage IIIB/C or IV NSCLC, no prior systemic anti-tumor therapy for advanced NSCLC, previously treated with platinum-based chemotherapy and PD-(L)1 monoclonal antibody and progressed
- Histologically or cytologically confirmed recurrent or metastatic HNSCC, no prior systemic therapy for recurrent/metastatic disease, previously treated with platinum-based chemotherapy and PD-(L)1 monoclonal antibody and progressed
- Histologically or cytologically confirmed advanced colorectal adenocarcinoma with microsatellite stabilization
- Measurable disease based on RECIST 1.1
- Adequate organ function
You will not qualify if you...
- Presence of small cell carcinoma components, EGFR-sensitive mutations, ALK fusion positive, ROS1 rearrangement, MET exon 14 skipping mutation, EGFR exon 20 insertion mutation, BRAF V600E mutation, NTRK gene fusion positive, or RET gene fusion positive
- Advanced colorectal adenocarcinoma with microsatellite instability-high or mismatch repair deficiency or other pathological types
- Participation in another clinical research study
- Known active central nervous system metastases or spinal cord metastasis or compression
- Active autoimmune disease requiring systemic treatment in the past 2 years
- Known active tuberculosis, syphilis, Hepatitis B or C infections
- Past or current non-infectious pneumonia or interstitial lung disease requiring systemic glucocorticoids
- Symptomatic pleural, pericardial effusions, or ascites requiring repeated drainage
- History of myocarditis, cardiomyopathy, or malignant arrhythmia
- Known allergy to any investigational drug components or severe hypersensitivity to monoclonal antibodies
- Pregnant or lactating female
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive IV infusions of AK129 combined with chemotherapy drugs every 3 weeks. Treatment includes an initial 4 cycles of combination therapy followed by continued AK129 with or without chemotherapy until disease progression.
Visits every 3 weeks for treatment infusions
Trial Site Locations
Total: 1 location
1
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110801
Actively Recruiting
Research Team
W
Wenting Li,M.D.
H
Hongxu Liu,M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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