Actively Recruiting
AK129 Combination Therapy for Advanced Solid Tumors
Led by Akeso · Updated on 2025-06-03
230
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open, multicenter phase Ib/II clinical study. The goal of this study is to confirm the Phase II recommended dose (RP2D) of AK129 combinations for advanced solid tumors and evaluate the safety and efficacy of AK129 combinations for non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), colorectal adenocarcinoma (CRC), and other advanced solid tumors.
CONDITIONS
Official 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 follow all study procedures
- Age 18 to 75 years, any gender
- ECOG performance status of 0 or 1
- Life expectancy longer than 3 months
- Confirmed diagnosis of Stage IIIB/C or IV NSCLC with prior platinum-based and PD-(L)1 antibody therapy and disease progression
- Confirmed diagnosis of recurrent or metastatic HNSCC with prior platinum-based and PD-(L)1 antibody therapy and disease progression
- Confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite stability
- Measurable disease according to RECIST 1.1
- Adequate organ function
You will not qualify if you...
- Presence of small cell carcinoma components, EGFR-sensitive mutations, ALK fusion positive, known 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/mismatch repair gene defect or other pathological types
- Participation in another clinical trial
- Active central nervous system metastases or spinal cord metastasis or compression
- Active autoimmune disease requiring systemic treatment within past 2 years
- Known active tuberculosis, syphilis, hepatitis B, or hepatitis C
- Past or current non-infectious pneumonia or interstitial lung disease requiring systemic glucocorticoids
- Pleural, pericardial, or ascites fluid causing symptoms or needing repeated drainage
- History of myocarditis, cardiomyopathy, or malignant arrhythmia
- Known allergy to any investigational drug component or severe hypersensitivity to monoclonal antibodies
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110801
Actively Recruiting
Research Team
W
Wenting Li,M.D.
CONTACT
H
Hongxu Liu,M.D.
CONTACT
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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