Status:
RECRUITING
AK129 Combination Therapy for Advanced Solid Tumors
Lead Sponsor:
Akeso
Conditions:
Non-small Cell Lung Cancer Stage IIIB/IV
Head and Neck Squamous Cell Carcinoma (HNSCC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 safe...
Eligibility Criteria
Inclusion
- Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);
- ≥18 years old and ≤ 75 years (regardless of sex);
- ECOG performance status 0-1;
- Life expectancy longer than 3 months;
- 1)Histologically or cytologically confirmed diagnosis of Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer \[AJCC\]); 2)No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC;must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of locally advanced or metastatic disease and progressed during or after receiving prior therapy;
- 1)Histologically or cytologically confirmed diagnosis of recurrent or metastatic HNSCC (American Joint Committee on Cancer \[AJCC\]); 2)No prior systemic anti-tumor therapy for recurrent or metastatic HNSCC ;must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of recurrent or metastatic disease and progressed during or after receiving prior therapy;
- Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite stabilization;
- Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
- Adequate organ function.
Exclusion
- Histologically or cytologically confirmed the presence of small cell carcinoma components/EGFR-sensitive mutations or ALK fusion positivite/known ROS1 rearrangement, MET exon 14 skipping mutation, EGFR exon 20 insertion mutation, BRAF V600E mutation, NTRK gene fusion positivite or RET gene fusion positivite;
- Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite highly unstable/mismatch repair gene expression defect (MSI-H/dMMR)or histopathological examination confirmed other pathological types;
- Participating in another clinical research;
- Has known active central nervous system (CNS) metastases, brain stem/meningeal metastasis, spinal cord metastasis or compression;
- Has an active autoimmune disease that has required systemic treatment in the past 2 years;
- Has known active tuberculosis (TB) and suspected active TB should be ruled out by clinical examination; known active syphilis infection; known active Hepatitis B or Hepatitis C;
- Past or currently has non-infectious pneumonia/interstitial lung disease that requires systemic glucocorticoid therapy;
- Has pleural effusion, pericardial effusion, or ascites that have clinical symptoms or require repeated drainage;
- Had a history of myocarditis, cardiomyopathy, and malignant arrhythmia;
- Has known allergy to any component of any investigational drug; a known history of severe hypersensitivity to other monoclonal antibodies;
- Pregnant or lactating female.
Key Trial Info
Start Date :
May 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT06943820
Start Date
May 21 2025
End Date
May 1 2028
Last Update
June 3 2025
Active Locations (1)
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1
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110801