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New treatment option for Non-small Cell Lung Cancer Stage IIIB/IV
Official title AK129 Combination Therapy for Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06943820
What this study is testing
What is AK129(dose 1)?
AK129(dose 1) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer stage iiib/iv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- Histologically or cytologically confirmed the presence of small cell carcinoma components/EGFR-sensitive mutations or ALK fusion positivite/known...
- Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite highly unstable/mismatch repair gene...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.