NCT06943820 AK129 Combination Therapy for Advanced Solid Tumors
| NCT ID | NCT06943820 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Akeso |
| Condition | Non-small Cell Lung Cancer Stage IIIB/IV |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2025-05-21 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 230 participants in total. It began in 2025-05-21 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: 1. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures); 2. ≥18 years old and ≤ 75 years (regardless of sex); 3. ECOG performance status 0-1; 4. Life expectancy longer than 3 months; 5. 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; 6. 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; 7. Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite stabilization; 8. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; 9. Adequate organ function. Exclusion Criteria: 1. 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; 2. 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; 3. Participating in another clinical research; 4. Has known active central nervous system (CNS) metastases, brain stem/meningeal metastasis, spinal cord metastasis or compression; 5. Has an active autoimmune disease that has required systemic treatment in the past 2 years; 6. 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; 7. Past or currently has non-infectious pneumonia/interstitial lung disease that requires systemic glucocorticoid therapy; 8. Has pleural effusion, pericardial effusion, or ascites that have clinical symptoms or require repeated drainage; 9. Had a history of myocarditis, cardiomyopathy, and malignant arrhythmia; 10. Has known allergy to any component of any investigational drug; a known history of severe hypersensitivity to other monoclonal antibodies; 11. Pregnant or lactating female.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06943820 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-small Cell Lung Cancer Stage IIIB/IV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06943820 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06943820 currently recruiting?
Yes, NCT06943820 is actively recruiting participants. Contact the research team at clinicaltrials@akesobio.com for enrollment information.
Where is the NCT06943820 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT06943820 clinical trial?
NCT06943820 is sponsored by Akeso. The trial plans to enroll 230 participants.
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