AK129 combination therapy for advanced solid tumors
A Phase Ib/II Study of Anti-PD-1/LAG-3 Bispecific Antibody AK129 Combinations in Advanced Solid Tumors
This study tests AK129 given with chemotherapy in adults with advanced non-small cell lung, head and neck, or colorectal cancers to find a safe dose and see if it helps control their disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Akeso Industry-sponsored |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06943820 on ClinicalTrials.gov |
What this trial studies
This is an open-label, multicenter phase Ib/II trial designed to confirm the recommended Phase II dose (RP2D) and to evaluate safety and early signs of efficacy for AK129 given in combination with standard chemotherapies. The program uses dose-escalation cohorts followed by expansion cohorts in tumor-specific groups including NSCLC, HNSCC, and colorectal adenocarcinoma. Interventions include AK129 at two dose levels combined with agents such as pemetrexed, paclitaxel, or carboplatin depending on the cohort. Eligible patients are adults (18–75) with ECOG 0–1 and meet tumor- and prior-treatment–specific criteria, and primary endpoints focus on safety and dose with secondary endpoints addressing anti-tumor activity.
Who should consider this trial
Good fit: Adults aged 18–75 with advanced NSCLC, recurrent/metastatic HNSCC, colorectal adenocarcinoma, or other advanced solid tumors who have ECOG 0–1 and meet the study's prior-treatment criteria are the intended participants.
Not a fit: Patients with poor performance status (ECOG >1), life expectancy under three months, cancers not listed, or who do not meet the cohort-specific prior-treatment requirements are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, these AK129 combinations could provide a new treatment option that improves tumor control or extends survival for some patients with advanced solid tumors.
How similar studies have performed: Combining novel agents with platinum-based chemotherapy and PD-(L)1–directed approaches has shown benefit in some cancer types, but AK129 appears to be a novel agent with limited published clinical data to date.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shenyang, Liaoning
- Liaoning Cancer Hospital — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Wenting Li,M.D.
- Email: clinicaltrials@akesobio.com
- Phone: +86(0760)89873999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.