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RECRUITINGPHASE1/PHASE2

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

NCT06943820•Akeso

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
+1 more criteria

Locations (1)

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Key Dates

Start Date

May 21, 2025

Primary Completion Date

December 1, 2026

Completion Date

May 1, 2028

Last Updated

June 3, 2025

Enrollment

230

ESTIMATED participants

Conditions

Non-small Cell Lung Cancer Stage IIIB/IVHead and Neck Squamous Cell Carcinoma (HNSCC)Colorectal AdenocarcinomaAdvanced Solid Tumors

Interventions

AK129(dose 1)

DRUG

Pemetrexed

DRUG

Paclitaxel

DRUG

Carboplatin

DRUG

AK129(dose 2)

DRUG

Docetaxel

DRUG

Cis-platinum

DRUG

5-FU (5-fluorouracil)

DRUG

Cetuximab

DRUG

Paclitaxel

DRUG

Docetaxel

DRUG

Chemotherapy

DRUG

AK129(RP2D)

DRUG

Penpulimab

DRUG

Contacts

Wenting Li,M.D.

CONTACT

+86(0760)89873999 clinicaltrials@akesobio.com

Hongxu Liu,M.D.

CONTACT

Hongxuliu@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

AK129 Combination Therapy for Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer

A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma