NCT06943820

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer Stage IIIB/IV
• Head and Neck Squamous Cell Carcinoma (HNSCC)
• Colorectal Adenocarcinoma
• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	AK129(dose 1)	IV infusion
DRUG	Pemetrexed	IV infusion;500mg/m2
DRUG	Paclitaxel	IV infusion;175mg/m2
DRUG	Carboplatin	IV infusion;AUC 5
DRUG	AK129(dose 2)	IV infusion
DRUG	Docetaxel	IV infusion;75mg/m2
DRUG	Cis-platinum	IV infusion;100 mg/m2
DRUG	5-FU (5-fluorouracil)	IV infusion;1000 mg/m2
DRUG	Cetuximab	IV infusion;400mg/m2/ 250mg/m2
DRUG	Paclitaxel	IV infusion;80mg/m2
DRUG	Docetaxel	IV infusion;35mg/m2
DRUG	Chemotherapy	IV infusion
DRUG	AK129(RP2D)	IV infusion
DRUG	Penpulimab	IV infusion;200mg

Timeline

• Start date: 2025-05-21
• Primary completion: 2026-12-01
• Completion: 2028-05-01
• First posted: 2025-04-24
• Last updated: 2025-06-03

Locations

1 site across 1 country: China