drugset
drugset / Trial / NCT06943820

AK129 Combination Therapy for Advanced Solid Tumors

NCT06943820 ↗

Phase 1/2 Recruiting 230 enrolled Akeso
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-05-21
Primary completion
2026-12
Completion
2028-05

Drugs

EvaluationDrugModalityDoseRoute
Subject AK129 Unknown — Intravenous
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Cetuximab Monoclonal antibody 400 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 100 mg/m2 Intravenous
Subject Docetaxel Small molecule 35 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous
Comparator Penpulimab Monoclonal antibody 200 mg Intravenous
Subject fluorouracil Small molecule 1000 mg/m2 Intravenous

Indications

colorectal adenocarcinoma head and neck squamous cell carcinoma non-small cell lung carcinoma