AK129 Combination Therapy for Advanced Solid Tumors

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

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

Sponsors & Collaborators

• Akeso

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-21

Primary Completion

2026-12-31

Completion

2028-05-31

Countries

• China

Study Locations