RecruitingPhase 1Phase 2NCT06943820

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


Sponsor

Akeso

Enrollment

230 participants

Start Date

May 21, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing AK129 — a new immunotherapy drug — in combination with other treatments for patients with advanced lung cancer (NSCLC), head and neck cancer (HNSCC), or colorectal cancer that has progressed after standard therapies including platinum chemotherapy and PD-1/PD-L1 immunotherapy. **You may be eligible if...** - You are aged 18–75 - You have confirmed advanced NSCLC, HNSCC, or colorectal cancer - Your cancer has progressed during or after platinum-based chemotherapy and a PD-1/PD-L1 immunotherapy drug - Your performance status is ECOG 0–1 and your life expectancy is more than 3 months - You have measurable disease on scans **You may NOT be eligible if...** - You have not previously received both platinum chemotherapy and immunotherapy - You have active brain metastases or untreated CNS involvement - You have severe autoimmune disease or organ dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAK129(dose 1)

IV infusion

DRUGPemetrexed

IV infusion;500mg/m2

DRUGPaclitaxel

IV infusion;175mg/m2

DRUGCarboplatin

IV infusion;AUC 5

DRUGAK129(dose 2)

IV infusion

DRUGDocetaxel

IV infusion;75mg/m2

DRUGCis-platinum

IV infusion;100 mg/m2

DRUG5-FU (5-fluorouracil)

IV infusion;1000 mg/m2

DRUGCetuximab

IV infusion;400mg/m2/ 250mg/m2

DRUGPaclitaxel

IV infusion;80mg/m2

DRUGDocetaxel

IV infusion;35mg/m2

DRUGChemotherapy

IV infusion

DRUGAK129(RP2D)

IV infusion

DRUGPenpulimab

IV infusion;200mg


Locations(1)

Liaoning Cancer Hospital

Shenyang, Liaoning, China

View Full Details on ClinicalTrials.gov

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NCT06943820


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