Trial intelligence / Profile preview

AK104 +/- Chemotherapy in First-line Advanced Esophageal Squamous Cell Carcinoma

NCT05522894Phase 2

Key facts

Status: Unknown
Start: Oct 2022
Primary completion: Apr 2024
Sponsor: Chinese Academy of Medical Sciences
Modality: Bispecific Antibodies

Drugs: cadonilimab
Conditions: Esophageal Squamous Cell Carcinoma (ESCC)

Overview

Phase 2, open-label trial of cadonilimab in Esophageal Squamous Cell Carcinoma (ESCC) (2 cohorts), sponsored by Chinese Academy of Medical Sciences. Primary endpoint: Objective Response Rate. Status: unknown.

Design

2 arms

Study design: Non-randomizedOpen-label

Cohort A
AK104 monotherapy (PD-L1 CPS >= 5)
Cohort B
AK104 + Chemotherapy (All comers)

Who it enrols

Patients with unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma who have not received prior systemic antitumor therapy. Cohort A requires PD-L1 CPS >= 5.

Endpoints

Primary

Objective Response RateUp to approximately 2 years

Secondary

Progression-Free SurvivalUp to approximately 2 years
Overall SurvivalUp to approximately 2 years
Disease Control RateUp to approximately 2 years
Duration of ResponseUp to approximately 2 years
Adverse EventsUp to approximately 2 years

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