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KN046 in Subjects With Late Stage Esophageal Squamous Cell Carcinoma

NCT03925870 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-08-05

No results posted yet for this study

Summary

This is an open-label, multi-center, single arm study to evaluate the efficacy, safety and tolerability of KN046 in subjects with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC).

The study is composed of 3 stages. Stage 1 (Safety run-in period) will enroll approximately 6 subjects with KN046 3 mg/kg Q2W IV, for at least 4 cycles; thereafter, Scientific Monitoring Committee (SMC) will held to review the safety profiling data and decide whether proceed to stage 2 (Expansion period). Stage 2 will enroll up to 30 subjects. After completion of the enrollment from Stage 2 and all subjects have completed at least two post baseline tumor evaluation, an interim analysis will be performed for efficacy evaluation. SMC will continuously review the safety and clinical efficacy during the study and at the interim analysis and be responsible for the decision of proceeding to Stage 3 (Biomarker enrich period).

Conditions

Interventions

DRUG

KN046

Eligible subjects will be enrolled and receive KN046 (3 mg/kg) monotherapy treatment until progressive disease according to RECIST 1.1, unacceptable toxicity, completion of 2 years' KN046 treatment, or withdrawal of informed consent, whichever comes first

Sponsors & Collaborators

  • Jiangsu Alphamab Biopharmaceuticals Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-21
Primary Completion
2021-08-26
Completion
2022-07-04

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03925870 on ClinicalTrials.gov