KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

NCT03927495 | Unknown Phase 2

• 1 other identifier: KN046-IST-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, phase II study of KN046 combined with chemotherapy and palliative radiotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma to evaluate the safety, efficacy and tolerance.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• dose-limiting toxicity KN046

  28 days after first dose

• 6-month progression free survival rate assessed by investigator based on RECIST 1.1

  6 months after first dose

• Objective response rate assessed by investigator based on RECIST 1.1

  2 years

Study Arms (2)

Concurrent chemoradiotherapy and KN046

EXPERIMENTAL

Participants in the Arm I will receive chemoradiotherapy and concurrent KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.

Drug: KN046; Radiation: palliative radiotherapy

chemoradiotherapy and sequential KN046

EXPERIMENTAL

Participants in the Arm II will receive chemoradiotherapy and sequential KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.

Radiation: palliative radiotherapy; Drug: KN046

Interventions

KN046 DRUG

Cisplatin+paclitaxel will be administered once every three weeks for four cycles. During the period of radiotherapy, KN046 will be administered once every two weeks until progressive disease, unacceptable toxicity or up to 2 years.

Also known as: Cisplatin+paclitaxel

Concurrent chemoradiotherapy and KN046

palliative radiotherapy RADIATION

3D conformal radiation therapy will be administered for esophageal lesion or nearby lymph node. Stereotactic body radiation will be administered for metastatic lesion.

Concurrent chemoradiotherapy and KN046; chemoradiotherapy and sequential KN046

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed inform consent form(ICF)
• Age ≥ 18 years and ≤ 75 years, male or female
• Histologically or cytologically documented recurrent or metastatic esophageal squamous cell carcinoma, with indications of radiotherapy and without prior systemic treatment
• At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function
• Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
• Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures

You may not qualify if:

• Known brain metastasis or another Central Nervous System (CNS) metastasis that is either symptomatic or untreated.
• Patients who are participating or have participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment.
• Patients who have received immune checkpoint proteins/antibody/medicine for treatment.
• Patients who have interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
• Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded
• Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.
• Known HIV infection or known history of acquired immune deficient syndrome (AIDS)
• Any unresolved the Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 toxicities from prior anti-cancer therapy except for vitiligo, alopecia
• Patients who have serious hypersensitive reaction to monoclonal antibodies and have history of uncontrolled allergic asthma

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• First Affiliated Hospital of Suzhou Medical College: collaborator

Study Sites (1)

The First Affiliated Hospital of Suzhou University

Suzhou, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

TP protocol

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Songbing Qin, MD

CONTACT

8651267780081; sdfyec@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Radiation Oncology

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: May 22, 2019
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

CN (1)