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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Clinicaltrials.gov identifier NCT03927495

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted May 29, 2019

Study Description

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.

  • Condition or Disease:Esophageal Squamous Cell Carcinoma
  • Intervention/Treatment: Drug: KN046
    Drug: KN046
    Radiation: palliative radiotherapy
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Phase II Study of KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma to Evaluate Safety, Efficacy and Tolerance
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Concurrent chemoradiotherapy and KN046
Participants in the Arm I will receive chemoradiotherapy and concurrent KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.
Drug: KN046
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.

Radiation: palliative radiotherapy
3D conformal radiation therapy will be administered for esophageal lesion or nearby lymph node. Stereotactic body radiation will be administered for metastatic lesion.
Experimental: chemoradiotherapy and sequential KN046
Participants in the Arm II will receive chemoradiotherapy and sequential KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.
Radiation: palliative radiotherapy
3D conformal radiation therapy will be administered for esophageal lesion or nearby lymph node. Stereotactic body radiation will be administered for metastatic lesion.

Drug: KN046
Cisplatin+paclitaxel will be administered once every three weeks for four cycles. After completion of radiotherapy, KN046 will be administered once every two weeks until progressive disease, unacceptable toxicity or up to 2 years.
Outcome Measures
  • Primary Outcome Measures: 1. dose-limiting toxicity KN046 [ Time Frame: 28 days after first dose ]
  • 2. 6-month progression free survival rate assessed by investigator based on RECIST 1.1 [ Time Frame: 6 months after first dose ]
  • 3. Objective response rate assessed by investigator based on RECIST 1.1 [ Time Frame: 2 years ]
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Contacts and Locations
Contacts

Contact: Songbing Qin, MD 8651267780081 ext 8651267780081 sdfyec@163.com

Locations

China
The First Affiliated Hospital of Suzhou University
Suzhou

Sponsors and Collaborators

Shanghai Chest Hospital

The First Affiliated Hospital of Suzhou University

More Information
  • Responsible Party: Shanghai Chest Hospital
  • ClinicalTrials.gov Identifier: NCT03927495 History of Changes
  • Other Study ID Numbers: KN046-IST-01
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: May 29, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Carcinoma
    Carcinoma, Squamous Cell
    Esophageal Squamous Cell Carcinoma