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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 Subjects With Late Stage Esophageal Squamous Cell Carcinoma

Clinicaltrials.gov identifier NCT03925870

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted July 10, 2020

Study Description

Brief 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).

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

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 30 participants
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of KN046 in Subjects With Advanced Unresectable or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: May 2021
Arms and interventions
Arm Intervention/treatment
Experimental: KN046 monotherapy
Eligible subjects will be enrolled and receive KN046 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.
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
Outcome Measures
  • Primary Outcome Measures: 1. Objective response (OR) [ Time Frame: up to 2 years ]
    Objective response (OR) per RECIST 1.1 criteria according to investigators assessment;
  • 2. Duration of response (DOR) [ Time Frame: up to 2 years ]
    Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment;
  • Secondary Outcome Measures: 1. Clinical benefit rate [ Time Frame: up to 2 years ]
    Clinical benefit rate
  • 2. Progression free survival (PFS) rates [ Time Frame: 6 months and 12 months ]
    Progression free survival (PFS) rates
  • 3. Overall survival (OS) rates [ Time Frame: 6 months and 12 months ]
    Overall survival (OS) rates
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 informed consent form;

- 18 years of age or older, Male or female,

- Pathologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)

- Had failed at front line regimen containing fluorouracil, paclitaxel and platinum.
Disease progression within 6 months from previous adjuvant chemotherapy will be
considered as failure of first line systemic therapy;

- Baseline measurable disease according to RECIST 1.1 from irradiated region or
progressed within a previous radiation field;

- ECOG performance status of 0 or 1;

- Have provided tumor tissue from locations not previously irradiated. Tumor biopsy may
be from either the primary or metastatic site of disease;

- Adequate organ function assessed within 7 days prior to first trial treatment:

- Have a life expectancy of at least 3 months;

- If female of childbearing potential, have a negative serum pregnancy test within 7
days prior to first trial treatment;

- If female of childbearing potential or a male subject with a partner with childbearing
potential, be willing to use a highly effective method of contraception (with a
failure rate of less than 1.0% per year) from first study treatment to 24 weeks after
completion of the trial treatment;

Exclusion Criteria:

- Untreated active CNS metastasis or leptomeningeal metastasis. Subjects may be eligible
provided they are treated and clinically stable for at least 4 weeks and have no
evidence of new or enlarging brain metastases and also are off steroids 7 days for
treating brain metastasis prior to first trial treatment;

- Is currently participating and receiving an investigational drug or has participated
in a study of an investigational drug within 4 weeks prior to the first dose of trial
treatment;

- Has received other anti-tumor treatment, including traditional Chinese medicine which
has approved anti-tumor indication within 4 weeks prior to the first trial treatment;

- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first
administration of trial treatment and/or if the subject has not fully recovered from
the surgery within 4 weeks of the first administration of trial treatment;

- Curative radiation within 3 months of the first dose of trial treatment. Radiation to
more than 30% of the bone marrow or with a wide field of radiation should not be used
within 4 weeks prior to the first administration of trial treatment;

- Subjects receiving immunosuppressive agents (such as steroids) for any reason should
be tapered off these drugs before initiation of trial treatment (with the exception of
subjects with adrenal insufficiency, who may continue corticosteroids at physiologic
replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids); - Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines); - Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;

Contacts and Locations
Contacts
Locations

China, Beijing
307 Hospital of PLA
Beijing

Sponsors and Collaborators

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

More Information
  • Responsible Party: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
  • ClinicalTrials.gov Identifier: NCT03925870 History of Changes
  • Other Study ID Numbers: KN046-204
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: July 10, 2020
  • Last Verified: June 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Esophageal Squamous Cell Carcinoma
    Carcinoma
    Carcinoma, Squamous Cell