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A Study of KN046 in Subjects With Locally Advanced or Metastatic Triple-negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT03872791
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Brief Summary:
This is an open-label, phase Ib/II, multi-center study to evaluate efficacy and safety of KN046 alone or in combination with nab-paclitaxel in subjects with locally advanced unresectable or metastatic triple negative breast cancer (TNBC). The study is composed of dose escalation and expansion parts. Every subject will subject tumor tissue used for biomarker evaluation. Each subject will receive KN046 or in combination with nab-paclitaxel untill confirmed progressive disease, unacceptable toxicity or withdrawal of informed consent whichever occurs first.

Condition or disease Intervention/treatment Phase
Triple-negative Breast Cancer Biological: KN046 Drug: Nab-paclitaxel Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib/II Study to Evaluate Efficacy, Safety and Tolerability of KN046 Monotherapy or in Combination With Nab-paclitaxel in Subjects With Triple-negative Breast Cancer
Actual Study Start Date : May 30, 2019
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : September 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: KN046
Subjects will receive KN046 at a dose of 3 mg/kg or 5 mg/kg via intravenous infusion on Days 1 and 15 of every 28-day cycle until disease progression, unacceptable toxicity or completion of 2 years of treatment
Biological: KN046
KN046 at a dose level of 3 or 5 mg/kg via intravenous infusion on Days 1 and 15 of 28-day cycle

Experimental: KN046 plus nab-paclitaxel
Subjects will receive KN046 at a dose of 3 mg/kg or 5 mg/kg via intravenous infusion on Days 1 and 15 of every 28-day cycle until disease progression, unacceptable toxicity or completion of 2 years of treatment Subjects will receive nab-paclitaxel at a dose of 100 mg/m2 via intravenous infusion on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity
Biological: KN046
KN046 at a dose level of 3 or 5 mg/kg via intravenous infusion on Days 1 and 15 of 28-day cycle

Drug: Nab-paclitaxel
Nab-paclitaxel at dose level of 100 mg/m2 via intravenous infusion on Days 1, 8 and 15 of 28-day cycle




Primary Outcome Measures :
  1. IRC assessed objective response [ Time Frame: From Day 1 to PD, assessed up to 12 months after last patient last dose ]
    Objective response is defined as complete response (CR) or partial response (PR), as determined by the independent review committee using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD

  2. IRC assessed duration of response [ Time Frame: From Day 1 to PD, assessed up to 12 months after last patient last dose ]
    Duration of response is defined as the time period from the date of initial independent review committee assessed CR or PR until the date of PD or death from any cause, whichever occurs first. CR is defined as the disappearance of all TLs and SA reduction to <10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions


Secondary Outcome Measures :
  1. PFS rate at 6 and 12 months [ Time Frame: From Day 1 to disease progression (PD) or death from any cause, assessed up to 12 months after last patient last dose ]
    PFS is defined as the time from Day 1 to the first occurrence of PD, as determined by the independent review committee or investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. PFS rate at 6 and 12 months is defined as percentage of subjects who are alive without progressive disease or death at 6 and 12 months

  2. Frequency and severity of treatment emergent adverse events [ Time Frame: From Day 1 to 90 days after last dose of KN046, through study completion, an average of 1 year ]
    Treatment emergent adverse event is defined as those events with onset days occurring during the on-treatment period till 90 days after last dose of KN046 or if the worsening of an event is during the on-treatment period till 90 days after last dose of KN046

  3. Percentage of subjects with anti-drug antibodies [ Time Frame: Day 1 (pre-dose) to 90 days after last dose of KN046, through study completion, an average of 1 year ]
    ADA is defined as human anti-drug antibodies



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent;
  • Age of 18 or above;
  • Histology confirmed locally advanced unresectable or metastatic triple-negative breaset cancer;
  • (KN046 monotherapy) failed at least one prior anthracycline and taxane containing systemic treatment, (KN046 plus nab-paclitaxel) systemic treatment naive;
  • Measurable disease at baseline;
  • ECOG 0-1;
  • Adequate organ functions.

Exclusion Criteria:

  • Untreated active CNS metastasis or leptomeningeal metastasis;
  • Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment;
  • Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent; History of uncontrolled intercurrent illness; Known severe hypersensitivity reactions to antibody drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872791


Locations
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China, Beijing
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Recruiting
Beijing, Beijing, China
Contact: Binghe Xu, MD    861087788495    cancergcp@163.com   
Sponsors and Collaborators
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

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Responsible Party: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
ClinicalTrials.gov Identifier: NCT03872791     History of Changes
Other Study ID Numbers: KN046-203
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 6 months after publication
Access Criteria: Health care professionals or researches may raise request to Sponsor to have access to study report, sub-group analysis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action