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Clinical Trials/NCT03847168
NCT03847168
Unknown
Phase 1

Phase I Study of KN026 in HER2 Expressing Breast Cancer, Astric/Gastroesophageal Junction Cancer and Other Locally Advanced/Metastatic Solid Tumors

Jiangsu Alphamab Biopharmaceuticals Co., Ltd1 site in 1 country22 target enrollmentStarted: June 18, 2019Last updated:
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ConditionsBreast CancerGastric/Gastroesophageal Junction Cancer
InterventionsKN026
DrugsKN026

Overview

Phase
Phase 1
Enrollment
22
Locations
1
Primary Endpoint
The proportion of patients experiencing dose limiting toxicities
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This is an open-label, phase 1 dose-escalation study of KN026 in subjects with HER2 positive advanced breast and Gastric Cancer. The standard "3 + 3" design was used for dose escalation. There are 3 proposed dose levels which are 10, 15, and 20 mg/kg, but dosing interval may be adjusted during the study (such as QW, OR Q2W, OR Q3W) based on emerging data from this trial and/or from phase 1 trial of KN026 in other country. Dose escalation will continue until the maximum tolerated dose (MTD) is reached or if MTD is not found, dose escalation will continue until the MAD of 20 mg / kg is reached.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Male or female subject \>= 18 years
  • •Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast cancer or gastric cancer.
  • •ECOG score 0 or 1
  • •Life expectancy \>3 months
  • •According to the definition of RECIST1.1, the patient has at least one measurable lesion
  • •Adequate organ function prior to start treatment with KN026
  • •Able to understand, voluntarily participate and willing to sign the ICF
  • •Subjects (women of child-bearing potential and males with fertile female partner) must be willing to use viable contraception method.

Exclusion Criteria

  • •Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
  • •Accepted radiotherapy within 4 weeks before enrollment
  • •An anthracyclines antibiotic treatment was received exceeding 300 mg/m² within 90 days before first KN026 dosing, or other equivalent dose antharcyclines
  • •Subjects are eligible with clinically controlled and stable neurologic function \>= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
  • •Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study
  • •History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
  • •Severe chronic and active infection, need to system antibiosis/antiviral treatment
  • •Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage

Arms & Interventions

KN026

Experimental

Patient will be intravenously administrated with one dose of KN026. Dosing interval may be adjusted during the study based on emerging data from this trial and/or from other trial.

Intervention: KN026 (Drug)

Outcomes

Primary Outcomes

The proportion of patients experiencing dose limiting toxicities

Time Frame: From screening to up to 28 days

Secondary Outcomes

  • Frequency and titer of anti-KN026 antibody(Throughout the duration of the study; up to 2 years)
  • The proportion of patients with an objective response (partial response or complete response) as defined by RECIST 1.1 criteria(Throughout the duration of the study; up to 2 years)
  • Time of Maximum observed serum concentration (Tmax) of KN026(Throughout the duration of the study; up to 84 days)
  • Progression free survival according to RECIST 1.1 criteria(Throughout the duration of the study; up to 2 years)
  • Maximum observed serum concentration (Cmax) of KN026(Throughout the duration of the study; up to 84 days)
  • Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest(From screening to up to 196 days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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