KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer

NCT03847168 | Unknown Phase 1 FDA Drug

• 1 other identifier: KN026-US-I-001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Gastric/Gastroesophageal Junction Cancer

Outcome Measures

Primary Outcomes (1)

• The proportion of patients experiencing dose limiting toxicities

  From screening to up to 28 days

Secondary Outcomes (6)

• Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest

  From screening to up to 196 days

• Maximum observed serum concentration (Cmax) of KN026

  Throughout the duration of the study; up to 84 days

• Time of Maximum observed serum concentration (Tmax) of KN026

  Throughout the duration of the study; up to 84 days

• 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

Study Arms (1)

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.

Drug: KN026

Interventions

KN026 DRUG

Patient will be intravenously administrated with one dose of KN026 every week or every other week.

KN026

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: lead

Study Sites (1)

Greenville Health System Center Institute

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 20, 2019
• Study Start: June 18, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 17, 2021

Record last verified: 2021-11

Locations

US (1)