Trial of KN026 in Patients With HER2-positive Advanced Malignant Breast Cancer and Gastric Cancer

NCT03619681 | Completed Phase 1

• 1 other identifier: KN026-CHN-001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first-in-human (FIH), 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 5 proposed dose levels which are 5, 10, 15, 20 and 30 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. Dose expansion will carried out in 20 mg/kg Q2W and 30 mg/kg Q3W.

Conditions

Breast Cancer; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• The proportion of patients experiencing dose limiting toxicities.

  From screening to up to 28 days

Secondary Outcomes (11)

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

  From screening to up to 112 days

• Percentage of participants who experience laboratory abnormalities and/or adverse events as defined by CTCAE that are related to treatment

  From screening to up to 112 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

• Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) for KN026.

  Throughout the duration of the study; up to 84 days

Study Arms (1)

KN026

EXPERIMENTAL

Drug: KN026

Interventions

KN026 DRUG

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.

KN026

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject \>= 18 years and =\<75 years.
• Histologically or 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(Subjects are eligible, which accepted palliative therapies within 2 weeks before the first dose of KN026 for osseous metastatic and all the AEs recovered).
• An anthracyclines antibiotic treatment, such as doxorubicin (Adriamycin) 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.
• Has not recovered (ie, \>Grade 1) from AEs except alopecia and anemia.
• 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)

Fudan University Shanghai Cancer Hospital

Shanghai, 200000, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach 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: August 3, 2018
• First Posted: August 8, 2018
• Study Start: September 17, 2018
• Primary Completion: June 30, 2022
• Study Completion: August 26, 2022
• Last Updated: March 12, 2024

Record last verified: 2023-11

Locations

CN (1)