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KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer

NCT04034823 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2019-07-26

No results posted yet for this study

Summary

This is an open-label, single arm phase II trial to evaluate the efficacy, safety and tolerability of KN035 in combination with trastuzumab and docetaxel. Eligible patient will be enrolled and receive protocol defined therapies until progressive disease, unacceptable toxicity or withdrawal of informed consent. Tumor assessment will be performed according to RECIST 1.1 criteria.

Conditions

Interventions

BIOLOGICAL

KN035

KN035 5 mg/kg s.c. Q3W

BIOLOGICAL

Trastuzumab

8 mg/kg IV loading followed by 6 mg/kg Q3W IV

DRUG

Docetaxel

100 mg/m2 Q3W IV

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-01-01
Completion
2022-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04034823 on ClinicalTrials.gov