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

Sun Yat-sen University logo

Sun Yat-sen University

Status and phase

Unknown
Phase 2

Conditions

HER2-positive Breast Cancer

Treatments

Biological: KN035
Drug: Docetaxel
Biological: Trastuzumab

Study type

Interventional

Funder types

Other

Identifiers

NCT04034823
KN035-TH-HER2

Details and patient eligibility

About

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.

Enrollment

59 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Written informed consent
  • Female subjects with age 18 to 70 (inclusive) years at the time of consent
  • LVEF ≥50% at baseline
  • ECOG performance status of 0-1
  • Have not received 1L treatment for recurrent or metastatic breast cancer
  • Adequate organ function

Exclusion criteria

  • History of exposure to the cumulative doses of doxorubicin > 400 mg / m2 or equivalent
  • History of autoimmune diseases
  • Active brain metastasis
  • Concurrent diseases that compromise patient's safety

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

59 participants in 1 patient group

KN035 in combination with trastuzumab and docetaxel
Experimental group
Treatment:
Biological: Trastuzumab
Biological: KN035
Drug: Docetaxel

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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