ARX788 in Breast Cancer With Low Expression of HER2

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    54
  • sponsor
    Fudan University
Updated on 15 May 2022

Summary

A Phase 2 Study of ARX788 in unresectable and/or metastatic breast cancer with low expression of HER2.

Description

A single arm, phase 2 study of ARX788 in unresectable and/or metastatic breast cancer with low expression of HER2. Subjects should received ≥2 lines of systemic chemotherapy regimens for recurrent or metastatic disease, and for HR positive subjects, also need to have received ≥2-line endocrine therapy ± targeted therapy (including neoadjuvant/adjuvant therapy). HER2 low expression is defined as HER2 IHC 1+ or HER2 IHC 2+ and FISH negative. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.

Details
Condition Breast Cancer With Low Expression of HER2
Treatment ARX788
Clinical Study IdentifierNCT05018676
SponsorFudan University
Last Modified on15 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Willing and able to understand and sign an informed consent inform
Age ≥18 years, and ≤75 years, male or female
Diagnosed as HR arbitrary/HER2 low expression unresectable and/or metastatic breast cancer. HER2 low expression is defined as HER2 IHC 1+ (FISH negative or FISH not done) or HER2 IHC 2+ and FISH negative
Received ≥2 lines of systemic chemotherapy regimens for recurrent or metastatic disease, and for HR positive subjects, also need to have received ≥2-line endocrine therapy ± targeted therapy (including neoadjuvant/adjuvant therapy)
Never had a HER2 positive result (IHC 3+ or FISH+) in previous pathological examinations
Have archived or fresh tumor tissue samples for HER2 status confirmation
According to the RECIST 1.1 standard, there is at least one measurable lesion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1; LVEF≥50%
Adequate organ functions
Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade ≤1
Life expectancy ≥ 3 months

Exclusion Criteria

History of allergic reactions to any component of ARX788, or with a history of protein drug allergy, a history of specific allergies (asthma, rheumatism, eczematous dermatitis), or a history of other severe allergic reactions, who are unsuitable for ARX788 treatment as per the investigator's judgments
Previous treatment with T-DM1 or other HER2-ADC drugs
Have other malignant tumors within 5 years before signing the informed consent form (except for non-melanoma skin cancer, cervical carcinoma in situ or other tumors that have been effectively treated, except malignant tumors that are considered cured)
Have primary central nervous system (CNS) tumors or CNS metastases
Prior history of interstitial pulmonary disease requiring hormone therapy, drug-induced interstitial pulmonary disease, radiation pneumonia, or current clinically active interstitial pulmonary disease
Suffering from keratitis, corneal diseases, retinal diseases or active eye infections that require intervention
Unwilling or unable to stop wearing contact lenses for the duration of the study
Cardiac insufficiency
Uncontrolled hypertension
Suffering severe or uncontrolled systemic diseases
Had chemotherapy, radiotherapy, or immunotherapy within 4 weeks before the first dose
Had breast cancer endocrine therapy within 2 weeks before the first dose
Had palliative radiotherapy for bone metastasis within 2 weeks before the first dose
Any uncontrolled infection, or other conditions that may limit trial compliance or interfere with evaluation
Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus or syphilis
Plan to receive major surgical treatment within 2 weeks before first dose or during the trial period, or have suffered severe traumatic injury
Pregnancy or lactation
Unwilling or unable to use acceptable methods for contraception during the entire treatment period of this trial and within 8 months after the last dose
Participated in other clinical trials and used other experimental drugs within 4 weeks before the first dose
Any mental or cognitive impairment may limit their understanding and implementation of the informed consent form
Not suitable for participating in this trial, such as poor compliance
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note