Overview

A Study of MRG002 in the Treatment of Patients With HER2-low Locally Advanced or Metastatic Breast Cancer (BC)

Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-low locally advanced or metastatic BC.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Miracogen Inc.
Criteria
Inclusion Criteria:

1. Voluntary to sign the ICF and follow the requirements specified in the protocol;

2. Aged ≥ 18, both genders;

3. Expected survival time ≥ 12 weeks;

4. The score of ECOG for performance status is 0 or 1;

5. Subjects with histologically confirmed HER2-low breast cancer, are currently in the
locally advanced or metastatic stage, and are ineligible for radical excision, and
have received at least first-line standard treatment for recurrent or metastatic
breast cancer;

6. Archival or biopsy tumor specimens should be provided;

7. Subjects must have imaging evidence of tumor progression during or after the most
recent treatment confirmed by the investigator and at least one measurable lesion at
the baseline according to the Response Evaluation Criteria In Solid Tumors (RECIST
1.1);

8. Prior anti-tumor treatment-related AEs (NCI CTCAE v5.0 Criteria) have recovered to ≤
Grade 1 (except for alopecia, non-clinically significant or asymptomatic laboratory
abnormalities);

9. No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%;

10. The level of organ functions must meet the basic requirements;

11. Reproductive male subjects and female subjects of childbearing age shall be willing to
take effective contraceptive measures from the date signing the ICF to 6 months after
the last dose of the IP.

Exclusion Criteria:

1. With previous history of other primary malignancies;

2. Received chemotherapy, radiotherapy, biotherapy, immunotherapy, or other anti-tumor
drugs within 4 weeks prior to the first dose;

3. The subjects have central nervous system (CNS) metastasis;

4. Subjects with clinical symptoms of pleural effusion, seroperitoneum or pericardial
effusion, for which treatment by puncture and drainage is required;

5. Subjects with peripheral neuropathy of greater than Grade 2 (NCI CTCAE v5.0);

6. Any severe or uncontrolled systemic disease;

7. Patients with poorly controlled heart disease;

8. Evidence of active infection, including but not limited to hepatitis B, hepatitis C or
human immunodeficiency virus (HIV) infection, uncontrolled active bacterial infection,
infection caused by other viruses, fungi, rickettsia or parasites;

9. History of hypersensitivity to any component of MRG002 or history of hypersensitivity
of ≥ Grade 3 to trastuzumab injection;

10. Disease progression or recurrence occurred during or after the previous treatment,
without evidence of CT/MRI examination results;

11. Subjects with uncontrolled concurrent diseases may have limited ability to obey the
study requirements or impaired ability to sign the written ICF;

12. Subjects with active autoimmune disease or a history of autoimmune disease are
receiving immunosuppressive agents or systemic hormone therapy, and are still
receiving within 2 weeks prior to enrollment;

13. Received anti-tumor vaccine treatment 4 weeks prior to the first dose, or plan to
participate in anti-tumor vaccine studies;

14. History of interstitial pneumonia, severe chronic obstructive pulmonary disease,
severe pulmonary insufficiency, symptomatic bronchospasm, etc;

15. Pulmonary embolism or deep vein thrombosis occurred within 3 months prior to the first
dose;

16. Female subjects with positive result in serum pregnancy test, or female subjects
within lactation period and do not agree to take adequate contraceptive measures
during the trial and 6 months after receiving the IP;

17. Other conditions inappropriate for participation in this study, as deemed by the
investigator.