Eligibility |
Inclusion Criteria:
1. Female subjects aged from 18 to 75 years old;
2. Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1;
3. Have a life expectancy of at least 6 months, in the opinion of the investigator;
4. Histologically or cytologically confirmed primary cervical squamous cell carcinoma,
adenocarcinoma, adenosquamous cell carcinoma, or small cell (neuroendocrine) cervical
cancer;
5. Have measurable disease assessable by RECIST v1.1;
6. Adequate haematological, hepatic and renal functions defined by the protocol;
Pathologically diagnosed patients with HER2 expression (defined as: IHC 3+ or IHC 2+
or HC 1+)advanced cervical cancer ;Note:It is also acceptable if the subject has
previous test results (confirmed by the investigator);
7. Negative blood pregnancy test at Screening for women of childbearing potential;Highly
effective contraception for female subjects if the risk of conception exists;
Exclusion Criteria:
1. History of malignant tumors other than cervical cancer, except for the following two
cases:a. The patient had received a potentially curative treatment and had no evidence
of the disease for 5 years;b. Successful resection of skin basal cell carcinoma, skin
squamous cell carcinoma, superficial bladder carcinoma, cervical carcinoma in situ,
and other carcinoma in situ was received;
2. Previous malignant disease (other than cervical cancer) within the last 5 years with
the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ
(bladder, cervical, colorectal, breast)Previous stem cell allogeneic or parenchymal
organ transplants;
3. Patients who had previously received other anti-tumor systemic therapy (including
traditional Chinese medicine with anti-tumor indications) less than 4 weeks before the
use of this study, or adverse events caused by previous treatment did not recover to
=CTCAE grade 1 (except for alopecia and pigmentation);
4. Had received a live vaccine within 4 weeks prior to the start of study dosing or
planned to receive any vaccine (except for COVID-19 vaccine) during the study period;
5. Previous or current congenital or acquired immunodeficiency disease;
6. Previous treatment with other antibody-coupled drugs;
7. Has not recovered from surgery, such as the presence of unhealed incisions or serious
postoperative complications;
8. The patient had a known or suspected allergy to the experimental drug;
9. The New York College of Cardiology (NYHA) classiifies heart failure as grade 3 and
above;
10. Severe infections that are active or poorly controlled clinically; Active infections,
including: a. HIV (HIV1/2 antibody) positive; b. Active hepatitis B (HBsAg positive or
HBV DNA > 2000IU/ml and abnormal liver function); c. Active hepatitis C (HCV antibody
positive or =103 copies /ml of HCV RNA and abnormal liver function); d. active
tuberculosis; d. Other uncontrolled active infections (CTCAE V5.0 > Grade 2);
11. Other significant clinical and laboratory abnormalities considered to affect safety
assessment, such as uncontrolled diabetes, chronic kidney disease, grade II or above
peripheral neuropathy (CTCAE V5.0), thyroid dysfunction, etc.; Other conditions deemed
unsuitable for inclusion by the researchers;
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