Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer

1. Systematic chemotherapy, novel hormone therapy, targeted therapy, immunotherapy, or other antitumor therapy (including 5-alpha reductase inhibitors, oestrogens, and medroxyprogesterone, etc.)was administered prior to the initial study drug, and treatment ended within 5 half-lives (or 2 weeks, whichever is shorter) of the initial study drug. Except maintenance castration therapy (LHRH agonists or LHRH antagonists) or bone metastasis therapy(e.g., denosumab, zoledronic acid); In the first study, Chinese medicines with anti-tumor indications were used 2 weeks before administration.

2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis (subjects who have been treated for brain metastases may be enrolled in this study provided they have stable disease \[no evidence of progression as determined by imaging for at least 4 weeks prior to study dosing and and all neurological symptoms have fully recovered\], there is no evidence of new or enlarging brain metastases, and discontinuation of steroid therapy at least 7 days prior to the first dose of the trial treatment. (This exception does not include carcinomatous meningitis, which should be excluded regardless of whether it is clinically stable or not).

3. Has received anti-HER2 therapy ;

4. Major surgery, systemic radiotherapy or biologic therapy within 4 weeks prior to first study drug administration, or minor surgery or local radiotherapy within 1 week prior to enrollment;

5. Toxicity due to prior antineoplastic therapy that has not recovered to Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) Grade 1 or below, with the exception of alopecia and abnormalities in laboratory tests or toxicity associated with LHRH agonists or LHRH antagonists that are not considered by the investigator to pose a safety risk;

6. Known allergic reactions to components of the study treatment or its analogues

7. Diagnosis of other malignancies that are expected to affect life expectancy or may interfere with disease assessment. Except for cured non-melanoma skin cancer and superficial bladder cancer

8. Severe and/or persistent infection within 14 days prior to starting the study drug

9. Serum virological tests: positive HBsAg test result with a positive HBV DNA copy number; positive HCVAb test result; positive HIVAb test result;

10. Known serious cardiovascular disease, including any of the following: myocardial infarction, thrombotic event, or unstable angina pectoris in the past 3 months; chronic heart failure, New York Heart Association (NYHA) class II or higher; presence of unstable arrhythmia; uncontrolled hypertension;

11. Combined grade 2 and higher (CTCAE version 5.0) peripheral neuropathy

12. Presence of other systemic diseases that, in the judgement of the investigator, are not under stable control, including diabetes mellitus, liver cirrhosis, pneumonitis, and obstructive pulmonary disease;

13. In the judgement of the investigator, there were other circumstances that made participation in the study unsuitable.

Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer

What this study is about

Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer

What this study is about