A Phase II Clinical Study of SHR-A1904 Monotherapy in Second-Line or Later Treatment of Advanced Neuroendocrine Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing GoBroad Hospital

About this trial

This is a prospective, single-center, phase II trial designed to evaluate the efficacy and safety of SHR-A1904 monotherapy in second-line or later treatment of advanced neuroendocrine carcinoma. The primary endpoint is the objective response rate. Secondary endpoints include progression free survival, overall survival rate, duration of response, disease control Rate and adverse event.

Eligibility criteria

Qualifiers

Willing to join in this study, signed informed consent, good adherence, can cooperate with the follow-up;

Age 18-75 years old, both genders;

Patients with histologically confirmed advanced neuroendocrine carcinoma;

Progressed form previous standard therapy (at least progressed form the first line of platinum-based chemotherapy);

Disqualifiers

Previous receipt of claudin 18.2-targeted therapy;

Previous receipt of any drug containing a topoisomerase I inhibitor drug, including antibody-drug conjugates;

Merkel cell carcinoma, neuroendocrine prostate cancer, and medullary thyroid carcinoma;

Untreated brain metastasis, or associated with meningeal metastasis, spinal cord compression, etc. Patients who had received previous treatment for brain metastases (radiotherapy or surgery) were eligible for enrollment if they had been stable for at least 4 weeks as confirmed by imaging and had been free of systemic hormone therapy (at a dose of >10 mg per day of prednisone or the equivalent) for more than 2 weeks and were asymptomatic;

Trial design

Treatments tested in this trial

  • SHR-A1904 Injection

Treatment groups

23 Participants
are divided into 1 treatment group

Sponsors and collaborators