A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Pharmaceuticals Holding Co., Ltd

About this trial

To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.

Eligibility criteria

Qualifiers

Metastatic and/or unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and/or unresectable advanced biliary tract carcinoma

HER2 positive or HER2 gene mutation;

Meet the requirements of previous treatment;

ECOG performance status of 0 or 1;

Disqualifiers

Subjects who have previously received anti-HER2 molecular targeted therapy;

Subjects who have been treated with any other clinical trial drug within 4 weeks prior to the first dose;

Subjects with uncontrolled or severe cardiovascular and cerebrovascular diseases; Subjects with severe lung disease; 4. Subjects who may have conditions that affect the absorption, distribution, metabolism, or excretion of the study drug determined by the investigator;

Trial design

Treatments tested in this trial

  • SPH5030

Treatment groups

60 Participants
are divided into 1 treatment group