Phase II Study of SPH5030 Tablets for Treating Her2-positive or Mutated Biliary Tract and Colorectal Cancers

What this Trial Is About

Researchers are evaluating the efficacy and safety of SPH5030 tablets in adults with Her2-positive or Her2-mutated biliary tract or colorectal cancer. This phase II clinical study focuses on patients with metastatic, unresectable, or advanced forms of these cancers who have specific genetic markers and meet certain health criteria. The study is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd and aims to better understand treatment outcomes in this group. Participants will receive SPH5030 tablets orally once daily at a dose of 600 mg. The study is open-label and single-arm, meaning all participants receive the same treatment without a placebo group. The treatment period and follow-up span approximately two years, during which multiple outcome measures will be assessed. During the study, participants will undergo regular evaluations to monitor tumor response, duration of remission, disease control, progression-free survival, overall survival, and any adverse events related to treatment. Researchers will also assess safety through clinical and laboratory tests. The total involvement for each participant is about two years, allowing for detailed observation of treatment effects and tolerability.

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