RecruitingPhase 2NCT06434597

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

A Multicenter, Open, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH5030 Tablets in Subjects With Her2-positive/Mutated Biliary Tract OR Colorectal Cancer.

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Enrollment

60 participants

Start Date

Jul 17, 2024

Study Type

INTERVENTIONAL

Conditions

Biliary Tract or Colorectal Cancer With Her2-positive/Mutated

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called SPH5030 for people with advanced colorectal cancer or bile duct cancer (biliary tract cancer) whose tumors have a specific overexpression or mutation in the HER2 protein — a marker found on some cancer cells. **You may be eligible if...** - You have metastatic, advanced, or unresectable colorectal adenocarcinoma, OR locally advanced, recurrent, or metastatic biliary tract carcinoma - Your tumor is confirmed HER2-positive or has a HER2 gene mutation - You meet prior treatment requirements as specified by the study - Your general health is good (ECOG 0–1) and your expected survival is at least 3 months - Your blood counts, liver, and kidney function are within acceptable ranges - You are not pregnant or breastfeeding and agree to use contraception **You may NOT be eligible if...** - You have previously received anti-HER2 targeted therapy - You participated in another clinical drug trial within the past 4 weeks - You have significant other medical conditions or organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSPH5030

SPH5030：Oral, QD, 600mg

Locations(30)

Beijing Friendship Hospital，Capital Medical University

Beijing, China

Chinese PLA General hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

The Second Affiliatedf Hospital of AFMU

Beijing, China

XiangYa Hospital CentralSouth University

Changsha, China

Changzhi People's Hospital

Changzhi, China

Fujian Cancer Hospital

Fuzhou, China

General Hospital of Fuzhou

Fuzhou, China

Guangdong Provincial People's Hospital

Guangzhou, China

Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Anhui Provincial Cancer Hospital

Hefei, China

Hengshui People's Hospital

Hengshui, China

Yunnan Cancer Hospital

Kunming, China

Fudan University Shanghai Cancer Center

Shanghai, China

Shanghai General Hospital

Shanghai, China

The Third Affiliated Hospital of Air Force Medical University

Shanghai, China

Zhongshan Hospital

Shanghai, China

Shantou University Medical College Cancer Hospital

Shantou, China

Liaoning Cancer Hospital

Shenyang, China

Shanxi Cancer Hospital

Taiyuan, China

Tianjin Medical University Cancer institute & Hospital

Tianjin, China

Hubei Cancer Hospital

Wuhan, China

Affiliated Hospital of Jiangnan University

Wuxi, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

Xiangyang Central Hospital

Xiangyang, China

Yantai Yuhuangding Hospital

Yantai, China

Henan Cancer Hospital

Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT06434597