Treatment of Her2-positive Biliary Tract or Colorectal Cancer with SPH5030 Tablets

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.

This study is testing if SPH5030 tablets can help people with advanced Her2-positive biliary tract or colorectal cancer feel better and manage their disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd (Industry-sponsored)
• Locations: 30 sites (Beijing and 29 other locations)
• Trial ID: NCT06434597 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the efficacy and safety of SPH5030 tablets in patients diagnosed with Her2-positive or mutated biliary tract or colorectal cancer. The trial focuses on individuals with metastatic or unresectable advanced stages of these cancers. Participants will be monitored for their response to the treatment and any potential side effects. The study aims to provide insights into a new therapeutic option for this specific patient population.

Who should consider this trial

Good fit: Ideal candidates include individuals with metastatic or unresectable advanced colorectal adenocarcinoma or biliary tract carcinoma who are Her2 positive or have a Her2 gene mutation.

Not a fit: Patients who have previously received anti-HER2 therapy or those with severe uncontrolled health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new option for patients with Her2-positive biliary tract or colorectal cancer, potentially improving their outcomes.

How similar studies have performed: While there have been studies targeting Her2-positive cancers, the specific approach with SPH5030 in this context is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Metastatic and/or unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and/or unresectable advanced biliary tract carcinoma
2. HER2 positive or HER2 gene mutation;
3. Meet the requirements of previous treatment;
4. ECOG performance status of 0 or 1；
5. Expected survival ≥ 3 months;
6. No serious abnormalities in hematopoietic function, liver or kidney function;
7. Females who are not pregnant, non-lactating.. Subjects who complied with the contraceptive requirements of the protocol.;
8. Fully informed subjects who voluntarily sign the ICF.

Exclusion Criteria:

1. Subjects who have previously received anti-HER2 molecular targeted therapy;
2. Subjects who have been treated with any other clinical trial drug within 4 weeks prior to the first dose;
3. 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;

5 Subjects who are taking potent CYP3A4 or CYP2C8 inhibitors or inducers; 6 Subjects with other malignancies in the past 5 years; 7 Subjects with CNS system metastasis with clinical symptoms; 8 Subjects who do not meet the protocol requirements for hepatitis B and C at screening, have a history of immunodeficiency, or other acquired、congenital immunodeficiency diseases, or have a history of organ transplantation; 9. Other situations that do not meet the requirements of the protolol.

Where this trial is running

Beijing and 29 other locations

• Beijing Friendship Hospital，Capital Medical University — Beijing, China (Recruiting)
• Chinese PLA General hospital — Beijing, China (Recruiting)
• Peking Union Medical College Hospital — Beijing, China (Recruiting)
• The Second Affiliatedf Hospital of AFMU — Beijing, China (Recruiting)
• XiangYa Hospital CentralSouth University — Changsha, China (Recruiting)
• Changzhi People's Hospital — Changzhi, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, China (Recruiting)
• General Hospital of Fuzhou — Fuzhou, China (Recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, China (Recruiting)
• Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine — Hangzhou, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, China (Recruiting)
• Harbin Medical University Cancer Hospital — Harbin, China (Recruiting)
• Anhui Provincial Cancer Hospital — Hefei, China (Recruiting)
• Hengshui People's Hospital — Hengshui, China (Recruiting)
• Yunnan Cancer Hospital — Kunming, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
• Shanghai General Hospital — Shanghai, China (Recruiting)
• The Third Affiliated Hospital of Air Force Medical University — Shanghai, China (Recruiting)
• Zhongshan Hospital — Shanghai, China (Recruiting)
• Shantou University Medical College Cancer Hospital — Shantou, China (Recruiting)
• Liaoning Cancer Hospital — Shenyang, China (Recruiting)
• Shanxi Cancer Hospital — Taiyuan, China (Recruiting)
• Tianjin Medical University Cancer institute & Hospital — Tianjin, China (Recruiting)
• Hubei Cancer Hospital — Wuhan, China (Recruiting)
• Affiliated Hospital of Jiangnan University — Wuxi, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, China (Recruiting)
• Xiangyang Central Hospital — Xiangyang, China (Recruiting)
• Yantai Yuhuangding Hospital — Yantai, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, China (Recruiting)

Study contacts

• Study coordinator: Jianming Xu

Conditions Biliary Tract or Colorectal Cancer With Her2-positive/Mutated