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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Jianming Xu
• Email: jfjzyygw@163.com
• Phone: 0086-010-66937166

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatment of HER2-positive Biliary Tract Cancer with SHR-A1811

  This study is testing a new treatment called SHR-A1811 to see if it helps people with advanced HER2-positive biliary tract cancer feel better and live longer.

  Recruiting at 2 sites Phase 2 Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Harbin, Heilongjiang and 1 other locations · NCT06778031

• Combination therapy for advanced HER2-positive biliary tract cancer

  This study is testing a new combination treatment for people with advanced HER2-positive biliary tract cancer to see if it can help them live longer and feel better.

  Recruiting Phase 1/2 Yonsei University · Seoul · NCT05749900

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.