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

Official title

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.

Overview

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

Interventions

• Drug SPH5030
  SPH5030：Oral, QD, 600mg

Primary outcome measures

• Objective response rate (ORR) [Time frame: Approximately 2 years]

Secondary outcome measures (5)

• Duration of remission (DOR) [Time frame: Approximately 2 years]
• Disease control rate (DCR) [Time frame: Approximately 2 years]
• Progression-free survival (PFS) [Time frame: Approximately 2 years]
• Overall Survival (OS) [Time frame: Approximately 2 years]
• Incidence of Treatment-Emergent Adverse Events [Time frame: Approximately 2 years]

Eligibility criteria

Inclusion criteria

• 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；
• Expected survival ≥ 3 months;
• No serious abnormalities in hematopoietic function, liver or kidney function;
• Females who are not pregnant, non-lactating.. Subjects who complied with the contraceptive requirements of the protocol.;
• Fully informed subjects who voluntarily sign the ICF.

Exclusion criteria

• 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;

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 30 centers

• Beijing Friendship Hospital，Capital Medical University — Beijing
• Chinese PLA General hospital — Beijing
• Peking Union Medical College Hospital — Beijing
• The Second Affiliatedf Hospital of AFMU — Beijing
• XiangYa Hospital CentralSouth University — Changsha
• Changzhi People's Hospital — Changzhi
• Fujian Cancer Hospital — Fuzhou
• General Hospital of Fuzhou — Fuzhou
• … and 22 more centers

Identifiers

NCT: NCT06434597 · SPH5030-201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗