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

August 15, 2025 updated by: Shanghai Pharmaceuticals Holding Co., Ltd

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.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
          • Jianming Xu
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Haitao Zhao
      • Beijing, China
        • Recruiting
        • Beijing Friendship Hospital,Capital Medical University
        • Contact:
          • Bangwei Cao
      • Beijing, China
        • Recruiting
        • The Second Affiliatedf Hospital of AFMU
        • Contact:
          • Haichuan Su
      • Changsha, China
        • Recruiting
        • XiangYa Hospital CentralSouth University
        • Contact:
          • Xuejun Gong
        • Contact:
          • Jie Ge
      • Changzhi, China
        • Recruiting
        • Changzhi People's Hospital
        • Contact:
          • Jun Zhao
      • Fuzhou, China
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Jianwei Yang
      • Fuzhou, China
        • Recruiting
        • General Hospital of Fuzhou
        • Contact:
          • Dongliang Li
      • Guangzhou, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Dong Ma
      • Hangzhou, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Haijun Zhong
      • Hangzhou, China
        • Recruiting
        • Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
        • Contact:
          • Hongming Pan
      • Harbin, China
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Yanqiao Zhang
      • Hefei, China
        • Recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
          • Yifu He
      • Hengshui, China
        • Recruiting
        • Hengshui People's Hospital
        • Contact:
          • Daqing Wang
      • Kunming, China
        • Recruiting
        • Yunnan Cancer Hospital
        • Contact:
          • Yunfeng Li
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Zhiyu Chen
      • Shanghai, China
        • Recruiting
        • Shanghai General Hospital
        • Contact:
          • Qi Li
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital
        • Contact:
          • Huichuan Sun
        • Contact:
          • Houbao Liu
      • Shanghai, China
        • Recruiting
        • The Third Affiliated Hospital of Air Force Medical University
        • Contact:
          • Qian Zhang
      • Shantou, China
        • Recruiting
        • Shantou University Medical College Cancer Hospital
        • Contact:
          • Yi Jiang
      • Shenyang, China
        • Recruiting
        • Liaoning Cancer Hospital
        • Contact:
          • Jingdong Zhang
      • Taiyuan, China
        • Recruiting
        • Shanxi Cancer Hospital
        • Contact:
          • Wenhui Yang
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
          • Zhanyu Pan
      • Wuhan, China
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
          • Lei Nie
      • Wuxi, China
        • Recruiting
        • Affiliated Hospital of Jiangnan University
        • Contact:
          • Gaoxiang
      • Xi'an, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Enxiao Li
      • Xiamen, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Weiwei Tang
      • Xiangyang, China
        • Recruiting
        • Xiangyang Central Hospital
        • Contact:
          • Wei Gong
      • Yantai, China
        • Recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
          • Jian Chen
      • Zhengzhou, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Xiaobing Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPH5030
Drug: SPH5030
SPH5030：Oral, QD, 600mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Approximately 2 years
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Approximately 2 years
From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Approximately 2 years
Disease control rate (DCR)
Time Frame: Approximately 2 years
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.
Approximately 2 years
Incidence of Treatment-Emergent Adverse Events
Time Frame: Approximately 2 years
Adverse event type, incidence, duration
Approximately 2 years
Duration of remission (DOR)
Time Frame: Approximately 2 years
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause.
Approximately 2 years
Overall Survival (OS)
Time Frame: Approximately 2 years
Determination of the overall survival times of all patients
Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 15, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPH5030-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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