Biliary Tract or Colorectal Cancer With Her2-positive/MutatedPhase 2NCT06434597
A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.
A Phase 2 study testing SPH5030 in people with Biliary Tract or Colorectal Cancer With Her2-positive/Mutated, run by Shanghai Pharmaceuticals Holding Co., Ltd at 30 sites in China.
Trial summary
To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract or Colorectal Cancer With Her2-positive/Mutated
- What is being tested?
- SPH5030
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 30 sitesChina
- Study dates
- 17 Jul 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites, 30 recruiting
- Recruiting
Beijing Friendship Hospital，Capital Medical University
Beijing
Bangwei Cao
- Recruiting
Chinese PLA General hospital
Beijing
Jianming Xu
- Recruiting
Peking Union Medical College Hospital
Beijing
Haitao Zhao
- Recruiting
The Second Affiliatedf Hospital of AFMU
Beijing
Haichuan Su
- Recruiting
XiangYa Hospital CentralSouth University
Changsha
Xuejun Gong
Jie Ge
- Recruiting
Changzhi People's Hospital
Changzhi
Jun Zhao
- Recruiting
Fujian Cancer Hospital
Fuzhou
Jianwei Yang
- Recruiting
General Hospital of Fuzhou
Fuzhou
Dongliang Li
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou
Dong Ma
- Recruiting
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou
Hongming Pan
- Recruiting
Zhejiang Cancer Hospital
Hangzhou
Haijun Zhong
- Recruiting
Harbin Medical University Cancer Hospital
Harbin
Yanqiao Zhang
- Recruiting
Anhui Provincial Cancer Hospital
Hefei
Yifu He
- Recruiting
Hengshui People's Hospital
Hengshui
Daqing Wang
- Recruiting
Yunnan Cancer Hospital
Kunming
Yunfeng Li
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Zhiyu Chen
- Recruiting
Shanghai General Hospital
Shanghai
Qi Li
- Recruiting
The Third Affiliated Hospital of Air Force Medical University
Shanghai
Qian Zhang
- Recruiting
Zhongshan Hospital
Shanghai
Houbao Liu
Huichuan Sun
- Recruiting
Shantou University Medical College Cancer Hospital
Shantou
Yi Jiang
- Recruiting
Liaoning Cancer Hospital
Shenyang
Jingdong Zhang
- Recruiting
Shanxi Cancer Hospital
Taiyuan
Wenhui Yang
- Recruiting
Tianjin Medical University Cancer institute & Hospital
Tianjin
Zhanyu Pan
- Recruiting
Hubei Cancer Hospital
Wuhan
Lei Nie
- Recruiting
Affiliated Hospital of Jiangnan University
Wuxi
Gaoxiang
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Enxiao Li
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Weiwei Tang
- Recruiting
Xiangyang Central Hospital
Xiangyang
Wei Gong
- Recruiting
Yantai Yuhuangding Hospital
Yantai
Jian Chen
- Recruiting
Henan Cancer Hospital
Zhengzhou
Xiaobing Chen
About this study
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.
To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.
- Being tested
- SPH5030
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH5030Drug
SPH5030：Oral, QD, 600mg
| Study group | Role | What they receive |
|---|---|---|
| SPH5030 | Experimental | Not described Receives: Drug: SPH5030 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Measured: Approximately 2 years
Secondary outcomes (5)
Duration of remission (DOR)
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.
Measured: Approximately 2 years
Disease control rate (DCR)
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.
Measured: Approximately 2 years
Progression-free survival (PFS)
From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Measured: Approximately 2 years
Overall Survival (OS)
Determination of the overall survival times of all patients
Measured: Approximately 2 years
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start17 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract or Colorectal Cancer With Her2-positive/MutatedStudies of the same condition, open and under way.
- More trials run by Shanghai Pharmaceuticals Holding Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434597
- Sponsor's protocol ID
- SPH5030-201
- Status last verified
- Aug 2025
- First submitted
- 23 May 2024
- Last updated
- 17 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06434597
- Acronym / sponsor ID
- SPH5030-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPH5030 | Experimental | Drug: SPH5030 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPH5030SPH5030：Oral, QD, 600mg | Drug | SPH5030 |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
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Advanced Solid Tumor, Advanced Malignant Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPH5030 in people with Biliary Tract or Colorectal Cancer With Her2-positive/Mutated, run by Shanghai Pharmaceuticals Holding Co., Ltd at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianming Xu (0086-010-66937166, jfjzyygw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.