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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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.

A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients. (NCT06434597) is a Phase 2 interventional studying Biliary Tract or Colorectal Cancer With Her2-positive/Mutated, sponsored by Shanghai Pharmaceuticals Holding Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Biliary Tract or Colorectal Cancer With Her2-positive/Mutated and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Biliary Tract or Colorectal Cancer With Her2-positive/Mutated subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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. You should be able to carry out daily activities with 0 level of ability (ECOG 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. Who Should NOT Join This Trial: 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 weakened immune system, or other acquired、congenital weakened immune system diseases, or have a history of organ transplantation; 9. Other situations that do not meet the requirements of the protolol. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

SPH5030

SPH5030：Oral, QD, 600mg

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Friendship Hospital，Capital Medical University
Beijing, China
Chinese PLA General hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
The Second Affiliatedf Hospital of AFMU
Beijing, China
XiangYa Hospital CentralSouth University
Changsha, China
Changzhi People's Hospital
Changzhi, China
Fujian Cancer Hospital
Fuzhou, China
General Hospital of Fuzhou
Fuzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Anhui Provincial Cancer Hospital
Hefei, China
Hengshui People's Hospital
Hengshui, China
Yunnan Cancer Hospital
Kunming, China
Fudan University Shanghai Cancer Center
Shanghai, China
Shanghai General Hospital
Shanghai, China
The Third Affiliated Hospital of Air Force Medical University
Shanghai, China
Zhongshan Hospital
Shanghai, China
Shantou University Medical College Cancer Hospital
Shantou, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06434597), the sponsor (Shanghai Pharmaceuticals Holding Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06434597 clinical trial studying?

To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06434597?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06434597?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06434597. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06434597. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.