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New pill shows promise for Hard-to-Treat HER2 cancers

NCT ID NCT05245058

Disease control Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new tablet called SPH5030 in 150 adults with advanced HER2-positive solid tumors that have not responded to standard treatments or have no standard options. The main goal is to check the drug's safety, find the best dose, and see how the body processes it. Participants must be in fairly good health (ECOG 0-1) and have measurable tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ECOG performance status of 0 to 1. 2. Life expectancy of more than 3 months. 3. At least one measurable lesion exists.(RECIST 1.1) 4. Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment. 5. Required laboratory values including following parameters: ANC: ≥ 1.5 x 109/L Plt count: ≥ 90x 109/L Hb: ≥ 90 g/L TBIL: ≤ 1.5 x ULN, ALT and AST: ≤ 2.5 x ULN and creatine clearance rate: ULN or≥ 50 mL/min 6. Toxicity from previous antitumor therapy returned to baseline (except for residual hair loss effects) or CTCAE≤ class 1. 7. Blood pregnancy test was negative within 3 days prior to first dose. Exclusion Criteria: 1. Subjects who have received the prescribed treatment at the prescribed time prior to first dosing. 2. Known active infection within 2 weeks prior to baseline. 3. Subjects with third space fluid that can not be controled. 4. Subjects with uncontrolled or severe cardiovascular disease. 5. Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry. 6. Subjects with severe lung disease. 7. Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption. 8. Using a potent CYP3A4 or CYP2C8 inhibitor or inducer. 9. Steroid treatment for more than 50 days before, or in need of long-term use of steroids. 10. Uncured other tumors within 5 years. 11. Subjects with symptomatic CNS metastasis, pia meningeal metastasis, or spinal cord compression due to metastasis. 12. Evidence of chronic active hepatitis B or C 13. Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment. 14. Receive any live or attenuated live vaccine within 28 days prior to baseline. 15. Evidence of severe allergies. 16. Evidence of alcohol or drug abuse. 17. Evidence of neurological or psychiatric disorders.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HER2-positive advanced solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anhui provincial hospital

    RECRUITING

    Hefei, Anhui, China

  • Anyang Cancer Hospital

    RECRUITING

    Anyang, Henan, China

  • Cancer Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • Guangxi Cancer Hospital

    RECRUITING

    Nanning, Guangxi, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • Linyi Cancer Hospital

    RECRUITING

    Linyi, Shandong, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Bengbu Medical University

    RECRUITING

    Bengbu, China

  • The First Affiliated Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi’an, Shanxi, China

  • The second people's hospital of neijiang

    RECRUITING

    Neijiang, China

  • Tianjin Cancer Hospital Airport Hospital

    RECRUITING

    Tianjin, China

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300181, China

  • Xiangyang Central Hospital

    RECRUITING

    Xiangyang, Hubei, China