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HER2-positive Advanced Solid TumorsEarly Phase 1NCT05245058

SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

A Early Phase 1 study testing SPH5030 tablets in people with HER2-positive Advanced Solid Tumors, run by Shanghai Pharmaceuticals Holding Co., Ltd at 17 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-positive Advanced Solid Tumors
What is being tested?
SPH5030 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
17 sitesChina
Study dates
21 Jan 2022to 21 Dec 2026
Phase
Early Phase 1
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

  • ECOG performance status of 0 to 1.
  • Life expectancy of more than 3 months.
  • At least one measurable lesion exists.(RECIST 1.1)
  • Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment.
  • 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
  • Toxicity from previous antitumor therapy returned to baseline (except for residual hair loss effects) or CTCAE≤ class 1.
  • Blood pregnancy test was negative within 3 days prior to first dose.

Who cannot join

  • Subjects who have received the prescribed treatment at the prescribed time prior to first dosing.
  • Known active infection within 2 weeks prior to baseline.
  • Subjects with third space fluid that can not be controled.
  • Subjects with uncontrolled or severe cardiovascular disease.
  • Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
  • Subjects with severe lung disease.
Show all 17Show fewer
  • Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
  • Using a potent CYP3A4 or CYP2C8 inhibitor or inducer.
  • Steroid treatment for more than 50 days before, or in need of long-term use of steroids.
  • Uncured other tumors within 5 years.
  • Subjects with symptomatic CNS metastasis, pia meningeal metastasis, or spinal cord compression due to metastasis.
  • Evidence of chronic active hepatitis B or C
  • Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment.
  • Receive any live or attenuated live vaccine within 28 days prior to baseline.
  • Evidence of severe allergies.
  • Evidence of alcohol or drug abuse.
  • Evidence of neurological or psychiatric disorders.

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xingchen Wang contact

+8615811589825

wangxc@sphchina.com

17 sites in 1 country

China17 sites, 17 recruiting

  • Anyang Cancer Hospital

    Anyang, Henan

    Jing Sun

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Binghe Xu

    Binghe Xu

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu

    Tingjing Yao

    Huan Zhou

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

    Yunxing Song, +86 17813230827, songyx@sphchina.com

    Yanxia Shi

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Qingyuan Zhang

    Recruiting

  • Anhui provincial hospital

    Hefei, Anhui

    Yueyin Pan

    Recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong

    Jingfen Wang

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

    Jinhai tang

    Recruiting

  • Guangxi Cancer Hospital

    Nanning, Guangxi

    Weimin Xie

    Recruiting

  • The second people's hospital of neijiang

    Neijiang

    Xujuan Wang

    Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning

    Fujian Liu

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Cuizhi Geng

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300181

    Yunxing Song, +86 17813230827, songyx@sphchina.com

    Zhongsheng Tong

    Recruiting

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin

    Yehui Shi

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

    Shuqun Zhang

    Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei

    Yuehua Wang

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Min Yan

    Recruiting

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors

Being tested
SPH5030 tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPH5030 tabletsDrug

    SPH5030 tablets orally once or twice daily.

Study groups in NCT05245058
Study groupRoleWhat they receive
SPH5030 tabletsExperimentalSubjects will take SPH5030 tablets orally on an empty stomach once or twice a day. Each subject will receive only one corresponding dose, and there were five dose groups: 50mg/ d, 100mg/ d, 200mg/ d, 300mg/ d and 400mg/ d.
Receives: Drug: SPH5030 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT)

    Measurement of DLT of SPH5030 in all subjects

    Measured: Up to 24 days

  2. Maximum tolerated dose（MTD）

    Measurement of MTD of SPH5030 in all subjects

    Measured: Up to 24 days

  3. Number of patients with adverse events

    Adverse event type, incidence, duration, correlation with study drug

    Measured: Up to 2 years

Secondary outcomes (17)

  1. Maximum serum concentration (Cmax) of SPH 5030

    To characterize the PK (Pharmacokinetics) of SPH 5030

    Measured: Up to 2 years

  2. Time of maximum serum concentration (Tmax) SPH 5030

    To characterize the PK (Pharmacokinetics) of SPH 5030

    Measured: Up to 2 years

  3. Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14) of SPH5030

    To characterize the PK (Pharmacokinetics) of SPH 5030

    Measured: Up to 2 years

  4. Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH5030

    To characterize the PK (Pharmacokinetics) of SPH 5030

    Measured: Up to 2 years

  5. Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH5030

    To characterize the PK (Pharmacokinetics) of SPH 5030

    Measured: Up to 2 years

  6. Accumulation ratio of maximum serum concentration (Rac_Cmax) of SPH5030

    To characterize the PK (Pharmacokinetics) of SPH 5030

    Measured: Up to 2 years

  7. Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of SPH5030

    To characterize the PK (Pharmacokinetics) of SPH 5030

    Measured: Up to 2 years

  8. Terminal rate constant(λz) of SPH5030

    To characterize the PK (Pharmacokinetics) of SPH 5030

    Measured: Up to 2 years

  9. Half-life (t1/2) of SPH5030

    To characterize the PK (Pharmacokinetics) of SPH 5030

    Measured: Up to 2 years

  10. Total clearance(CL) of SPH5030

    To characterize the PK (Pharmacokinetics) of SPH 5030

    Measured: Up to 2 years

  11. Volume of distribution(Vz) of SPH5030

    To characterize the PK (Pharmacokinetics) of SPH 5030

    Measured: Up to 2 years

  12. Percentage of area under the serum concentration-time curve (AUC) obtained by extrapolation (%AUCex) of SPH5030

    To characterize the PK (Pharmacokinetics) of SPH 5030

    Measured: Up to 2 years

  13. Objective Response Rate (Investigator)

    Determination of the Objective Response Rate of all patients by investigators

    Measured: Up to 2 years

  14. Duration of remission (DOR)

    Time from first documentation of objective response (CR or PR) to first documentation of PD/death due to any cause in absence of documented PD, based on central radiology review as per RECIST v1.1.

    Measured: Up to 2 years

  15. Disease control rate (DCR)

    The proportion of patients with best confirmed RECIST response of CR, PR, or duration of SD.

    Measured: Up to 2 years

  16. Progression-free survival (PFS)

    The interval between the dates of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first.

    Measured: Up to 2 years

  17. 6-month Progression-free Survival (6mPFS)

    Number of Patients Achieving 6-month Progression-free Survival

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2022
  2. Study start21 Jan 2022
  3. Primary completion21 Dec 2026 (estimated)
  4. Study completion21 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05245058
Sponsor's protocol ID
SPH5030-101
Status last verified
Aug 2025
First submitted
8 Feb 2022
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing SPH5030 tablets in people with HER2-positive Advanced Solid Tumors, run by Shanghai Pharmaceuticals Holding Co., Ltd at 17 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 17 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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Xingchen Wang (+8615811589825, wangxc@sphchina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: Up to 24 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05245058.

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 5 May 2026.

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