A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.

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

An Open, Multicenter, Dose-escalation, and Dose-expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SPH7485 Tablets in Patients With Advanced Solid Tumors.

To evaluate the efficacy and safety of SPH7485 tablets in patients with advanced solid tumors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: jian Zhang

Study Contact Backup

Study Locations

  • China
      • Changsha, China
        • Recruiting
        • XiangYa Hospital CentralSouth University
        • Contact:
          • Yan Tian
        • Contact:
          • Dai Li
      • Fuzhou, China
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • An Lin
      • Hangzhou, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Jianqing Zhu
      • Kunming, China
        • Recruiting
        • Yunnan Cancer Hospital
        • Contact:
          • Hongying Yang
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • jian Zhang
        • Contact:
          • Xiaohua Wu
      • Wuhan, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Guiling Li

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed advanced solid tumors；
  2. At least one extracranial measurable lesion;
  3. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1;
  4. Subjects whose laboratory examination indicators meet the prescribed standards during the screening period;
  5. Life expectancy≥3 months;
  6. Subjects whose toxic reactions to previous antitumor therapy returned to baseline or CTCAE≤grade 1;
  7. Female subjects whose pregnancy tests are negative; Male subjects agree not to donate sperm; Subject and partner agree to use reliable contraception;
  8. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Subjects willing to follow and able to complete all test procedures.

Exclusion Criteria:

  1. Subjects who have received the prescribed other anti-tumor treatments at the prescribed time prior to the first dose;
  2. Subjects who have received previous drugs with the same target;
  3. Subjects with active infections requiring systemic treatment;
  4. Subjects with third gap fluid accumulation that cannot be controlled by drainage or other methods;
  5. Subjects with uncontrolled or severe cardiovascular disease;
  6. Severe lung disease;
  7. Subjects with conditions that may affect the absorption, distribution, metabolism, or excretion of the test drug;
  8. Subjects taking strong/moderate inhibitors or inducers of CYP3A4;
  9. Subjects who use or require long-term use of hormonotherapy before screening;
  10. Subjects who have had other malignancies within the past 5 years;
  11. Subjects with symptomatic CNS metastasis, pial metastasis, or spinal cord compression due to metastasis;
  12. Subjects who have undergone or are scheduled to undergo major surgery, or have not yet recovered from surgery;
  13. Abnormal virological examination during screening; History of immune deficiency;
  14. Uncontrolled systemic diseases;
  15. Subjects who have participated in any other clinical trial and received treatment within 21 days prior to the first dose;
  16. Subjects who have received or plan to receive live or attenuated vaccines within 28 days prior to first dose;
  17. Subjects with a history of severe allergy or known allergy to this product and its excipients;
  18. Subjects who cannot follow the study protocol to complete the required study visit and dosing;
  19. Subjects with a history of alcohol or drug abuse;
  20. Lactating female patients;
  21. Subjects with a clear past history of neurological or psychiatric disorders. Subjects with primary diseases of other vital organs deemed unsuitable for inclusion by the investigator;
  22. Subjects deemed unsuitable for this clinical study by the investigator for other reasons.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SPH7485
Drug: SPH7485
SPH7485： Orally, once daily, 50-400mg, 21 days per cycle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Approximately 2 years
DLT(Dose-limiting toxicity)
Time Frame: Approximately 24 days
Measurement of DLT of SPH7485 in all subjects
Approximately 24 days
Maximum tolerated dose（MTD）
Time Frame: Approximately 24 days
Measurement of MTD of SPH7485 in all subjects
Approximately 24 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ORR(Objective Response Rate)
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
DoR(Duration of response)
Time Frame: Approximately 2 years
DOR was defined as the time interval between the date of the first documented response (CR or PR) and the date of the first documented disease progression or death due to any cause
Approximately 2 years
DCR(Disease Control Rate)
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
PFS(Progression-free survival)
Time Frame: Approximately 2 years
PFS was defined as the time interval between study treatment initiation and the first occurrence of progression disease or death, whichever occurred first.
Approximately 2 years
PK(Pharmacokinetics):Tmax
Time Frame: Approximately 3 days
Time to peak plasma concentration (Tmax)
Approximately 3 days
PK(Pharmacokinetics):Cmax
Time Frame: Approximately 3 days
Maximum serum concentration(Cmax)
Approximately 3 days
PK(Pharmacokinetics):AUC
Time Frame: Approximately 3 days
Area under the plasma concentration versus time curve (AUC)
Approximately 3 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPH7485-101

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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