Advanced Solid TumorPhase 1NCT06487455
A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.
A Phase 1 study testing SPH7485 in people with Advanced Solid Tumor, run by Shanghai Pharmaceuticals Holding Co., Ltd at 6 sites in China.
Trial summary
To evaluate the efficacy and safety of SPH7485 tablets in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- SPH7485
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 6 sitesChina
- Study dates
- 6 Aug 2024to 31 Dec 2027
- Phase
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed advanced solid tumors；
- At least one extracranial measurable lesion;
- ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1;
- Subjects whose laboratory examination indicators meet the prescribed standards during the screening period;
- Life expectancy≥3 months;
- Subjects whose toxic reactions to previous antitumor therapy returned to baseline or CTCAE≤grade 1;
- Female subjects whose pregnancy tests are negative; Male subjects agree not to donate sperm; Subject and partner agree to use reliable contraception;
- 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.
Who cannot join
- Subjects who have received the prescribed other anti-tumor treatments at the prescribed time prior to the first dose;
- Subjects who have received previous drugs with the same target;
- Subjects with active infections requiring systemic treatment;
- Subjects with third gap fluid accumulation that cannot be controlled by drainage or other methods;
- Subjects with uncontrolled or severe cardiovascular disease;
- Severe lung disease;
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- Subjects with conditions that may affect the absorption, distribution, metabolism, or excretion of the test drug;
- Subjects taking strong/moderate inhibitors or inducers of CYP3A4;
- Subjects who use or require long-term use of hormonotherapy before screening;
- Subjects who have had other malignancies within the past 5 years;
- Subjects with symptomatic CNS metastasis, pial metastasis, or spinal cord compression due to metastasis;
- Subjects who have undergone or are scheduled to undergo major surgery, or have not yet recovered from surgery;
- Abnormal virological examination during screening; History of immune deficiency;
- Uncontrolled systemic diseases;
- Subjects who have participated in any other clinical trial and received treatment within 21 days prior to the first dose;
- Subjects who have received or plan to receive live or attenuated vaccines within 28 days prior to first dose;
- Subjects with a history of severe allergy or known allergy to this product and its excipients;
- Subjects who cannot follow the study protocol to complete the required study visit and dosing;
- Subjects with a history of alcohol or drug abuse;
- Lactating female patients;
- 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;
- Subjects deemed unsuitable for this clinical study by the investigator for other reasons.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jian Zhang contact
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
XiangYa Hospital CentralSouth University
Changsha
Yan Tian
Dai Li
- Recruiting
Fujian Cancer Hospital
Fuzhou
An Lin
- Recruiting
Zhejiang Cancer Hospital
Hangzhou
Jianqing Zhu
- Recruiting
Yunnan Cancer Hospital
Kunming
Hongying Yang
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Xiaohua Wu
Jian Zhang
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Guiling Li
About this study
Official title: 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- SPH7485
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH7485Drug
SPH7485： Orally, once daily, 50-400mg, 21 days per cycle
| Study group | Role | What they receive |
|---|---|---|
| SPH7485 | Experimental | Not described Receives: Drug: SPH7485 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT(Dose-limiting toxicity)
Measurement of DLT of SPH7485 in all subjects
Measured: Approximately 24 days
Maximum tolerated dose（MTD）
Measurement of MTD of SPH7485 in all subjects
Measured: Approximately 24 days
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Approximately 2 years
Secondary outcomes (7)
ORR(Objective Response Rate)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Measured: Approximately 2 years
DoR(Duration of response)
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
Measured: Approximately 2 years
DCR(Disease Control Rate)
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
Measured: Approximately 2 years
PFS(Progression-free survival)
PFS was defined as the time interval between study treatment initiation and the first occurrence of progression disease or death, whichever occurred first.
Measured: Approximately 2 years
PK(Pharmacokinetics):Tmax
Time to peak plasma concentration (Tmax)
Measured: Approximately 3 days
PK(Pharmacokinetics):Cmax
Maximum serum concentration(Cmax)
Measured: Approximately 3 days
PK(Pharmacokinetics):AUC
Area under the plasma concentration versus time curve (AUC)
Measured: Approximately 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start6 Aug 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 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
- NCT06487455
- Sponsor's protocol ID
- SPH7485-101
- Status last verified
- Aug 2025
- First submitted
- 27 Jun 2024
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- 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
- 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.
- ClinicalTrials.gov ID
- NCT06487455
- Acronym / sponsor ID
- SPH7485-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Jul 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 SPH7485 tablets in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPH7485 | Experimental | Drug: SPH7485 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed advanced solid tumors；
- At least one extracranial measurable lesion;
- ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1;
- Subjects whose laboratory examination indicators meet the prescribed standards during the screening period;
- Life expectancy≥3 months;
Key exclusion criteria (22 listed)
- Subjects who have received the prescribed other anti-tumor treatments at the prescribed time prior to the first dose;
- Subjects who have received previous drugs with the same target;
- Subjects with active infections requiring systemic treatment;
- Subjects with third gap fluid accumulation that cannot be controlled by drainage or other methods;
- Subjects with uncontrolled or severe cardiovascular disease;
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 |
|---|---|---|
| SPH7485SPH7485： Orally, once daily, 50-400mg, 21 days per cycle | Drug | SPH7485 |
Primary outcome
DLT(Dose-limiting toxicity)
Time frame: Approximately 24 days
Measurement of DLT of SPH7485 in all subjects
Maximum tolerated dose（MTD）
Time frame: Approximately 24 days
Measurement of MTD of SPH7485 in all subjects
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)
7 secondary outcomes
ORR(Objective Response Rate)
Time frame: Approximately 2 years
DoR(Duration of response)
Time frame: Approximately 2 years
DCR(Disease Control Rate)
Time frame: Approximately 2 years
PFS(Progression-free survival)
Time frame: Approximately 2 years
PK(Pharmacokinetics):Tmax
Time frame: Approximately 3 days
PK(Pharmacokinetics):Cmax
Time frame: Approximately 3 days
PK(Pharmacokinetics):AUC
Time frame: Approximately 3 days
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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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.
Jian Zhang contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPH7485 in people with Advanced Solid Tumor, run by Shanghai Pharmaceuticals Holding Co., Ltd at 6 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 22 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 6 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Xiaohua Wu (0086-021-34778299, shanboer@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT(Dose-limiting toxicity) (time frame: Approximately 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?
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.