Advanced Solid TumorEarly Phase 1NCT06266923
A Clinical Study of SPH6516 Tablets in the Treatment of Advanced Solid Tumors.
A Early Phase 1 study testing SPH6516 tablets in people with Advanced Solid Tumor, run by Shanghai Pharmaceuticals Holding Co., Ltd at 2 sites in China.
Trial summary
To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SPH6516 tablets in the treatment of advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- SPH6516 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesChina
- Study dates
- 20 Jan 2022to 1 Nov 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced solid tumors;
- The ECOGscore is 0 to 1.
- Expected survival ≥3 months.
- Good organ function before first use of the investigational drug.
- Any toxicity associated with previous antitumor therapy must have returned to ≤ grade 1.
- Voluntarily participate in this clinical trial, understand the research procedures and be able to sign the informed consent in person.
Who cannot join
- Subjects who have received certain treatment in the prescribed period prior to their first medication;
- Subjects who have undergone major surgery within 6 weeks before the first medication, or who plan to undergo major surgery within 12 weeks after the first medication;
- Subjects who have participated in any other clinical trials and received treatment within 4 weeks prior to the first medication;
- Subjects with third space fluid accumulation that cannot be controlled by drainage or other methods; Subjects with factors affecting drug administration and absorption;
- Subjects with allergic constitution or a history of severe allergies;
- Subjects with active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, or a history of immunodeficiency;
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- Subjects with a history or evidence of high risk cardiovascular disease;
- Subjects with severe lung disease;
- Pregnant and lactating female subjects; Female subjects of childbearing age or male subjectswith fertile partners who were unwilling to take effective contraceptive measures throughout the entire trial period;
- Subjects with a clear history of neurological or psychiatric disorders;
- Other situations in which the investigator did not consider it appropriate to participate in the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Sun Yat-sen University Cancer Center
Guangzhou
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of SPH6516 Tablets in Subjects With Advanced Solid Tumors.
To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SPH6516 tablets in the treatment of advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- SPH6516 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH6516 tabletsDrug
SPH6516 tablets ： Orally, once daily, 25-200mg, 28 days a cycle
| Study group | Role | What they receive |
|---|---|---|
| SPH6516 tablets | Experimental | Not described Receives: Drug: SPH6516 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD（Maximum tolerated dose）
Maximum tolerated dose
Measured: Approximately 2 years
Secondary outcomes (7)
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Measured: Approximately 2 years
Peak Plasma Concentration (Cmax）
PK (Pharmacokinetics)
Measured: Approximately 2 years
Peak time（Tmax）
PK (Pharmacokinetics)
Measured: Approximately 2 years
Area under the plasma concentration versus time curve (AUC)
PK (Pharmacokinetics)
Measured: Approximately 2 years
half-life（T1/2）
PK (Pharmacokinetics)
Measured: Approximately 2 years
Objective response rate(ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1
Measured: Approximately 2 years
Progression-free survival (PFS)
The interval between the date of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first.
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start20 Jan 2022
- Primary completion20 Apr 2023
- Study completion1 Nov 2023
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
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
- NCT06266923
- Sponsor's protocol ID
- SPH6516-101
- Status last verified
- Jan 2024
- First submitted
- 29 Jan 2024
- Last updated
- 20 Feb 2024
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of SPH6516 Tablets in Subjects With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT06266923
- Acronym / sponsor ID
- SPH6516-101
- Conditions
- Advanced Solid Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 20 Feb 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 safety, tolerability, pharmacokinetics and preliminary efficacy of SPH6516 tablets in the treatment of 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 |
|---|---|---|
| SPH6516 tablets | Experimental | Drug: SPH6516 tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Advanced solid tumors;
- The ECOGscore is 0 to 1.
- Expected survival ≥3 months.
- Good organ function before first use of the investigational drug.
- Any toxicity associated with previous antitumor therapy must have returned to ≤ grade 1.
Key exclusion criteria (11 listed)
- Subjects who have received certain treatment in the prescribed period prior to their first medication;
- Subjects who have undergone major surgery within 6 weeks before the first medication, or who plan to undergo major surgery within 12 weeks after the first medication;
- Subjects who have participated in any other clinical trials and received treatment within 4 weeks prior to the first medication;
- Subjects with third space fluid accumulation that cannot be controlled by drainage or other methods; Subjects with factors affecting drug administration and absorption;
- Subjects with allergic constitution or a history of severe allergies;
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 |
|---|---|---|
| SPH6516 tabletsSPH6516 tablets ： Orally, once daily, 25-200mg, 28 days a cycle | Drug | SPH6516 tablets |
Primary outcome
MTD（Maximum tolerated dose）
Time frame: Approximately 2 years
Maximum tolerated dose
7 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: Approximately 2 years
Peak Plasma Concentration (Cmax）
Time frame: Approximately 2 years
Peak time（Tmax）
Time frame: Approximately 2 years
Area under the plasma concentration versus time curve (AUC)
Time frame: Approximately 2 years
half-life（T1/2）
Time frame: Approximately 2 years
Objective response rate(ORR)
Time frame: Approximately 2 years
Progression-free survival (PFS)
Time frame: Approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SPH6516 tablets in people with Advanced Solid Tumor, run by Shanghai Pharmaceuticals Holding Co., Ltd at 2 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD（Maximum tolerated dose） (time frame: Approximately 2 years). 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 20 Feb 2024.