Solid TumorPhase 1NCT05088070
Clinical Study of SPH3348 Tablets, a C-Met Inhibitor, in Patients with Advanced Solid Tumors
A Phase 1 study testing SPH 3348 in people with Solid Tumor, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site in China.
Trial summary
This is a phase 1 clinical trial of SPH3348 tablets, a c-Met inhibitor, in patients with advanced solid tumors with c-Met abnormalities. A modified 3 + 3 design was adopted in patients with advanced solid tumors with c-Met abnormalities, with a total of 6 dose groups, in which accelerated dose escalation was adopted… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- SPH 3348
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2020to 30 Jul 2023
- Phase
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced solid tumors with c-Met abnormalities who have failed standard of care or are not eligible for standard therapy currently
- ECOG score of 0 or 1.
- Patients must have measurable lesion that can be assessed by imaging per RECIST 1.1 criteria.
- Expected survival > 12 weeks.
- Patients must have adequate organ function
- Patients must give informed consent to the study and sign the informed consent form prior to the trial.
Who cannot join
- Received anti-tumor therapies, including but not limited to chemotherapy, biotherapy, radiotherapy, targeted therapy, etc., within 4 weeks prior to the first dose of study drug; received nitrosoureas or mitomycin C within 6 weeks prior to the start of study drug.
- Received small molecule tyrosine kinase inhibitors within 2 weeks prior to the first dose.
- Received strong CYP3A4 inducers or inhibitors or CYP3A4 substrates with narrow therapeutic windows within 2 weeks prior to the start of study drug.
- Patients with active hepatitis B (hepatitis B surface antigen (HBsAg) positive) or hepatitis C (HCV).
- Toxicities caused by prior treatments have not recovered to CTCAE Grade ≤ 1 or having ≥Grade 2 peripheral neuropathy, except for alopecia and other events judged as tolerable by the investigator.
- Known allergy to any component of the reference drug.
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- Known drug or alcohol dependence.
- Received surgical treatment including surgical and interventional procedures within 4 weeks prior to the start of study drug.
- Patients with brain metastases.
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or evidence of any clinically active interstitial lung disease.
- Acute bacterial, viral, or fungal infection requiring systemic therapy or unexplained fever (temperature > 38.5 °C) during screening, prior to the first dose.
- Neurological and psychiatric patients with obvious poor compliance.
- Any of the following within 6 months prior to signing of informed consent form: uncontrolled congestive cardiac failure, severe or unstable angina pectoris, myocardial infarction, stroke, coronary/peripheral artery bypass surgery, pulmonary embolism.
- Arrhythmia uncontrolled by medication or sustained QTcB prolongation.
- Hypertension uncontrolled by medication
- Participated in other drug clinical studies within 28 days prior to the first dose of study drug.
- Women who are pregnant or in lactation period or women/men with childbearing plans.
- Patients who cannot take oral medication, or have previous surgical history or serious gastrointestinal diseases such as dysphagia, active gastric ulcer, which may impair the absorption of the study drug in the investigator's opinion.
- Other prior or current concomitant malignancies.
- Patients who are ineligible to participate in this trial for any reason judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
About this study
Official title: Phase I Clinical Study of SPH3348 Tablets, a C-Met Inhibitor, in Patients with Advanced Solid Tumors with C-Met Abnormalities
This is a phase 1 clinical trial of SPH3348 tablets, a c-Met inhibitor, in patients with advanced solid tumors with c-Met abnormalities. A modified 3 + 3 design was adopted in patients with advanced solid tumors with c-Met abnormalities, with a total of 6 dose groups, in which accelerated dose escalation was adopted for the lowest dose group, and 3 + 3 dose escalation was adopted from the second dose group. The primary objective was to evaluate the safety and tolerability of SPH3348 tablets in patients with advanced solid tumors with c-Met abnormalities.
- Conditions
- Solid Tumor
- Being tested
- SPH 3348
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH 3348Drug
2 tablets of 8mg SPH3348 will be orally administered once a day with empty stomach
SPH 3348Drug
1 tablet of 40mg SPH3348 will be orally administered once a day with empty stomach
SPH 3348Drug
2 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach
SPH 3348Drug
4 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach
SPH 3348Drug
6 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach
SPH 3348Drug
8 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach
| Study group | Role | What they receive |
|---|---|---|
| SPH 3348 tablets | Experimental | 6 different dosage group of SPH 3348 will be assigned with 16mg, 40mg, 80mg, 160mg, 240mg and 320mg respectively. Receives: Drug: SPH 3348 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Incidence of DLT in all subjects.
Measured: 24 days
Maximum tolerated dose (MTD)
Measurement of MTD in all subjects.
Measured: 24 days
Secondary outcomes (9)
Maximum serum concentration (Cmax) of SPH 3348.
To characterize the PK (Pharmacokinetics) of SPH 3348.
Measured: 24 days
Time of maximum serum concentration (Tmax) SPH 3348.
To characterize the PK (Pharmacokinetics) of SPH 3348.
Measured: 24 days
Area under the concentration-time curve (AUC) of SPH 3348.
To characterize the PK (Pharmacokinetics) of SPH 3348.
Measured: 24 days
Half-life (t1/2) of SPH 3348.
To characterize the PK (Pharmacokinetics) of SPH 3348.
Measured: 24 days
Objective Response Rate (ORR)
Measurement of ORR in all subjects.
Measured: 24 days
Disease control rate (DCR)
Measurement of DCR in all subjects.
Measured: 24 days
Duration of remission (DOR)
Measurement of DOR in all subjects.
Measured: 24 days
Progression-free survival (PFS)
Measurement of PFS in all subjects.
Measured: 24 days
Biomarker expression level
Evaluate the level of hepatocyte growth factor(HGF).
Measured: 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start2 Jul 2020
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zishu Wang, Principal investigator, The First Affliated Hospital of Bengbu Medical CollegeHuan Zhou, Principal investigator, The First Affliated Hospital of Bengbu Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088070
- Sponsor's protocol ID
- SPH3348-101
- Status last verified
- Aug 2024
- First submitted
- 24 Sep 2021
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of SPH3348 Tablets, a C-Met Inhibitor, in Patients with Advanced Solid Tumors with C-Met Abnormalities
- ClinicalTrials.gov ID
- NCT05088070
- Acronym / sponsor ID
- SPH3348-101
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 21 Oct 2021 (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.
This is a phase 1 clinical trial of SPH3348 tablets, a c-Met inhibitor, in patients with advanced solid tumors with c-Met abnormalities. A modified 3 + 3 design was adopted in patients with advanced solid tumors with c-Met abnormalities, with a total of 6 dose groups, in which accelerated dose escalation was adopted for the lowest dose group, and 3 + 3 dose escalation was adopted from the second dose group. The primary objective was to evaluate the safety and tolerability of SPH3348 tablets in patients with advanced solid tumors with c-Met abnormalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPH 3348 tablets | Experimental | Drug: SPH 33486 different dosage group of SPH 3348 will be assigned with 16mg, 40mg, 80mg, 160mg, 240mg and 320mg respectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with advanced solid tumors with c-Met abnormalities who have failed standard of care or are not eligible for standard therapy currently
- ECOG score of 0 or 1.
- Patients must have measurable lesion that can be assessed by imaging per RECIST 1.1 criteria.
- Expected survival > 12 weeks.
- Patients must have adequate organ function
Key exclusion criteria (20 listed)
- Received anti-tumor therapies, including but not limited to chemotherapy, biotherapy, radiotherapy, targeted therapy, etc., within 4 weeks prior to the first dose of study drug; received nitrosoureas or mitomycin C within 6 weeks prior to the start of study drug.
- Received small molecule tyrosine kinase inhibitors within 2 weeks prior to the first dose.
- Received strong CYP3A4 inducers or inhibitors or CYP3A4 substrates with narrow therapeutic windows within 2 weeks prior to the start of study drug.
- Patients with active hepatitis B (hepatitis B surface antigen (HBsAg) positive) or hepatitis C (HCV).
- Toxicities caused by prior treatments have not recovered to CTCAE Grade ≤ 1 or having ≥Grade 2 peripheral neuropathy, except for alopecia and other events judged as tolerable by the investigator.
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 |
|---|---|---|
| SPH 33482 tablets of 8mg SPH3348 will be orally administered once a day with empty stomach | Drug | SPH 3348 tablets |
| SPH 33481 tablet of 40mg SPH3348 will be orally administered once a day with empty stomach | Drug | SPH 3348 tablets |
| SPH 33482 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach | Drug | SPH 3348 tablets |
| SPH 33484 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach | Drug | SPH 3348 tablets |
| SPH 33486 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach | Drug | SPH 3348 tablets |
| SPH 33488 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach | Drug | SPH 3348 tablets |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 24 days
Incidence of DLT in all subjects.
Maximum tolerated dose (MTD)
Time frame: 24 days
Measurement of MTD in all subjects.
9 secondary outcomes
Maximum serum concentration (Cmax) of SPH 3348.
Time frame: 24 days
Time of maximum serum concentration (Tmax) SPH 3348.
Time frame: 24 days
Area under the concentration-time curve (AUC) of SPH 3348.
Time frame: 24 days
Half-life (t1/2) of SPH 3348.
Time frame: 24 days
Objective Response Rate (ORR)
Time frame: 24 days
Disease control rate (DCR)
Time frame: 24 days
Duration of remission (DOR)
Time frame: 24 days
Progression-free survival (PFS)
Time frame: 24 days
Biomarker expression level
Time frame: 24 days
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 30 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Zishu Wang principal investigator
The First Affliated Hospital of Bengbu Medical College
Huan Zhou principal investigator
The First Affliated Hospital of Bengbu Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPH 3348 in people with Solid Tumor, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site 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 20 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 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Dose-limiting toxicity (DLT) (time frame: 24 days). The study lists 2 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 30 Aug 2024.