Advanced Solid TumorPhase 1NCT04423380
A Study to Investigate Safety and Tolerability of SH3051 Capsule in Patients With Advanced Solid Tumors
A Phase 1 study testing SH3051 capsule treatment in people with Advanced Solid Tumor, run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 1 site in China.
Trial summary
The primary objective is to determine the safety profile of SH3051 in subjects with advanced solid tumors. The second objective is to evaluate the PK profile and preliminary efficacy of SH3051 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?
- SH3051 capsule treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2020to May 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years inclusive;
- Histologically or cytologically confirmed advanced malignant solid tumors, eligible patients have failed standard treatment, have no standard treatment, or are not suitable for standard treatment at this stage as determined by the investigator.
- Must have at least one evaluable lesion in dose escalation period and one unidimensional measurable lesion according to RECIST version 1.1;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy ≥3 months;
- Adequate hematological and biological function, confirmed by the following laboratory values:ANC≥1.5×10^9/L;PLT≥75×10^9/L;Hb≥90g/L;TBIL≤1.5×ULN;AST and ALT≤3×ULN(ALT and AST≤5×ULN for subjects with liver cancer or hepatic metastases);CLcr>50 mL/min(according to Cockcroft-Gault);Child-Pugh score between 0~7 for subjects with primary hepatic carcinoma;APTT≤1.5×ULN;INR≤1.5×ULN.
- Men and women of childbearing potential are willing to employ an effective method of contraception for the entire duration of study and 6 months after the last dose, and female subjects of childbearing potential have a negative pregnancy test at baseline.
- Provision of signed and dated, written informed consent prior to any study-specific evaluation.
Who cannot join
- Previous treatment with any TGF-β inhibitors.
- Anticancer treatment including radiation therapy, chemotherapy, hormonal therapy, molecular targeted therapy, or immunotherapy within 4 weeks prior to the first dose of SH3051(use of mitomycin or nitrosoureas within 6 weeks prior to the first dose;use of oral oral fluorouracil and small molecule targeted drugs within 2 weeks ,or 5 half-lifes prior to the first dose;use of Chinese herbal anti-tumor treatment with 2 weeks prior to the first dose).
- Have systematic hormonal therapy(prednisone>20mg/d or similar drugs with equivalent dose)or immunosuppressor therapy with 14 days prior to the first dose of study drug, except using topical,ocular,intra-articular,intranasal,inhaled corticosteroids,and preventive therapy using corticosteroids in short period(for instance,to prevent hypersensitivity to contrast media).
- Participate in other clinical trials within 4 weeks prior to study entry.
- Concomitant use of any strong inhibitors or inducers of CYP3A4(except drug withdrawal within one week prior to first dose of study drug).
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
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- Adverse events occurred during previous anticancer therapy have not been recovered to ≤1(CTCAE 5.0)except toxicity with no significant risk determined by investigators such as alopecia.
- Evidence of central nervous system (CNS) metastases accompanied with clinical symptoms, or other evidence of uncontrolled CNS metastases Judged by investigators that the patient should not participate in the study.
- Presence of grade 3 or 4 gastrointestinal bleeding or esophageal and gastric varices.
- Have moderate or severe cardiac disease, including but not limited to severe arrhythmias or abnormal cardiac conduction, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block,QTcF≥450 ms for male, QTcF≥470 ms for female, or other structural heart disease with high risk as determined by investigators;history of acute coronary syndrome, congestive heart failure,aortic dissection,stroke or other≥grade 3 cardiovascular and cerebrovascular events within 6 months prior to the first dose of study drug;New York Heart Association (NYHA) Class II or greater heart failure, or LVEF<55%;cTnT or cTnI above the normal limit;NT-proBNP>1.25×ULN;uncontrolled hypertension;any risk factors to increase QTc or arrhythmias, including heart failure,hypokalemia,congenital long QTc syndrome,family history of long QT interval syndrome or history of unexplained sudden death occurred in first degree relative less than 40 years of age, or using any concomitant medication known to produce QTc prolongation.
- Have active infection requiring systemic with one week prior to the first dose the study drug.
- Infection with hepatitis B virus(HBV)and hepatitis C virus(HCV) (volunteers with HBsAg positive but HBV-DNA negative, or volunteers with HCV antibody positive but HCV-RNA negative can be enrolled).
- History of immune deficiency including HIV antibody positive.
- Major surgery(not include biopsy),or significant traumatism,or requiring selective operation within 4 weeks prior to study entry.
- Inability to swallow the drug, or severe gastrointestinal disease affecting absorption of the drug.
- Uncontrolled effusion in the third space, not suitable for entry as determined by the investigator.
- With alcohol or drug abuse disorder.
- With mental disorders or non-compliance.
- Women who are pregnancy or breastfeeding.
- Judgment by the investigator that the patient should not participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai
Jin Li, 13761222111, lijin@csso.org.cn
About this study
Official title: A Phase I, Open-Label Study to Determine Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of SH3051 Capsule in Patients With Advanced Solid Tumors
The primary objective is to determine the safety profile of SH3051 in subjects with advanced solid tumors. The second objective is to evaluate the PK profile and preliminary efficacy of SH3051 solid tumors.
Read the detailed description
This is a phase I, open-label study to assess the safety,tolerability, pharmacokinetics and preliminary efficacy of SH3051 capsule, a small molecule inhibitor of type I transforming growth factor-β(TGF-β) receptor serine/threonine kinase, in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- SH3051 capsule treatment
- Keywords
- advanced solid tumor, TGF-β RI, ALK5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SH3051 capsule treatmentDrug
Starting dose 20mg,oral administered twice daily.If tolerated subsequent cohorts will test increasing doses (40mg,60mg,80mg,100mg) of SH3051.
| Study group | Role | What they receive |
|---|---|---|
| SH3051 capsules treatment | Experimental | Oral Twice Daily Administration of SH3051 Receives: Drug: SH3051 capsule treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose(MTD)
Measured: Within the first 28 days of consecutive treatment
Incidence of Dose Limiting Toxicity (DLT)
Measured: Within the first 28 days of consecutive treatment
Secondary outcomes (7)
Area under the plasma concentration versus time curve(AUC)of SH3051
Measured: 4 weeks
Elimination half-life(T1/2)of SH3051
Measured: 4 weeks
Maximum(or peak)concentration of SH3051
Measured: 4 weeks
Overall Response Rate(ORR)
Measured: up to 12 months
Progression-free survival(PFS)
Measured: up to 12 months
Disease control rates(DCR）
Measured: up to 12 months
Duration of response(DOR)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start14 May 2020
- Primary completionMar 2021 (estimated)
- Study completionMay 2021 (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.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, MD, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423380
- Sponsor's protocol ID
- SHC033-I-01
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study to Determine Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of SH3051 Capsule in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04423380
- Acronym / sponsor ID
- SHC033-I-01
- Conditions
- Advanced Solid Tumor
- Keywords
- advanced solid tumor, TGF-β RI, ALK5
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 May 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 9 Jun 2020 (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.
The primary objective is to determine the safety profile of SH3051 in subjects with advanced solid tumors. The second objective is to evaluate the PK profile and preliminary efficacy of SH3051 solid tumors.
Detailed description
This is a phase I, open-label study to assess the safety,tolerability, pharmacokinetics and preliminary efficacy of SH3051 capsule, a small molecule inhibitor of type I transforming growth factor-β(TGF-β) receptor serine/threonine kinase, 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 |
|---|---|---|
| SH3051 capsules treatment | Experimental | Drug: SH3051 capsule treatmentOral Twice Daily Administration of SH3051 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 70 years inclusive;
- Histologically or cytologically confirmed advanced malignant solid tumors, eligible patients have failed standard treatment, have no standard treatment, or are not suitable for standard treatment at this stage as determined by the investigator.
- Must have at least one evaluable lesion in dose escalation period and one unidimensional measurable lesion according to RECIST version 1.1;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy ≥3 months;
Key exclusion criteria (20 listed)
- Previous treatment with any TGF-β inhibitors.
- Anticancer treatment including radiation therapy, chemotherapy, hormonal therapy, molecular targeted therapy, or immunotherapy within 4 weeks prior to the first dose of SH3051(use of mitomycin or nitrosoureas within 6 weeks prior to the first dose;use of oral oral fluorouracil and small molecule targeted drugs within 2 weeks ,or 5 half-lifes prior to the first dose;use of Chinese herbal anti-tumor treatment with 2 weeks prior to the first dose).
- Have systematic hormonal therapy(prednisone>20mg/d or similar drugs with equivalent dose)or immunosuppressor therapy with 14 days prior to the first dose of study drug, except using topical,ocular,intra-articular,intranasal,inhaled corticosteroids,and preventive therapy using corticosteroids in short period(for instance,to prevent hypersensitivity to contrast media).
- Participate in other clinical trials within 4 weeks prior to study entry.
- Concomitant use of any strong inhibitors or inducers of CYP3A4(except drug withdrawal within one week prior to first dose of study drug).
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 |
|---|---|---|
| SH3051 capsule treatmentStarting dose 20mg,oral administered twice daily.If tolerated subsequent cohorts will test increasing doses (40mg,60mg,80mg,100mg) of SH3051. | Drug | SH3051 capsules treatment |
Primary outcome
Maximum tolerated dose(MTD)
Time frame: Within the first 28 days of consecutive treatment
Incidence of Dose Limiting Toxicity (DLT)
Time frame: Within the first 28 days of consecutive treatment
7 secondary outcomes
Area under the plasma concentration versus time curve(AUC)of SH3051
Time frame: 4 weeks
Elimination half-life(T1/2)of SH3051
Time frame: 4 weeks
Maximum(or peak)concentration of SH3051
Time frame: 4 weeks
Overall Response Rate(ORR)
Time frame: up to 12 months
Progression-free survival(PFS)
Time frame: up to 12 months
Disease control rates(DCR）
Time frame: up to 12 months
Duration of response(DOR)
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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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.
Jin Li, MD principal investigator
Shanghai East Hospital
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 SH3051 capsule treatment in people with Advanced Solid Tumor, run by Nanjing Sanhome Pharmaceutical, 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 8 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: status not confirmed, as of the sponsor's last update on 9 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xian Shen (18651825172, shenxian@sanhome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose(MTD) (time frame: Within the first 28 days of consecutive treatment). 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 9 Jun 2020.