Advanced Solid TumorPhase 1NCT04843033
A Study to Investigate Safety and Tolerability of SH3809 Tablet in Patients With Advanced Solid Tumors
A Phase 1 study testing SH3809 tablet 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 and tolerability of SH3809 in subjects with advanced solid tumors. The second objective is to evaluate the PK profile and preliminary efficacy of SH3809 in 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?
- SH3809 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2021to Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years inclusive;
- Histologically or cytologically confirmed advanced malignant solid tumors, eligible patients should be either refractory or intolerant to all available therapies known to confer a clinical benefit as determined by the investigator, except for primary hepatic carcinoma;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy ≥ 3 months;
- Adequate hematologic, hepatic and renal function;
- Participant willing to agree to not father a child/become pregnant and comply with effective contraception criteria;
- Provision of signed and dated, written informed consent prior to any study-specific evaluation.
Who cannot join
- Previous treatment with any SHP2 inhibitors;
- Spinal cord compression, meningeal metastases or brain metastases unless asymptomatic, stable and not requiring steroids for at least 2 weeks prior to start of study treatment;
- Life-threatening autoimmune disease or autoimmune disorder with long-term steroid treatment;
- Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) and treponema pallidum (TP);
- Patients who have impaired cardiac function or clinically significant cardiac diseases;
- Active, clinically significant interstitial lung disease or pneumonitis;
- Females who are pregnant 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 Chest Hospital
Shanghai, Shanghai Municipality, 200030
Shun Lu, Ph D, 22200000-3123, shunlu_shchest@sina.com
Shun Lu, Ph D
About this study
Official title: A Phase I, Open-Label Study to Determine Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of SH3809 Tablet in Patients With Advanced Solid Tumors in China
The primary objective is to determine the safety and tolerability of SH3809 in subjects with advanced solid tumors. The second objective is to evaluate the PK profile and preliminary efficacy of SH3809 in solid tumors.
Read the detailed description
This is a phase I, open-label study to assess the safety,tolerability, pharmacokinetics and preliminary efficacy of SH3809 tablet, a small molecule inhibitor of SHP2 receptor , in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- SH3809 tablet
- Keywords
- advanced solid tum, SHP2, EGFR, NSCLC, Colorectal cancer, KRAS G12
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SH3809 tabletDrug
Starting dose 2mg,oral administered once daily. If tolerated subsequent cohorts will test increasing doses (4mg,6mg,8mg,10mg,12mg) of SH3809.
| Study group | Role | What they receive |
|---|---|---|
| Daily oral administration of SH3809 tablet | Experimental | Not described Receives: Drug: SH3809 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities (DLTs)
Incidence and nature of DLTs in the dose escalation phase
Measured: Within the first 28 days of consecutive treatment
Maximum tolerated dose(MTD)
Measured: Within the first 28 days of consecutive treatment
Secondary outcomes (8)
Cmax
Highest observed plasma concentration of SH3809
Measured: 4 weeks
Tmax
Time of highest observed plasma concentration of SH3809
Measured: 4 weeks]
T1/2
Elimination half-life of SH3809
Measured: 4 weeks
Area Under the Curve (AUC)
Area under the plasma concentration time curve of SH3809
Measured: 4 weeks
Overall Response Rate(ORR)
Overall response rate of SH3809 per RECIST v1.1
Measured: up to 12 months
Progression-free survival(PFS)
Measured: up to 12 months
Disease control rates(DCR)
Disease control rates of SH3809 per RECIST v1.1
Measured: up to 12 months
Duration of response(DOR)
Duration of response of SH3809 per RECIST v1.1
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 posted13 Apr 2021
- Study start2 Apr 2021
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843033
- Sponsor's protocol ID
- SHC024-I-01
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2021
- Last updated
- 13 Apr 2021
- 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 13 Apr 2021. 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 SH3809 Tablet in Patients With Advanced Solid Tumors in China
- ClinicalTrials.gov ID
- NCT04843033
- Acronym / sponsor ID
- SHC024-I-01
- Conditions
- Advanced Solid Tumor
- Keywords
- advanced solid tum, SHP2, EGFR, NSCLC, Colorectal cancer, KRAS G12
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Apr 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.
The primary objective is to determine the safety and tolerability of SH3809 in subjects with advanced solid tumors. The second objective is to evaluate the PK profile and preliminary efficacy of SH3809 in solid tumors.
Detailed description
This is a phase I, open-label study to assess the safety,tolerability, pharmacokinetics and preliminary efficacy of SH3809 tablet, a small molecule inhibitor of SHP2 receptor , 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 |
|---|---|---|
| Daily oral administration of SH3809 tablet | Experimental | Drug: SH3809 tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 75 years inclusive;
- Histologically or cytologically confirmed advanced malignant solid tumors, eligible patients should be either refractory or intolerant to all available therapies known to confer a clinical benefit as determined by the investigator, except for primary hepatic carcinoma;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy ≥ 3 months;
- Adequate hematologic, hepatic and renal function;
Key exclusion criteria (8 listed)
- Previous treatment with any SHP2 inhibitors;
- Spinal cord compression, meningeal metastases or brain metastases unless asymptomatic, stable and not requiring steroids for at least 2 weeks prior to start of study treatment;
- Life-threatening autoimmune disease or autoimmune disorder with long-term steroid treatment;
- Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) and treponema pallidum (TP);
- Patients who have impaired cardiac function or clinically significant cardiac diseases;
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 |
|---|---|---|
| SH3809 tabletStarting dose 2mg,oral administered once daily. If tolerated subsequent cohorts will test increasing doses (4mg,6mg,8mg,10mg,12mg) of SH3809. | Drug | Daily oral administration of SH3809 tablet |
Primary outcome
Number of participants with dose limiting toxicities (DLTs)
Time frame: Within the first 28 days of consecutive treatment
Incidence and nature of DLTs in the dose escalation phase
Maximum tolerated dose(MTD)
Time frame: Within the first 28 days of consecutive treatment
8 secondary outcomes
Cmax
Time frame: 4 weeks
Tmax
Time frame: 4 weeks]
T1/2
Time frame: 4 weeks
Area Under the Curve (AUC)
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 13 Apr 2021.
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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.
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 SH3809 tablet 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 7 inclusion and 8 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 13 Apr 2021. 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 Shun Lu, Ph D (22200000-3123, shunlu_shchest@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose limiting toxicities (DLTs) (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 13 Apr 2021.