Extensive-Stage Small Cell Lung CancerPhase 1NCT04404543
A Study of SYHA1807 in Subjects With Extensive-Stage Small Cell Lung Cancer
A Phase 1 study testing SYHA1807 in people with Extensive-Stage Small Cell Lung Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
This is a phase I, open-label, multi-center, non-randomized, 2-part first time inhuman (FTIH) study for SYHA1807. Part 1 is a dose escalation phase to determine the recommended phase 2 dose (RP2D) for SYHA1807 based on the safety, tolerability and pharmacokinetics (PK) profiles observed after oral administration of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Extensive-Stage Small Cell Lung Cancer
- What is being tested?
- SYHA1807
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 30 Jun 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
- Histologically confirmed diagnosis of advanced SCLC;
- ECOG(Eastern Cooperative Oncology Group) performance status of 0 or 1;
- Measurable disease according to RECIST v1.1;
- Recovered from all toxicities associated with previous treatments;
- Life expectancy ≥ 3 months;
- Adequate organ function;
- Use of reliable contraceptive methods;
- Signed informed consent from the patient;
Who cannot join
- Patients with primary malignant tumor other than small cell lung cancer;
- Identified central nervous system metastasis (such as brain metastasis or meningeal metastasis);
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Inadequate washout period for previous anti-tumor therapy;
- Previous treatment with any LSD1(lysine specific demethylase 1) inhibitor;
- Unable to swallow oral medications;
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- History of serious systemic diseases;
- History of serious autoimmune diseases；
- HIV positive;
- Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics and Clinical Activity of SYHA1807 Given Orally in Subjects With Extensive-Stage Small Cell Lung Cancer
This is a phase I, open-label, multi-center, non-randomized, 2-part first time inhuman (FTIH) study for SYHA1807. Part 1 is a dose escalation phase to determine the recommended phase 2 dose (RP2D) for SYHA1807 based on the safety, tolerability and pharmacokinetics (PK) profiles observed after oral administration of SYHA1807. The dose escalation study will be performed according to the 3+3 design. Once RP2D is identified, an expansion cohort (Part 2) of up to 12~40 subjects will be enrolled to further evaluate the clinical activity and tolerability of SYHA1807 in subjects with extensive-stage Small Cell Lung Cancer (SCLC).
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Being tested
- SYHA1807
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYHA1807Drug
Escalation Cohort Administration: Orally
SYHA1807Drug
Dose Expansion Cohort Administration: Orally
| Study group | Role | What they receive |
|---|---|---|
| Escalation Cohort | Experimental | Five dose levels will be tested according to the "3 + 3" dose-escalation design.
The dose-limiting toxicity (DLT) will be assessed from the first administration of SYHA1807 to the end of the first cycle (28 days). Receives: Drug: SYHA1807 |
| Dose Expansion Cohort | Experimental | Once the RP2D has been determined, an expansion cohort of up to 12~40 subjects will be enrolled in order to better characterize the clinical activity and safety profile of the RP2D. Receives: Drug: SYHA1807 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1:Number of Participants With Adverse Events
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Through study completion, an average of 2 year
Part 1:Number of Participants With Serious Adverse Events (SAEs)
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function.
Measured: Through study completion, an average of 2 year
Part 1:Number of Participants With Dose Limiting Toxicities (DLT)
An event was considered a DLT if it occurs within the first 28 days of treatment.
Measured: Through study completion, an average of 2 year
Number of Participants With Dose Reduction or Delays
The number of participants who had any dose reduction or delay have been presented. All dose reductions were due to AEs.
Measured: Through study completion, an average of 2 year
Number of Participants Withdrawn Due to Toxicities
Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to toxicities has been presented.
Measured: Through study completion, an average of 2 year
Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline
Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The number of participants with any grade increase in hematology parameters have been presented.
Measured: Through study completion, an average of 2 year
Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug
Vital sign measurements includes systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature, respiration rate and heart rate. The number of participants with critical changes in values of vital signs in response to drug have been presented.
Measured: Through study completion, an average of 2 year
Secondary outcomes (6)
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of SYHA1807
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Measured: Through study completion, an average of 2 year
Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of SYHA1807
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Measured: Through study completion, an average of 2 year
Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of SYHA1807
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed. Tmax is the time to reach Cmax, determined directly from the concentration-time data.
Measured: Through study completion, an average of 2 year
Apparent Terminal Phase Elimination Rate Constant (λz) Following Single and Repeat Dose Administration of SYHA1807
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Measured: Through study completion, an average of 2 year
Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of SYH1A1807
The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed.
Measured: Through study completion, an average of 2 year
Number of Participants Achieving Disease Control Rate at Week 6、12
Clinical response was assessed by the investigator using computer tomography or magnetic resonance imaging scans. Clinical response was defined as disease control rate ,CR(Complete response)+PR(Partial response)+SD(Stable disease),based on RECIST version 1.1 at Week 6、12.
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kun Lou, Study chair, Department of Medicine, CSPC Clinical Development Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404543
- Sponsor's protocol ID
- SYHA1807-CSP-001
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 27 May 2020
- 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 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics and Clinical Activity of SYHA1807 Given Orally in Subjects With Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04404543
- Acronym / sponsor ID
- SYHA1807-CSP-001
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 27 May 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.
This is a phase I, open-label, multi-center, non-randomized, 2-part first time inhuman (FTIH) study for SYHA1807. Part 1 is a dose escalation phase to determine the recommended phase 2 dose (RP2D) for SYHA1807 based on the safety, tolerability and pharmacokinetics (PK) profiles observed after oral administration of SYHA1807. The dose escalation study will be performed according to the 3+3 design. Once RP2D is identified, an expansion cohort (Part 2) of up to 12~40 subjects will be enrolled to further evaluate the clinical activity and tolerability of SYHA1807 in subjects with extensive-stage Small Cell Lung Cancer (SCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escalation Cohort | Experimental | Drug: SYHA1807Five dose levels will be tested according to the "3 + 3" dose-escalation design. The dose-limiting toxicity (DLT) will be assessed from the first administration of SYHA1807 to the end of the first cycle (28 days). |
| Dose Expansion Cohort | Experimental | Drug: SYHA1807Once the RP2D has been determined, an expansion cohort of up to 12~40 subjects will be enrolled in order to better characterize the clinical activity and safety profile of the RP2D. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed diagnosis of advanced SCLC;
- ECOG(Eastern Cooperative Oncology Group) performance status of 0 or 1;
- Measurable disease according to RECIST v1.1;
- Recovered from all toxicities associated with previous treatments;
- Life expectancy ≥ 3 months;
Key exclusion criteria (10 listed)
- Patients with primary malignant tumor other than small cell lung cancer;
- Identified central nervous system metastasis (such as brain metastasis or meningeal metastasis);
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Inadequate washout period for previous anti-tumor therapy;
- Previous treatment with any LSD1(lysine specific demethylase 1) inhibitor;
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 |
|---|---|---|
| SYHA1807Escalation Cohort Administration: Orally | Drug | Escalation Cohort |
| SYHA1807Dose Expansion Cohort Administration: Orally | Drug | Dose Expansion Cohort |
Primary outcome
Part 1:Number of Participants With Adverse Events
Time frame: Through study completion, an average of 2 year
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Part 1:Number of Participants With Serious Adverse Events (SAEs)
Time frame: Through study completion, an average of 2 year
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function.
Part 1:Number of Participants With Dose Limiting Toxicities (DLT)
Time frame: Through study completion, an average of 2 year
An event was considered a DLT if it occurs within the first 28 days of treatment.
Number of Participants With Dose Reduction or Delays
Time frame: Through study completion, an average of 2 year
The number of participants who had any dose reduction or delay have been presented. All dose reductions were due to AEs.
Number of Participants Withdrawn Due to Toxicities
Time frame: Through study completion, an average of 2 year
Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to toxicities has been presented.
Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline
Time frame: Through study completion, an average of 2 year
Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The number of participants with any grade increase in hematology parameters have been presented.
Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug
Time frame: Through study completion, an average of 2 year
Vital sign measurements includes systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature, respiration rate and heart rate. The number of participants with critical changes in values of vital signs in response to drug have been presented.
6 secondary outcomes
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of SYHA1807
Time frame: Through study completion, an average of 2 year
Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of SYHA1807
Time frame: Through study completion, an average of 2 year
Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of SYHA1807
Time frame: Through study completion, an average of 2 year
Apparent Terminal Phase Elimination Rate Constant (λz) Following Single and Repeat Dose Administration of SYHA1807
Time frame: Through study completion, an average of 2 year
Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of SYH1A1807
Time frame: Through study completion, an average of 2 year
Number of Participants Achieving Disease Control Rate at Week 6、12
Time frame: Through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 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.
Kun Lou study chair
Department of Medicine, CSPC Clinical Development Division
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYHA1807 in people with Extensive-Stage Small Cell Lung Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
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 10 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 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Kun Lou (031167808817 ext. 031167808817, loukun@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1:Number of Participants With Adverse Events (time frame: Through study completion, an average of 2 year). The study lists 7 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 27 May 2020.