Advanced Solid TumorsPhase 1NCT04309968
Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activity of SYHA1801 Monotherapy in Patients With Advanced Solid Tumors
A Phase 1 study testing Drug: SYHA1801 in people with Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of SYHA1801, a BRD4 inhibitor in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Drug: SYHA1801
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2020to 30 Jun 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 ≥18, ≤75 years, no gender limitation.
- Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors, for which standard therapy either does not exist or has proven ineffective, intolerable or inacceptable for the patient.
- At least one measurable lesion as per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤1.
- Life expectancy ≥3 months.
- Adequate bone marrow reserve, renal and liver function.
- Women of childbearing potential should agree to use contraceptive measures (such as IUD, contraceptive or condom) during the study and within 6 months after the end of the study; the serum pregnancy test should be negative within 7 days before enrollment, and must be non-lactating subjects; men should agree to use contraceptive measures during the study and within 6 months after the end of the study.
- Signed informed consent form.
Who cannot join
- Administration of chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatment within 4 weeks before the first dose of the study drug, except the following: using nitrosourea and mitomycin C within 6 weeks, using fluorouracil and small molecule targeted drugs within 2 weeks (or within 5 half time period), using traditional Chinese medicine with anti-tumor indications within 2 weeks.
- Administration of other unlisted clinical research drugs within 4 weeks before the first dose of SYHA1801.
- Major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose of SYHA1801.
- Administration of glucocorticoids or other immunosuppressants within 14 days prior to the first dose of SYHA1801, except the following: local, ocular, intraarticular, intranasal and inhaled glucocorticoids; short-term use of glucocorticoids for preventive treatment.
- Concomitant therapy with strong CYP3A4 inhibitors or inducers within 14 days.
- Prior treatment with BET inhibitors.
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- Persistent grade >1 clinically significant toxicity related to prior antineoplastic therapies (except alopecia).
- Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, that is not suitable for the group according to the judgment of the investigator.
- Uncontrollable active infection.
- History of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency, or organ transplant history.
- Active hepatitis B; positive for hepatitis C antibody.
- History of serious cardiovascular disease.
- Inability to swallow oral medications or presence of a gastrointestinal disorder deemed to jeopardize intestinal absorption of SYHA1801.
- Other serious illness or medical conditions.
- Alcohol or drug dependence.
- A clear history of neurological or psychiatric disorders.
- Pregnant or breast-feeding female.
- In the opinion of the investigator, not suitable for enrollment due to other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 022
Ba Yi, doctor, 022-23340123-1051, bayi@tjmuch.com
About this study
Official title: A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Anti-tumor Activity of SYHA1801 Capsules in Patients With Advanced Solid Tumors.
This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of SYHA1801, a BRD4 inhibitor in patients with advanced solid tumors.
Read the detailed description
This study will be performed in two parts. Part 1 will enroll patients with advanced solid tumors. Patients will receive SYHA1801 orally on Days 1 and 4-31 in the first cycle. Enrollment will follow a dose-escalation schedule until grade 3 drug-related adverse events are observed, at this point the i3+3 enrollment design will be used. Dose increments will be guided by data generated from previous levels. The dose and possibly the schedule will be adjusted to determine the Maximum Tolerated Dose (MTD). If a patient wishes to continuously receive study treatment on completion of Cycle 1, the patient can continue study treatment in 28-day Cycle 2 and subsequent cycles.
Part 2 will enroll patients with specific solid tumor which might potentially respond to BRD4 inhibitor. Patients will receive SYHA1801 at a dose and schedule established in Part 1.
- Conditions
- Advanced Solid Tumors
- Being tested
- Drug: SYHA1801
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: SYHA1801Drug
Drug: SYHA1801 administered orally
| Study group | Role | What they receive |
|---|---|---|
| solid tumors | Experimental | Experimental: Solid tumors Part 1 - Dose-escalation of SYHA1801 in patients with advanced solid tumors.Daily dosing of SYHA1801 on Days 1 and 4-31 of 28-day cycle. Escalating dose cohorts. Receives: Drug: Drug: SYHA1801 |
| advanced cancers | Experimental | Part 2 - Dose-expansion of SYHA1801 in patients with advanced cancers potentially sensitive to BRD4 inhibitor.The dose level and schedule of SYHA1801 of 28-day cycle at the MTD determined in Part 1. Receives: Drug: Drug: SYHA1801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate AE,SAE and DLT of SYHA1801.
The occurrence and frequency of AE, SAE and DLT. To evaluate the safety and tolerability of SYHA1801.
Measured: 28 days
To evaluate the MTD of SYHA1801
The maximum tolerable dose (MTD) (if it has), recommended phase II dose (RP2D) and dosage regimen of SYHA1801.
Measured: through study completion, an average of 1 year
Secondary outcomes (10)
AUC0-last of SYHA1801.
To evaluate AUC0-last of SYHA1801.
Measured: 31 days
AUC0-∞ of SYHA1801.
To evaluate AUC0-∞ of SYHA1801.
Measured: 31 days
Cmax of SYHA1801.
To evaluate Cmax of SYHA1801.
Measured: 31 days
Tmax of SYHA1801.
To evaluate Tmax of SYHA1801.
Measured: 31 days
t½ of SYHA1801.
To evaluate t½ of SYHA1801.
Measured: 31 days
CL/F of SYHA1801.
To evaluate CL/F of SYHA1801.
Measured: 31 days
ORR of SYHA1801
To evaluate ORR of SYHA1801
Measured: 2 months
PFS of SYHA1801
To evaluate PFS of SYHA1801
Measured: 2 months
DCR of SYHA1801
To evaluate DCR of SYHA1801
Measured: 2 months
DOR of SYHA1801
To evaluate DOR of SYHA1801
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start7 Apr 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 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 TumorsStudies 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
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309968
- Sponsor's protocol ID
- SYHA1801201901/PRO
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 9 Jun 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 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Anti-tumor Activity of SYHA1801 Capsules in Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT04309968
- Acronym / sponsor ID
- SYHA1801201901/PRO
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 17 Mar 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 safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of SYHA1801, a BRD4 inhibitor in patients with advanced solid tumors.
Detailed description
This study will be performed in two parts. Part 1 will enroll patients with advanced solid tumors. Patients will receive SYHA1801 orally on Days 1 and 4-31 in the first cycle. Enrollment will follow a dose-escalation schedule until grade 3 drug-related adverse events are observed, at this point the i3+3 enrollment design will be used. Dose increments will be guided by data generated from previous levels. The dose and possibly the schedule will be adjusted to determine the Maximum Tolerated Dose (MTD). If a patient wishes to continuously receive study treatment on completion of Cycle 1, the patient can continue study treatment in 28-day Cycle 2 and subsequent cycles.
Part 2 will enroll patients with specific solid tumor which might potentially respond to BRD4 inhibitor. Patients will receive SYHA1801 at a dose and schedule established in Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| solid tumors | Experimental | Drug: Drug: SYHA1801Experimental: Solid tumors Part 1 - Dose-escalation of SYHA1801 in patients with advanced solid tumors.Daily dosing of SYHA1801 on Days 1 and 4-31 of 28-day cycle. Escalating dose cohorts. |
| advanced cancers | Experimental | Drug: Drug: SYHA1801Part 2 - Dose-expansion of SYHA1801 in patients with advanced cancers potentially sensitive to BRD4 inhibitor.The dose level and schedule of SYHA1801 of 28-day cycle at the MTD determined in Part 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18, ≤75 years, no gender limitation.
- Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors, for which standard therapy either does not exist or has proven ineffective, intolerable or inacceptable for the patient.
- At least one measurable lesion as per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤1.
- Life expectancy ≥3 months.
Key exclusion criteria (18 listed)
- Administration of chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatment within 4 weeks before the first dose of the study drug, except the following: using nitrosourea and mitomycin C within 6 weeks, using fluorouracil and small molecule targeted drugs within 2 weeks (or within 5 half time period), using traditional Chinese medicine with anti-tumor indications within 2 weeks.
- Administration of other unlisted clinical research drugs within 4 weeks before the first dose of SYHA1801.
- Major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose of SYHA1801.
- Administration of glucocorticoids or other immunosuppressants within 14 days prior to the first dose of SYHA1801, except the following: local, ocular, intraarticular, intranasal and inhaled glucocorticoids; short-term use of glucocorticoids for preventive treatment.
- Concomitant therapy with strong CYP3A4 inhibitors or inducers within 14 days.
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 |
|---|---|---|
| Drug: SYHA1801Drug: SYHA1801 administered orally | Drug | advanced cancers, solid tumors |
Primary outcome
To evaluate AE,SAE and DLT of SYHA1801.
Time frame: 28 days
The occurrence and frequency of AE, SAE and DLT. To evaluate the safety and tolerability of SYHA1801.
To evaluate the MTD of SYHA1801
Time frame: through study completion, an average of 1 year
The maximum tolerable dose (MTD) (if it has), recommended phase II dose (RP2D) and dosage regimen of SYHA1801.
10 secondary outcomes
AUC0-last of SYHA1801.
Time frame: 31 days
AUC0-∞ of SYHA1801.
Time frame: 31 days
Cmax of SYHA1801.
Time frame: 31 days
Tmax of SYHA1801.
Time frame: 31 days
t½ of SYHA1801.
Time frame: 31 days
CL/F of SYHA1801.
Time frame: 31 days
ORR of SYHA1801
Time frame: 2 months
PFS of SYHA1801
Time frame: 2 months
DCR of SYHA1801
Time frame: 2 months
DOR of SYHA1801
Time frame: 2 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.
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 Drug: SYHA1801 in people with Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology 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 18 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate AE,SAE and DLT of SYHA1801. (time frame: 28 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 9 Jun 2020.