Solid TumorPhase 1NCT05046847
A Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3811 Tablets in Patients With Advanced Malignant Tumors
A Phase 1 study testing TQB3811 in people with Solid Tumor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
TQB3811 tablet is a second-generation tropomyosin receptor kinase (TRK) inhibitor that selectively inhibits the kinase activity of TRKA, TRKB, and TRKC, and also selectively inhibits the kinase activity of TRKA, TRKB, and TRKC that produce secondary drug-resistant mutations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- TQB3811
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2021to Dec 2022
- 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
- Patients with advanced malignancy diagnosed histologically and/or cytologically, who have failed standard treatment or are unable to receive standard treatment or have no effective treatment.
- Age: 18~75 years old.
- Women of childbearing age must be negative for serum or urine HCG within 7 days prior to study enrollment and must be non-lactating; Patients should agree to use contraception during the study period and for 6 months after the study period.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- Patients voluntarily joined the study and signed the informed consent, showing good compliance.
Who cannot join
- Patients has had or is currently having other malignant tumors within 3 years.
- Patients have multiple factors that affect their oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction).
- The patient had unmitigated toxic reactions due to any prior treatment.
- Patients underwent major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to the start of study treatment.
- Patients have long-term unhealed wounds or fractures.
- The patient had experienced an arterial/venous thrombosis event in the past 6 months, such as a cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis, and pulmonary embolism.
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- The patient has a history of psychotropic drug abuse and cannot quit or has mental disorders.
- Patients are taking cytochrome P450 3A (CYP3A) inhibitors or inducers.
- Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.
- Patients with brain metastases with symptoms or control of symptoms for less than 2 weeks.
- The patients were currently breastfeeding or planned to breastfeed during the study period.
- Patients who, in the investigator's judgment, have a comorbidity that seriously endangers patient safety or interferes with study completion, or who are considered unsuitable for inclusion for other reasons
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
LIN SHEN, Master, 010-88196561, doctorshenlin@sina.cn
About this study
Official title: Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3811 Tablets in Patients With Advanced Malignant Tumors
TQB3811 tablet is a second-generation tropomyosin receptor kinase (TRK) inhibitor that selectively inhibits the kinase activity of TRKA, TRKB, and TRKC, and also selectively inhibits the kinase activity of TRKA, TRKB, and TRKC that produce secondary drug-resistant mutations.
- Conditions
- Solid Tumor
- Being tested
- TQB3811
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3811Drug
TQB3811 is a second-generation TrkA inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| TQB3811 | Experimental | The initial dose is 2.5mg, once a day (QD), and the medication stage is divided into single administration and continuous administration. The single administration is given once a day, and the continuous administration is entered 4 days after drug withdrawal. The drug is administered continuously until the disease progresses. Receives: Drug: TQB3811 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
To evaluate MTD of TQB3811 tablets in Chinese adult patients with advanced solid tumors
Measured: Baseline up to 32 weeks
Adverse events (AEs) and serious adverse events (SAEs)
The occurrence of all AEs and SAEs
Measured: Baseline up to 28 days
Dose-limiting toxicity (DLT)
To evaluate DLT of TQB3811 tablets in Chinese adult patients with advanced solid tumors
Measured: Baseline up to 32 weeks
Secondary outcomes (10)
Time to reach maximum (peak) plasma concentration following drug administration（Tmax）
To characterize the pharmacokinetics of TQB3811 by assessment of time to reach maximum plasma concentration after single and multiple dosing
Measured: 15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Maximum (peak) plasma drug concentration （Cmax）
Cmax is the maximum plasma concentration of TQB3811 or metabolite(s).
Measured: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1.
Elimination half-life （t1/2）
t1/2 is time it takes for the blood concentration of TQB3811 or metabolite(s) to drop by half.
Measured: 15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Area under the plasma concentration-time curve from time zero to time t （AUC0-t）
To characterize the pharmacokinetics of TQB3811 by assessment of area under the plasma concentration time curve from the first dose to infinity.
Measured: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1.
Maximum (peak) steady-state plasma drug concentration during a dosage interval （Cmax,ss）
Cmax,ss is maximum (peak) steady-state plasma drug concentration during a dosage interval .
Measured: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Minimum steady-state plasma drug concentration during a dosage interval （Css-min）
Css-min is minimum steady-state plasma drug concentration during a dosage interval.
Measured: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Concentration at the end of the dosing interval (AUCtau,ss)
To characterize the pharmacokinetics of TQB3811 by assessment of area The concentration at the end of the administration interval
Measured: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Progress Free Survival（PFS）
From the start of randomization to the first tumor progression or time of death.
Measured: up to 96 weeks
Disease control rate（DCR）
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: up to 96 weeks
Duration of Response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Measured: up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start30 Nov 2021
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
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 Chia Tai Tianqing Pharmaceutical Group 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046847
- Sponsor's protocol ID
- TQB3811-I-01
- Status last verified
- Dec 2021
- First submitted
- 13 Sep 2021
- Last updated
- 3 Dec 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 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3811 Tablets in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT05046847
- Acronym / sponsor ID
- TQB3811-I-01
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Sep 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.
TQB3811 tablet is a second-generation tropomyosin receptor kinase (TRK) inhibitor that selectively inhibits the kinase activity of TRKA, TRKB, and TRKC, and also selectively inhibits the kinase activity of TRKA, TRKB, and TRKC that produce secondary drug-resistant mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB3811 | Experimental | Drug: TQB3811The initial dose is 2.5mg, once a day (QD), and the medication stage is divided into single administration and continuous administration. The single administration is given once a day, and the continuous administration is entered 4 days after drug withdrawal. The drug is administered continuously until the disease progresses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with advanced malignancy diagnosed histologically and/or cytologically, who have failed standard treatment or are unable to receive standard treatment or have no effective treatment.
- Age: 18~75 years old.
- Women of childbearing age must be negative for serum or urine HCG within 7 days prior to study enrollment and must be non-lactating; Patients should agree to use contraception during the study period and for 6 months after the study period.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- Patients voluntarily joined the study and signed the informed consent, showing good compliance.
Key exclusion criteria (12 listed)
- Patients has had or is currently having other malignant tumors within 3 years.
- Patients have multiple factors that affect their oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction).
- The patient had unmitigated toxic reactions due to any prior treatment.
- Patients underwent major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to the start of study treatment.
- Patients have long-term unhealed wounds or fractures.
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 |
|---|---|---|
| TQB3811TQB3811 is a second-generation TrkA inhibitor. | Drug | TQB3811 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Baseline up to 32 weeks
To evaluate MTD of TQB3811 tablets in Chinese adult patients with advanced solid tumors
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline up to 28 days
The occurrence of all AEs and SAEs
Dose-limiting toxicity (DLT)
Time frame: Baseline up to 32 weeks
To evaluate DLT of TQB3811 tablets in Chinese adult patients with advanced solid tumors
10 secondary outcomes
Time to reach maximum (peak) plasma concentration following drug administration（Tmax）
Time frame: 15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Maximum (peak) plasma drug concentration （Cmax）
Time frame: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1.
Elimination half-life （t1/2）
Time frame: 15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Area under the plasma concentration-time curve from time zero to time t （AUC0-t）
Time frame: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1.
Maximum (peak) steady-state plasma drug concentration during a dosage interval （Cmax,ss）
Time frame: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Minimum steady-state plasma drug concentration during a dosage interval （Css-min）
Time frame: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Concentration at the end of the dosing interval (AUCtau,ss)
Time frame: 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.
Progress Free Survival（PFS）
Time frame: up to 96 weeks
Disease control rate（DCR）
Time frame: up to 96 weeks
Duration of Response (DOR)
Time frame: up to 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 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 TQB3811 in people with Solid Tumor, run by Chia Tai Tianqing Pharmaceutical Group 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 5 inclusion and 12 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 3 Dec 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 LIN SHEN, Master (010-88196561, doctorshenlin@sina.cn), 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: Baseline up to 32 weeks). The study lists 3 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 3 Dec 2021.