Advanced Solid TumorsPhase 1NCT04408079
A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets
A Phase 1 study testing TQB3558 in people with Advanced Solid Tumors, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a study to evaluate the maximum tolerated dose (MTD) , occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3558 tablets in Chinese adult patients with advanced solid tumors .The study is divided into phase Ia and phase Ib. 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?
- TQB3558
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2020to 31 Oct 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
- 1. Histologically or cytologically confirmed advanced malignant solid tumors, without conventional treatment methods or fail or relapse after treatment.
- 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
- 3. Has at least one measurable lesion (based on RECIST 1.1) or bone metastases. 4. Adequate organ system function. 5. Patients need to adopt effective methods of contraception. 6. Understood and signed an informed consent form.
Who cannot join
- 1. Has received TRK inhibitors. 2. Has participated in any other clinical trials, or used other anti-cancer drugs, or received major surgical operations within 4 weeks before first administration.
- 3. Has received local radiotherapy within 7 days or bone marrow radiotherapy within 4 weeks before the first administration.
- 4. Has other malignant tumors in 2 years, except for cured or locally curable cancers.
- 5. Has known spinal cord compression and cancerous meningitis. 6. Has interstitial lung disease, drug-induced interstitial lung disease, history of radiation lung disease requiring steroid therapy.
- 7. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage.
- 8. Obvious cardiovascular diseases. 9. Has a history of autoimmune disease, immunodeficiency. 10. Lactating women. 11. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Zan Shen, Doctor, 021-24058431, Sshenzzan@vip.sina.com
Zan Shen, Doctor
About this study
Official title: A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets
This is a study to evaluate the maximum tolerated dose (MTD) , occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3558 tablets in Chinese adult patients with advanced solid tumors .The study is divided into phase Ia and phase Ib. Phase Ia: dose escalation period, to evaluate the safety and tolerability of TQB3558 tablets, determine MTD; Phase Ib: effectiveness exploration period, to expand the safe and effective dose group, recommend appropriate dosage and method for subsequent clinical research.
- Conditions
- Advanced Solid Tumors
- Being tested
- TQB3558
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3558Drug
TQB3558 is a kinase inhibitor of the TRK protein family.
| Study group | Role | What they receive |
|---|---|---|
| TQB3558 Tablets | Experimental | TQB3558 tablets administered orally once. Then TQB3558 tablet administered orally, once daily in 28-day cycle after 4 days of first administration. Receives: Drug: TQB3558 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
Measured: Baseline up to 28 days
Adverse events (AE) and serious adverse events (SAE)
The occurrence of all adverse events (AE) and serious adverse events (SAE).
Measured: Baseline up to 28 days
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Measured: up to 96 weeks
Secondary outcomes (7)
Tmax
To characterize the pharmacokinetics of TQB3558 by assessment of time to reach maximum plasma concentration.
Measured: 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
Cmax
Cmax is the maximum plasma concentration of TQB3558 or metabolite(s).
Measured: 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
AUC0-t
To characterize the pharmacokinetics of TQB3558 by assessment of area under the plasma concentration time curve from zero to infinity.
Measured: 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
CL/f
CL/f is total clearance rate for TQB3558.
Measured: 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
Disease control rate（DCR）
Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Measured: up to 96 weeks
Progression-free survival (PFS)
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Measured: up to 96 weeks
Duration of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
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 posted29 May 2020
- Study start25 Jun 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Oct 2022 (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 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
- 70 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
- NCT04408079
- Sponsor's protocol ID
- TQB3558-Ⅰ-01
- Status last verified
- Jun 2020
- First submitted
- 26 May 2020
- Last updated
- 8 Jul 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 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets
- ClinicalTrials.gov ID
- NCT04408079
- Acronym / sponsor ID
- TQB3558-Ⅰ-01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 29 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 study to evaluate the maximum tolerated dose (MTD) , occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3558 tablets in Chinese adult patients with advanced solid tumors .The study is divided into phase Ia and phase Ib. Phase Ia: dose escalation period, to evaluate the safety and tolerability of TQB3558 tablets, determine MTD; Phase Ib: effectiveness exploration period, to expand the safe and effective dose group, recommend appropriate dosage and method for subsequent clinical research.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB3558 Tablets | Experimental | Drug: TQB3558TQB3558 tablets administered orally once. Then TQB3558 tablet administered orally, once daily in 28-day cycle after 4 days of first administration. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Histologically or cytologically confirmed advanced malignant solid tumors, without conventional treatment methods or fail or relapse after treatment.
- 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
- 3. Has at least one measurable lesion (based on RECIST 1.1) or bone metastases. 4. Adequate organ system function. 5. Patients need to adopt effective methods of contraception. 6. Understood and signed an informed consent form.
Key exclusion criteria (6 listed)
- 1. Has received TRK inhibitors. 2. Has participated in any other clinical trials, or used other anti-cancer drugs, or received major surgical operations within 4 weeks before first administration.
- 3. Has received local radiotherapy within 7 days or bone marrow radiotherapy within 4 weeks before the first administration.
- 4. Has other malignant tumors in 2 years, except for cured or locally curable cancers.
- 5. Has known spinal cord compression and cancerous meningitis. 6. Has interstitial lung disease, drug-induced interstitial lung disease, history of radiation lung disease requiring steroid therapy.
- 7. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage.
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 |
|---|---|---|
| TQB3558TQB3558 is a kinase inhibitor of the TRK protein family. | Drug | TQB3558 Tablets |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Baseline up to 28 days
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
Adverse events (AE) and serious adverse events (SAE)
Time frame: Baseline up to 28 days
The occurrence of all adverse events (AE) and serious adverse events (SAE).
Overall response rate (ORR)
Time frame: up to 96 weeks
Percentage of participants achieving complete response (CR) and partial response (PR).
7 secondary outcomes
Tmax
Time frame: 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
Cmax
Time frame: 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
AUC0-t
Time frame: 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
CL/f
Time frame: 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
Disease control rate（DCR）
Time frame: up to 96 weeks
Progression-free survival (PFS)
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 8 Jul 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 TQB3558 in people with Advanced Solid Tumors, 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 3 inclusion and 6 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 8 Jul 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 Zan Shen, Doctor (021-24058431, Sshenzzan@vip.sina.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: Baseline up to 28 days). 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 8 Jul 2020; AzTrials last refreshed its copy on 1 Nov 2026.