Relapsed or Refractory Lymphoma or Advanced CancerPhase 1NCT03510767
A Study of TQ-B3525 on Tolerance and Pharmacokinetics
A Phase 1 study testing TQ-B3525 in people with Relapsed or Refractory Lymphoma or Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
To study the pharmacokinetic characteristics of TQ-B3525 in the human body, recommend a reasonable regimen for subsequent research. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed or Refractory Lymphoma or Advanced Cancer
- What is being tested?
- TQ-B3525
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2018to Aug 2024
- 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
- Relapsed or refractory lymphoma or advanced solid tumor that diagnosed Pathologically or cytologically diagnosed
- ECOG PS≤1
- Adequate blood cell counts, kidney function and liver function
- Patients should participate in the study voluntarily and sign informed consent
Who cannot join
- Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history
- Hypertension (systolic BP ≥150 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication
- Hepatitis B virus patients with active replication (DNA> 500 cps / mL), hepatitis C
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
People's Hospital of Tianjin
Tianjin, Tianjin Municipality, 300121
Huaqing Wang, doctor, +86-022-022-2757483, huaqingw@163.com
About this study
Official title: A Phase I Study of TQ-B3525 on Tolerance and Pharmacokinetics
To study the pharmacokinetic characteristics of TQ-B3525 in the human body, recommend a reasonable regimen for subsequent research.
- Being tested
- TQ-B3525
- Medical subject headings
- Recurrence, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ-B3525Drug
TQ-B3525 p.o. qd
| Study group | Role | What they receive |
|---|---|---|
| TQ-B3525 | Experimental | Not described Receives: Drug: TQ-B3525 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicities (DLT)
DLT: An adverse event occurring after initiation of TQ-B3525 that met any following criteria:
- >=Grade 3 of non-hematology toxicity
- Grade 4 hematology toxicity
Measured: Baseline up to 28 days
Maximum Tolerated Dose (MTD)
MTD was defined as the highest dose level studied for which the incidence of first cycle DLT was < 33%.
Measured: Baseline up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start20 Jun 2018
- Primary completion15 Aug 2022
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Lymphoma or Advanced CancerStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huaqing Wang, doctor, Study chair, People's Hospital of Tianjin Tianjin,China,300121Wenqi Jiang, doctor, Study chair, Sun Yat-sen University Cancer Center,Guangzhou,Guangdong,China, 510060
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510767
- Sponsor's protocol ID
- TQ-B3525-I-01
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2018
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of TQ-B3525 on Tolerance and Pharmacokinetics
- ClinicalTrials.gov ID
- NCT03510767
- Acronym / sponsor ID
- TQ-B3525-I-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- Aug 2024 (estimated)
- First posted
- 27 Apr 2018 (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.
To study the pharmacokinetic characteristics of TQ-B3525 in the human body, recommend a reasonable regimen for subsequent research.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQ-B3525 | Experimental | Drug: TQ-B3525 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Relapsed or refractory lymphoma or advanced solid tumor that diagnosed Pathologically or cytologically diagnosed
- ECOG PS≤1
- Adequate blood cell counts, kidney function and liver function
- Patients should participate in the study voluntarily and sign informed consent
Key exclusion criteria (3 listed)
- Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history
- Hypertension (systolic BP ≥150 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication
- Hepatitis B virus patients with active replication (DNA> 500 cps / mL), hepatitis C
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 |
|---|---|---|
| TQ-B3525TQ-B3525 p.o. qd | Drug | TQ-B3525 |
Primary outcome
Dose-Limiting Toxicities (DLT)
Time frame: Baseline up to 28 days
DLT: An adverse event occurring after initiation of TQ-B3525 that met any following criteria: 1. >=Grade 3 of non-hematology toxicity 2. Grade 4 hematology toxicity
Maximum Tolerated Dose (MTD)
Time frame: Baseline up to 28 days
MTD was defined as the highest dose level studied for which the incidence of first cycle DLT was < 33%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Huaqing Wang, doctor study chair
People's Hospital of Tianjin Tianjin,China,300121
Wenqi Jiang, doctor study chair
Sun Yat-sen University Cancer Center,Guangzhou,Guangdong,China, 510060
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 TQ-B3525 in people with Relapsed or Refractory Lymphoma or Advanced Cancer, 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 4 inclusion and 3 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 14 Apr 2023. 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 Huaqing Wang, doctor (+86-022-022-2757483, huaqingw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicities (DLT) (time frame: Baseline up to 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 14 Apr 2023.