- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05610202
Tolerability and Pharmacokinetics Study of TQB3702 Tablets in Hematologic Tumor Subjects
November 2, 2022 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase I Clinical Trial of Tolerability and Pharmacokinetics of TQB3702 Tablets in Hematologic Tumor Subjects
This project is an open, dose escalation and expansion phase I clinical study.
The first phase is a dose escalation study, and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase.
The purpose is to evaluate the tolerability and preliminary efficacy of TQB3702 tablets in hematological tumor subjects.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
137
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zengjun Li, Doctor
- Phone Number: +86-13642138692
- Email: zengjunli@163.com
Study Contact Backup
- Name: Fei Li, Doctor
- Phone Number: +86-13970038386
- Email: yx021021@sina.com
Study Locations
-
-
Jiangxi
-
Nanchang, Jiangxi, China, 330006
- The First Affiliated Hospital Of Nanchang University
-
Contact:
- Fei Li, Doctor
- Phone Number: +86-13970038386
- Email: yx021021@sina.com
-
-
Shandong
-
Jinan, Shandong, China, 250117
- The Cancer Hospital Affiliated to Shandong First Medical University
-
Contact:
- Zengjun Li, Doctor
- Phone Number: +86-13642138692
- Email: zengjunli@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
- ≥18 years old and ≤ 80 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period.
- Clearly diagnosed recurrent / refractory hematological tumors that meet the WHO definition;
- At least 1 measurable lesion for efficacy evaluation.
- The function of main organs is normal.
- Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; a negative serum pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
Exclusion Criteria:
- Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved 5 consecutive years of disease free survival (DFS)s. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)].
- Subjects with central nervous system aggression (CNS);
- Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) or had active graft-versus-host disease (GVHD) requiring immunosuppressive therapy within 12 months before the first dose;
- Multiple factors that affect the absorption of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction);
- Unrelieved toxicity of ≥CTC AE grade 1 due to any previous treatment, excluding alopecia and fatigue;
- Major surgical treatment, open biopsy, and significant traumatic injury were received within 28 days before the start of study treatment.
- The presence of active or uncontrolled primary autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP);
- Patients with evidence or history of bleeding constitution; Or any bleeding event (such as gastrointestinal bleeding) greater than or equal to CTC AE level 3 within 4 weeks before the first medication;
- Subjects had an arteriovenous thrombosis event within 6 months.
- Subjects have history of psychotropic substance abuse and are unable to abstain or have mental disorders;
- Subjects with any severe and/or uncontrolled disease.
- Within 2 weeks before the first treatment, the subjects had received proprietary Chinese medicines with anti-tumor indications specified in the NMPA approved drug instructions;
- Uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (investigator judgment);
- Study treatment related: subjects received live or mRNA vaccines within 4 weeks before the first treatment or were scheduled to receive live or mRNA vaccines during the study;
- Participated in clinical trials of other antitumor drugs within 4 weeks before the first treatment;
- According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for enrollment for other reasons.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TQB3702 tablets
TQB3702 tablets were administered orally, 28 days as a treatment cycle until the progressive diseases or the investigator judges that it is not suitable for subject to continue to take this medicine.
|
TQB3702 tablets are selective BTK inhibitors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD)
Time Frame: Baseline up to 104 weeks
|
To evaluate the maximum tolerated dose of TQB3702 tablets in the treatment of relapsed/refractory hematologic tumors.
|
Baseline up to 104 weeks
|
Dose limited toxicity (DLT)
Time Frame: Baseline up to 104 weeks
|
To evaluate the dose-limiting toxic dose of TQB3702 tablets in the treatment of relapsed/refractory hematologic tumors.
|
Baseline up to 104 weeks
|
Recommended Phase II Dose (RP2D)
Time Frame: Baseline up to 104 weeks
|
To evaluate the phase II recommended dose of TQB3702 tablets in the treatment of relapsed/refractory hematological tumors.
|
Baseline up to 104 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Reach the Maximum Plasma Concentration (Tmax)-single dose
Time Frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
|
Time to Reach the Maximum Plasma Concentration after single dose
|
before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
|
Time to Reach the Maximum Plasma Concentration (Tmax)-multiple dose
Time Frame: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
|
Time to Reach the Maximum Plasma Concentration after multiple dose
|
before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
|
Maximum plasma concentration (Cmax)-Single dose
Time Frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
|
Cmax is the maximum plasma concentration of TQB3702 after single dose
|
before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
|
Maximum plasma concentration (Cmax)-Multiple dose
Time Frame: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
|
Cmax is the maximum plasma concentration of TQB3702 after multiple dose
|
before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
|
Elimination half-life (t1/2)-Single dose
Time Frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 hours after administration.
|
t1/2 is time it takes for the blood concentration of TQB3702 or metabolite(s) to drop by half after single dose.
|
before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 hours after administration.
|
Elimination half-life (t1/2)-Multiple dose
Time Frame: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
|
t1/2 is time it takes for the blood concentration of TQB3702 or metabolite(s) to drop by half after multiple dose.
|
before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
|
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)-Single dose
Time Frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
|
To characterize the pharmacokinetics of TQB3702 by assessment of area under the plasma concentration time curve from the first dose to a certain time.
|
before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
|
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)-Multiple dose
Time Frame: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
|
To characterize the pharmacokinetics of TQB3702 by assessment of area under the plasma concentration time curve from the first dose to a certain time.
|
before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
|
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)-Single dose
Time Frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
|
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss) after Single dose
|
before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
|
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)-Multiple dose
Time Frame: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
|
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss) after Multiple dose
|
before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
|
steady state area under the concentration-time curve over a dosing interval (AUCtau, ss)-single dose
Time Frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
|
steady state area under the concentration-time curve over a dosing interval (AUCtau, ss) after single dose
|
before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
|
steady state area under the concentration-time curve over a dosing interval (AUCtau, ss)-multiple dose
Time Frame: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
|
steady state area under the concentration-time curve over a dosing interval (AUCtau, ss) after multiple dose
|
before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
|
Minimum steady-state plasma drug concentration during a dosage interval (Css-min)-Single dose
Time Frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
|
Minimum steady-state plasma drug concentration during a dosage interval (Cmin-ss) after Single dose
|
before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.
|
Minimum steady-state plasma drug concentration during a dosage interval (Css-min)-multiple dose
Time Frame: before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
|
Minimum steady-state plasma drug concentration during a dosage interval (Cmin-ss) after multiple dose
|
before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment.
|
Objective Response Rate (ORR)
Time Frame: Baseline up to 104 weeks
|
The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
|
Baseline up to 104 weeks
|
Complete Remission Rate (CRR)
Time Frame: Baseline up to 104 weeks
|
The proportion of tumors that have a complete response after treatment
|
Baseline up to 104 weeks
|
Disease Control Rate (DCR)
Time Frame: Baseline up to 104 weeks
|
The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a cancer treatment in clinical trials.
|
Baseline up to 104 weeks
|
Duration of Response (DOR)
Time Frame: Baseline up to 104 weeks
|
The time from the date of first documentation of a CR or PR or PD to the date of first documentation of tumor progression.
|
Baseline up to 104 weeks
|
Progression Free Survival (PFS)
Time Frame: Baseline up to 104 weeks
|
The time from the first dose to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first
|
Baseline up to 104 weeks
|
Overall Survival (OS)
Time Frame: Baseline up to 104 weeks
|
the time from start of study treatment to date of death due to any cause
|
Baseline up to 104 weeks
|
Adverse events (AE)
Time Frame: Baseline up to 104 weeks
|
The occurrence of all adverse events (AE)
|
Baseline up to 104 weeks
|
Serious adverse events (SAE)
Time Frame: Baseline up to 104 weeks
|
The occurrence of all serious adverse events (SAE)
|
Baseline up to 104 weeks
|
Bruton's tyrosine kinase (BTK) occupancy
Time Frame: Baseline up to 104 weeks
|
The BTK occupancy in peripheral blood mononuclear cell (PMBC)
|
Baseline up to 104 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2022
Primary Completion (Anticipated)
August 1, 2024
Study Completion (Anticipated)
August 1, 2024
Study Registration Dates
First Submitted
November 2, 2022
First Submitted That Met QC Criteria
November 2, 2022
First Posted (Actual)
November 9, 2022
Study Record Updates
Last Update Posted (Actual)
November 9, 2022
Last Update Submitted That Met QC Criteria
November 2, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TQB3702-I-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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