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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05610202
Other study ID # TQB3702-I-01
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date November 2022
Est. completion date August 2024

Study information

Verified date April 2022
Source Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Contact Zengjun Li, Doctor
Phone +86-13642138692
Email zengjunli@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 137
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
TQB3702 tablets
TQB3702 tablets are selective BTK inhibitors.

Locations

Country Name City State
China The Cancer Hospital Affiliated to Shandong First Medical University Jinan Shandong
China The First Affiliated Hospital of Nanchang University Nanchang Jiangxi

Sponsors (1)

Lead Sponsor Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose (MTD) To evaluate the maximum tolerated dose of TQB3702 tablets in the treatment of relapsed/refractory hematologic tumors. Baseline up to 104 weeks
Primary Dose limited toxicity (DLT) To evaluate the dose-limiting toxic dose of TQB3702 tablets in the treatment of relapsed/refractory hematologic tumors. Baseline up to 104 weeks
Primary Recommended Phase II Dose (RP2D) To evaluate the phase II recommended dose of TQB3702 tablets in the treatment of relapsed/refractory hematological tumors. Baseline up to 104 weeks
Secondary Time to Reach the Maximum Plasma Concentration (Tmax)-single dose 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.
Secondary Time to Reach the Maximum Plasma Concentration (Tmax)-multiple dose 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.
Secondary Maximum plasma concentration (Cmax)-Single dose 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.
Secondary Maximum plasma concentration (Cmax)-Multiple dose 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.
Secondary Elimination half-life (t1/2)-Single dose 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.
Secondary Elimination half-life (t1/2)-Multiple dose 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.
Secondary Area under the plasma concentration-time curve from time zero to time t (AUC0-t)-Single dose 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.
Secondary Area under the plasma concentration-time curve from time zero to time t (AUC0-t)-Multiple dose 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.
Secondary Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)-Single dose 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.
Secondary Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)-Multiple dose 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.
Secondary steady state area under the concentration-time curve over a dosing interval (AUCtau, ss)-single dose 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.
Secondary steady state area under the concentration-time curve over a dosing interval (AUCtau, ss)-multiple dose 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.
Secondary Minimum steady-state plasma drug concentration during a dosage interval (Css-min)-Single dose 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.
Secondary Minimum steady-state plasma drug concentration during a dosage interval (Css-min)-multiple dose 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.
Secondary Objective Response Rate (ORR) The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period Baseline up to 104 weeks
Secondary Complete Remission Rate (CRR) The proportion of tumors that have a complete response after treatment Baseline up to 104 weeks
Secondary Disease Control Rate (DCR) 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
Secondary Duration of Response (DOR) 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
Secondary Progression Free Survival (PFS) 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
Secondary Overall Survival (OS) the time from start of study treatment to date of death due to any cause Baseline up to 104 weeks
Secondary Adverse events (AE) The occurrence of all adverse events (AE) Baseline up to 104 weeks
Secondary Serious adverse events (SAE) The occurrence of all serious adverse events (SAE) Baseline up to 104 weeks
Secondary Bruton's tyrosine kinase (BTK) occupancy The BTK occupancy in peripheral blood mononuclear cell (PMBC) Baseline up to 104 weeks
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