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Status unknownNCT05610202Updated Nov 9, 2022

Tolerability and Pharmacokinetics Study of TQB3702 Tablets in Hematologic Tumor Subjects

A Phase 1 interventional study of TQB3702 tablets in Hematologic Malignancy, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Status unknown at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-11-09.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (part of Sino Biopharmaceutical Limited) · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
137
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hematologic Malignancy
03

In context

Hematologic Neoplasms

1,494 studies on the registry are indexed under Hematologic Neoplasms; 438 are open to participants now.

This study's planned enrollment of 137 is above the median of 45 across 1,090 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 320 studies on the registry; 76 are open to participants now.

Browse Chia Tai Tianqing Pharmaceutical Group Co., Ltd. studies →All Sino Biopharmaceutical Limited studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
137 participants (estimated)

Study arms

  • 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.

    Drug: TQB3702 tablets

Interventions

06

What researchers measure

Primary outcomes

  1. Maximum tolerated dose (MTD)

    To evaluate the maximum tolerated dose of TQB3702 tablets in the treatment of relapsed/refractory hematologic tumors.

    Time frame: Baseline up to 104 weeks

  2. Dose limited toxicity (DLT)

    To evaluate the dose-limiting toxic dose of TQB3702 tablets in the treatment of relapsed/refractory hematologic tumors.

    Time frame: Baseline up to 104 weeks

  3. Recommended Phase II Dose (RP2D)

    To evaluate the phase II recommended dose of TQB3702 tablets in the treatment of relapsed/refractory hematological tumors.

    Time frame: Baseline up to 104 weeks

Secondary outcomes

  1. Time to Reach the Maximum Plasma Concentration (Tmax)-single dose

    Time to Reach the Maximum Plasma Concentration after single dose

    Time frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.

  2. Time to Reach the Maximum Plasma Concentration (Tmax)-multiple dose

    Time to Reach the Maximum Plasma Concentration after 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.

  3. Maximum plasma concentration (Cmax)-Single dose

    Cmax is the maximum plasma concentration of TQB3702 after single dose

    Time frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.

  4. Maximum plasma concentration (Cmax)-Multiple dose

    Cmax is the maximum plasma concentration of TQB3702 after 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.

  5. 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.

    Time frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 hours after administration.

  6. 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.

    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.

  7. 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.

    Time frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.

  8. 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.

    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.

  9. 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

    Time frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.

  10. 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

    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.

  11. 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

    Time frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.

  12. 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

    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.

  13. 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

    Time frame: before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration.

  14. 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

    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.

  15. Objective Response Rate (ORR)

    The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period

    Time frame: Baseline up to 104 weeks

  16. Complete Remission Rate (CRR)

    The proportion of tumors that have a complete response after treatment

    Time frame: Baseline up to 104 weeks

  17. 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.

    Time frame: Baseline up to 104 weeks

  18. 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.

    Time frame: Baseline up to 104 weeks

  19. 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

    Time frame: Baseline up to 104 weeks

  20. Overall Survival (OS)

    the time from start of study treatment to date of death due to any cause

    Time frame: Baseline up to 104 weeks

  21. Adverse events (AE)

    The occurrence of all adverse events (AE)

    Time frame: Baseline up to 104 weeks

  22. Serious adverse events (SAE)

    The occurrence of all serious adverse events (SAE)

    Time frame: Baseline up to 104 weeks

  23. Bruton's tyrosine kinase (BTK) occupancy

    The BTK occupancy in peripheral blood mononuclear cell (PMBC)

    Time frame: Baseline up to 104 weeks

07

Study locations

2 sites
  • The First Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330006, China
  • The Cancer Hospital Affiliated to Shandong First Medical University
    Jinan, Shandong 250117, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2022; primary completion for Aug 2024, 21 months later.

Of 112 industry-sponsored phase 1 interventional studies under Hematologic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 78. This study's planned 21 months is below that.

Counting every sponsor, half of 179 studies reached it within 54 months; a quarter within 30 and three quarters within 85.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2022
First posted
Nov 9, 2022
StartEst.
Nov 2022
Primary completionEst.
Aug 2024
CompletionEst.
Aug 2024
Last update
Nov 9, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05610202
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Nov 9, 2022
Start date
Nov 2022 (estimated)
Primary completion
Aug 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
Nov 9, 2022

Study contacts

Zengjun Li, Doctor
Contact
zengjunli@163.com
+86-13642138692
Fei Li, Doctor
Contact
yx021021@sina.com
+86-13970038386

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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