AzTrials
AzTrials

Hematologic MalignancyPhase 1NCT06211751

A Clinical Trial of TQB3909 Tablets Combined With TQB3702 Tablets in Patients With Hematologic Malignancy

A Phase 1 study testing TQB3909 tablets and TQB3702 tablets in people with Hematologic Malignancy, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is an open, multi-cohort 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hematologic Malignancy
What is being tested?
TQB3909 tablets and TQB3702 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
1 siteChina
Study dates
Jan 2024to Jun 2026
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
  • ≥ 18 years old, ≤75 years old (when signing informed consent form); Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period.
  • Subject population:
  • Dose escalation stage: non-Hodgkin's B-cell lymphoma;
  • Dose expansion stage: non-Hodgkin's lymphoma, etc.
  • At least 1 lesion / measurable disease 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 the completion of the study; 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 the completion of the study.

Who cannot join

  • Patients has occured or is currently having other malignant tumors within 5 years. The following two conditions can be included: other malignant tumors treated with a single operation to achieved 5 consecutive years of disease free survival (DFS). Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basal membrane)] and papillary thyroid carcinoma.
  • Burkitt lymphoma, lymphoblastic lymphoma/leukemia, etc.
  • For cohort A and cohort B: Richter transformation occured.
  • Subjects with central nervous system (CNS) aggression;
  • Previously received allogeneic hematopoietic stem cell transplantation;
  • For Cohort B/D/E: Received autologous hematopoietic stem cell transplantation within 3 months before the first dose;
Show all 18Show fewer
  • Multiple factors that affect the absorption of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction);
  • Unrelieved toxicity of ≥CTCAE grade 1 due to any previous treatment, excluding alopecia and fatigue;
  • Major surgical treatment, open biopsy, and significant traumatic injury received within 28 days before the start of study treatment.
  • Having active or uncontrolled primary autoimmune hemocytopenia, including autoimmune hemolytic anemia (AIHA), primary immune thrombocytopenia (ITP), etc.
  • Patients with evidence or history of bleeding constitution; Or any bleeding event (such as gastrointestinal bleeding) greater than or equal to CTCAE level 3 within 4 weeks before the first dose;
  • Subjects who had an arteriovenous thrombosis event within 6 months.
  • Subjects who had a history of psychotropic substance abuse and are unable to abstain or have mental disorders;
  • Subjects with any severe and/or uncontrolled disease.
  • Within one weeks before the first dose, the subjects had received proprietary Chinese medicines with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions;
  • 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 dose;
  • 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

Trial locations and contacts

1 site in 1 country.

Yanyan Liu, Doctor contact

+86-13838176375

yyliu@zzu.edu.cn

China1 site

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Yanyan Liu, Doctor, +86-13838176375, yyliu@zzu.edu.cn

Other trials in China

About this study

Official title: A Phase Ib Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of TQB3909 Tablets Combined With TQB3702 Tablets in Hematologic Malignancy Subjects.

This is an open, multi-cohort 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 safety and preliminary efficacy of TQB3909 tablets combined with TQB3702 tablets in hematologic malignancy subjects.

Being tested
TQB3909 tablets, TQB3702 tablets
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB3909 tabletsDrug

    TQB3909 is a protein inhibitor.

  • TQB3702 tabletsDrug

    TQB3702 is a kinase inhibitor.

Study groups in NCT06211751
Study groupRoleWhat they receive
TQB3909 tablets+ TQB3702 tabletsExperimentalTQB3909 tablets combined with TQB3702 tablets, administered orally, 28 days as a treatment cycle.
Receives: Drug: TQB3909 tablets; Drug: TQB3702 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limited toxicity (DLT)

    DLT will be defined as toxicities that meet pre-defined severity criteria (according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0), and assessed as having a suspected relationship to study drug.

    Measured: Baseline up to 104 weeks

  2. Adverse events (AE)

    The occurrence of all adverse events (AE).

    Measured: Baseline up to 104 weeks

  3. Serious adverse events (SAE)

    The occurrence of all serious adverse events (SAE).

    Measured: Baseline up to 104 weeks

  4. Clinical laboratory abnormalities

    Incidence of participants with abnormal clinical laboratory test results.

    Measured: Baseline up to 104 weeks

Secondary outcomes (14)

  1. Complete remission rate (CRR)/ Complete remission with incomplete bone marrow recovery rate (CRi)

    The proportion of patients with tumor hat have a complete response or complete remission with incomplete bone marrow recovery after treatment.

    Measured: Baseline up to 104 weeks

  2. Objective Response Rate (ORR)

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

    Measured: Baseline up to 104 weeks

  3. Undetectable measurable residual disease (U-MRD) ratio of peripheral blood and/or bone marrow

    Refers to the undetected residual lesions. Flow cytometry was used to detect less than 1 Chronic Lymphocytic Leukemia (CLL) cell (less than 10-4) in 10,000 white blood cells in peripheral blood and/or bone marrow.

    Measured: Baseline up to 104 weeks

  4. Duration of complete remission / complete remission with incomplete bone marrow recovery

    The time from the date of first achieving CR or CRi to the date of first definite disease progression or death from any cause (whichever occurs first).

    Measured: Baseline up to 104 weeks

  5. Duration of Response (DOR)

    For all subjects whose best response was partial response (PR), Complete Response (CR), the time from the date of first achieving PR, CR to the date of first definite disease progression or death from any cause (whichever occurs first).

    Measured: Baseline up to 104 weeks

  6. Time to complete remission

    The time from beginning the treatment to the first achieving complete remission/ complete remission with incomplete bone marrow recovery.

    Measured: Baseline up to 104 weeks

  7. Time to remission (TTR)

    Time from the beginning of treatment to the first recording of remission (PR or better remission), only the remission population will be analyzed.

    Measured: Baseline up to 104 weeks

  8. 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

    Measured: Baseline up to 104 weeks

  9. Overall Survival (OS)

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

    Measured: Baseline up to 104 weeks

  10. 2 years' PFS rate

    The proportion of patients with progression free survival in 2 years.

    Measured: Baseline up to 104 weeks

  11. 2 years' OS rate

    The proportion of patients achieving overall survival in two years.

    Measured: Baseline up to 104 weeks

  12. Time to reach the maximum plasma concentration (Tmax)

    Time to reach the maximum plasma concentration after dose

    Measured: Before the first dose of TQB3702 tablet and target dose of TQB3909 tablet. 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after the first target dose of TQB3909 tablet. The 4th /11th day before dosing with target dose of TQB3909 tablet.

  13. Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)

    Cmax is the maximum plasma concentration of TQB3909 and TQB3702

    Measured: Before the first dose of TQB3702 tablet and target dose of TQB3909 tablet. 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after the first target dose of TQB3909 tablet. The 4th /11th day before dosing with target dose of TQB3909 tablet.

  14. Minimum steady-state plasma drug concentration during a dosage interval (Css-min)

    Cmin is the minimum plasma concentration of TQB3909 and TQB3702.

    Measured: Before the first dose of TQB3702 tablet and target dose of TQB3909 tablet. 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after the first target dose of TQB3909 tablet. The 4th /11th day before dosing with target dose of TQB3909 tablet.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2024
  2. Study startJan 2024 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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
208 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06211751
Sponsor's protocol ID
TQB3909-TQB3702-Ib -01
Status last verified
Jan 2024
First submitted
9 Jan 2024
Last updated
18 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQB3909 tablets and TQB3702 tablets in people with Hematologic Malignancy, 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 8 inclusion and 18 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 18 Jan 2024. 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 Yanyan Liu, Doctor (+86-13838176375, yyliu@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limited toxicity (DLT) (time frame: Baseline up to 104 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06211751.

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 18 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in