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Advanced Breast CancerPhase 1/2NCT05775575

A Clinical Trial of TQB3909 Tablets in Patients With Breast Cancer

A Phase 1/2 study testing TQB3909 tablets in people with Advanced Breast Cancer, 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

TQB3909 is an inhibitor targeting B-cell lymphoma (BCL)-2 protein. By binding to BCL-2 protein, TQB3909 releases Pro apoptotic proteins such as BCL-2-Anatagonist/Killer 1(BAK), BCL-2 associated X (BAX) protein and BCL-2 associated death (BAD) protein, promotes the release of cytochrome c from mitochondria… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Advanced Breast Cancer
What is being tested?
TQB3909 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteChina
Study dates
2 Mar 2023to Dec 2023
Phase
Phase 1/2
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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
  • Age: 18 to 75 years old; female patient, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Histopathologically confirmed HR positive and HER2 negative advanced or metastatic breast cancer.
  • Patients who have been treated with endocrine therapy and have experienced disease progression.
  • Patients previously treated with any CDK4/6 inhibitor and not treated with BCL-2 inhibitor.
  • Has at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria
  • The main organs function well;
  • Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.

Who cannot join

  • 1. Concomitant disease and medical history:
  • There were other malignant tumors in 3 years before the first medication.
  • Has multiple factors affecting oral medication;
  • Unalleviated toxicity ≥ grade 1 due to any previous therapy;
  • Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study; e．Arteriovenous thrombotic events occurred within 6 months before the first medication, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; f．Have a history of psychotropic drug abuse and can not quit or have mental disorders; g．Subjects with any severe and / or uncontrolled disease included: Cirrhosis, active hepatitis, history of immunodeficiency;
  • Tumor-related symptoms and treatment:
Show all 13Show fewer
  • Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
  • have received radiotherapy, other antineoplastic therapy within 2 weeks prior to the first dose;
  • Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
  • Known hypersensitivity to TQB3909, LHRH agonists (e.g., goserelin), or any excipients.
  • Subjects who have received the vaccine within 28 days prior to the first dose, or are planning to receive the vaccine during the study period.
  • Has Participated in other clinical trials within 4 weeks before first dose.
  • According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Quchang Ouyang, Doctor, +86 13973135318, oyqc1969@126.com

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib/II Study to Investigate the Safety, Tolerance and Pharmacokinetics of TQB3909 With HR-positive, HER2-negative Advanced Breast Cancer

TQB3909 is an inhibitor targeting B-cell lymphoma (BCL)-2 protein. By binding to BCL-2 protein, TQB3909 releases Pro apoptotic proteins such as BCL-2-Anatagonist/Killer 1(BAK), BCL-2 associated X (BAX) protein and BCL-2 associated death (BAD) protein, promotes the release of cytochrome c from mitochondria, phosphatidylserine eversion, stimulates caspase 3/7 activity and caspase 3/9 cleavage, and induces apoptosis.

Being tested
TQB3909 tablets

What participants receive

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

  • TQB3909 tabletsDrug

    TQB3909 is an inhibitor targeting BCL-2 protein

Study groups in NCT05775575
Study groupRoleWhat they receive
TQB3909 tabletsExperimental200-1000mg of TQB3909 tablets once a day; Oral administration under fast condition, 28 days as a cycle.
Receives: Drug: TQB3909 tablets

What is being measured

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

  1. Dose Limiting Toxicity (DLT)

    DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred from the first dose to the end of the first treatment cycle.

    Measured: At the end of Cycle 1 (Cycle 1, Day 28)

  2. Maximum tolerated dose (MTD)

    MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.

    Measured: At the end of Cycle 1 (Cycle 1, Day 28)

  3. Recommended Phase II Dose (RP2D)

    DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3909 tablets in adult patients with Breast cancers

    Measured: Baseline up to 24 months

Secondary outcomes (8)

  1. Time to reach maximum (peak)plasma concentration (Tmax)

    To characterize the pharmacokinetics of TQB3909 by assessment of time to reach maximum plasma concentration after single and multiple dosing.

    Measured: before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.

  2. Peak concentration (Cmax)

    Maximum observed concentration (Cmax) of TQB3909

    Measured: before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.

  3. Terminal half-life (T1/2)

    Pharmacokinetics parameters to evaluate the half life of TQB3909 (T1/2)

    Measured: before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.

  4. Area under the plasma concentration-time curve from time zero to time t (AUC0-t)

    To characterize the pharmacokinetics of TQB3909 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.

    Measured: before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.

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

    Cmax,ss is the steady state maximum concentration of TQB3909.

    Measured: before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.

  6. Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss)

    Cmin,ss is the minimum plasma concentration of TQB3909.

    Measured: before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28.

  7. Clinilca Benefit Rate (CBR)

    Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).

    Measured: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks.

  8. Objective Response Rate (ORR)

    Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria

    Measured: From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks.

Timeline

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

  1. First posted20 Mar 2023
  2. Study start2 Mar 2023
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05775575
Sponsor's protocol ID
TQB3909-Ib/II-01
Status last verified
Sep 2022
First submitted
7 Dec 2022
Last updated
20 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TQB3909 tablets in people with Advanced Breast 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 8 inclusion and 13 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 20 Mar 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) (time frame: At the end of Cycle 1 (Cycle 1, Day 28)). The study lists 3 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 NCT05775575.

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 20 Mar 2023.

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