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Advanced Malignant NeoplasmPhase 1NCT06165809

A Clinical Trial of TQB3015 Tablets in Patients With Advanced Malignant Cancer

A Phase 1 study testing TQB3015 tablets in people with Advanced Malignant Neoplasm, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is divided into two stages: dose escalation and dose extension, including a single dose and a multiple dose clinical study. This is a single-center, open, non randomized, single arm study to the safety and tolerability of TQB3015 tables in patients with advanced malignant cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignant Neoplasm
What is being tested?
TQB3015 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
Dec 2023to May 2024
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 75 years
  • All sexes
  • 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; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Advanced malignant tumors confirmed by tissue or cellular pathology and the routine standard treatment was ineffective or lack of effective treatment plans, or patients cannot tolerate the standard treatment;
  • Has at least one assessable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria;
  • The main organs function well;
  • Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures during the study period and until at least 6 months after the last dose of study drug.

Who cannot join

  • Concomitant disease and medical history:
  • There were other malignant tumors occured within 3 years before the first dose of study drug.
  • Has multiple factors affecting oral medication;
  • Unalleviated toxicity ≥ grade 1 according to CTCAE v5.0 due to any previous therapy, excluding hair loss;
  • Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study, or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period;
  • Arteriovenous thrombotic events occurred within 6 months before the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
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  • Have a history of psychotropic drug abuse and can not quit or have mental disorders;
  • Subjects with any severe and/or uncontrolled disease including active hepatitis, immunodeficiency;
  • Tumor-related symptoms and treatment:
  • Has known symptomatic central nervous system metastases and/or cancerous meningitis;
  • Have received surgery, chemotherapy, radiation therapy (2 weeks for brain radiation therapy) or other anti-cancer therapies within 4 weeks prior to the first dose.
  • Thoracic/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within one month after receiving the investigational drug for the first time.
  • 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

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the Safety and Tolerance of TQB3015 Tablets With Advanced Malignant Cancer.

This study is divided into two stages: dose escalation and dose extension, including a single dose and a multiple dose clinical study. This is a single-center, open, non randomized, single arm study to the safety and tolerability of TQB3015 tables in patients with advanced malignant cancer.

Being tested
TQB3015 tablets

What participants receive

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

  • TQB3015 tabletsDrug

    TQB3015 is a protein inhibitor

Study groups in NCT06165809
Study groupRoleWhat they receive
TQB3015 tabletsExperimentalTQB3015 tables is administered as a single dose or multiple dose, 2-40mg once a day; Oral administration on fast condition, 21 days as a cycle.
Receives: Drug: TQB3015 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 Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity, 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 (Day 21).

  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 (Day 21).

  3. Recommended Phase II Dose (RP2D)

    DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3015 tablets in adult patients with Advanced Malignant Cancer.

    Measured: Baseline up to 24 months

  4. Incidence of abnormal clinical laboratory

    Incidence of participants with clinical laboratory abnormalities

    Measured: 30 days after the last administration.

Secondary outcomes (10)

  1. Adverse events (AE)

    The occurrence of all adverse events (AE).

    Measured: 30 days after the last administration.

  2. Serious adverse events (SAE)

    The occurrence of all serious adverse events (SAE).

    Measured: 30 days after the last administration.

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

    To characterize the pharmacokinetics of TQB3015 by assessment of time to reach maximum plasma concentration after single and multiple dosing.

    Measured: Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.

  4. Peak concentration (Cmax)

    The maximum observed plasma concentration of study drug.

    Measured: Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.

  5. Half-life (t1/2)

    The time required for half of the drug to be eliminated from the plasma.

    Measured: Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.

  6. Area under the concentration-time curve from zero to infinity (AUC0-∞)

    To characterize the pharmacokinetics of TQB3015 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.

    Measured: Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.

  7. Area under the concentration-time curve from zero to last observation (AUC [0-t])

    To characterize the pharmacokinetics of TQB3015 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.

    Measured: Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.

  8. Apparent clearance (CL/F)

    Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.

    Measured: Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.

  9. Apparent volume of distribution (Vd/F)

    Apparent volume of distribution of the TQB3015 in plasma.

    Measured: Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.

  10. Objective response rate (ORR)

    The percentage of patients with complete response (CR) and/or partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1

    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 posted12 Dec 2023
  2. Study startDec 2023 (estimated)
  3. Primary completionMay 2024 (estimated)
  4. Study completionMay 2024 (estimated)

Why it stopped: The sponsor voluntarily withdraw the project.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06165809
Sponsor's protocol ID
TQB3015-I-01
Status last verified
Dec 2023
First submitted
4 Dec 2023
Last updated
29 Dec 2023
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 TQB3015 tablets in people with Advanced Malignant Neoplasm, 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 6 inclusion and 14 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: withdrawn, as of the sponsor's last update on 29 Dec 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 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 (Day 21).). 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 NCT06165809.

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 29 Dec 2023.

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