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Advanced Malignant NeoplasmPhase 1NCT05997342

A Clinical Study of TQB3912 Tablets in Patients With Advanced Malignant Tumor

A Phase 1 study testing TQB3912 tablets in people with Advanced Malignant Neoplasm, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a study to evaluate the maximum tolerated dose (MTD), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters and antitumor effect of TQB3912 tablets in Chinese adult patients with advanced malignant neoplasm. 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?
TQB3912 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesChina
Study dates
16 Aug 2023to 27 May 2025
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

  • Subjects who voluntarily join the study, sign the informed consent form, and have good compliance.
  • Aged from 18 to 75 years; Eastern Cooperative Oncology Group performance status score: 0-2; at least 3 months of expected survival period.
  • Subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology and/or cytology.
  • The function of main organs is normal.
  • Subjects need to adopt effective methods of contraception.

Who cannot join

  • Subjects with other malignancies currently or suffered within 3 years.
  • Subjects with Grade 1 or above unhealed toxicity reaction of Common Terminology Criteria for Adverse Events Version 5.0 due to previous antitumor treatment.
  • Subjects who have received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before first administration.
  • Subjects with long lasting wounds or fractures.
  • Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders.
  • Subjects with any severe and/or uncontrolled disease.
Show all 11Show fewer
  • Subjects who have received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first administration.
  • Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration approved within 2 weeks before the first administration.
  • Subjects with pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.
  • Subjects who have participated in other clinical studies within 4 weeks before the first administration.
  • According to the judgment of the investigators, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China hospital, Sichuan university

    Chengdu, Sichuan, 610000

Other trials in China

About this study

Official title: A Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3912 Tablets in Subjects With Advanced Malignancies

This is a study to evaluate the maximum tolerated dose (MTD), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters and antitumor effect of TQB3912 tablets in Chinese adult patients with advanced malignant neoplasm. The study was divided into phase Ia and phase Ib, Phase Ia: Dose escalation period, to evaluate the safety and tolerability of TQB3912 tablets, determine MTD; Phase Ib: Effectiveness exploration period, to expand the safe and effective dose group, and to recommend appropriate dosage and method for subsequent clinical research.

Being tested
TQB3912 tablets

What participants receive

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

  • TQB3912 tabletsDrug

    TQB3912 is a small molecule Phosphorylated protein kinase inhibitor. Activation of the pathway plays an important role in cell survival, proliferation, migration, and differentiation.

Study groups in NCT05997342
Study groupRoleWhat they receive
TQB3912 tabletsExperimentalTQB3912 tablets, 28 days as a treatment cycle.
Receives: Drug: TQB3912 tablets

What is being measured

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

  1. Dose Limiting Toxicities (DLT)

    Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug: grade III or above of non-hematological toxicity, grade III hematological toxicity, Neutropenia associated with fever.

    Measured: During the first 28 days.

  2. Maximum tolerated dose (MTD)

    MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).

    Measured: During the first 29 days.

  3. Overall response rate (ORR)

    From the first drug treatment to the last drug treatment.

    Measured: Up to 2 years

Secondary outcomes (11)

  1. Incidence of adverse events (AEs)

    Number of patients with adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: From the time of informed consent signed to 90 days after the last dose

  2. Incidence of serious adverse events (SAEs)

    Number of patients with serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: From the time of informed consent signed to 90 days after the last dose

  3. Disease control rate (DCR)

    The proportion of subjects with Complete response (CR), Partial response (PR), or Stable Disease (SD).

    Measured: Up to 2 years

  4. Progression-free survival (PFS)

    The time from the first dose of TQB3912 to the first occurrence of disease progression or death from any cause.

    Measured: Up to 2 years

  5. Duration of Response (DOR)

    The time from first documented response to documented disease progression.

    Measured: Up to 2 years

  6. Overall survival (OS)

    The time between the date of first administration and the date of death due to any cause.

    Measured: Up to 5 years

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

    To characterize the pharmacokinetics of TQB3912 by assessment of time to reach maximum plasma concentration after single and multiple dosing.

    Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.

  8. Maximum (peak) plasma drug concentration (Cmax)

    Cmax is the maximum plasma concentration of TQB3912 or metabolite(s).

    Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.

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

    Cmax,ss is the maximum steady-state plasma concentration of TQB3912 or metabolite(s).

    Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.

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

    To characterize the pharmacokinetics of TQB3912 by assessment of area under the plasma concentration time curve from the first dose to time t.

    Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.

  11. Elimination half-life (t1/2) (to be used in one-or non- compartmental model)

    t1/2 is time it takes for the blood concentration of TQB3912 or metabolite(s) to drop by half.

    Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.

Timeline

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

  1. First posted18 Aug 2023
  2. Study start16 Aug 2023
  3. Primary completion27 May 2025
  4. Study completion27 May 2025

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
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05997342
Sponsor's protocol ID
TQB3912-I-01
Status last verified
Aug 2025
First submitted
10 Aug 2023
Last updated
11 Aug 2025
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 TQB3912 tablets in people with Advanced Malignant Neoplasm, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Toxicities (DLT) (time frame: During the first 28 days.). 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 NCT05997342.

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 11 Aug 2025.

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