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Advanced Malignant TumorsPhase 1NCT05110807

A Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3617 Capsule in Patients With Advanced Malignant Tumors

A Phase 1 study testing TQB3617 in people with Advanced Malignant Tumors, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

TQB3617 is a bromodomain and extra-terminal (BET) inhibitor that can competitively bind to bromodomains (BRDs) with Acetylated lysine(Kac) and block or partially block the role of KAc in subsequent gene transcription and regulation of chromatin structure, thereby playing an anti-tumor role. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignant Tumors
What is being tested?
TQB3617
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
2 sitesChina
Study dates
5 Jan 2022to Dec 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged: ≥18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Life expectancy ≥ 3 months.
  • Patients with advanced malignancy tumor who have failed standard treatment or are unable to receive standard treatment or have no effective treatment.
  • Female and male subjects should agree to use an adequate method of contraception starting with signing informed consent form (ICF) through 180 days after the last dose of study. The women of reproductive age who blood/urine results were positivetherapy before the first study drug is administered within less than 7 days.

Who cannot join

  • Patients has had or is currently having other malignant tumors within 3 years.
  • Patients have multiple factors that affect their oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction).
  • The patient had unmitigated toxic reactions due to any prior treatment.
  • Patients underwent major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to the start of study treatment.
  • Patients have long - term unhealed wounds or fractures.
  • Patients were taking Cytochrome P450 3A4, Cytochrome P450 3A5, Cytochrome P450 2A6, Cytochrome P450 2D6 (CYP3A4, CYP3A5, CYP2A6,CYP2D6) inhibitors or inducers before oral medication.
  • Patients who, in the investigator's judgment, have a comorbidity that seriously endangers patient safety or interferes with study completion, or who are considered unsuitable for inclusion for other reasons.

Trial locations and contacts

2 sites in 1 country.

Xiaojia Wang, Master contact

0571-88122146

huang_jian22@aliyun.com

China2 sites, 2 recruiting

  • Sun Yat-sen University Cancer Cen

    Guangzhou, Guangdong, 510060

    Qingqing Cai, Doctor, 020-87343356, caiqq@sysucc.org.cn

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 31002

    Xiaojia Wang, Master, 0571-88122146, huang_jian22@aliyun.com

    Recruiting

Other trials in China

About this study

Official title: Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3617 Capsule in Patients With Advanced Malignant Tumors

TQB3617 is a bromodomain and extra-terminal (BET) inhibitor that can competitively bind to bromodomains (BRDs) with Acetylated lysine(Kac) and block or partially block the role of KAc in subsequent gene transcription and regulation of chromatin structure, thereby playing an anti-tumor role.

Being tested
TQB3617

What participants receive

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

  • TQB3617Drug

    TQB3617 is a BET inhibitor.

Study groups in NCT05110807
Study groupRoleWhat they receive
TQB3617Experimental0.1mg, once daily, was used as the initial dose, and the medication stage was divided into single administration and continuous administration stages. The single administration was given once, and the continuous administration stage was entered 7 days after drug withdrawal. The drug was administered continuously until the disease progressed.
Receives: Drug: TQB3617

What is being measured

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

  1. Maximum tolerated dose (MTD)

    The highest dose of a drug or treatment that does not cause unacceptable side effects.

    Measured: Baseline up to 48 weeks

  2. Adverse events (AEs) and serious adverse events (SAEs)

    The occurrence of all AEs and SAEs

    Measured: Baseline up to 48 weeks

Secondary outcomes (11)

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

    To characterize the pharmacokinetics of TQB3617 by assessment of time to reach maximum plasma concentration after single and multiple dosing

    Measured: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.

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

    Cmax is the maximum plasma concentration of TQB3617 or metabolite(s).

    Measured: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.

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

    t1/2 is time it takes for the blood concentration of TQB3617 or metabolite(s) to drop by half.

    Measured: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours, after oral administration of a single drug delivery.

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

    Maximum (peak) steady-state plasma drug concentration during a dosage interval

    Measured: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.

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

    Minimum steady-state plasma drug concentration during a dosage interval

    Measured: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.

  6. Concentration at the end of the dosing interval AUCtau,ss

    To characterize the pharmacokinetics of TQB3617 by assessment of area the concentration at the end of the administration interval

    Measured: Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28.

  7. Overall response rate (ORR)

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

    Measured: up to 96 weeks

  8. Progress Free Survival（PFS）

    From the start of randomization to the first tumor progression or time of death.

    Measured: up to 96 weeks

  9. Disease control rate（DCR）

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

    Measured: up to 96 weeks

  10. Duration of Response (DOR)

    The time when the participants first achieved complete or partial remission to disease progression.

    Measured: up to 96 weeks

  11. Overall Survival（OS）

    From date of first administration of test drug until the date of death from any cause，

    Measured: assessed up to 100 months

Timeline

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

  1. First posted8 Nov 2021
  2. Study start5 Jan 2022
  3. Primary completionOct 2022 (estimated)
  4. Study completionDec 2022 (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
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05110807
Sponsor's protocol ID
TQB3617-I-01
Status last verified
Feb 2022
First submitted
4 Nov 2021
Last updated
14 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang Y, Yin Q, Zhao B, Liu F, Li S, Cai J, Fang X, Bai B, Nie M, Zou Q, Ding D, Wang X, Zhu J, Yu D, Wang X, Zhang X, Wang L, Xia Y, Cai Q. TQB3617, a bromodomain and extra-terminal inhibitor, in patients with relapsed or refractory lymphoma: A multicenter, phase 1 trial. Med. 2026 Jan 9;7(1):100893. doi: 10.1016/j.medj.2025.100893. Epub 2025 Oct 27.

    PubMed 41151587

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQB3617 in people with Advanced Malignant Tumors, 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 7 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 14 Feb 2022. 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?

Results are not available in the source record.

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

Contact Xiaojia Wang, Master (0571-88122146, huang_jian22@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: Baseline up to 48 weeks). The study lists 2 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 NCT05110807, which also lists 1 linked publication.

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 14 Feb 2022.

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