Anti-Infective Agents

All Drugs and Chemicals

Itraconazole

Rifampin

Hydroxyitraconazole

Clotrimazole

Miconazole

Antifungal Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 CYP3A Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Itraconazole capsules, 0.2g once daily from Day 3 to Day 10 TQB3909 tablets, single oral dose on Day 1 and Day 8.

Rifampicin capsule, 0.6g once daily from Day 3 to Day 11. TQB3909 tablets, single oral dose on Day 1 and Day 10.

TQB3909 tablets

Itraconazole capsule is a strong inhibitor of CYP3A4.

Itraconazole capsule

Rifampicin capsule is a strong inducer of CYP3A4.

Rifampicin capsule

Fei Hua, MD, PhD

Weiying Gu, MD, PhD

This is a single-center, open, single-dose, self-controlled phase I clinical trial to evaluate the effects of Itraconazole Capsules/Rifampicin Capsules on pharmacokinetics of TQB3909 tablets in vivo, and the safety of TQB3909 tablets and combined with Itraconazole Capsules/Rifampicin Capsules after single oral dose.

A Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets

A Phase I Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets

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

The maximum observed plasma concentration of TQB3909

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

Incidence of adverse events (AEs) based on the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

200-1000mg of TQB3909 tablets once a day; Oral administration under fast condition, 28 days as a cycle.

TQB3909 is an inhibitor targeting BCL-2 protein

Quchang Ouyang, Doctor

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.

female patient aged from 18 to 75 years old, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

A Clinical Trial of TQB3909 Tablets in Patients With Breast Cancer

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

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.

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

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

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

Maximum observed concentration (Cmax) of TQB3909

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

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.

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

Cmin,ss is the minimum plasma concentration of TQB3909.

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

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

Take 100-1200mg once a day; Oral administration on an empty stomach, 28 days as a cycle.

TQB3909 Tablets

Jianyong Li, Doctor

Wei Xu, Doctor

Jianxiang Wang, Doctor

Junyuan Qi, Doctor

TQB3909 is an inhibitor targeting at 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.

A Clinical Trial of TQB3909 Tablets in Subjects With Advanced Malignant Tumors

A Phase I Clinical Trial Evaluating the Tolerance and Pharmacokinetics of TQB3909 Tablets in Patients With Relapsed or Refractory Advanced Malignant Tumors

DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.

DLT describes side effects of a drug or other treatment that are serious enough to To evaluate RP2D of TQB3909 tablets in adult patients with advanced solid tumors

The incidence and severity of AEs and SAEs, as well as abnormal laboratory test indicators.

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

Cmax is the maximum plasma concentration of TQB3909.

Css-max is the steady state maximum concentration of TQB3909 .

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

AUCss is the area under the curve of TQB3909.

CL/F is total clearance rate for TQB3909.

t1/2 is time it takes for the blood concentration of TQB3909 to drop by half.

MRT describes the average time that TQB3909 remains in the body.

Css-min is the minimum plasma concentration of TQB3909.

DF is the volatility coefficient of TQB3909.

Css-av is the average of steady-state plasma concentration of TQB3909 .

Vd/F is the bioavailability corrected apparent distribution volume of TQB3909

PFS is defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

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

CRR refers to the percentage of patients who enter the clinical disappearance period of the disease after a certain treatment.

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

The period from the participants first achieving CR or PR to disease progression.

OS is defined as the time from the first administration to all-cause death.

To evaluate the changes of BCL-2 signaling pathway related to proteins or genes.

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

TQB3909 tablets combined with TQB3702 tablets, administered orally, 28 days as a treatment cycle.

TQB3702 tablets

Yanyan Liu, Doctor

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.

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

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

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.

The occurrence of all adverse events (AE).

The occurrence of all serious adverse events (SAE).

Incidence of participants with abnormal clinical laboratory test results.

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

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

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.

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).

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).

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

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

The time from the first dose to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first

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

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

The proportion of patients achieving overall survival in two years.

Time to reach the maximum plasma concentration after dose

Cmax is the maximum plasma concentration of TQB3909 and TQB3702

Cmin is the minimum plasma concentration of TQB3909 and TQB3702.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets	NCT06165822	Advanced Malign...	TQB3909 tablets Itraconazole ca... Rifampicin caps...	18 Years - 45 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Trial of TQB3909 Tablets in Patients With Breast Cancer	NCT05775575	Advanced Breast...	TQB3909 tablets	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Trial of TQB3909 Tablets in Subjects With Advanced Malignant Tumors	NCT04975204	Advanced Malign...	TQB3909 Tablets	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Trial of TQB3909 Tablets Combined With TQB3702 Tablets in Patients With Hematologic Malignancy	NCT06211751	Hematologic Mal...	TQB3909 tablets TQB3702 tablets	18 Years - 80 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Trial of TQB3909 Tablets in Subjects With Advanced Malignant Tumors	NCT04975204	Advanced Malign...	TQB3909 Tablets	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Trial of TQB3909 Tablets in Subjects With Advanced Malignant Tumors	NCT04975204	Advanced Malign...	TQB3909 Tablets	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets	NCT06165822	Advanced Malign...	TQB3909 tablets Itraconazole ca... Rifampicin caps...	18 Years - 45 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Trial of TQB3909 Tablets in Patients With Breast Cancer	NCT05775575	Advanced Breast...	TQB3909 tablets	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets	NCT06165822	Advanced Malign...	TQB3909 tablets Itraconazole ca... Rifampicin caps...	18 Years - 45 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Trial of TQB3909 Tablets in Subjects With Advanced Malignant Tumors	NCT04975204	Advanced Malign...	TQB3909 Tablets	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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