Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Abiraterone Acetate

Prednisone

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Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets，28 days as a treatment cycle.

TQB3823 tablet is an inhibitor of poly ADP-ribose polymerase (PARP).

TQB3823 tablets

Abiraterone acetate tablet is an inhibitor of cytochrome P450 17（CYP17）

Abiraterone acetate tablets

Prednisone acetate tablet is a kind of glucocorticoids

prednisone acetate tablets

This is a phase Ib/II clinical study to explore the safety and efficacy of TQB3823 tablets combined with abiraterone acetate tablets and prednisone acetate tablets in patients with metastatic castration-resistant prostate cancer.

This is a two-phase, open-label Phase Ib clinical trial. The first phase plans to enroll 6-12 patients as two cohorts to explore the safety and of TQB3823 tablets combined with abiraterone and prednisone and the recommended dose of phase II of TQB3823. Subjects involved in cohort one accepts TQB3823 treatment during cycle one and then TQB3823 combined with abiraterone and prednisone from cycle two till the disease progression. The second phase plans to enroll a total of 40-60 subjects, aiming to evaluate the safety and efficacy of TQB3823 tablets combined with abiraterone and prednisone.

To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer

Phase Ib/II Clinical Study of TQB3823 Tablets Combined With Abiraterone Acetate Tablets and Prednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer

The relevant adverse reactions occurred within the first cycle

The dose of TQB3823 tablet which is recommended to use during phase II clinical trial

Proportion of subjects without disease progression assessed by radiology within 12 months

rPFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause evaluated by radiological examination

Proportion of subjects without disease progression assessed by radiology within 6 months

Proportion of subjects with reduction of PSA

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

OS defined as the time from randomization until the death from any cause

Proportion of subjects with clinical benefit

The time when the participants first achieved CR or PR to disease progression or death from any cause.

Time to progression of bone disease in subjects

The time it takes for the drug's concentration in the body to drop by half

The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Subjects receive TQB3823 in the first cycle for a total of 28 days , a single dose on Day 1. Day 2 to Day 7 are the elution period, and the continuous doses are from Day 8 to Day 21. From the second cycle, continuous treatment for 28 days is as a treatment cycle.

TQB3823 is a small molecule Poly ADP-ribose Polymerase (PARP) inhibitor that can inhibit the enzyme activity of PARP1/2, making it difficult to repair the DNA in cancer cells, leading to cell death and delaying or blocking tumor development.

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 TQB3823 tablets in Chinese adult patients with advanced solid tumors .The study was divided into phase Ia and phase Ib, Phase Ia: Dose escalation period, to evaluate the safety and tolerability of TQB3823 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.

A Clinical Study of TQB3823 in Patients With Advanced Malignant Tumor

A Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3823 Tablets in Subjects With Advanced Malignancies

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

The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment

The occurrence of all AEs and SAEs，such as Anemia, Platelet count decreased, Nausea, Vomiting, Elevated transaminase.

Overall response rate（From the first drug treatment to the last drug treatment）

Disease control rate（From the first drug treatment to the last drug treatment）

First-time progression of disease/ recurrence /death）

Baseline up to progression of disease/ recurrence /death

To characterize the pharmacokinetics of TQB3823 by assessment of time to reach maximum plasma concentration after single and multiple dosing

Cmax is the maximum plasma concentration of TQB3823 or metabolite(s).

To characterize the pharmacokinetics of TQB3823 by assessment of area under the plasma concentration time curve from the first dose to infinity.

CL/f is total clearance rate for TQB3823.

t1/2 is time it takes for the blood concentration of TQB3823 or metabolite(s) to drop by half.

MRT describes the average time that TQB3823 or metabolite(s) remain in the body.

Css-min is the minimum plasma concentration of TQB3823 or metabolite(s).

Css-av is mean steady-state plasma concentration of TQB3823 or metabolite(s).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer	NCT05405439	Metastatic Cast...	TQB3823 tablets Abiraterone ace... prednisone acet...	18 Years - 85 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Study of TQB3823 in Patients With Advanced Malignant Tumor	NCT05021367	Advanced Solid ...	TQB3823 tablets	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer	NCT05405439	Metastatic Cast...	TQB3823 tablets Abiraterone ace... prednisone acet...	18 Years - 85 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer	NCT05405439	Metastatic Cast...	TQB3823 tablets Abiraterone ace... prednisone acet...	18 Years - 85 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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