NCT05021367 - A Clinical Study of TQB3823 in Patients With Advanced Malignant Tumor | Crick

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects who voluntarily join the study, sign the informed consent form, and have good compliance. 2. Aged from 18 to 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1; at least 3 months expected survival period. 3. Subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology and / or cytology, lack of conventional effective treatment methods. 4. The function of main organs is normal. 5. Subjects need to adopt effective methods of contraception. Exclusion Criteria: 1. Subjects with other malignancies currently or suffered within 3 years. The following two conditions can be enrolled: other malignant tumors treated with a single operation to achieve disease-free survival (DFS) for 5 consecutive years; cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors\[ Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\]. 2. Subjects with multiple factors affecting oral administration. 3. Subjets with unhealed toxicity above Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 due to previous antitumor treatment. 4. Subjects who have received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before first administration. 5. Subjects with long lasting wounds or fractures. 6. Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders. 7. Subjects with any severe and/or uncontrolled disease. 8. Subjects who have received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first administration ( 2 weeks for brain radiotherapy ). 9. Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration (NMPA)approved within 2 weeks before the first administration. 10. Subjects with pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage. 11. Subjects with known central nervous system metastases and/or cancerous meningitis. 12. Subjects who have participated in other clinical studies within 4 weeks before the first administration. 13. 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.

Outcomes

Primary Outcomes

Dose Limiting Toxicities (DLT)

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.

Time frame: Baseline up to 28 days

Maximum tolerated dose (MTD)

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

Time frame: Baseline up to 28 days

Secondary Outcomes

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

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

Time frame: Baseline up to 28 days

Overall response rate (ORR)

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

Time frame: 21 days

Disease control rate（DCR）

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

Time frame: 21 days

Progression-free survival (PFS)

First-time progression of disease/ recurrence /death）

Time frame: 21 days

Duration of Response (DOR)

Baseline up to progression of disease/ recurrence /death

Time frame: 21 days

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

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

Time frame: Hour 0 (pre-dose), 1, 2, 3, 4, 6, 8, 11, 24, 48, 72, 120, 168 hours post-dose on single dose; Hour 0(pre-dose) of day 7,day 14 on multiple dose and Hour 0 (pre-dose), 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on multiple dose of day 21.

Maximum (peak) plasma drug concentration （Cmax）

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

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

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

Area under the plasma concentration-time curve from time zero to time t （AUC0-t）、Area under the plasma concentration-time curve from time zero to infinity （ACU0-∞）

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

Apparent total clearance of the drug from plasma after oral administration （CL/f）

CL/f is total clearance rate for TQB3823.

Elimination half-life（t1/2）

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

Mean residence time (MRT)

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

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

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

Average steady-state plasma drug concentration during multiple-dose administration （Css-av）

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

A Clinical Study of TQB3823 in Patients With Advanced Malignant Tumor

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes