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

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 site in 1 country164 target enrollmentSeptember 23, 2021

ConditionsAdvanced Solid Tumor

InterventionsTQB3823 tablets

DrugsTQB3823 tablets

Overview

Phase: Phase 1
Intervention: TQB3823 tablets
Conditions: Advanced Solid Tumor
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 164
Locations: 1
Primary Endpoint: Dose Limiting Toxicities (DLT)
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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 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.

Registry

clinicaltrials.gov

Start Date

September 23, 2021

End Date

October 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 (ECOG) performance status score: 0-1; at least 3 months expected survival period.
•Subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology and / or cytology, lack of conventional effective treatment methods.
•The function of main organs is normal.
•Subjects need to adopt effective methods of contraception.

Exclusion Criteria

•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\[ Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\].
•Subjects with multiple factors affecting oral administration.
•Subjets with unhealed toxicity above Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) 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.
•Subjects who have received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first administration ( 2 weeks for brain radiotherapy ).
•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.
•Subjects with pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.

Arms & Interventions

TQB3823 tablets

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.

Intervention: TQB3823 tablets

Outcomes

Primary Outcomes

Dose Limiting Toxicities (DLT)

Time Frame: Baseline up to 28 days

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.

Maximum tolerated dose (MTD)

Time Frame: Baseline up to 28 days

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

Secondary Outcomes

Adverse events (AEs) and serious adverse events (SAEs)(Baseline up to 28 days)
Overall response rate (ORR)(21 days)
Disease control rate（DCR）(21 days)
Duration of Response (DOR)(21 days)
Time to reach maximum (peak) plasma concentration following drug administration（Tmax）(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.)
Progression-free survival (PFS)(21 days)
Maximum (peak) plasma drug concentration （Cmax）(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.)
Apparent total clearance of the drug from plasma after oral administration （CL/f）(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.)
Elimination half-life（t1/2）(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) steady-state plasma drug concentration during a dosage interval （Cmax,ss）(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.)
Mean residence time (MRT)(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.)
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-∞）(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.)
Minimum steady-state plasma drug concentration during a dosage interval （Css-min）(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.)
Average steady-state plasma drug concentration during multiple-dose administration （Css-av）(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.)