A Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3912 Tablets in Subjects With Advanced Malignancies

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.2 sites in 1 country36 target enrollmentAugust 16, 2023

ConditionsAdvanced Malignant Neoplasm

InterventionsTQB3912 tablets

DrugsTQB3912 tablets

Overview

Phase: Phase 1
Intervention: TQB3912 tablets
Conditions: Advanced Malignant Neoplasm
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 36
Locations: 2
Primary Endpoint: Dose Limiting Toxicities (DLT)
Status: Completed
Last Updated: 8 months 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 TQB3912 tablets in Chinese adult patients with advanced malignant neoplasm. The study was divided into phase Ia and phase Ib, Phase Ia: Dose escalation period, to evaluate the safety and tolerability of TQB3912 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

August 16, 2023

End Date

May 27, 2025

Last Updated

8 months 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 performance status score: 0-2; at least 3 months of expected survival period.
•Subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology and/or cytology.
•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.
•Subjects with Grade 1 or above unhealed toxicity reaction of Common Terminology Criteria for Adverse Events 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.
•Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration approved within 2 weeks before the first administration.
•Subjects with pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.
•Subjects who have participated in other clinical studies within 4 weeks before the first administration.

Arms & Interventions

TQB3912 tablets

TQB3912 tablets, 28 days as a treatment cycle.

Intervention: TQB3912 tablets

Outcomes

Primary Outcomes

Dose Limiting Toxicities (DLT)

Time Frame: During the first 28 days.

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

Maximum tolerated dose (MTD)

Time Frame: During the first 29 days.

MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).

Overall response rate (ORR)

Time Frame: Up to 2 years

From the first drug treatment to the last drug treatment.

Secondary Outcomes

Time to reach maximum (peak) plasma concentration (Tmax)(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.)
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.)
Incidence of adverse events (AEs)(From the time of informed consent signed to 90 days after the last dose)
Incidence of serious adverse events (SAEs)(From the time of informed consent signed to 90 days after the last dose)
Disease control rate (DCR)(Up to 2 years)
Progression-free survival (PFS)(Up to 2 years)
Elimination half-life (t1/2) (to be used in one-or non- compartmental model)(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.)
Overall survival (OS)(Up to 5 years)
Duration of Response (DOR)(Up to 2 years)
Maximum (peak) plasma drug concentration (Cmax)(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.)
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.)