A Clinical Study of TQB3912 Tablets in Patients With Advanced Malignant Tumor

Advanced Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05997342
• Other study ID #: TQB3912-I-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 2023
• Est. completion date: August 2025

Study information

• Verified date: August 2023
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Qiang Wei, Doctor
• Phone: +86 028-85422449
• Email: wq933[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: August 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

• 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.

Related Conditions & MeSH terms

• Advanced Malignant Neoplasm
• Neoplasms

Intervention

Drug:
• TQB3912 tablets
TQB3912 is a small molecule Phosphorylated protein kinase inhibitor. Activation of the pathway plays an important role in cell survival, proliferation, migration, and differentiation.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan
China	West China hospital, Sichuan university	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicities (DLT)	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.	During the first 28 days.
Primary	Maximum tolerated dose (MTD)	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).	During the first 29 days.
Primary	Overall response rate (ORR)	From the first drug treatment to the last drug treatment.	Up to 2 years
Secondary	Incidence of adverse events (AEs)	Number of patients with adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0	From the time of informed consent signed to 90 days after the last dose
Secondary	Incidence of serious adverse events (SAEs)	Number of patients with serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0	From the time of informed consent signed to 90 days after the last dose
Secondary	Disease control rate (DCR)	The proportion of subjects with Complete response (CR), Partial response (PR), or Stable Disease (SD).	Up to 2 years
Secondary	Progression-free survival (PFS)	The time from the first dose of TQB3912 to the first occurrence of disease progression or death from any cause.	Up to 2 years
Secondary	Duration of Response (DOR)	The time from first documented response to documented disease progression.	Up to 2 years
Secondary	Overall survival (OS)	The time between the date of first administration and the date of death due to any cause.	Up to 5 years
Secondary	Time to reach maximum (peak) plasma concentration (Tmax)	To characterize the pharmacokinetics of TQB3912 by assessment of time to reach maximum plasma concentration after single and multiple dosing.	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.
Secondary	Maximum (peak) plasma drug concentration (Cmax)	Cmax is the maximum plasma concentration of TQB3912 or metabolite(s).	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.
Secondary	Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)	Cmax,ss is the maximum steady-state plasma concentration of TQB3912 or metabolite(s).	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.
Secondary	Area under the plasma concentration-time curve from time zero to time t (AUC0-t)	To characterize the pharmacokinetics of TQB3912 by assessment of area under the plasma concentration time curve from the first dose to time 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.
Secondary	Elimination half-life (t1/2) (to be used in one-or non- compartmental model)	t1/2 is time it takes for the blood concentration of TQB3912 or metabolite(s) to drop by half.	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.