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

NCT ID: NCT05997342

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-16
• Study Completion Date: 2025-05-27

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.

Conditions

Advanced Malignant Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB3912 tablets

TQB3912 tablets, 28 days as a treatment cycle.

Group Type: EXPERIMENTAL

TQB3912 tablets

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hunan Cancer Hospital

Changsha, Hunan, China

West China hospital, Sichuan university

Chengdu, Sichuan, China

Countries

China

Other Identifiers

TQB3912-I-01

Identifier Type: -

Identifier Source: org_study_id