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

NCT05997342 | Completed Phase 1

• 1 other identifier: TQB3912-I-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• Overall response rate (ORR)

  From the first drug treatment to the last drug treatment.

  Up to 2 years

Secondary Outcomes (11)

• 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

• Duration of Response (DOR)

  Up to 2 years

Study Arms (1)

TQB3912 tablets

EXPERIMENTAL

TQB3912 tablets, 28 days as a treatment cycle.

Drug: TQB3912 tablets

Interventions

TQB3912 tablets 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.

TQB3912 tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

West China hospital, Sichuan university

Chengdu, Sichuan, 610000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: August 16, 2023
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

CN (2)