A Clinical Trial of TQB3006 Tablets in Patients With Advanced Malignant Cancer

Advanced Malignant Neoplasm Clinical Trial

Official title:

A Phase I Study to Evaluate the Safety, Tolerance and Pharmacokinetics of TQB3006 Tablets in Patients With Advanced Malignant Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06344351
• Other study ID #: TQB3006-I-01
• Status: Recruiting
• Phase: Phase 1
• Start date: April 25, 2024
• Est. completion date: August 2026

Study information

• Verified date: March 2024
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Tongsen Zheng, Doctor
• Phone: 15134569619
• Email: zhengtongsen[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study includes two stage: dose escalation and dose extension, with a single dose and a multiple dose study. This is a single-center, open, non-randomized, single arm, study to evaluate the safety, tolerability and pharmacokinetics of TQB3006 tables in patients with advanced malignant cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: August 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;

• Age: 18 to 75 years old; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

• Has at least one assessable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1;

• Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures during the study period to at least 6 months after the last dose of study drug.

Exclusion Criteria:

• There were other malignant tumors within 3 years;

• Has multiple factors affecting oral medication;

• Unalleviated toxicity = grade 1 of CTCAE v5.0 due to any previous therapy , excluding hair loss;

• Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study,or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period;

• Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;

• Have a history of psychotropic drug abuse and can not quit or have mental disorders;

• Subjects with any severe and / or uncontrolled disease including active hepatitis, a history of immunodeficiency, etc.;

• Tumor-related symptoms and treatment:

1. Has known symptomatic central nervous system metastases and/or cancerous meningitis;

2. Thoracic/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within 1 month after receiving the investigational drug for the first time;

3. Has participated in other clinical trials within 4 weeks before first dose.

• According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Related Conditions & MeSH terms

• Advanced Malignant Neoplasm
• Neoplasms

Intervention

Drug:
• TQB3006 tablets
TQB3006 is an inhibitor protein.

Locations

Country	Name	City	State
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang

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 toxicity (DLT)	DLT will be defined as toxicities that meet pre-defined severity criteria (according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version5.0), and assessed as having a suspected relationship to study drug that occurred from first medication to the end of the first treatment cycle.	At the end of Cycle 1 (21 Days).
Primary	Maximum tolerated dose (MTD)	MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.	At the end of Cycle 1 (21 Days).
Primary	Recommended phase II dose (RP2D)	DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3006 tablets in adult patients with Advanced Malignant Cancer	Baseline up to 24 months.
Secondary	Adverse events (AE)	The occurrence of all adverse events (AE).	30 days after the last dose.
Secondary	Serious adverse events (SAE)	The occurrence of all serious adverse events (SAE).	30 days after the last dose.
Secondary	Time to reach maximum plasma concentration (Tmax)	To characterize the pharmacokinetics of TQB3006 by assessment of time to reach maximum plasma concentration after single and multiple dosing.	Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
Secondary	Peak concentration (Cmax)	he maximum observed plasma concentration of study drug.	Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
Secondary	Half-life (t1/2)	Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.	Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
Secondary	Area under the concentration-time curve (AUC [0-infinity])	Area under the concentration-time curve from zero to infinity	Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
Secondary	Area under the concentration-time curve (AUC [0-t])	Area under the concentration-time curve from the first dose to a certain time point.	Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
Secondary	Apparent clearance (CL/F)	Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.	Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
Secondary	Apparent volume of distribution (Vd/F)	Apparent volume of distribution of the TQB3006 in plasma.	Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.
Secondary	Objective response rate (ORR)	Defined as the percentage of patients with complete response (CR) or partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.	From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks