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

NCT06344351 | Completed Phase 1

• 1 other identifier: TQB3006-I-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Advanced Malignant Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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).

• 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).

• 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 Outcomes (10)

• Adverse events (AE)

  30 days after the last dose.

• Serious adverse events (SAE)

  30 days after the last dose.

• Time to reach maximum plasma concentration (Tmax)

  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.

• Peak concentration (Cmax)

  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.

• Half-life (t1/2)

  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.

Study Arms (1)

TQB3006 tablets

EXPERIMENTAL

TQB3006 tables is administered as a single dose or multiple dose .Take200-1200 mg per day; Take TQB3006 orally on an empty stomach once or twice a day, 21 days as a cycle.

Drug: TQB3006 tablets

Interventions

TQB3006 tablets DRUG

TQB3006 is an inhibitor protein.

TQB3006 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:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (5)

Anhui Provincial Hospital

Hefei, Anhui, 230000, China

Location

Peking University Shougang Hospital

Beijing, Beijing Municipality, 100144, China

Location

Chongqing university Cancer Hospital

Chongqing, Chongqing Municipality, 400015, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

Location

The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, 450003, 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: March 28, 2024
• First Posted: April 3, 2024
• Study Start: April 25, 2024
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: May 22, 2025

Record last verified: 2024-08

Locations

CN (5)