A Clinical Trial of TQB3015 Tablets in Patients With Advanced Malignant Cancer

NCT06165809 | Withdrawn Phase 1

• 1 other identifier: TQB3015-I-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is divided into two stages: dose escalation and dose extension, including a single dose and a multiple dose clinical study. This is a single-center, open, non randomized, single arm study to the safety and tolerability of TQB3015 tables in patients with advanced malignant cancer.

Conditions

Advanced Malignant Neoplasm

Outcome Measures

Primary Outcomes (4)

• Dose Limiting Toxicity (DLT)

  DLT will be defined as toxicities that meet pre-defined severity criteria according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity, and assessed as having a suspected relationship to study drug that occurred from the first dose to the end of the first treatment cycle.

  At the end of Cycle 1 (Day 21).

• 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 (Day 21).

• Recommended Phase II Dose (RP2D)

  DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3015 tablets in adult patients with Advanced Malignant Cancer.

  Baseline up to 24 months

• Incidence of abnormal clinical laboratory

  Incidence of participants with clinical laboratory abnormalities

  30 days after the last administration.

Secondary Outcomes (10)

• Adverse events (AE)

  30 days after the last administration.

• Serious adverse events (SAE)

  30 days after the last administration.

• Time to reach maximum (peak) plasma concentration (Tmax)

  Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.

• Peak concentration (Cmax)

  Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.

• Half-life (t1/2)

  Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.

Study Arms (1)

TQB3015 tablets

EXPERIMENTAL

TQB3015 tables is administered as a single dose or multiple dose, 2-40mg once a day; Oral administration on fast condition, 21 days as a cycle.

Drug: TQB3015 tablets

Interventions

TQB3015 tablets DRUG

TQB3015 is a protein inhibitor

TQB3015 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;
• Advanced malignant tumors confirmed by tissue or cellular pathology and the routine standard treatment was ineffective or lack of effective treatment plans, or patients cannot tolerate the standard treatment;
• Has at least one assessable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria;
• The main organs function well;
• Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures during the study period and until at least 6 months after the last dose of study drug.

You may not qualify if:

• Concomitant disease and medical history:
• There were other malignant tumors occured within 3 years before the first dose of study drug.
• Has multiple factors affecting oral medication;
• Unalleviated toxicity ≥ grade 1 according to 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 before the first dose, 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, immunodeficiency;
• Tumor-related symptoms and treatment:
• Has known symptomatic central nervous system metastases and/or cancerous meningitis;
• Have received surgery, chemotherapy, radiation therapy (2 weeks for brain radiation therapy) or other anti-cancer therapies within 4 weeks prior to the first dose.
• Thoracic/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within one 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 (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, 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: December 4, 2023
• First Posted: December 12, 2023
• Study Start: December 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

CN (1)