A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3804 in Subjects With Advanced Malignant Tumors

NCT04128085 | Unknown Phase 1

• 1 other identifier: TQB3804-I-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), phase II recommended dose (RP2D), and maximum tolerated dose (MTD) of single and multiple oral doses of TQB3804 in patients with advanced malignant tumors.

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (DLT)

  Subjects appear the following toxic reaction relate to the drug after treatment within 28 days ：III °or above of non-hematological toxicity, IV° hematological toxicity , neutropenia associated with fever.

  Baseline up to 28 days

Secondary Outcomes (6)

• Cmax

  Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 168 hours post-dose on single dose; Hour 0 of day 8,day 15,day14,day 22,day 28 on multiple dose and Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24 hours post-dose on multiple dose of day 28.

• Tmax

  Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 168 hours post-dose on single dose; Hour 0 of day 8,day 15,day14,day 22,day 28 on multiple dose and Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24 hours post-dose on multiple dose of day 28.

• AUC0-t

  Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 168 hours post-dose on single dose; Hour 0 of day 8,day 15,day14,day 22,day 28 on multiple dose and Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24 hours post-dose on multiple dose of day 28.

• Progression Free Survival (PFS)

  Baseline up to 52 weeks

• Objective Response Rate(ORR)

  Baseline up to 52 weeks

Study Arms (1)

TQB3804

EXPERIMENTAL

TQB3804 tablet administered orally , once daily in 28-day cycle.

Drug: TQB3804

Interventions

TQB3804 DRUG

A kind of tyrosine kinase inhibitor.

TQB3804

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. Understood and signed an informed consent form. 2. 18 and 70 years old. 3. Histologically or cytologically confirmed advanced malignant tumor. 4. Has EGFR mutations. 5. Life expectancy ≥12 weeks. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
• Adequate organ system function. 8.At least one measurable lesion.

You may not qualify if:

• Hypersensitivity to TQB3804 or its excipient. 2. Has diagnosed and/or treated additional malignancy within 5 years with the exception of cured carcinoma in situ of the cervix、intramucosal carcinoma of gastrointestinal tract、breast and non-melanoma skin cancers and superficial bladder tumors.
• Has interstitial pneumonia. 4.Brain metastases with symptom . 5.Has currently uncontrollable congestive heart failure. 6.Has history of arterial thromboembolism within 6 months. 7.Has any bleeding tendency or coagulopathy within 6 months. 8.Has skin toxicity ≥ grade 2 within 4 weeks. 9.Has serious gastrointestinal diseases within 4 weeks. 10.Has received any major surgery within 4 weeks. 11.Participated in other clinical trials within 4 weeks. 12.Has active viral, bacterial and fungal infections within 4 weeks. 13.Has received any cancer therapy within 4 weeks or 5 times of t1/2. 14.Has ≥ grade 2 toxicity caused by previous anti-tumor treatment. 15. HBsAg positive and HBV DNA positive (≥ULN);HCV antibody and HCV-RNA positive (≥ULN); HIV positive or ≥HIV ULN.
• \. Has multiple factors affecting oral medication. 17. Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study.
• \. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Sponsors & Collaborators

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

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510050, China

RECRUITING

Central Study Contacts

Wu yilong, Doctor

CONTACT

020-83877557; syylwu@live.cn

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: October 14, 2019
• First Posted: October 16, 2019
• Study Start: November 15, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2021
• Last Updated: December 16, 2019

Record last verified: 2019-12

Locations

CN (1)