NCT04128085UnknownPhase 1
A Phase I, Open-label, Multicenter, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB3804 in Subjects With Advanced Malignant Tumors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 site in 1 country30 target enrollmentStarted: November 15, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Dose-limiting toxicity (DLT)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Understood and signed an informed consent form.
- •18 and 70 years old.
- •Histologically or cytologically confirmed advanced malignant tumor.
- •Has EGFR mutations.
- •Life expectancy ≥12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to
- •7.Adequate organ system function. 8.At least one measurable lesion.
Exclusion Criteria
- •1.Hypersensitivity to TQB3804 or its excipient.
- •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.
- •3.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/
- •14.Has ≥ grade 2 toxicity caused by previous anti-tumor treatment.
- •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.
- •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.
Arms & Interventions
TQB3804
Experimental
TQB3804 tablet administered orally , once daily in 28-day cycle.
Intervention: TQB3804 (Drug)
Outcomes
Primary Outcomes
Dose-limiting toxicity (DLT)
Time Frame: Baseline up to 28 days
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.
Secondary Outcomes
- 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.)
- 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.)
- 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)
- Disease Control Rate(DCR)(Baseline up to 52 weeks)
Investigators
Study Sites (1)
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