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

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Criteria

Inclusion Criteria:

• 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.

7.Adequate organ system function. 8.At least one measurable lesion.

Exclusion Criteria:

• 1.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.

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 t1/2. 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.

16. Has multiple factors affecting oral medication. 17. Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study.

18. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.