A Phase Ib Study With Pegylated Recombinant Human Endostatin in Advanced / Metastatic NSCLC or Other Solid Tumors

• Status: Recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to examine the safety, tolerability and pharmacokinetics of PEG-ENDO in combination with docetaxel in subjects previously treated or untreated (standard therapy is not suitable or without standard therapy) for advanced or metatatic non-small cell lung cancer (NSCLC) or other solid tumors.

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

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Docetaxel; Endostatins

Criteria

Inclusion Criteria:

1. Provision of signed and dated, written informed consent.

2. 18-70years old, male or female.

3. Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer(NSCLC) or other solid tumor, previous treated with standard therapy , or standard therapy not suitabl ,or without standard therapy.

4. At least one measurable disease according to RECIST v1.1.

5. Life expectancy of at least 3 months.

6. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.

7. Demonstrate adequate organ function -

Exclusion Criteria:

1. uncontrolled primary CNS tumors, brain metastases, or meningeal metastases.

2. Evidence of a tumor that compresses or invades major blood vessels.

3. History of hemoptysis (>1/2 teaspoon per event) or severe bleeding or evidence of bleeding disorders in the last 3 months.

4. Clinically significant active cardiovascular disease within 6 months prior to planned start of PEG-ENDO.

5. Prior treatment with anti-agiogenetic agent.

6. Pregnant female patients; breastfeeding female patients.

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