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

Simcere

Status and phase: Unknown; Phase 1

Conditions: Solid Tumor; NSCLC

Treatments: Drug: Pegylated Recombinant Human Endostatin（PEG-ENDO）

Study type: Interventional

Funder types: Industry

Identifiers

NCT04413227

SIM181202-PEGENDO-102

Details and patient eligibility

About

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.

Full description

This is a multicenter, open-label, dose-escalation study in subjects with advanced or metatatic non-small cell lung cancer (NSCLC) or other solid tumors.There will be five cohorts planning as following:

cohort 1: PEG-ENDO 1 mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 2: PEG-ENDO 2mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 3: PEG-ENDO 4 mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 4: PEG-ENDO 6 mg/kg+Docetaxel75 mg/m2,once every 3 weeks at day 1 cohort 5: PEG-ENDO 8 mg/kg+Docetaxel75 mg/m2, once every 3 weeks at day 1

* Every 3 weeks as a treatment cycle. Subjects received only PEG-ENDO in the first cycle. For second cycle or the higher, they received a combination therapy of PEG-ENDO and docetaxel. Docetaxel was limited in 4 or 6 cycles。 The observation period of DLT was the 21 days after the first administration of PEG-ENDO. During the observation period of DLT (cycle 1), subjects only receive the corresponding dose of PEG-ENDO , for the second cycle and higher ,they will treated with the combination of PEG-ENDO and Docetaxel until disease progression (PD) or intolerance . Docetaxel was limited in 4 or 6 cycles。

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

PEG-ENDO+Docetaxel

Experimental group

Description:

PEG-ENDO( 1 mg/kg or 2mg/kg or 4mg/kg or 6mg/kg or 8mg/kg）+Docetaxel 75 mg/m2，once every 3 weeks at day 1

Treatment:

Drug: Pegylated Recombinant Human Endostatin（PEG-ENDO）