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

NCT04413227 | Unknown Phase 1

• 1 other identifier: SIM181202-PEGENDO-102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

NSCLC; Solid Tumor

Keywords

pegylated recombinant human endostatin (PEG-ENDO)

Outcome Measures

Primary Outcomes (11)

• Dose Limiting Toxicities (DLT)

  Incidence of Dose Limiting Toxicity

  First 21days for dosing（Cycle1，each cycle is 21 days)

• Adverse Event(AE)

  Incidence of Adverse Events

  From the time the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment

• Serious Adverse Event(SAE)

  Incidence of Serious Adverse Events

  From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment

• Laborarory test abnormality

  Incidence of clinically significant laboratory abnormalities

  From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment

• Vital signs abnormality

  Incidence of vital signs abnormalities

  From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment

• Electrocardiogram(ECG) abnormality

  Incidence of clinically significant ECG abnormalities

  From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment

• Serum concentration

  Serum concentration of PEG-ENDO

  Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.

• The maximum (or peak) serum ,Cmax

  Cmax of PEG-ENDO following dose concentration.

  Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.

• AUC

  The area under the plot of serum concentration of drug (not logarithm of the concentration) against time after drug administration.

  Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.

• other PK parameters

  The other PK parameters (if applicable).

  Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.

• Maximum Tolerated Dose(MTD)

  To determine the Maximum Tolerated Dose (MTD) of PEG-ENDO in subjects with Advanced / Metastatic NSCLC or Other Solid Tumors

  First 21days for dosing（Cycle1，each cycle is 21 days)

Secondary Outcomes (3)

• Overall Response Rate(ORR)

  at least 12 weeks

• Duration of Response(DOR)

  Estimated at 4 months after fist documented PD or CR

• Progression-free survival (PFS)

  Estimated at 4 months.

Study Arms (1)

PEG-ENDO+Docetaxel

EXPERIMENTAL

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

Drug: Pegylated Recombinant Human Endostatin（PEG-ENDO）

Interventions

Pegylated Recombinant Human Endostatin（PEG-ENDO） DRUG

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

Also known as: Docetaxel

PEG-ENDO+Docetaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated, written informed consent.
• years old, male or female.
• 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.
• At least one measurable disease according to RECIST v1.1.
• Life expectancy of at least 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
• Demonstrate adequate organ function -

You may not qualify if:

• uncontrolled primary CNS tumors, brain metastases, or meningeal metastases.
• Evidence of a tumor that compresses or invades major blood vessels.
• History of hemoptysis (\>1/2 teaspoon per event) or severe bleeding or evidence of bleeding disorders in the last 3 months.
• Clinically significant active cardiovascular disease within 6 months prior to planned start of PEG-ENDO.
• Prior treatment with anti-agiogenetic agent.
• Pregnant female patients; breastfeeding female patients.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Beijing Hospital

Beijing, Beijing Municipality, 100005, China

NOT YET RECRUITING

Tianjin medical university cancer institute&hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Huang Dingzhi, Ph.D

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

• Li Lin, Ph.D

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huang Dingzhi, Ph.D

CONTACT

02223340123; dingzhih72@163.com

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: May 25, 2020
• First Posted: June 2, 2020
• Study Start: April 2, 2020
• Primary Completion: May 31, 2021
• Study Completion: September 30, 2021
• Last Updated: June 2, 2020

Record last verified: 2020-05

Locations

CN (2)