Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor

Dose Escalation Study of Tolerability and Pharmacokinetics of PEDylated Recombinant Human Endostatin(M2ES)in the Treatment of Advanced Solid Tumor

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01260025

Enrollment

Registered

2010-12-15

Start date

2009-09-30

Completion date

2011-01-31

Last updated

2012-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endostatin, Pharmacokinetics, Tolerability

Keywords

Tolerability, Pharmacokinetics, Endostatin, antiangiogenesis, cancer

Brief summary

1. MTD and DLT of M2ES 2. Pharmacokinetics of M2ES

Detailed description

Patients received infusion of M2ES for 120 minutes weekly（d1,d8,d15）by calculated pump and underwent evaluation of vital signs including blood pressure, pulse, respiratory rate, and temperature before treatment, at intervals during infusion, and hourly for 6 hours after infusion. After infusion, patients underwent serial pharmacokinetic sampling. All patients were seen weekly during the study therapy and follow-up and underwent evaluation with physical examination including ECOG performance status, vital signs, and laboratory evaluation with complete blood count with manual differential, chemistry evaluation, prothrombin time/partial thromboplastin time, and urinalysis.

Interventions

DRUGPEDylated Recombinant Human Endostatin

The initial dose of PEDylated Recombinant Human Endostatin (M2ES) will be 7.5mg/m2.Dose Escalation to a next higher level will occur when 3 patients in the same dose level complete 28 days of continuous treatment without experiencing a dose-limiting toxicity.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age between 18 and 65 years;Genders eligible for study: both; * Histologic diagnosis of solid malignancies ; * Performance status of 0 or 1; * Tumor not amenable to standard curative or palliative therapy; * life expectancy beyond 3 months; * Ability to give signed informed consent

Exclusion criteria

* Pregnancy or lactation; * Had a history of brain metastasis or a primary brain tumor; * An active, potentially severe autoimmune disease; * Serum creatinine ≥1.5mg/dl or a calculated creatinine clearance \<60ml/min; WBC count \< 2.0×109/L，hemoglobin \< 90g/L，and platelet count \< 100×109/L; Total bilirubin value \< 2.0 times the upper limit of normal (ULN), ALT level \< 2.0 times ULN, AST \< 2.0 times ULN; * Positive of anti-HIV antibodies; * An active infection; * had received chemotherapy or immunotherapy within the prior 4 weeks before study entry * Participation in a clinical study during the last 28 days * QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG

Design outcomes

Primary

Measure	Time frame	Description
Maxinum tolerated dose of M2ES	one month	To assess the adverse events

Secondary

Measure	Time frame	Description
Tumor response rate	one month	To assess the tumor response rate of M2ES in patients with solid, malignant tumours
Pharmacokinetic effect	one month	Pharmacokinetic effect of M2ES in patients with solid, malignant tumours
DLT of M2ES	one month	To assess the adverse events

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026