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ACTIVE NOT RECRUITING
NCT05167448
PHASE1/PHASE2

A Study of ES104 in Patients With Metastatic Colorectal Cancer

Sponsor: Elpiscience (Suzhou) Biopharma, Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this open-label, Multicenter Phase I/II study is to evaluate the safety, tolerability, preliminary anti-tumor efficay, pharmacokinetics, anti-drug antibodies and biomarkers of ES104 in patients with unresectable locally advanced or metastatic colorectal cancer who have failed systemic therapies.

Official title: Phase I/II Clinical Trial of ES104 in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer Who Have Failed Systemic Therapies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2022-02-25

Completion Date

2026-07-31

Last Updated

2023-02-15

Healthy Volunteers

No

Interventions

DRUG

ES104

ES104 is administered via Intravenous infusion, at dose of 10 mg/kg, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.

DRUG

ES104

ES104 is administered via Intravenous infusion, at dose of 12.5 mg/kg, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.

DRUG

ES104

ES104 is administered via Intravenous infusion, at dose of RP2D, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.

Locations (1)

Beijing Cancer Hospital

Beijing, China