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RECRUITING
NCT04412616
PHASE1

ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies

Sponsor: Changchun Intellicrown Pharmaceutical Co. LTD

View on ClinicalTrials.gov

Summary

This is a Phase 1, Multicenter, Open-label study to assess the safety, tolerability and preliminary efficacy of ZZ06 in participants with all Adult Patients with Advanced EGFR-positive Solid Tumor Malignancies who are not able to have current standard anti-tumor therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) , to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of ZZ06 as a single agent in adult participants with advanced solid tumors.

Official title: A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Evidence of Antitumor Activity of ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2020-09-01

Completion Date

2026-07-06

Last Updated

2025-06-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

ZZ06

The phase I "3 + 3" study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of ZZ06 : 0.03mg/kg,0.06mg/kg,0.12mg/kg,0.22mg/kg,0.39mg/kg,0.70mg/kg,1 mg/kg.

Locations (5)

Cedars Sinai Medical Center

Los Angeles, California, United States

Kansas University Cancer Center

Fairway, Kansas, United States

Montefiore Medical Center

The Bronx, New York, United States

Jilin Cancer Hospital

Changchun, Jilin, China

The first Bethune hospital of Jilin University

Changchun, Jilin, China