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A Study of RC118 in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours

Metastatic Solid Tumor Clinical Trial

Official title:
Phase 1, First-in-Human, Multicentre, Open-label Study of RC118 for Injection in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours

Clinical Trial Summary

This is a Phase 1, First-in-Human, Multicentre, Open-label Study of RC118 for Injection in Patients with Locally Advanced Unresectable/Metastatic Solid Tumours to determine the safety and tolerability of RC118, including the maximum tolerated dose (MTD)/maximum administered dose (MAD), and to define the recommended Phase II dose (RP2D).

Clinical Trial Description

This is an open-label, Phase 1, FIH, study consisting of dose-escalation (Part A) and dose confirmation (Part B) in Australia. This trial is to evaluate the safety, tolerability (MTD/MAD), PK, immunogenicity of RC118, and further determine the RP2D. In addition, the preliminary anti-tumour efficacy of RC118 as single agent will be assessed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04914117
Study type Interventional
Source RemeGen Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date November 29, 2021
Completion date March 11, 2023
View Details
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