NCT04914117

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Unresectable Solid Tumor
• Metastatic Solid Tumor
• Locally Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	RC118 for injection	RC118 will be administered intravenously (IV) on Day 1 of every 14-day cycle.

Timeline

• Start date: 2021-11-29
• Primary completion: 2022-11-15
• Completion: 2023-03-11
• First posted: 2021-06-04
• Last updated: 2023-06-22

Locations

4 sites across 1 country: Australia