drugset / Trial / NCT05205850

A Study of RC118 in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors

NCT05205850 ↗

Phase 1/2 Recruiting 135 enrolled RemeGen Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

In Phase I, This study will explore the tolerability and safety of RC118 in patients with locally advanced unresectable or metastatic malignant solid tumors with positive Claudin 18.2 expression, and determine the maximum tolerated dose (MTD) and the recommended dose in phase II clinical trials (RP2D); In Phase IIa, to explore the clinical effectiveness and safety of long-term use of RC118 at RP2D doses for patients with different tumor types。

Timeline

Start
2022-03-03
Primary completion
2025-09-30
Completion
2025-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject RC118-ADC Unknown 0.25 mg/kg —
Subject RC118-ADC Unknown 0.5 mg/kg —
Subject RC118-ADC Unknown 1 mg/kg —
Subject RC118-ADC Unknown 1.5 mg/kg —
Subject RC118-ADC Unknown 2 mg/kg —
Subject RC118-ADC Unknown 2.5 mg/kg —
Subject RC118-ADC Unknown 3 mg/kg —

Indications