drugset
drugset / Trial / NCT06016062

A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors

NCT06016062 ↗

Phase 1/2 Recruiting 221 enrolled RemeGen Co., Ltd.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of Phase I of this trial is to evaluate the safety, tolerability, maximum tolerated dose (MTD)/maximum administered dose (MAD) of RC148 in patients with locally advanced unresectable or metastatic solid tumors to determine the recommended Phase II dose (RP2D), and the secondary objective is to evaluate the PK and PD characteristics, immunogenicity and preliminary clinical efficacy of RC148. Phase II will primarily evaluate the efficacy of the RC148 combination regimen, and secondarily will assess safety and tolerability, PK characteristics, and immunogenicity. During the trial, investigators will also evaluate the potential correlation of biomarkers with efficacy.

Timeline

Start
2023-09-14
Primary completion
2025-12-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject RC148 Unknown 1 mg/kg Intravenous
Subject RC148 Unknown 3 mg/kg Intravenous
Subject RC148 Unknown 10 mg/kg Intravenous
Subject RC148 Unknown 20 mg/kg Intravenous
Subject RC148 Unknown 30 mg/kg Intravenous
Background Disitamab Vedotin Other / unclassified 2 mg/kg Intravenous
Background Docetaxel Small molecule 75 mg/m2 Intravenous
Background RC88 Unknown 2 mg/kg Intravenous

Indications

cancer