drugset / Trial / NCT05639153

A Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DR30303 in Patients With Advanced Solid Tumors

NCT05639153 ↗

Phase 1 Terminated 13 enrolled Zhejiang Doer Biologics Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This study is an open-label Phase 1, First in Human trial of DR30303, a recombinant humanized monoclonal antibody that targets Claudin18.2 (CLDN18.2). It is composed of humanized variable domain of heavy chain of antibody (VHH) fused with engineered immunoglobulin gamma-1(IgG1) Fc. It is being testing against advanced and/or metastatic solid tumors.

Timeline

Start
2022-05-13
Primary completion
2025-12-30
Completion
2026-03-18

Outcome

Outcome not reported

Stopped (Business): “This trial was terminated voluntarily by the Sponsor for reasons related to its corporate strategic development, with no safety concerns or efficacy signals related to the investigational product identified.”

Drugs

EvaluationDrugModalityDoseRoute
Subject DR30303 Monoclonal antibody — Intravenous