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NOT YET RECRUITING
NCT07797426
PHASE1/PHASE2

A Study of RT023 in Patients With Advanced Solid Tumors

Sponsor: Shanghai Ruotuo Biosciences Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of RT023 in Subjects with Advanced Malignant Solid Tumour. In dose escalation and dose expasion phase, the safety, tolerability of RT023 in patients with advanced malignant solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase 2 dose (RP2D) of RT023. In clinical expansion phase, the preliminary antitumor activity of RT023 in target solid tumors will be evaluated. In addition, the pharmacokinetic characteristics, and immunogenicity of RT023 in patients with advanced malignant solid tumors will be evaluated.

Official title: A Phase I/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RT023 in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

318

Start Date

2026-09-12

Completion Date

2029-06-30

Last Updated

2026-09-01

Healthy Volunteers

No

Interventions

DRUG

RT023

Intravenous (IV) Infusion