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A Study of RT023 in Patients With Advanced Solid Tumors

NCT07797426 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2026-09-01

No results posted yet for this study

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.

Conditions

  • Advanced Malignant Solid Tumours

Interventions

DRUG

RT023

Intravenous (IV) Infusion

Sponsors & Collaborators

  • Shanghai Ruotuo Biosciences Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-12
Primary Completion
2029-06-30
Completion
2029-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07797426 on ClinicalTrials.gov