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Study of RGL-270 Single Drug and Combined With Adebelimab in Patients in Patients at High Risk of Recurrence After Radical Treatment of Malignant Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Study of RGL-270 Single Drug and Combined With Adebelimab in Patients in Patients at High Risk of Recurrence After Radical Treatment of Malignant Solid Tumors

An Open, Multi-center Phase I Clinical Study Evaluating the Safety, Tolerance, Pharmacokinetics and Immunogenicity of RGL-270 Single Drug and Combined With Adebelimab in Patients at High Risk of Recurrence After Radical Treatment of Malignant Solid Tumors

NCT07348042•Xian-Jun Yu

View on ClinicalTrials.gov

Summary

This study is a phase I clinical trial of multi-center, open label, dose increase and dose expansion. It aims to evaluate the safety, tolerance, PK characteristics, immunogenicity and initial efficacy of personalized new antigen mRNA vaccine RGL-270 (hereinafter referred to as RGL-270) alone and combined with adebelizumab in patients with high risk of recurrence of malignant solid tumors after radical treatment.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Pre-screening period
•1. Subjects should understand and abide by the relevant research procedures, and voluntarily sign the prior informed consent form;
•2. Age 18-75 years old (including boundary value), gender is not limited;
•3. For malignant solid tumors confirmed by histology or cytology after radical resection, the subjects are allowed to complete standard adjuvant treatment, or no standard adjuvant treatment, or adjuvant treatment intolerance before receiving the first administration of this study:
•4. Willing to provide sufficient tumor tissue specimens and peripheral blood for genetic testing and new antigen analysis;
•5. Fertile female subjects and male subjects whose partners are women of childbearing age must agree to comply with the contraceptive requirements for 6 months from the signing of the pre-informed consent form until the end of the last treatment.
•Screening period
•1. Subjects should understand and abide by the relevant research procedures, and voluntarily sign the owner's informed consent form;
•2. Eastern American Oncology Collaborative Group (ECOG) score: 0 or 1 point;
•3. Willing to provide blood samples needed to detect immunogenicity and biomarkers before and after drug treatment;
+4 more criteria

Exclusion Criteria

•Pre-screening period
•1. Have received immune cell or tumor vaccine treatment, including but not limited to tumor infiltration lymphocytes (TILs), chimeric antigen receptor T cells (CAR-T), T cell receptor chimeric T cells (TCR-T) and therapeutic tumor vaccines;
•2. Plan to inoculate live attenuated vaccine during the screening period or during the research period and within 90 days after the end of the research drug treatment (inactivated vaccine is allowed);
•3. Anyone who is evaluated by researchers as not suitable for immunotherapy;
•4. There is an autoimmune disease (except for hypothyroidism who need hormone replacement treatment caused by autoimmune thyroiditis);
•5. Known history of epilepsy or other symptomatic neurological diseases;
•6. Known history of psychotropic substance abuse, alcoholism or drug abuse;
•7. There is evidence of active tuberculosis infection within 1 year before the pre-screening period and during the pre-screening period, whether it is treated or not;
•8. Subjects with known or suspected interstitial pneumonia, or evidence of interstitial pneumonia in the chest CT during the pre-screening period; known history of idiopathic pulmonary fibrosis, mechanized pneumonia (such as occlusive bronchitis or occult mechanized pneumonia);
•9. Combined history of other malignant tumors within 5 years before the pre-screening period;
+20 more criteria

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Key Dates

Start Date

September 7, 2025

Primary Completion Date

March 31, 2027

Completion Date

December 31, 2027

Last Updated

January 16, 2026

Enrollment

198

ESTIMATED participants

Conditions

Tumor, Solid

Interventions

RGL-270 Injection

DRUG

Adebelimab Injection

DRUG

Contacts

Xianjun Yu, Doctor

CONTACT

138 0166 9875 yuxianjun@fudanpci.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of RGL-270 Single Drug and Combined With Adebelimab in Patients in Patients at High Risk of Recurrence After Radical Treatment of Malignant Solid Tumors

Inclusion Criteria

Exclusion Criteria

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