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

NCT07348042 | Recruiting Phase 1

• 1 other identifier: RGL-270-101
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tumor, Solid

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of RGL-270 monotherapy or the maximum dose (MAD) when MTD is not reached, and determine the recommended extended dose (RDE) for RGL-270

  Evaluate the safety and tolerability of RGL-270 monotherapy and combined with , Adebelimab in patients at high risk of recurrence after radical treatment of malignant solid tumors, determine the maximum tolerated dose (MTD) of RGL-270 monotherapy or the maximum dose (MAD) when MTD is not reached, and determine the recommended extended dose (RDE) for RGL-270 combined with Adebelimab treatment

  Day 1 to week 24 after RGL-270 administration

Secondary Outcomes (3)

• Specific T-cell response and antidrug antibody (ADA)

  Day 1 to week 24 after RGL-270 administration

• Preliminary therapeutic effect- DFS rate

  Day 1 to month 24 after RGL-270 administration

• Preliminary therapeutic effect- OS rate

  Day 1 to month 24 after RGL-270 administration

Study Arms (3)

Increase the dose of single-drug treatment

EXPERIMENTAL

(Part A)

Drug: RGL-270 Injection

Combined treatment dose increase

EXPERIMENTAL

(Part B)

Drug: RGL-270 Injection; Drug: Adebelimab Injection

Combined treatment dose expansion

EXPERIMENTAL

(Part C)

Drug: RGL-270 Injection; Drug: Adebelimab Injection

Interventions

RGL-270 Injection DRUG

Repeated medication, increase the dose

Combined treatment dose expansion; Combined treatment dose increase; Increase the dose of single-drug treatment

Adebelimab Injection DRUG

Repeated medication, the dose is maintained

Combined treatment dose expansion; Combined treatment dose increase

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre-screening period
• Subjects should understand and abide by the relevant research procedures, and voluntarily sign the prior informed consent form;
• Age 18-75 years old (including boundary value), gender is not limited;
• 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:
• Willing to provide sufficient tumor tissue specimens and peripheral blood for genetic testing and new antigen analysis;
• 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
• Subjects should understand and abide by the relevant research procedures, and voluntarily sign the owner's informed consent form;
• Eastern American Oncology Collaborative Group (ECOG) score: 0 or 1 point;
• Willing to provide blood samples needed to detect immunogenicity and biomarkers before and after drug treatment;
• The functions of important organs meet the following criteria (no blood components and cell growth factors have been used within 14 days before the start of research and treatment):
• A) Blood routine: neutrophil count (ANC) ≥1.5×109/L, lymphocyte count (LYM) ≥0.5×109/L, platelet count (PLT) ≥1× normal lower limit (LLN), hemoglobin (Hb) ≥90g/L; B) Blood biochemical: total bilirubin (TBIL) ≤1.5× normal upper limit (ULN), glutathione transaminase (ALT) and glutathione transaminase (AST) ≤2.5×ULN, serum albumin (ALB) ≥30g/L, serum creatine (Scr) ≤1×ULN; C) Coagulation routine: International Standardized Ratio (INR) ≤1.5, activated partial prothrombin time (APTT) ≤1.5×ULN; D) Heart function: Left ventricular blood ejection fraction (LVEF) ≥50%; E) Electrocardiogram: The QT interval (QTcF) corrected by Fridericia method is \<470 milliseconds; the QTc interval must be corrected according to Fridericia's standard, and the correction formula QTcF=QT/RR\^0.33.
• Clinical examination, chest and abdomen CT and head MRI baseline radiological evaluation within 14 days before the first vaccine administration showed no evidence of disease recurrence;
• Fertile female subjects must take a serum pregnancy test within 7 days before the first vaccination, and the result is negative and must be non-lactating.

You may not qualify if:

• Pre-screening period
• 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;
• 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);
• Anyone who is evaluated by researchers as not suitable for immunotherapy;
• There is an autoimmune disease (except for hypothyroidism who need hormone replacement treatment caused by autoimmune thyroiditis);
• Known history of epilepsy or other symptomatic neurological diseases;
• Known history of psychotropic substance abuse, alcoholism or drug abuse;
• 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;
• 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);
• Combined history of other malignant tumors within 5 years before the pre-screening period;
• Known history of allogeneic organ transplantation or history of allogeneic hematopoietic stem cell transplantation;
• Known allergy to research drugs or any of their auxiliaries, or a history of severe allergic reactions to other vaccines;
• Suffering from congenital or acquired immunodeficiencies, such as cellular immunodeficiencies (such as DiGeorge syndrome, T-negative severe combined immunodeficiency \[SSCID\]) or combined T-cell and B-cell immunodeficiency (such as T- and B-negative combined immunodeficiency, Wiskott-Al Drich syndrome, ataxia telangiectasia, common variable immunodeficiency); or infected with human immunodeficiency virus (HIV);
• Poorly controlled or severe cardiovascular and cerebrovascular diseases: congestive heart failure (NYHA standard III or level IV), severe arrhythmia requiring treatment or intervention, and poorly controlled hypertension after full treatment (systolic pressure ≥160mmHg, diastolic pressure ≥100mmHg );
• Pregnant or lactating female subjects;

Sponsors & Collaborators

• Xian-Jun Yu: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Xianjun Yu, Doctor

CONTACT

138 0166 9875; yuxianjun@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The current director of Fudan University Affiliated Cancer Hospital and the director of Shanghai and Fudan University Pancreatic Tumor Research Institute.

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: January 16, 2026
• Study Start: September 7, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)