Tumor, SolidPhase 1NCT07348042

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

A Phase 1 study testing RGL-270 Injection and Adebelimab Injection in people with Tumor, Solid, run by Xian-Jun Yu at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Tumor, Solid
What is being tested?: RGL-270 Injection and Adebelimab Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 198 participants
Where: 1 siteChina
Study dates: 7 Sep 2025to 31 Dec 2027
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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):
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.

Who cannot join

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;

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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;
The data analysis results of tumor tissue sequencing show that there are not enough new antigens available for vaccine preparation or vaccine preparation fails;
The researcher judges that the subject may not be able to continue to participate in the study:
Any other disease in which the subject faces the risk of safety;
Subjects with poor compliance or active request to withdraw from pre-screening;
There is a recurrence of the disease during the pre-screening period. Screening period
Postoperative complications have not recovered, or the complications are higher than the Clavien-Dindo complication grade 2;
The toxicity caused by auxiliary treatment before the first vaccine administration has not recovered to the baseline level or >1 (except for hair loss and pigmentation), and the neurotoxicity is >2;
There is evidence of active tuberculosis infection during the screening period, whether it is treated or not;
Chest CT during the screening period suggests evidence of interstitial pneumonia;
Concurrent severe infection within 28 days before the first vaccination (such as intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical diagnosis and treatment standards);
Within 28 days before the first vaccination, there is pleural fluid or ascites that are not clinically controlled and require thoracic puncture or abdominal puncture drainage;
Active hepatitis B (defined as active hepatitis B virus surface antigen [HBsAg] test results during the screening period are positive and HBV DNA≥500IU/mL or higher than the upper limit of the normal detection value of the research center), or hepatitis C (defined as hepatitis C antibodies during the screening period [HCV -Ab] The test result is positive, and HCV-RNA is positive);
Myocardial infarction or stroke occurred within 3 months before the first vaccination (except for transient cerebral ischemia and cavity cerebral infarction), or unstable angina pectoris within 1 month;
Arteriovenous thrombosis, such as deep vein thrombosis or pulmonary embolism, occurred within 3 months before the first vaccination;
The researcher judges other circumstances that may affect the progress of clinical research and the results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xianjun Yu, Doctor contact

138 0166 9875

yuxianjun@fudanpci.org

China1 site, 1 recruiting

Fudan University Shanghai Cancer Center
Shanghai
WEI, 086-021-64175590, weimiaoyan@fudanpci.org
Recruiting

Other trials in China

About this study

Official title: 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

Conditions: Tumor, Solid
Being tested: RGL-270 Injection, Adebelimab Injection
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RGL-270 InjectionDrug
Repeated medication, increase the dose
Adebelimab InjectionDrug
Repeated medication, the dose is maintained

Study groups in NCT07348042
Study group	Role	What they receive
Increase the dose of single-drug treatment	Experimental	(Part A) Receives: Drug: RGL-270 Injection
Combined treatment dose increase	Experimental	(Part B) Receives: Drug: RGL-270 Injection; Drug: Adebelimab Injection
Combined treatment dose expansion	Experimental	(Part C) Receives: Drug: RGL-270 Injection; Drug: Adebelimab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 1 to week 24 after RGL-270 administration

Secondary outcomes (3)

Specific T-cell response and antidrug antibody (ADA)
Evaluate the rate of specific T-cell response positivity and change in response from baseline, and the rate and duration of antibody to drug (ADA) positivity
Measured: Day 1 to week 24 after RGL-270 administration
Preliminary therapeutic effect- DFS rate
Evaluate the disease-free survival (DFS), 18-month/24-month DFS rate
Measured: Day 1 to month 24 after RGL-270 administration
Preliminary therapeutic effect- OS rate
Evaluate the overall survival (OS), 18-month/24-month OS rate
Measured: Day 1 to month 24 after RGL-270 administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Sep 202531 Dec 2027

First posted16 Jan 2026
Study start7 Sep 2025
Primary completion31 Mar 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tumor, SolidStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 198 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07348042
Sponsor's protocol ID: RGL-270-101
Status last verified: Dec 2025
First submitted: 15 May 2025
Last updated: 16 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Xianjun Yu, Doctor

138 0166 9875

yuxianjun@fudanpci.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Tumor, Solid trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07348042
Acronym / sponsor ID: RGL-270-101
Conditions: Tumor, Solid
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 198 participants (estimated)
Lead sponsor: Xian-Jun YuUniversity, hospital or other
Study start: 7 Sep 2025 (actual)
Primary completion: 31 Mar 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 16 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Increase the dose of single-drug treatment	Experimental	Drug: RGL-270 Injection(Part A)
Combined treatment dose increase	Experimental	Drug: RGL-270 Injection, Drug: Adebelimab Injection(Part B)
Combined treatment dose expansion	Experimental	Drug: RGL-270 Injection, Drug: Adebelimab Injection(Part C)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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;

Key exclusion criteria (30 listed)

Pre-screening period
Any other disease in which the subject faces the risk of safety;
Subjects with poor compliance or active request to withdraw from pre-screening;
There is a recurrence of the disease during the pre-screening period. Screening period

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RGL-270 InjectionRepeated medication, increase the dose	Drug	Combined treatment dose expansion, Combined treatment dose increase, Increase the dose of single-drug treatment
Adebelimab InjectionRepeated medication, the dose is maintained	Drug	Combined treatment dose expansion, Combined treatment dose increase

Primary outcome

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
Time frame: Day 1 to week 24 after RGL-270 administration
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

3 secondary outcomes

Specific T-cell response and antidrug antibody (ADA)
Time frame: Day 1 to week 24 after RGL-270 administration
Preliminary therapeutic effect- DFS rate
Time frame: Day 1 to month 24 after RGL-270 administration
Preliminary therapeutic effect- OS rate
Time frame: Day 1 to month 24 after RGL-270 administration

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Individual participant dataSharing planned: No

Related trials for Tumor, Solid

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Xianjun Yu, Doctor contact

138 0166 9875

yuxianjun@fudanpci.org

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RGL-270 Injection and Adebelimab Injection in people with Tumor, Solid, run by Xian-Jun Yu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xianjun Yu, Doctor (138 0166 9875, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Day 1 to week 24 after RGL-270 administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07348042.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.