Individualized Neoantigen Therapy with Unusual Radiotherapy Enhancement (iNATURE)

NCT06314087 | Recruiting Phase 2 DMC

• 1 other identifier: Neoantigen Radiotherapy
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 2

Brief Summary

In this study, the investigators provide an individualized tumor neoantigen peptide vaccine in combination with radiotherapy to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the individualized tumor neoantigen peptide vaccine in combination with radiotherapy

Conditions

Advanced Tumors

Keywords

Neoantigen Peptide Vaccines

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Number of participants with Adverse Events as a measure of safety and tolerability

  Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months

Study Arms (2)

Control arm: Arm #1

ACTIVE COMPARATOR

Other: Placebo + conventional treatment including radiotherapy

Experimental arm: Arm #2

EXPERIMENTAL

Personalized tumor peptide vaccine + conventional treatment including radiotherapy group

Combination Product: Radiation: Radiation Therapy；Biological: Personalized tumor peptide vaccine

Interventions

Placebo + conventional treatment including radiotherapy OTHER

Placebo + conventional treatment including radiotherapy

Also known as: Chemical: per standard care

Control arm: Arm #1

Radiation: Radiation Therapy；Biological: Personalized tumor peptide vaccine COMBINATION_PRODUCT

The peptide vaccine treatment will take 5 months as a treatment course until the treatment suspension event as stipulated in the plan occurred.

Experimental arm: Arm #2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: both male and female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female
• age\>18 years old
• with advanced or recurrent malignancies diagnosed by pathology and imaging, who have failed systemic standard therapy or disease progression prior to enrollment and have no effective first-line therapy (for effective therapy, refer to the latest version of the treatment guidelines published by the Chinese Society of Clinical Oncology)
• have at least one imaging measurable lesion
• with an expected survival of ≥ 3 months
• with an ECOG (Eastern Cooperative Oncology Group) score of 0-2
• have access to sufficient tumor DNA (circulating tumor DNA or tissue samples) for analysis, or have genomic/exonic/transcriptional data from tumor and normal tissues and the data meet the analysis requirements, qualified for tumor neoantigen screening, or have prepared neoantigen peptides from a certified company (GMP)
• women of childbearing age should have negative pregnancy tests within 7 days prior to enrollment, and have no short-term plans to have children and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial
• compliant patients who is and able to follow the study protocol and the follow-up procedures

You may not qualify if:

• No neoantigens detected in the sequencing data.
• with a history of bone marrow or stem cell transplantation
• enrolled in other therapeutic clinical trials; clinical trials of Chinese medicine
• with active bacterial or fungal infections
• with active HIV (human immunodeficiency virus, human immunodeficiency virus), HCV (hepatitis C virus), HBV (hepatitis B virus), or the herpes virus (except for crusting for more than 4 weeks), or with respiratory viral infections (except for those who have been cured for more than 4 weeks)
• with asthma, autoimmune disease, immunodeficiency
• under treatment with immunosuppressive drugs
• with severe coronary or cerebrovascular disease, or other conditions that concerns the investigator for enrollment
• have clinical, psychological or social factors affecting informed consent or study implementation
• have a history of drug or peptide allergy, or allergy to other potential immunotherapies
• no decision making capacity for civil conduct

Sponsors & Collaborators

• The University of Hong Kong-Shenzhen Hospital: lead

Study Sites (2)

University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

University of Hong Kong-Shenzhen Hospital

Shenzhen, guangzhou, China

ENROLLING BY INVITATION

Related Publications (1)

• Zhang Y, Hu YF, Ma L, Wu Y, Chao D, Chen X, Xu Z, Su X, Dai W, Huang J, Fu P, Kong FS. A phase II randomized trial of individualized neoantigen peptide vaccine combined with unusual radiotherapy (iNATURE) in advanced solid tumors-GCOG0028. Front Immunol. 2025 Aug 21;16:1538032. doi: 10.3389/fimmu.2025.1538032. eCollection 2025.

  PMID: 40918097 DERIVED

Study Officials

• Clinical Cancer Center Hong Kong University Shenzhen Hospital

  Municipal hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng-Ming (Spring) Kong

CONTACT

18807550703; Kong001@hku.hk

Yan Zhang

CONTACT

18807550703; Kong001@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomized
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 15, 2024
• Study Start: January 31, 2024
• Primary Completion (Estimated): August 16, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)