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Status unknownNCT05202561Updated Mar 23, 2022

A Study of RNA Tumor Vaccine in Patients With Advanced Solid Tumors

A Phase 1 interventional study of RNA tumor vaccine and RNA tumor vaccine+Navuliumab in Advanced Solid Tumor, sponsored by The First Affiliated Hospital of Bengbu Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-23.

Sponsored by The First Affiliated Hospital of Bengbu Medical University · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a single-arm, open-label, clinical pharmacology study to evaluate the safety of RNA tumor vaccine injection alone/in combination with PD-1 inhibitor in the treatment of advanced solid tumors with KRAS mutation.

The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, pharmacokinetics and of RNA tumor vaccine.

Read the detailed description

This is an investigator initiated , sinle-arm, open-label clinical pharmacology to evaluate the safety and efficacy of RNA vaccine injection alone/in combination with PD-1 inhibitor in patients with advanced solid tumors with KRAS mutation (G12C, G12D, or G12V) and HLA type HLA-A11:01 or HLA C08:02. 10 subjects were enrolled. Monotherapy and combination therapy are included. Some eligible subjects will receive single drug therapy with RNA tumor vaccine injection, and some will receive combined treatment with PD-1. Among them:

Arm A:RNA tumor vaccine The single-agent study evaluated the safety, efficacy and pharmacokinetic characteristics of a fixed-dose (600ng) KRAS-targeted RNA vaccine injection as a single agent in humans. Eligible subjects will receive a single dose of RNA vaccine injection on day 1, day 4, day 7, and day 14, each dose of 600ng.

Arm B: RNA tumor vaccine+Navuliumab Subjects will receive maintenance therapy with a PD-1 inhibitor in addition to monotherapy with the RNA tumor vaccine injection. Subjects received a single dose of RNA vaccine injection on day 1, day 4, day 7, and day 14, with each dose of 600 ng. Inhibitors, accept the Navuliumab on day 14, the recommended dose is 3 mg/kg, intravenous injection every 2 weeks.

02

Conditions studied

  • Advanced Solid Tumor

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Keywords

  • KRAS mutation
  • RNA tumor vaccine
  • injection
  • PD-1
  • immunotherapy
  • Advanced Solid Tumor
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 10 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

The First Affiliated Hospital of Bengbu Medical University is the lead sponsor of 16 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The patient is at least 18 years old with no gender limitation;
  2. Patients with advanced malignant solid tumors confirmed by histopathology or cytology and failed to receive standard treatment or without standard treatment;
  3. Identification of at least one KRAS mutation: G12C, G12D or G12V;
  4. The subtype was identified as HLA-A11:01 or C08:02;
  5. Have at least one measurable lesion according to RECIST V1.1;
  6. ECOG PS score was 0-2 in the Eastern Oncology Group;
  7. Full organ and bone marrow function, as defined below:
  8. Sign written informed consent and be able to comply with the visits and related procedures specified in the program;
  9. Eligible fertile patients (male and female) must agree to use a reliable contraceptive method (hormonal or barrier methods or abstinence) during the study period;

Exclusion criteria

Exclusion Criteria:

  1. A history of severe allergy to biological products;
  2. Those in pregnancy or lactation;
  3. The expected survival time is less than 3 months;
  4. Those who have undergone major surgery within 4 weeks prior to signing the informed consent, or who plan to undergo major surgery during the study period;
  5. Received chemotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor drugs within 2 weeks before the first administration;
  6. Participating in other clinical studies;
  7. Patients with central nervous system metastasis or a history of central nervous system metastasis;
  8. Adverse effects of previous antitumor therapy have not recovered to NCI CTCAE V5.0 rating ≤1 (except hair loss);
  9. Serious cardiovascular and cerebrovascular diseases, hypertension that is still poorly controlled after standard treatment (systolic blood pressure > 150mmHg, diastolic blood pressure > 90mmHg);
  10. Patients with active ulcers and gastrointestinal bleeding;
  11. Patients with uncontrollable pleural effusion, abdominal effusion and pericardial effusion;
  12. Active infection requiring treatment;
  13. HIV, HCV, syphilis, CMV, EBV infected patients; Patients with active HBV replication;
  14. A history of interstitial lung disease;
  15. The patient has an autoimmune disease or is in an immunosuppressed state; Current systemic steroid use (except recent or current inhaled steroid use);
  16. Other conditions that the investigator assessed as ineligible for inclusion.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Arm A

    Drug: RNA tumor vaccine Administration: intramuscular injection Dose: 600 ng/ time Dosing cycle: Day 1, day 4, day 7, and day 14.

    Biological: RNA tumor vaccine

  • Experimental
    Arm B

    Drug: RNA tumor vaccine+Navuliumab Administration: intravenous injection Dose: 3 mg/kg Timing of administration: Administration was initiated 14 days after the first intramuscular injection of the RNA tumor vaccine. Duration of administration: once every 2 weeks.

    Biological: RNA tumor vaccine+Navuliumab

Interventions

  • BiologicalRNA tumor vaccine

    Subjects will receive single dose of RNA tumor vaccine injection on day 1, day 4, day 7, and day 14, each dose of 600 ng.

  • BiologicalRNA tumor vaccine+Navuliumab

    RNA tumor vaccine+Navuliumab Subjects will receive maintenance therapy with a PD-1 inhibitor in addition to monotherapy with the RNA tumor vaccine injection. Subjects received a single dose of RNA vaccine injection on day 1, day 4, day 7, and day 14, with each dose of 600 ng. Inhibitors, accept the Navuliumab on day 14, the recommended dose is 3 mg/kg, intravenous injection every 2 weeks.

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events

    Graded according to the NCI CTCAE version 5.0.

    Time frame: Up to 6 months

Secondary outcomes

  1. To evaluate the antitumor activity

    To assess per RECIST and iRECIST

    Time frame: Up to 2 years

  2. The changes of the immunoreactivity during treatment.

    Peripheral blood T lymphocyte subtype

    Time frame: Up to 28 Days

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital Bengbu Medical College
    Bengbu, Anhui 233030, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05202561
Lead sponsor
The First Affiliated Hospital of Bengbu Medical University
Responsible party
Wang Zishu (MD, The First Affiliated Hospital of Bengbu Medical University) — Principal investigator
First posted
Jan 21, 2022
Start date
Mar 10, 2022
Primary completion
Jan 19, 2023 (estimated)
Completion
Jan 19, 2024 (estimated)
Last update
Mar 23, 2022

Study contacts

zhou huan, MD
Contact
zhouhuanbest@163.com
13665527160

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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