Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05202561
Other study ID # LWY21084CBY
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 10, 2022
Est. completion date January 19, 2024

Study information

Verified date March 2022
Source First Affiliated Hospital Bengbu Medical College
Contact zhou huan, MD
Phone 13665527160
Email zhouhuanbest@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date January 19, 2024
Est. primary completion date January 19, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
RNA 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.
RNA 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.

Locations

Country Name City State
China First Affiliated Hospital Bengbu Medical College Bengbu Anhui

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital Bengbu Medical College

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events Graded according to the NCI CTCAE version 5.0. Up to 6 months
Secondary To evaluate the antitumor activity To assess per RECIST and iRECIST Up to 2 years
Secondary The changes of the immunoreactivity during treatment. Peripheral blood T lymphocyte subtype Up to 28 Days
See also
  Status Clinical Trial Phase
Recruiting NCT06223308 - A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT05508100 - Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors Phase 1
Not yet recruiting NCT05515185 - B7-H3 Targeting CAR-T Cells Therapy for B7-H3 Positive Solid Tumors Early Phase 1
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT02836600 - A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors Phase 1
Recruiting NCT04890613 - Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation Phase 1
Recruiting NCT04390737 - Evaluate the Safety and Clinical Activity of HH2853 Phase 1/Phase 2
Recruiting NCT05981703 - A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT06007482 - A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1
Completed NCT04108676 - Effect of Omeprazole on PK of Fluzoparib in Healthy Male Subjects Phase 1
Recruiting NCT05798611 - Study of ART0380 in Patients With Biologically Selected Solid Tumors Phase 2
Recruiting NCT05076396 - PM14 Administered Intravenously to Patients With Advanced Solid Tumors Phase 1
Recruiting NCT06008366 - A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06054932 - Safety, Tolerability, and Immunogenicity of LK101 Alone in Participants With Incurable Solid Tumors Phase 1
Recruiting NCT04825392 - A Phase Ib Study of HX008 in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT05569057 - A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma Phase 1
Recruiting NCT05461287 - Safety, Tolerability and Pharmacokinetics Study of QLS31904 in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT05443126 - A Study of EP0031 in Patients With Advanced RET-altered Malignancies Phase 1/Phase 2
Recruiting NCT04592653 - Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab (ARTISTRY-3) Phase 1/Phase 2