NWRD09 for HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer

NCT07092007 | Recruiting

• 1 other identifier: NEWISH-HPV-M001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open label, two cohorts, multi-center clinical study to evaluate the safety and efficacy of HPV-16 targeted mRNA vaccine (NWRD09) in HPV-16 related Cervical, vaginal, and vulvar intraepithelial neoplasia (LSIL and HSIL) patients (cohort A) and HPV-16 related cervical cancer patients (cohort B).

Conditions

Intraepithelial Neoplasia; Cervical Cancer

Keywords

HPV16; Intraepithelial Neoplasia; Cervical Cancer; mRNA vaccine

Outcome Measures

Primary Outcomes (2)

• Safety（Cohort A and B）

  All adverse events (AE) will be determined based on the rate and severity grade of events, including incidence and severity of serious adverse events (SAE) (according to NCI-CTCAE Standard version 5.0 of common Terms for Adverse Events).

  From first administration of NWRD09 to 14 days after the last administration

• Dose-limiting toxicity (DLT) （Cohort A and B）

  It would be determined based on the rate and severity grade of events or abnormalities through evaluating systemic or local adverse events, clinical laboratory test results, vital signs that is definitely, probably, or possibly related to the test drug occurring within 21 days of the first dosing will be classified as DLT during dosing climb.

  14 days after the first administration

Secondary Outcomes (6)

• Immunogenicity （Cohort A and B）

  To week 24.

• Histopathology outcome and HPV Viral clearance （Cohort A）

  To week 24.

• Objective Response Rate (ORR) （Cohort B）

  To week 24.

• Progression-free survival (PFS) （Cohort B）

  To week 24.

• Duration of response (DOR) （Cohort B）

  To week 24.

Study Arms (2)

Cohort A( HPV-16 related Cervical, vaginal, and vulvar intraepithelial neoplasia patients )

EXPERIMENTAL

Patients will be assigned to three dose groups. Each patient will be administered NWRD09 by intramuscular injection. The Maximum Tolerated Dose of NWRD09 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.

Biological: NWRD09 administered by intramuscular injection

Cohort B(HPV-16 related cervical cancer patients)

EXPERIMENTAL

Patients will be assigned to three dose groups. Each patient will be administered NWRD09 by intramuscular injection. The Maximum Tolerated Dose of NWRD09 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.

Biological: NWRD09 administered by intramuscular injection

Interventions

NWRD09 administered by intramuscular injection BIOLOGICAL

NWRD09 administered by intramuscular injection according to the study protocol.

Cohort A( HPV-16 related Cervical, vaginal, and vulvar intraepithelial neoplasia patients ); Cohort B(HPV-16 related cervical cancer patients)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged between 18 and 60 years.
• HPV16 is positive during the screening period.
• Histologically confirmed HPV-16-associated cervical, vaginal, and vulvar intraepithelial neoplasia (LSIL and HSIL). In the case of LSIL, it is necessary to meet persistent HPV16 infection for more than 6 months. In the case of HSIL, it is necessary to meet the requirements of satisfactory colposcopy at screening, which is defined as the squamous columnar epithelial junction (class I or class II transformation zone) is fully visible, and the upper limit of the white epithelium acetate or suspected CIN lesions are fully visible.
• Eligible subjects of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence, etc.) with their partner for the duration of the trial or for at least 6 months after the last dose. For premenopausal women with the possibility of childbearing, blood pregnancy tests must be negative within 7 days prior to the first use of the NWRD09.
• Have fully understood the study and voluntarily signed the ICF, have good communication with the investigator, and are able to complete all treatments, examinations, and visits stipulated in the study protocol.
• Women aged ≥ 18 years.
• HPV16-related recurrent or metastatic advanced cervical cancer (Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma) patients who have progressed after at least one lines of standard therapy or are intolerant to toxic side effects, or for which there is no standard treatment at present (Treatment failure refers to: disease progression during or after treatment with systemic antineoplastic regimens; Intolerance refers to: the patient has grade 3-4 adverse reactions after receiving standard therapy, and the patient refuses to continue the original treatment).
• At least 1 measurable lesion (RECIST 1.1). Tumor lesions that have received prior radiotherapy or other local therapy are considered measurable only if disease progression at the treatment site is clearly documented after completion of treatment.
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
• Had recovered from all toxicities related to prior anticancer therapies to grade≤1 or baseline level as defined by CTCAE v5.0 (except for the asymptomatic laboratory examination abnormalities such as elevated ALP, hyperuricemia, elevated serum amylase/lipase, elevated blood glucose, etc., and toxicities judged by the investigator to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy, etc.).
• Major organ functions must meet the following criteria:
• Blood routine: absolute neutrophil count (ANC) ≥ 1.5×10\^9/L, platelet count ≥ 80×10\^9/L, hemoglobin ≥ 90 g/L,
• Liver function: total bilirubin (TBIL) ≤ 1.5 ULN (≤ 3 ULN for Gilbert's syndrome, liver cancer, or liver metastases), AST and ALT ≤ 2.5 ULN for subjects without liver metastases, and ≤ 5.0 ULN for subjects with liver metastases,
• Renal function: creatinine (Cr) ≤ 1.5 ULN, or creatinine clearance (Ccr) ≥ 50 mL/min (using the Cockcroft and Gault formula),
• Coagulation function: international normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 ULN.

You may not qualify if:

• Patients with any of the following were excluded from the study:
• Any histopathologically confirmed adenocarcinoma or adenocarcinoma in situ (AIS) or invasive cancer.
• Pregnant, breastfeeding, or planning to conceive during the study period.
• Received any non-live vaccine injection within 2 weeks prior to the first dose of NWRD09.
• Received any live vaccine injection within 4 weeks prior to the first dose of NWRD09.
• Received treatment for LSIL or HSIL within 4 weeks prior to the first dose of NWRD09.
• Participated in another clinical trial or is in the observation period of another clinical trial within 30 days prior to screening.
• Continuous (more than 1 week) use of corticosteroids (equivalent to \>10 mg/day of prednisone) within 30 days prior to screening, except for hormone replacement therapy and local administration such as inhaled or ocular treatments.
• History of immunodeficiency or autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis).
• Current or anticipated use of disease-modifying antirheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) and biological agents (e.g., infliximab, adalimumab, etanercept).
• Continuous (more than 1 week) use of immunosuppressants (e.g., cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, and anti-lymphocyte globulin) within 30 days prior to screening.
• History of solid organ or bone marrow transplantation.
• Past or current malignancies, except for adequately treated and completely cured ductal carcinoma in situ of the breast, basal cell carcinoma of the skin, superficial bladder tumors, or any other malignancies cured more than 5 years before entering the study.
• Uncontrolled severe infections (\>Grade 2 NCI-CTCAE adverse events, version 5.0).
• History of HIV infection or syphilis carrier.

Sponsors & Collaborators

• Newish Technology (Beijing) Co., Ltd.: lead

Study Sites (1)

Heze Municipal Hospita

Heze, Shandong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma in Situ; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Guodong Sun, Master

CONTACT

(+86)0530-5613206; sunguodong0723@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3+3 dose climb

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: June 5, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 29, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)