Safety and Efficacy Study of NWRD09 in HPV-16 Positive and HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer Patients.

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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 positive and HPV-16 related cervical, vaginal, and vulvar intraepithelial neoplasia (LSIL and HSIL) patients (cohort A) and HPV-16 related cervical cancer patients (cohort B).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
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∙ Patients had to meet all of the following inclusion criteria:

• Women aged between 18 and 60 years.

• HPV16 is positive during the screening period, and other subtypes of HPV co-infection can be included. 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.

∙ Patients had to meet all of the following inclusion criteria:

• 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 two lines of standard therapy or are intolerant to toxic side effects, or for which there is no standard treatment at present.

• 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.

• Has life expectancy of at least 3 months in the best judgement of the investigator.

• 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.

Locations
Other Locations
China
Affiliated Hospital of Jiangnan University
RECRUITING
Wuxi
Contact Information
Primary
Yong Mao, M.D.
mydoctorwx@aliyun.com
+8618651581690
Time Frame
Start Date: 2024-06-24
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 18
Treatments
Experimental: Cohort A Cohort A( HPV-16 related Cervical, vaginal, and vulvar intraepithelial neoplasia patients )
Patients in Cohort A 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.
Experimental: Cohort B(HPV-16 related cervical cancer patients)
Patients in Cohort B 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.
Related Therapeutic Areas
Sponsors
Leads: Newish Technology (Beijing) Co., Ltd.

This content was sourced from clinicaltrials.gov