A clinical study to assess how safe and tolerable the therapy EI-201 is, how it induces an immune response and how it affects the tumor in cancer patients with a human papillomavirus 16 positive cancer

Phase 1

• Conditions: Incurable recurrent or metastatic (R/M) HPV16-positive (HPV16+) tumors (e.g. oropharyngeal cancer, cervical, vulvar, vaginal, anal, penile cancer, etc.); MedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10061424Term: Anal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10034299Term: Penile cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 20.0Level: LLTClassification code 10047777Term: Vulvar cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10046885Term: Vaginal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2021-004277-31-BE
• Lead Sponsor: eTheRNA immunotherapies NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-10
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

- Age greater than or equal to 18 years.
-
Cohort 1: Confirmed recurrent and/or metastatic (R/M) HPV16+ cancer (including oropharyngeal, cervical, vulval, vaginal, anal, penile cancer) based on expression analysis of HPV type 16 in tumor tissue by HPV 16 ISH or HPV E1 PCR. Cancer must have progressed after at least 1 available standard therapy for incurable disease, or the subject is intolerant to or refuses standard therapy(ies) or has a tumor for which no standard therapy(ies) exists.
Cohort 2: Confirmed R/M HPV16+ oropharyngeal (based on expression of HPV type 16 in tumor tissue by HPV 16 ISH or HPV E1 PCR), and eligible for 1st line monotherapy pembrolizumab treatment OR Subjects with confirmed R/M anogenital HPV16+ cancer (cervical, anal, penile, vulvar, or vaginal cancer) confirmed by HPV 16 ISH or HPV E1 PCR. Maximum 2 previous systemic therapies with chemotherapy and/or targeted therapies for recurrent and/or metastatic disease, no prior aPD(L)-1, and a CPS>1.
- At least one measurable lesion, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1; Eisenhauer et al, 2009).
- Subjects entering the study will need to consent to provide a tumor tissue sample (formalin fixed paraffin embedded blocks/slides less than 2 months old or older only upon approval by Sponsor) or a fresh biopsy.
- Adequate hematologic function
- Adequate renal and hepatic function
- Adequate coagulation parameters
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

- Grade 3 or 4 peripheral neuropathy at time of screening.
- Subjects with active or history of autoimmune disease or immune deficiency.
- Subjects with serious intercurrent chronic or acute illness.
- Subjects who have had a splenectomy.
- Subjects with known hypersensitivity to any component of the Investigational Medicinal Product and/or pembrolizumab (Cohort 2).
- Prior treatment with HPV therapeutic vaccines. Subjects may have received a preventive HPV vaccine.
- Subjects who received an mRNA LNP based vaccine less than 30 days prior to start of the therapy.
Additional Criteria for Cohort 2:
- Chemotherapy, targeted small molecule therapy, or radiotherapy within 4 weeks prior to start of treatment with EI-201 for subjects with anogenital cancers.
- Subjects who have received prior systemic therapy and/or active immunotherapy for HNSCC, such as antigen loaded dendritic cells, chimeric antigen receptor (CAR) T cells, or checkpoint inhibitors are excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified