Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (OVACT)
A Phase I/Ib, Multi-centre, Open-label Study to Evaluate the Safety, Tolerability, and Immunogenicity of CryptiVax-1001, a mRNA Lipid Nanoparticle Therapeutic Cancer Vaccine, in Participants With FIGO Stage III-IV High-Grade Serous or Predominantly Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Following Optimal Primary/Interval Debulking Surgery and First-Line Platinum-Based Chemotherapy (OVACT Study)
Ovarian, fallopian tube, or primary peritoneal cancer, collectively referred to as ovarian cancer, remains the deadliest type of gynaecological cancer. The most common and aggressive form is called high-grade serous ovarian cancer.
The main purpose of this study is to understand whether an experimental study vaccine, CryptiVax-1001, is safe when administered to patients with high-grade serous ovarian cancer (HGSOC). The study vaccine is a cancer vaccine, which aims to delay or possibly prevent the cancer from coming back. However, as this is the first study of the vaccine in patients, the primary purpose of this study is to assess the safety of the study vaccine.
Following surgery and platinum-based chemotherapy participants may enter the trial and receive CryptiVax-1001 as an explorative maintenance therapy.
The main purposes of this study are therefore to:
- assess how well the study vaccine is tolerated and identify any side effects.
- analyse the study vaccine's capacity to activate your immune system
The study will test escalating dose levels of CryptiVax-1001 based on the safety evaluations to estimate appropriate future dose levels for CryptiVax-1001.
연구 개요
상태
개입 / 치료
상세 설명
The OVACT study is the First in Human clinical evaluation of Cryptivax-1001 in patients with advanced high-grade serous or predominantly serous ovarian, fallopian tube, or primary peritoneal cancer, following optimal debulking surgery (R0 or R1 after either IDS or PDS), and no recurrence or progression after completion of platinum-based chemotherapy. This phase I/Ib dose escalation and expansion study will assess safety, tolerability, and immunogenicity in a population where there is a high unmet need and no clearly effective maintenance therapy options. By focusing on the BRCAwt/HRP subgroup, the study addresses the majority of patients who currently lack access to biologically-matched maintenance strategies.
The study consist of 2 parts - a dose escalation part and an optional dose expansion part
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Head of Development Operations
- 전화번호: +4530660105
- 이메일: Gertrud.Rasmussen@epitopea.com
연구 연락처 백업
- 이름: Head of Oncology Development
- 전화번호: +4795113393
- 이메일: Siri.Torhaug@Epitopea.com
연구 장소
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Cambridge, 영국, CB2 0QQ
- 모병
- Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
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Edinburgh, 영국, EH4 2XR
- 아직 모집하지 않음
- The University of Edinburgh - Western General Hospital - Edinburgh Cancer Research Centre
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Glasgow, 영국, G12 0YN
- 모병
- Beatson West of Scotland Cancer Centre
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Leeds, 영국, LS9 7TF
- 모병
- St. James's University Hospital
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Leicester, 영국, LE2 7LX
- 모병
- University Hospitals of Leicester NHS Trust -Leicester Royal Infirmary
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London, 영국, SE1 9RT
- 아직 모집하지 않음
- Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
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London, 영국, SW3 6JJ
- 모병
- Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
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London, 영국, NW1 2PG
- 모병
- University College London Hospitals NHS Foundation Trust - Cancer Clinical Trials Unit
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Preston, 영국, PR2 9HT
- 모병
- Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
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Sutton, 영국, SM2 5PT
- 모병
- Royal Marsden NHS Foundation Trust - Institute of Cancer Research
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Able to comprehend and are willing to sign the ICF and willing to follow the study procedures
- Female, aged 18 years of age or older at the time of informed consent.
- Histologically confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma of high-grade serous histology or other high-grade predominantly serous subtypes
- The FIGO 2014 stage III or IV disease at initial diagnosis.
- Underwent optimal PDS or IDS with residual disease ≤1 cm (R0 or R1 resection)
- Completed first-line platinum-based chemotherapy (minimum 4 cycles of carboplatin and paclitaxel, or equivalent, received in either neoadjuvant or adjuvant, or both settings).
- In the presence of measurable target lesion, achieved CR or PR per investigator assessment based on RECIST 1.1 after completion of chemotherapy. In the absence of measurable target lesion, no new lesion or overt progression per investigator assessment based on RECIST 1.1 after completion of chemotherapy.
- A minimum of 4 weeks from screening since the last dose of first-line platinum-based chemotherapy but not more than 12 weeks from screening since the last dose of first-line platinum-based chemotherapy.
- No evidence of radiologic or clinical progression between the end of chemotherapy and baseline screening.
- Known BRCAwt status.
- HRP confirmed
- No prior, current, or planned treatment with bevacizumab or PARPi in the first-line maintenance setting.
- ECOG performance status of 0 or 1.
- Adequate haematologic and organ function
- Negative pregnancy test for WOCBP.
- HLA type matching Cryptivax-1001
Exclusion Criteria:
- Non-epithelial or low malignant potential ovarian tumours
- Presence of uncontrolled ascites or pleural effusion requiring drainage within 4 weeks of screening.
- Concurrent malignancy or history of another malignancy within the past 3 years except for malignancies with a negligible risk of metastasis or death
- Active autoimmune disease requiring systemic immunosuppression
- Uncontrolled intercurrent illness that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments
- History of anaphylactic reaction to mRNA-LNP therapies.
- Previous treatment with any cancer vaccine, checkpoint inhibitor, or adoptive cellular immunotherapy.
- Administration of any vaccine within 30 days prior to first dosing.
- Participation in a clinical study involving administration of an IMP (new chemical entity) in the past 90 days or 5 half-lives of that drug (if known) prior to first dosing, whichever is longer.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 복용량 수준 1
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i.m injection
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실험적: 복용량 수준 2
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i.m injection
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실험적: 복용량 수준 3
|
i.m injection
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실험적: 복용량 수준 4
|
i.m injection
|
|
실험적: 복용량 수준 5
|
i.m injection
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실험적: Recommended Dose
Recommended phase 2 dose or another safe dose, based on Dose Escalation part
|
i.m injection
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To evaluate the safety and tolerability of CryptiVax-1001
기간: Through study completion, an average of up 2 to years
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Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs) per Common Terminology Criteria for Adverse Events
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Through study completion, an average of up 2 to years
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To evaluate the safety and tolerability of CryptiVax-1001
기간: From Day 1 to Day 21
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Incidence and nature of dose-limiting toxicities (DLTs) during the DLT observation period
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From Day 1 to Day 21
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To evaluate the safety and tolerability of CryptiVax-1001
기간: Through study completion, an average of up to 2 years
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Clinically significant changes from baseline in vital signs (body temperature, pulse rate, respiratory rate, systolic and diastolic blood pressure)
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Through study completion, an average of up to 2 years
|
|
To evaluate the safety and tolerability of CryptiVax-1001
기간: Through study completion, and average of up to 2 years
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Clinically significant changes from baseline in clinical laboratory assessments (hematology and chemistry)
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Through study completion, and average of up to 2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To characterise the immunogenicity of Cryptivax-1001
기간: At pre-defined timepoints during treatment and Follow-up period, an average of up to 2 years
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Detection and quantification of antigen-specific T cells in peripheral blood at predefined timepoints
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At pre-defined timepoints during treatment and Follow-up period, an average of up to 2 years
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Susana Banerjee, MBBS MA FRCP PhD, Royal Marsden NHS Foundation Trust
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- OVCA-1
- UTN U1111-1332-3427 (기타 식별자: WHO)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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