Trial Title:
First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine
NCT ID:
NCT05104515
Condition:
Prostate Cancer
Non Small Cell Lung Cancer
Ovarian Cancer
Conditions: Official terms:
Lung Neoplasms
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
The first part (Phase 1a) comprises a first-in-human (FIH) multiple-dose,
sequential-cohort 3+3 design to establish a dose of OVM-200 that is safe and tolerable,
and that elicits an immune response in humans.
This dose will be taken forward into the second part (Phase 1b) of the study. Phase 1b
will further assess the safety and tolerability of the selected dose and investigate the
immune and tumour response in 3 expansion cohorts of additional patients with NSCLC,
ovarian cancer, and prostate cancer.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
OVM-200
Description:
The first part (Phase 1a) comprises a first-in-human (FIH) multiple-dose,
sequential-cohort 3+3 design to establish a dose of OVM-200 that is safe and tolerable,
and that elicits an immune response in humans.
This dose will be taken forward into the second part (Phase 1b) of the study. Phase 1b
will further assess the safety and tolerability of the selected dose and investigate the
immune and tumour response in 3 expansion cohorts of additional patients with NSCLC,
ovarian cancer, and prostate cancer.
Arm group label:
OVM-200
Summary:
OVM-200 will be tested in humans for the first time in Study OVM-200-100. Up to 52
patients aged 18-75 with prostate, lung or ovarian cancer will be enrolled in the Study
to find out if OVM-200 is safe to continue studying it in patients with cancer. The Study
consists of 2 parts: a dose escalation part and a dose expansion part. In the dose
escalation part, up to 4 increasing doses of OVM-200 will be evaluated in small groups of
cancer patients to find the recommended dose for the expansion part. The recommended dose
of OVM-200 will then be given to cancer patients in the dose expansion part to confirm
safety and understand how effective it is against their disease and if there are any side
effects.
Patients who agree to participate in the Study and pass screening will receive 3 doses of
OVM-200 in total at 2-week intervals as an injection under the skin. After completing
treatment with OVM-200 patients will be followed up for side effects and to monitor
changes in their cancer. Patients will stay on the Study for about 6 months in total
during which they will have 10 hospital visits. The Study will run at around 5 sites in
the UK.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Histologically confirmed metastatic or locally advanced inoperable NSCLC,
ovarian cancer, or prostate cancer that have already received at least 1 line
of approved cancer therapy and either: exhausted current recognized treatment
options; or are stable in a planned treatment-free interval following
completion of a set course of treatment; or in the case of prostate cancer, are
currently stable on an antihormonal treatment.
2. Are not receiving active cancer treatment other than supportive therapies or
androgen deprivation therapies for prostate cancer, which may be continued,
and, in the opinion of the investigator, are not anticipated to require further
approved cancer treatment options until the Week 8 assessment (up to 9 weeks)
after the first dose of OVM-200 per standard of care.
3. At least 1 measurable lesion that can be accurately assessed at baseline by
computed tomography (CT)/magnetic resonance imaging (MRI) and is suitable for
repeated assessment (NSCLC only).
4. Age ≥ 18 years and ≤ 75 years. 5. Eastern Cooperative Oncology Group (ECOG)
performance status ≤ 2 (Section 7.2.6).
6. Predicted life expectancy ≥ 3 months. 7. Adequate bone marrow, renal, and
hepatic function.
Exclusion Criteria:
1. Known history or evidence of significant immunodeficiency due to underlying illness.
Patients with a condition requiring systemic treatment with either corticosteroids
(> 10 mg daily prednisolone equivalent) or other immunosuppressive medications
within 14 days of the first dose of study drug. Inhaled or topical steroids and
adrenal replacement steroids are permitted in the absence of autoimmune disease.
2. Patients with a history of or active, known, or suspected autoimmune disease or a
syndrome that requires systemic or immunosuppressive agents. Patients with vitiligo,
type I diabetes mellitus, residual hypothyroidism due to autoimmune disease only
requiring hormone replacement, psoriasis not requiring systemic treatment, or
conditions not expected to recur in the absence of an external trigger are permitted
to enrol.
3. Prior therapy with an anticancer vaccine; anti-PD-1, anti-PD-L1, anti-PD-L2,
anti-CD137, or anti-CTLA-4 antibody; or any other antibody or drug specifically
targeting T-cell co-stimulation or immune checkpoint pathways in the 28 days before
the first dose of study drug.
4. Administration of an investigational drug in the 28 days or 6 half-lives (whichever
is longer) before the first dose of study drug.
5. Major surgery or treatment with any chemotherapy, or radiation therapy for cancer in
the 28 days before the first dose of study drug.
6. Active infection requiring antibiotics or physician monitoring, or recurrent fevers
(> 38.0°C) associated with a clinical diagnosis of active infection.
7. Active viral disease, positive test for hepatitis B virus using hepatitis B surface
antigen test, or positive test for hepatitis C virus (HCV) using HCV ribonucleic
acid or HCV antibody test indicating acute or chronic infection. Positive test for
human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome; testing is
not required in the absence of history.
8. Receipt of any vaccine within 28 days before the first dose of study drug.
9. Other prior malignancy within the previous 3 years, except for local or
organ-confined early stage cancer that has been definitively treated with curative
intent and does not require ongoing treatment, has no evidence of residual disease,
and has a negligible risk of recurrence and is therefore unlikely to interfere with
the primary and secondary endpoints of the study, including response rate and safety
and tolerability.
10. Symptomatic brain metastases or any leptomeningeal metastasis.
11. Any serious or uncontrolled medical disorder (including cardiovascular, respiratory,
renal, or autoimmune disease) that, in the opinion of the investigator or the
medical monitor, may increase the risk associated with study participation or study
drug administration, impair the ability of the patient to receive protocol therapy,
or interfere with the interpretation of study results.
12. History of allergic reaction or hypersensitivity to any component of the OVM-200
therapeutic vaccine or adjuvant.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University College London Hospitals NHS Foundation Trust
Address:
City:
London
Zip:
W1T 7HA
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Todd Rawlins
Investigator:
Last name:
Martin Forster, MBBS FRCP PhD
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Research Institute UK
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Rebecca Mills
Investigator:
Last name:
Anja Williams
Email:
Principal Investigator
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Tania Cutts
Investigator:
Last name:
Fiona Thistlethwaite, MB, BChir, PhD, MRCP
Email:
Principal Investigator
Facility:
Name:
Oxford University Hospitals NHS Foundation Trust
Address:
City:
Oxford
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
James Staddon
Investigator:
Last name:
Mark Tuthill
Email:
Principal Investigator
Start date:
November 1, 2021
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Oxford Vacmedix UK Ltd.
Agency class:
Industry
Source:
Oxford Vacmedix UK Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05104515
