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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OVM-200 | Experimental | 2 mg/mL OVM-200 solution. Proposed dose levels for Phase 1a: 250, 500, and 1000 μg. The planned doses may be adjusted based on SRC recommendations. Following review of the data, 1 additional dose level may be added up to a maximum of 2000 μg. The dose level for Phase 1b will be selected following review of the data from Phase 1a and will not exceed the dose safely administered in Phase 1a. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OVM-200 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint (safety and tolerability) for this study is the occurrence and intensity of adverse events. | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Immune response to OVM 200 as measured by ELISpot for T cell responses and ELISA for antibody responses. | 24 Weeks | |
| Disease progression and tumour response evaluated using Response Evaluation Criteria in Solid Tumour (RECIST) | 24 Weeks |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London Hospitals NHS Foundation Trust | Recruiting | London | London | W1T 7HA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41536940 | Derived | Wijaya W, Morris T, Forster MD, Flynn M, Tuthill M, Thistlethwaite F, Williams A, Finch W, Lu W, Jiang S. Survivin recombinant overlapping peptide (ROP) vaccine in advanced solid tumours: a first-in-human, multicentre, open-label, phase 1a dose-escalation study. EClinicalMedicine. 2025 Dec 27;91:103717. doi: 10.1016/j.eclinm.2025.103717. eCollection 2026 Jan. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
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|
| In ovarian cancer patients, tumour marker CA-125 measured and evaluated according to Gynecologic Cancer Intergroup Criteria (GCIC). | 24 Weeks |
| In prostate cancer patients, tumour markers prostate-specific antigen (PSA) and total alkaline phosphatase (ALP) as per PCWG3 response criteria. | 24 Weeks |
| Survivin expression will be correlated to response (based on immune response, tumour assessments, and tumour marker measurements) achieved after OVM-200 administration. | 24 Weeks |
| Sarah Cannon Research Institute UK | Recruiting | London | United Kingdom |
|
| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
|
| Oxford University Hospitals NHS Foundation Trust | Not yet recruiting | Oxford | United Kingdom |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D005833 | Genital Neoplasms, Female |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |